Patent Law Blog (Patently-O)

An Objective View of Fault in Patent Infringement

By Jason Rantanen

In GlobalTech v. SEB, the Supreme Court is addressing the question "[w]hether the legal standard for the state of mind element of a claim for actively inducing infringement under 35 U.S.C. § 271(b) is "deliberate indifference of a known risk" that an infringement may occur...or instead "purposeful, culpable expression and conduct" to encourage an infringement.”  Yet, as I suggested last month, perhaps framing the issue as an involving an inquiry into the subjective state of mind of an accused inducer isn't the best approach.  Instead, I propose that an analysis akin to civil recklessness - asking whether a high risk of infringement of a valid patent would have been obvious to a reasonable person in the accused party's position - is the better way to view the fault component of indirect infringement.  

That's the central argument of a draft article that I've prepared, and I'm interested in any feedback readers might have.  The abstract is provided below; the complete paper is available here. 

Unlike direct patent infringement (a strict liability claim), indirect and willful infringement require the patent holder to demonstrate fault on the part of the accused infringer. The conventional approach to the fault elements of these doctrines views them as involving a subjective inquiry into the accused party’s state of mind. Inducement of infringement, for example, requires that the alleged infringer possess mental culpability for it to be found liable. The question presented by the Supreme Court’s recent grant of certiorari in Global-Tech v. SEB is the quintessential illustration of this conventional view, asking whether the “state of mind” of the accused party is one of “deliberate indifference” or “purpose.” This mens rea-based approach to fault is likely the product of indirect infringement’s origins as an adaptation of the tort theory of aiding and abetting, an intentional tort.

This paper asserts that this conventional view of fault for indirect infringement is inherently flawed, and is largely nonsensical in the modern context in which indirect infringement is assessed. In large part this is because fault in patent infringement, unlike the tort tradition in which it was developed, involves assessment of particular legal – as opposed to factual – consequences, consequences that are both rarely certain and unlikely to ever be desired.

Rather than continuing to view the fault elements of these doctrines as if they were traditional intentional torts, this paper proposes that the law should instead apply an objective test more closely tailored to the specific context in which patent infringement arises. Specifically, it suggests that a better approach is to conceive of the fault element as requiring an objective inquiry into whether a high risk of patent infringement would have been obvious to another in the accused party’s position. In addition to providing a more accurate and usable articulation of the fault element, viewing the question in terms of risk enables finer tuning of the doctrine when seeking optimal deterrence effects. Furthermore, this change would parallel recent shifts in the approach to fault in the context of willful infringement, and would be consistent with the actual normative standard being applied by courts.

 

Supreme Court to Decide Microsoft Patent Case that Could Make it Easier to Invalidate Patents

By Dennis Crouch

Microsoft Corp. v. i4i Ltd. (Supreme Court 2010)

The Supreme Court has granted Microsoft's petition for a writ of certiorari and will consider whether patent law requires clear and convincing evidence of invalidity in order to invalidate an issued patent. Microsoft asks that the standard be lowered – at least for the situation where the evidence of invalidity was not considered by the patent office before the patent issued. The Supreme Court has not directly ruled on the issue. However, in KSR v. Teleflex, the Supreme Court did note that the "the rationale underlying the presumption — that the PTO, in its expertise, has approved the claim — seems much diminished" in cases where the patentee "fail[ed] to disclose" the key prior art to the PTO.

I expect that the court will agree that the statutory presumption of validity does not require a clear and convincing standard and that the standard should be lowered when a court is presented with evidence that is substantially different from that considered by the USPTO. Without explanation, Chief Justice Roberts has recused himself from this case – leaving eight justices to decide. At this point, I expect that all members of the court will agree that the standard should be lowered with some disagreement on the exact rule.

Clear and Convincing Evidence: Felony criminal cases require that prosecutors prove their case beyond a reasonable doubt. Most civil cases only require a preponderance of the evidence – often referred to as "more likely than not." Thus, in patent infringement cases, the patentee need only prove that it is more likely than not that the defendant infringed. However, the Federal Circuit has long required that invalidity defenses be proven with clear and convincing evidence. The clear and convincing standard is somewhere between a preponderance of the evidence and beyond a reasonable doubt and is sometimes referred to as "substantially more likely than not." Microsoft has not directly challenged the CAFC's rule of corroborative evidence that a single person's testimony is never sufficient to invalidate a patent.

i4i's case: In 2009, an Eastern District of Texas jury awarded $200 million + interest to i4i after finding that Microsoft willfully infringed the Canadian company's patent. Judge Davis subsequently added-on $40 million for willful infringement. The judge also issued an injunction ordering Microsoft to stop selling Word Products with the capability of using "custom XML." That injunction was stayed by the Federal Circuit pending appeal. On appeal, the Federal Circuit affirmed the lower court's findings of validity, willful infringement, enhanced damages, and permanent injunctive relief. In the meantime, the USPTO has concluded its reexamination of the i4i patent — confirming that the claims at issue are patentable. Microsoft filed a second reexamination request in August 2010 (shortly after it filed its petition to the Supreme Court). However, on November 24, 2010, the USPTO denied the request to begin a new reexamination – finding that the newly asserted prior art failed to raise a substantial new question of patentability (SNQ) as required by statute. Microsoft will likely appeal that denial. In addition, Microsoft apparently patched its software to prevent someone from using custom XML in Word in an effort to avoid the injunction and any further damages.

Microsoft has now moved-on to the Supreme Court — asking the high court to reject the "clear and convincing" evidence standard for proving a patent invalid. As Microsoft wrote in its petition for writ of certiorari, the question is "Whether the court of appeals erred in holding that Microsoft's invalidity defense must be proved by clear and convincing evidence" when the prior-art was not considered by the USPTO. This is essentially the same question that Microsoft raised in its 2008 petition in z4. That petition was withdrawn after the parties settled.

The Patent: i4i's asserted patent (U.S. Patent No. 5,787,449) covers a system for editing the metacodes of an HTML or XML document. The system uses a metacode map that is stored separately from the XML document and provides a menu of potential metacodes. The patent application was filed in 1994 and should remain in-force until 2015.

Microsoft's Invalidity Argument: Microsoft was not able to uncover any prior publication or patent that would invalidate the invention. However, the software giant argued at trial that i4i had sold an embodiment of the invention in the US more than one year prior to the 1994 patent application date. In particular, Microsoft argues that the invention was "embedded in a system called S4 - that the inventors of the ′449 Patent developed and sold to SEMI, a client of i4i's predecessor, over a year before applying for the ′449 Patent." That sale was not disclosed to the USPTO during the original prosecution and could not be presented during reexamination because reexaminations are limited to a review of prior art patents and publications. At the trial, the inventors (Vulpe and Owens) testified that the S4 system did not include a metacode map or separate the map from the marked-up document – two key features of their invention. Because the source-code for the 1993 custom software was no longer available, Microsoft primarily relied on testimony from a former i4i employee and upon written statements that Vulpe had made to investors and to the Canadian Government suggesting that the S4 software did separate metacode information.

The jury form asked "Did Microsoft prove by clear and convincing evidence that any of the listed claims of the '449 patent are invalid?" The jury answered "no." On appeal, the Federal Circuit held that the jury had sufficient evidence to rule that the patent was not anticipated by S4.

Importance of the Rule: A recent study conducted by Etan Chatlynne and published on Patently-O looked at all 119 Federal Circuit decisions on patent validity for the past several years. The study found that lowering the burden of proof would not have made any difference for 74% of those cases but might have made a difference in 26% of the cases. None of the decisions expressly stated that the result would be different if the standard had been reduced.

The clear and convincing standard probably has an important psychological impact in jury (and judicial) deliberations where the defendant's high burden for proving invalidity is contrasted with the plaintiff's lower burden for proving infringement.

Nuance Communications v. Abbyy Software

By Jason Rantanen

Cases involving foreign parties often raise complex procedural issues.  In this case, two of the defendants - a Russian corporation and a Cypriot corproration - argued that the district court lacked personal jurisdiction and that the plaintiff's attempts at service were insufficient.

Nuance Communications, Inc. v. Abbyy Software House (Fed. Cir. 2010)
Panel: Rader (author) Newman, Prost

In 2008, Nuance Communications sued Abbyy USA Software House, Abbyy Production, and Abbyy Software for patent infringement.  Abbyy Production, a corporation organized under the laws of the Russian Federation, and Abbyy Software, a Cypriot corporation, filed a motion to dismiss for lack of personal jurisdiction and improper service of process.  In a short order, the district court granted the motion and declined to consider Nuance's request for jurisdictional discovery by not addressing that issue.

On appeal, the Federal Circuit reversed the district court's ruling.  On the question of personal jurisdiction, the panel first noted that because this is a patent case, Federal Circuit precedent applies rather than that of the regional circuit.  The overarching analysis, however, focused on the traditional "minimum contacts" approach: "whether the defendant purposefully established 'minimum contacts' in the forum state."  Because the question in this case was one of specific jurisdiction, it thus required examining:

(1) whether the defendant purposefully directed activities at residents of the forum; (2) whether the claim arises out of or relates to those activities; and (3) whether assertion of personal jurisdiction is reasonable and fair.

Slip. Op. at 8.  Applying this test, the majority concluded that the district court had erred in dismissing Abbyy Production and Abbyy Software.  With respect to Abbyy Production, the appellate court noted that the defendant had engaged in a variety of activities directed at California, including its distribution of the allegedly infringing software to Abbyy USA, a California entity.  These activities also satisfied the second prong, as Nuance alleged in its Complaint that Abbyy Production's importation of the software into California infringed and induced infringement of the patents-in-suit.  The panel further found that the third prong was met, noting that even beyond the fact that Abbyy Production purposefully targeted activities at the forum state, it and Abbyy USA operated under a shared management team and were represented by the same counsel.

The panel declined to conduct a similar analysis for Abbyy Software, concluding that the extent of its involvement in sales of the accused product was uncertain on the facts before the court.  Consequently, the court remanded for additional jurisdictional discovery.

The Federal Circuit also reversed the dismissal based on improper service of process.  After a lengthy discussion of the applicability of Hague Convention procedures to service of process on corporations in the Russian Federation, the panel declined to opine on whether personal service on corporations was permissible in this case.  Rather, the court held that permitting substituted service under Federal Rule of Civil Procedure 4(f)(3) was called for here, and service on Abbyy USA would be sufficient to satisfy constitutional notions of due process for service on Abbyy Production. 

Note: The panel also reversed the district court's sua sponte dismissal of Abbyy Software for improper service of process, noting that the court lacked authority to do so because Abbyy Software had waived the objection.

Liability for Future Indirect Infringement

By Jason Rantanen

In an earlier post, I summarized the Federal Circuit's affirmance of a preliminary injunction prohibiting Apotex from marketing its generic version of AstraZeneca's budesonide in AstraZeneca LP v. Apotex, Inc. 

The majority's discussion of inducement of infringement in this case is particularly interesting because it deals with inducement of infringement in the context of future acts, as opposed to damages for past inducement - and when dealing with future infringement, it's unclear whether an intent element should apply to indirect infringement at all.

Apotex Had Specific Intent to Cause Infringement
In its opinion affirming the district court's preliminary finding of inducement, the Federal Circuit rejected Apotex's argument that it lacked specific intent to cause infringement, concluding that Apotex knew about potential infringement problems posed by its label but nevertheless decided to proceed nonetheless.  Similarly unpersuasive to the court was Apotex's argument that it lacked specific intent because the FDA required it to include the pivotal titration language.  The majority pointed out that Apotex had a variety of options besides proceeding in the face of a risk of an infringement suit, including waiting until the patents expire, challenging infringement and validity, and formally appealing the FDA's denial of Apotex's proposed labeling amendment.  Given these circumstances, the court concluded that Apotex had the necessary specific intent to cause inducement.

Is Intent to Cause Infringement Even Relevant When Dealing With the Future?
The court's ruling, however, could be supported in another way: by concluding that inducement with respect to future acts of infringement does not require the patentee to establish that the accused party posessed "specific intent" to infringe the patent.   This is because when dealing with the future, there will necessarily be a court finding that the relevant third party conduct infringes. Inherent in the court's determination is the conclusion that once-daily use of Apotex's product - the use that the court concluded would result from Apotex's label - infringes AstraZeneca's patents.   In other words, once the court made this determination, AstraZeneca conclusively knew¹ that patients taking its medication in a manner that it intended (i.e.: once daily) would infringe the method claims, and therefore continuing to engage in that conduct would satisfy the requrements of specific intent.  That Apotex may not want to infringe the patents is beside the point: its knowledge that the third party's conduct infringes, coupled with an intent to cause that conduct, is all that is required for this element of inducement, and for future acts those requirements would automatically be met. 

I'm not the first to identify this issue - Professor Timothy Holbrook made it few years back as well.  See Timothy Holbrook, The Intent Element of Induced Infringement, 22 SANTA CLARA COMPUTER & HIGH TECH. L.J. 399, 406 (2006).  Nevertheless, this is an instance where the argument that inducement of future infringement does not require the patent holder to prove specific intent to infringe could have been raised, and the parties apparently did not.

¹ Note that this case involved a preliminary injunction, and thus the court's findings were necessarily non-final.  Thus one could argue that Apotex did not "know" that the future conduct would infringe despite the district court's preliminary determination of infringement because it could be subject to later change.   However, as in many pharmaceutical patent cases, the lower court's determination was made following substantial briefing and argument (along with a five-day hearing), and its reasoning was affirmed on appeal.  Furthermore, even in the preliminary injunction context, the focus should not be on the question of what Apotex thought in the past about infringement, but rather whether it would be substantially certain that the third party conduct would infringe in the future - an analysis that collapses into the district court's determination on the question of infringement.

Missouri Law Review Patent Law Writing Competition: $5,000 Award

The Missouri Law Review announces a student writing competition in association with its annual Symposium to be held February 25, 2011, at the University of Missouri School of Law. Submissions should fit with the symposium topic of "The Patent Jurisprudence of the Court of Appeals for the Federal Circuit." The winner will be awarded a $5,000 cash prize.

Eligibility: Submissions should follow the format of a case note or law summary cited in Bluebook style and must be submitted by January 14, 2011, via email to umclawrev@missouri.edu with the subject line "Patent Law Writing Competition." The submission must be between 20 and 30 pages and have at least 125 footnotes. The submission should be unpublished, and the author must be willing to publish the work in the Missouri Law Review. The competition is limited to current law students studying in a U.S. J.D. program. Current members of the Missouri Law Review are excluded from participating. Send questions to the Missouri Law Review at umclawrev@missouri.edu.

Deadline: Friday, 1/14/2011

Award: $5,000

Cross-Border Inventors

The number of inventors per patent has been steadily increasing over the past forty years. Patents issued during the past six months, have an average of 2.7 inventors per patent. In all, 68% of these patents list multiple inventors with 13% listing five or more inventors. Prior to 1990, most patents listed only one inventor.

I wanted to look at cross-border or transnational inventing. To do that, I pulled-up all patents that listed inventors from two or more separate nations. For this, I used the inventor's country of residence that is typically supplied when a patent application is filed. Patents with a US inventor (US patents) had an 8% rate of including a cross-border inventor. For US patents, Germany was the most likely country of residence for collaborators. Of the top-10 patenting countries, Japan had the lowest rate of cross-border inventorship at 3% while 48% of Swiss patents listed a non-Swiss inventor. The table below provides more comparative values.

Inventor Country	Percent that Included Cross-Border Inventor	Most Likely Country of Co-Inventor
US	8%	Germany
Japan	3%	US
Germany	20%	US
Korea	4%	US
Taiwan	10%	China
Canada	26%	US
Great Britain	36%	US
France	26%	US
China	38%	US
Switzerland	48%	Germany
Italy	22%	US
Israel	23%	US
Netherlands	33%	US
Australia	19%	US

[Updated] Assignees with the most cross-border patents include IBM, Microsoft, Hong Fu Jin Precision Industry (Shenzhen), Intel, Cisco, GE, Schlumberger, Nokia, HP, ExxonMobile, Novartis, and Infineon. Several readers e-mailed and correctly noted that continental European cross-border co-inventorship should be expected because many Europeans cross a border for their jobs. Apparently, Novartis' main building is in Basel Switzerland, but is so close to the border that one Novartis parking lot is actually in France. University of California has a large number of US-China co-invented patents that likely arise from Chinese graduate students seeking their PhD in the US.

Note on the data: The table above includes a classification for "inventor country." The "inventor countries" of a patent include all countries that are designated as the country of residence for at least one of the inventors. Thus, a single patent may be classified as both a US patent and a German patent if there were inventors from each nation. The inventors submit their country of residence as part of the patent application process. The country of residence may be different from the nationality or correspondence address.

Note on spelling: I injured my shoulder this past week and will now be typing with one hand for a while.

 

Correlating Patent Term Adjustment with Patent Claim Count

The following graphs come from an analysis of patents issued over the past six months.

Final Draft of ACTA Released

By Jason Rantanen

Yesterday, the negotiating parties (which include the United States) released the final draft of the Anti-Counterfeiting Trade Agreement (ACTA), a document that purports to combat the proliferation of pirated and counterfeit goods.  The development of this Agreement has been subject to considerable controversy, in large part due to the secretive nature of its negotiation, which took place outside conventional International IP bodies such as TRIPS and WIPO.  The Electronic Frontier Foundation, for example, has written extensively about the subject, as has Michael Geist. 

In its final state, ACTA relates primarily to copyright and trademark infringement, and expressly disclaims application to patent law in several sections.  Nevertheless, everyone interested in intellectual property law issues should give it a read (and at only 24 pages long it's a surprisingly concise document), as within the area of trademark and copyright infringement the scope of ACTA is very broad: despite its characterization as a "Trade Agreement," it covers the enforcement of IP rights in the domestic civil, criminal, and digital spheres in addition to providing for border control measures, 

Although ACTA generally tracks existing U.S. law on copyright and trademark infringement, the Agreement has a clear pro-rights holder slant.  For instance, provisions on discovery discuss only the rights of the party asserting the infringement claim, and do not require similar rights on the part of the alleged infringer.  Readers may also want to pay particular attention to the criminal provisions - which seem on their surface to make any commercial willful trademark or copyright infringement subject to criminal penalties.

Given that this document likely will be scrutinized by scholars and practitioners concerned about the implications of strong copyright and digital property rights, I'll identify just a few specific drafting issues that leaped out at me.

• "Trademark counterfeiting" and "copyright piracy" are broadly defined, and seem to include any form of trademark or copyright infringement.  In other words, these terms could be readily replaced with "trademark infringement" and "copyright infringement" wherever they appear in the document.  That said, the trademark counterfeiting language is somewhat ambiguous, and could plausibly be read to only apply to instances where the mark "cannot be distinguished in its essential aspects" from the registered trademark.
• Another issue is the sudden appearance of "copyright or related right," which is first used in Chapter Two, Article 2.2(1).  Perhaps this is an artifact from earlier drafts, but I didn't see any definition of these "related rights."
• The procedures for civil enforcement of IP rights largely appear to parallel U.S. law.  However, the damages provisions strongly favor rights holders, perhaps more so than current domestic copyright and trademark law. 
• Similarly, to the extent the sections on litigation discovery procedures expand parties' rights and obligations, they may create a disjunction with current law.
• In the context of border measures, the terms "goods of a commercial nature" and "goods of a non-commercial nature" are left undefined.  On the surface, it seems like nearly every good hs a commercial nature, but perhaps I'm just picking at nits with this one.
• Likewise, the term "acts carried out on a commercial scale," used in the context of the section on criminal penalties, seems equally broad, especially given that it includes "at least those carried out as commercial activities for direct or indirect economic or commercial advantage."
• The pro-rights holder forum and education campaign requirements seem quite one-sided, especially for such a sensitive subject.  Chapter Three, Articles 3.1(4) and 3.4 are particularly strong in their requirement that governments present a pro-IP rights holder message.

The full text of the proposed version of ACTA is available here:  Download Finalized ACTA text.  In addition to substantive issues, some organizations have raised concerns about the potential approval of ACTA via Executive Agreement, as opposed to ratification by the Senate.  If the former approach is indeed used, it will likely have profound legal implications that courts, practitioners and scholars will need to address.

Update: As one commenter pointed out, Terry Hart's blog Copyhype has a detailed point-by-point comparison of many ACTA provisions to the relevant U.S. law.  Mr. Hart also responds to some of the negotiation transparency criticisms that various organizations have raised. 

Guest Post: Copyrights, Patents, and International Exhaustion

By Professor Ryan Vacca

Last week, the Supreme Court heard oral arguments in Costco Wholesale Corporation v. Omega, S.A., to determine whether copyrighted works first sold in Switzerland and then imported into the U.S. infringed the copyright owner's right of distribution or whether the first sale doctrine (aka the exhaustion doctrine) applied to make the importation non-infringing.

The facts are fairly straightforward.  Omega is a watch company that manufactures watches in Switzerland.  Omega owns a copyright in a small visual image that is laser-engraved onto each Swiss-manufactured watch.  Costco, a U.S. warehouse retailer, acquired genuine Omega watches from a third party, who had purchased them from an authorized Omega distributor abroad.  Costco subsequently sold these watches in the United States.  Omega alleged that Costco's sale of these watches infringed its exclusive right to distribute copies of its copyrighted work under § 106(3) of the Copyright Act because § 602(a)(1) provides that:

Importation into the United States, without the authority of the owner of the copyright under this title, of copies … of a work that have been acquired outside the United States is an infringement of the exclusive right to distribute copies … under section 106.

Costco argued that its sales in the U.S. were non-infringing under the exhaustion doctrine codified in § 109, which provides:

Notwithstanding the provisions of section 106(3), the owner of a particular copy … lawfully made under this title, or any person authorized by such owner, is entitled, without the authority of the copyright owner, to sell or otherwise dispose of the possession of that copy.

As I blogged earlier and others have discussed here and here, the Court is wrestling with what the phrase "lawfully made under this title" means in § 109 of the Copyright Act.

Costco argues that goods manufactured abroad can still fall within this phrase whereas Omega argues that goods manufactured abroad are not "made under this title" unless the goods are made or sold with permission from the copyright owner to import the goods into the United States. At oral argument, the Justices quickly pointed out the difficulties in these two interpretations on both a textual and policy level.

In contrast to the formidable task before the Court in the copyright context, patent law takes a relatively easier approach to the international exhaustion issue. The seminal Supreme Court case on international exhaustion under patent law is Boesch v. Graff, 133 U.S. 697 (1890). In Boesch, the plaintiffs held a U.S. patent and German patent for an improvement to lamp burners. The defendants purchased burners in Germany from Mr. Hecht, who was authorized to make these burners in Germany because of Germany's prior user defense (Hecht was not authorized by the patentees). When the defendants imported these burners into the U.S., the patentees sued for infringement. The defendants argued that their legal purchase in Germany from Mr. Hecht permitted them to import and sell them in the United States. The Court disagreed and held that although Mr. Hecht had a right to make and sell the burners in Germany under German patent law, this had no effect on the U.S. patentee's ability to enforce its U.S. patent in the United States.

Over a century later, the issue of international patent exhaustion arose again in Jazz Photo v. ITC, 264 F.3d 1094 (Fed. Cir. 2001) and Fuji Photo Film v. Jazz Photo, 394 F.3d 1368 (2005), where the Federal Circuit reaffirmed the Supreme Court's holding in Boesch and clarified that the exhaustion doctrine would not apply even if the U.S. patentee or its licensees authorized the first sale abroad. In other words, even if the U.S. patentee permitted the first sale in a foreign country, a subsequent attempt to import such an item into the U.S. would still constitute infringement. In support of its holding, the Federal Circuit noted that the U.S. patentee's "foreign sales can never occur under a United States patent because the United States patent system does not provide for extraterritorial effect."

Based on the dialogue between the Justices and the attorneys in Costco, it appears that the Court may be uncomfortable limiting the exhaustion doctrine in the copyright context solely to situations where the first sale took place within the United States. They seem to be struggling to articulate a standard that allows some foreign sales to take advantage of the exhaustion doctrine while giving the phrase "lawfully made under this title" some meaning.

If, in the end, the rule announced by the Court in Costco differs from the holdings in Boesch and Jazz Photo, then what effect may this have on the future of patent law's exhaustion doctrine? Of course, the Court could maintain a dual approach, where copyright exhaustion and patent exhaustion are treated differently. However, if presented with an international patent exhaustion case, the Court could rely on its Costco holding and try to align the copyright and patent rules. We have seen the Court take this approach recently in MGM Studios v. Grokster, 545 U.S. 913 (2005), when it created a new theory of secondary liability in copyright law (the inducement theory) by relying, in large part, on patent law's recognition of this theory via statute in § 271(a) of the Patent Act.

Another possibility for harmonization of copyright and patent law is that the Court takes its cue from patent law and hold that exhaustion in the copyright context only applies when the copyrighted works were first sold or otherwise distributed in the United States. If this disrupts the policy concerns underlying the exhaustion doctrine, then Congress can always step in to resolve this issue.

How Effective are Pre-Appeal Brief Conferences?

As part of its appeal rules package, the USPTO has released further information on the role of pre-appeal brief conferences in the prosecution process. As its name suggests, the pre-appeal brief conference program involves a meeting that occurs before an applicant files the formal appeal brief. The "conference" is an internal meeting between examiners and does not actually include the patent applicant or its representative. Rather, the applicant submits a short (5-page) memo that is reviewed at the conference. The program was introduced in FY2005 as a mechanism for helping to avoid unnecessary appeals.

The table below shows that the number of pre-appeal brief conference requests has been steadily rising since being introduced. The results have stayed relatively steady. During the five-year reported period. 56% of the pre-appeal brief conferences resulted in a decision by the conference members that the examiner's rejection was proper and that the case should proceed to the BPAI. 38% of the conferences resulted in the examiner withdrawing one or more rejections and then re-opening prosecution. 4% of the conferences resulted in a decision that all claims were patentable. And, 2% of the conferences rejected the pre-appeal brief conference request as defective.

FY	Number of Pre-Appeal Brief Conference Requests	Percent of Appeals	Proceed to Board	Reopen Prosecution	Withdraw Rejections	Defective Request
2006	6,525	24%	55%	37%	5%	3%
2007	7,240	25%	56%	38%	4%	2%
2008	8,255	27%	59%	37%	2%	2%
2009	9,967	30%	56%	39%	3%	2%
2010	12,019	34%	56%	38%	5%	1%

Prior to the pre-appeal brief conference program, a majority of appeals cases never reached the Board because the rejections were withdrawn after the applicant filed its formal brief. The pre-appeal brief conference program appears to have shifted that decisionmaking process forward. Now, examiners are much less likely than before to withdraw their rejections after an applicant files its formal appeal brief. That decision is made at a separate conference termed the appeal brief conference. In FY2010, the appeal brief conference resulted in a decision to file an examiner answer in 59% of cases. That is up from 39% in FY2005. Thus, the pre-appeal brief conference program does not seem to actually reduce patent examiner workload. However, it does help speed prosecution and allows a substantial number of applicants to avoid filing the formal appeal brief.

In an e-mail, Foley partner Stephen Maebius focused on the relative rates of re-opening prosecution. Pre-appeal brief conferences are relatively more likely to determine that prosecution should be re-opened (and presumably a new rejection issued). As compared with the pre-appeal brief conference results, appeal brief conferences are much more likely to determine that all rejections should be withdrawn. Maebius writes that "re-opening prosecution may increase the chance of lengthening a patent term adjustment, depending on the dates associated with earlier periods of the prosecution history. This may be an advantage where immediate issuance is not an objective and patent life is more valuable at the end of the patent term as in the case of pharmaceuticals. . . . On the other hand . . . filing a full appeal may be a better strategy when gaining immediate allowance is the objective."

PDF of Rules with Data: http://edocket.access.gpo.gov/2010/pdf/2010-28493.pdf

Untouchable: Sham Reexamination Requests

Lockwood v. SHEPPARD MULLIN (Fed. Cir. 2010) (nonprecedential)

Last week, I wrote about the Lockwood case involving allegations that Sheppard Mullin should be held liable for filing a sham reexamination request.  The district court had dismissed Lockwood's complaint — holding that there could be no federal cause of action for filing a sham reexamination request because, inter alia, that area is preempted by Federal Patent Laws. 

The Federal Circuit (Judges Newman, Plager, and Prost) has now decided the appeal — affirming the district court decision without opinion. (Rule 36).  Federal Circuit Rule 36 indicate that a panel may “enter a judgment of affirmance without opinion . . . [if] an opinion would have no precedential value.”  Here, the Rule 36 opinion is surprising given the lack of precedent on this topic, the obvious third-party interest in the outcome of the case, and the dramatic rise in the use of reexaminations over the past decade.

In the appeal, briefs amici were filed by the TPL Group (arguing that “nothing in the reexamination law … indicates that Congress intended to prevent patent holders from [pursuing a state law claim of unlawful business conduct] when a baseless request for reexamination is filed for the purpose of harming a competitor); Professor Hricik (arguing that liability should be available); NDP Managed Security (arguing that the suit is not barred by California law); and O'Melveny & Myers (arguing that the reexamination statute preempts a court action for sham filing of a reexamination).  Raymond Mercado (who previously worked for Lockwood) has written an academic article explaining his findings of extensive “reexamination abuse” by third-party requesters.  Mercado argues that patentee's subject to sham reexamination requests should certainly be able to bring an action under the common law tort of malicious prosecution. In addition, Mercado argues for a new federal cause of action.

This case opens the door to some amount of bad-behaviour in the filing of reexamination requests.  Patent attorneys who file sham-requests  can be sanctioned through the USPTO's Office of Enrollment & Discipline. However, an anonymous third party requester may be untouchable.

–  Dennis 

USPTO Proposes New Rules Intended to Streamline Appeals to the BPAI

In recent years, the Board of Patent Appeals and Interferences (BPAI or Board) has seen a tremendous influx in the number of appeals being filed and a growing backlog of cases to be decided.  In response, the Office is struggling for ways to streamline the appeal process without sacrificing decision quality.

The USPTO has now issued a new set of proposed rules for proceedings in Ex Parte Appeals before the Board.  This new set of rules is a major complete revision of the BPAI rules that had been proposed in 2008 and should be seen as operating in parallel to ongoing changes-in-practice at the BPAI announced earlier in 2010.

Comments on the proposed rules should be submitted to BPAI.Rules@uspto.gov by January 14, 2011.

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Particular proposed rule changes include:

• The Board will take jurisdiction over appeals as soon as the reply brief is filed, and examiners would no longer have an opportunity to respond to a reply brief.
• Once it takes jurisdiction, a procedural remand of the case would require Director's approval.
• The Board will presume that all pending claims under rejection are being appealed.
• The Rules will no longer require certain statements that simply reiterate information already of record. (e.g., claims appendix and statement on the grounds for rejection).
• An examiner's answer that includes a rejection based on new evidence will be designated as a new ground of rejection, and applicants will be allowed to delay the appeal in order to await a decision on a petition seeking review of an examiner's failure to designate a rejection in the answer as a new ground of rejection prior to filing a reply brief.

File Attachment: 2010.Appeal.Rules.Proposed.pdf (176 KB).

En Banc Federal Circuit Arguments in TheraSense and TiVo: Update

By Jason Rantanen

Update: Binal Patel from Banner & Witcoff was kind enough to provide Patently-O with a transcript that the firm prepared of the TheraSense oral argument.  It can be obtained here: Download Therasense v Becton - transcription

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Today the en banc Federal Circuit heard arguments in TheraSense v. BD and Bayer (Inequitable Conduct) and TiVo v. Echostar (post-injunction infringement proceedings).  Audio of both arguments is now available via the Federal Circuit's website, and Bruce Wexler of Paul Hastings has written a summary of the TheraSense argument.

Discussion: Patent Prosecution Rates

A Patently-O Reader e-mailed with the hope of starting a discussion on the topic of patent attorney and agent fees for patent prosecution. 

He writes “large clients have … pushed down their rates, some in 2009 and some in 2010. In at least two cases, these are clients flush with incredible amounts of cash. Thus, this is not a problem of client-liquidity.” His clients have created rules that would block both a partner and an associate from billing on the same response. “To some clients, this appears to be two attorneys doing work that can be finished by a single attorney.” In addition, his clients are “unwilling to allow their prosecution to be used as a type of training exercise. They want the work done quickly, at the lowest cost. Being part of a training exercise does not achieve this purpose.”  In the background is the reality that there are “many unemployed or underemployed patent attorneys willing to do this work and do it effectively, at [under 2007] rates.”

Statutory Bar Prior Art in the Nonobviousness Analysis

I am continually troubled with disconnects between the text of 35 U.S.C. § 103(a) and its application by the courts. 

Section 103(a) defines the doctrine of nonobviousness and reads (in part) as follows:

(a) A patent may not be obtained . . . if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. . . .

A plain reading of the statute that considers the obviousness of an invention “at the time the invention was made.”  In its 1965 Foster decision, the Court of Customs and Patent Appeals (CCPA) made clear that “the existence of unobviousness under that section, as a necessary prerequisite to patentability, we reiterate, must be determined as of 'the time the invention was made' without utilizing after-acquired knowledge.”  343 F.2d 980 (CCPA 1965).

Despite that seeming clarity, in its obviousness analyses, the Foster Court (and subsequently, the CAFC) has given full 103(a) consideration to post-invention activities that qualify as prior art under Section 102(b).  The justification for this interpretation appears to come in the form of an estoppel that blocks inventors who “sleep on [their] rights more than a year after the invention has become entirely obvious to the public.”  Foster indicated that any other interpretation of the statute would be an interpretation that “Congress could not possibly have intended in view of its express indication that section 102(b) is merely a continuation of the prior law.” 

The leading opinion on-point is likely In re Corcoran, 640 F.2d 1331 (CCPA 1981) which was written by Judge Rich.  In that decision, the court held that the application of 102(b) prior art in 103(a) rejections “finds its statutory base in both of those sections.”  See also Lough v. Brunswick Corp., 86 F.3d 1113, 1121 n.5 (Fed. Cir. 1996); Baker Oil Tools v. Geo Vann, Inc., 828 F.2d 1558, 156 (Fed. Cir. 1987) (what was offered for sale before the critical date becomes a "reference under section 103 against the claimed invention").

Although the weight of precedent is on the side of the current rule, the current statutory-language-focused Supreme Court just might have a point of view.  Let me know if you get a test-case going.

See also, Rethinking the Scope of Prior Art in Obviousness Cases.

Patently-O Bits and Bytes

• Nineteen new jobs have been posted to the Patently-O Job board in the past two weeks, including positions at MedImmune; Medtronic; Apple; the USPTO; Ventana Medical Systems; L’Oréal; Frost Brown Todd; Wenderoth, Lind & Ponack; Morgan Lewis; Michaud-Kinney; Marjama Muldoon; Roberts Mlotkowski Safran & Cole; Infinity Pharmaceuticals; HP; Gen-Probe; and a Telecom Software Startup in Silicon Valley.
• This weekend, I watched the Facebook movie “The Social Network.”  IP Law 360 is reporting that Quinn Emanuel should receive its $13 million in fees based on the $65 million settlement that Facebook reached with Tyler and Cameron Winklevoss and Divya Narendra.  The trio is challenging some elements of the settlement and had argued that Quinn's fees should be delayed until their dispute with facebook is fully resolved.
• In other Facebook news, the company has sued several companies for infringing its patents. The lawsuit is a retaliatory action against companies that previously sued Facebook for infringement.

Sham Reexamination Requests and Federal Preemption

Lockwood v. Sheppard Mullin (Fed. Cir. 2010)

This is an interesting case that is pending before the Federal Circuit. The focus of the appeal is whether a patentee has any cause of action for a third-party's baseless filing of a reexamination request. The patent laws themselves offer no remedy so Lockwood turned to California State Court – alleging that the Sheppard Mullin law firm should be held liable for Malicious Prosecution, Interference, and Fraud by filing their reexamination request. Lockwood argues that "[Sheppard Mullin lawyers] chose to violate the strict duty of candor required before the USPTO by making deceptive misrepresentations about the nature of purported 'prior art' in two Requests for Reexamination. Respondents filed the Requests to gain a tactical advantage during infringement litigation, in furtherance of their stated aim of putting Lockwood 'out of business,' and without any reasonable basis in patent law."

The District Court granted a 12(b)(6) motion to dismiss – holding that the Federal Patent Laws and administrative structure of the USPTO preempted any cause of action in court against a sham reexamination request filed by a third party. Several law professors are involved with the litigation. Professor Jay Thomas (Georgetown) testified on behalf of Lockwood (stating that the PTO is "an agency in crisis" whose examiners are "overworked, overextended, undertrained, and underpaid"), and Professor David Hricik (Mercer) led a group of law professors who filed an amicus brief supporting Lockwood's position.

The leading Supreme Court case on the merits is Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). In that case, the Court held that Buckman's state-law claim for fraud on the FDA was preempted by the Food Drug & Cosmetics Act because the "federal statutory scheme amply empowers the FDA to punish and deter fraud against the Agency, and that this authority is used by the Agency to achieve a somewhat delicate balance of statutory objectives." The FDA holds and actually asserts relatively greater power than the USPTO with respect to fraud on the office. As Professor Hricik writes, "since 1992, the Patent Office has not investigated inequitable conduct, and … cannot award civil damages or recover damages caused to the Office by frivolous filings."

Off the Cuff: One aspect of the law that is unclear to me is how this case differs from the ordinary prosecution malpractice situation. If the USPTO administrative and disciplinary structure preempts a civil action for patent attorney bad-behavior in reexamination filings, it seems that it would also preempt a civil against by a former client against an attorney broke USPTO ethical rules and injured his client. What is the difference?

Update: Raymond Mercodo forwarded a copy of his academic article: The Use and Abuse of Patent Reexamination: Sham Petitioning Before the USPTO.

Cancer Research Technology v. Barr Laboratories: Prosecution Laches and Inequitable Conduct

By Jason Rantanen

Cancer Research Technology Ltd. v. Barr Laboratories, Inc. (Fed. Cir. 2010)
Panel: Newman, Lourie (author), Prost (dissenting)

Although overshadowed by the en banc Federal Circuit arguments in TheraSense v. Becton Dickinson this morning, Cancer Research Technology v. Barr Laboratories may provide a preview of what the opinions in TheraSense could look like - although it doesn't necessarily indicate which view of inequitable conduct will ultimately prevail.  In Cancer Research, Judges Lourie and Newman reversed a district court finding of prosecution laches and inequitable conduct, while dissenting Judge Prost would have reached the opposite result.

The patent at issue (the '291 patent) involved a set of thirteen tetrazine derivatives that the original 1982 specification identified as possessing anticancer activities based on animal studies.  During the first nine years of prosecution, the examiner repeatedly rejected the claims due to lack of utility; rather than file a response to the office actions, the applicant instead filed continuation after continuation.  In 1991, Cancer Research obtained ownership of the patent application and shortly thereafter responded to the examiner's arguments.  The patent issued in 1993 and expires in 2014. 

Following Cancer Research's clinical testing, the FDA approved one of the compounds covered by the '291 patent (marketed as TEMODAR) for the treatment of one type of cancer in 1999 and a second in 2005.  In 2007, Barr Laboratories filed an Abbreviated New Drug Application ("ANDA") for a generic form of TEMODAR.  Cancer Research sued Barr for infringement four months later.  During the district court proceedings, the parties stipulated to validity and infringement and, after a bench trial, the court found that the patent was unenforceable due to prosecution laches and inequitable conduct. 

Prosecution Laches
Given the nearly ten-year delay before any meaningful response to the examiner's rejection was filed, Barr contended that the patent was unenforceable due to prosecution laches.  The district agreed, concluding that the delay in prosecution was unreasonable and unexplained.

On appeal, the majority reversed the finding of prosecution laches, holding that the doctrine requires not just unreasonable delay, but also a showing of prejudice.  The majority further held that "to establish prejudice, an accused infringer must show evidence of intervening rights, i.e., that either the accused infringer or others invested in, worked on, or used the claimed technology during the period of delay."  (Slip Op. at 9).  Here, there was no evidence of intervening rights during the prosecution period, such as evidence showing that someone other than the patent holder attempted to develop the claimed compounds.  Even Barr itself waited until 2007 - four years later than required - before filing its ANDA.  The majority also noted that there was no public harm: in the absence of the patent, Cancer Research likely would not have been incentivized to develop TEMODAR at all. 

Writing in dissent, Judge Prost rejected the notion that prosecution laches requires prejudice, let alone intervening rights; rather, under her reading of the precedent such a requirement is not part of the laches determination.  Furthermore, in her opinion, both Barr and the public were harmed by Barr's inability to market a generic version of TEMODOR.

Comment: I'm unconvinced by Judge Prost's argument on this point.  If she is correct, then the '291 patent was never enforceable - be it in 2007, when Barr filed its ANDA, or 1993, when it issued.  Yet without an enforceable patent, Cancer Research would never have developed TEMODOR, let alone engaged in the expensive Phase III clinical studies necessary to demonstrate its safety and efficacy.  Thus, the "harm" to the public would been greater in the absence of the '291 patent, not less.

Inequitable Conduct
The majority also rejected the district court's finding of inequitable conduct, while the dissent reached the opposite conclusion.  Both opinions focused on the subject of intent to deceive. 

The inequitable conduct issue in this case revolved around an extensive series of articles by an inventor on the '291 patent that presented data from post-application clinical trials of the claimed compounds.  These articles included conclusions indicating that some of the claimed compounds demonstrated high toxicity and low anticancer activity, which the district court found to be highly material to the patent claims because it directly contradicted statements in the '291 patent regarding the compounds' utility in treating cancers, as well as the patentability of a broadly written claim.

The majority, following the "intent cannot be inferred from materiality" line of thought, concluded that the district court's only basis for finding intent was its determination that the withheld articles were highly material.  "Because the district court did not rely on any other evidence to support its finding of deceptive intent beyond that used to find the withheld data material, the court in effect relied solely on its materiality finding to infer intent to deceive."  Slip Op. at 17.  The majority also concluded that the inference of deceptive drawn by the district court about the inventor's publication of data was not the only reasonable inference; rather, the broad publication of this data in multiple articles is inconsistent with an inference of intent to deceive.  Thus, an equally reasonable inference is that the inventor did not appreciate the potential importance of the published data to the patentability of the patent claims.

Judge Prost, again writing in dissent, would have affirmed the district court's determinations.  In contrast to the majority, which required independent evidence of intent, her view of inequitable conduct is that it does not require separate evidentiary bases for materiality and intent; rather it is appropriate to cite to the same evidence for materiality and intent.  Furthermore, here there was additional evidence of intent in the form of the district court's credibility findings, "which are virtually unreviewable by this court."  Thus, under her approach to intent in inequitable conduct, "[w]e should not draw inference that the district court has already excluded based on its own credibility findings."

Comment: The majority and dissent's views on intent can be partially reconciled under the position that, although an intent to deceive may be partially based on evidence of materiality, materiality cannot be the sole basis for the finding of intent to deceive.  Here, in the majority's opinion, the finding of materiality was the sole basis for the intent to deceive determination, because the only additional factor - the credibility determination - was based on an erroneous inference.  On the other hand, in the dissent's view credibility determinations are unreviewable and are sufficient to provide the "beyond the materiality" support for an intent to deceive finding.

Hyatt v. Kappos: Federal Circuit Opens Door to Post-BPAI Civil Actions

By Dennis Crouch

Hyatt v. Kappos (Fed. Cir. 2010) (en banc)

Summary: In a 6-2-1 en banc decision, the Federal Circuit has reversed its prior precedent and held that a patent applicant must be allowed to introduce new evidence in a Section 145 civil action filed to challenge a USPTO refusal to grant patent rights and that the issues implicated by the new facts must be considered de novo.

[W]e hold that the only limitations on the admissibility of evidence applicable to a § 145 proceeding are the limitations imposed by the Federal Rules of Evidence and Federal Rules of Civil Procedure. Therefore, we hold that the district court applied the wrong legal standard for the admissibility of evidence in a § 145 proceeding and abused its discretion when it excluded Mr. Hyatt's declaration. . . .

The particular significance of a § 145 civil action is that it affords an applicant the opportunity to introduce new evidence after the close of the administra-tive proceedings—and once an applicant introduces new evidence on an issue, the district court reviews that issue de novo.

However, the Court also wrote that an applicant may still be barred from presenting new "issues" in the civil action and that, when no new evidence is presented, that BPAI findings and rulings should be given deference under the Administrative Procedures Act.

Impact: This decision could be seen as relieving some pressure on applicants to ensure that their cases for patentability are exhaustively presented to the USPTO's internal Board of Patent Appeals and Interferences (BPAI). The decision is especially important in light of the growing role of BPAI appeals in the ordinary course of patent prosecution. In its argument, the USPTO suggests that a strategic applicant may now choose hold-back some evidence from the BPAI appeal in order to overcome the APA deference if the case goes to the District Court.

Statute in Question: 35 U.S.C. § 145 creates a right to a "civil action" in Federal District Court against the USPTO Director whenever an applicant is "dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a)." In the alternative, an applicant may appeal directly to the Court of Appeals for the Federal Circuit.

Background: Gil Hyatt is a well-known inventor and successful patentee. Hyatt filed a civil action in 2003 after the BPAI sustained written description and enablement rejections for seventy-nine of Hyatt's claims. The examiner had issued "2546 separate rejections of Mr. Hyatt's 117 claims" based on the doctrines of inadequate "written description, lack of enablement, double patenting, anticipation, and obviousness." The Board reversed all of the examiner rejections except for the § 112 p1 arguments. Complicating this case is the fact that the application's claimed priority date is 1975. Hyatt has aggressively pushed the bounds of USPTO practice. This decision is one of more than a dozen Federal Circuit decisions focusing on Hyatt's patent rights. When California pursued Hyatt for tax revenue for his patent licenses, Hyatt took the case to the Supreme Court and eventually won a $388 million judgment against the state of California for invasion of privacy.

After the Board affirmed a set of written description and enablement rejections, Hyatt filed a Section 145 civil action and included a declaration offering new evidence of enablement and written description. The district court excluded that inventor-declaration from evidence based on Hyatt's "negligence" in failing to previously submit the information to the PTO. In a 2009 panel decision, the Federal Circuit held that the district court had properly excluded the new evidence – holding that the district court may properly exclude evidence that Hyatt should have produced to the PTO. That opinion was penned by former Chief Judge Michel and Joined by Judge Dyk. Judge Moore wrote a vigorous dissent that supported a patent applicant's right to a full civil action including the right to submit additional evidence when challenging a PTO decision.

Judge Moore wrote the en banc decision that was joined by Chief Judge Rader and Judges Lourie, Bryson, Linn, and Prost. Judge Dyk dissented and was joined by Judge Gajarsa. Judge Newman Concurred-in-Part – arguing that the civil action should not give deference to PTO factual determinations.

A key to the majority decision is the notion that a Section 145 civil action is not an appeal, but rather a new, separate lawsuit filed to force the PTO to act. In its analysis, the court began with a focus on the 150-year history of the civil action right (and its predecessor Bill in Equity) and the reality that new evidence has always a part of those remedies. See, e.g., Gandy v. Marble, 122 U.S. 432 (1887) (explaining that the [predecessor] § 4915 suit in equity was "not a technical appeal from the Patent Office, nor confined to the case as made in the record on that office"). The court then reviewed the current text of the statute, implications of the APA, and various policy arguments before reaching its conclusions.

In a 37-page dissent, Judge Dyk argued that the majority made an improper leap from (1) the correct premise that new evidence should be admissible in the civil action to (2) the incorrect conclusion that the law provides no meaningful limits on the introduction of new evidence regardless of what was presented at the BPAI.

Notes:

• Michael Barclay's Discussion of the case
• Oral Arguments
• Appellate specialist Aaron Panner argued the case on behalf of Hyatt. The USPTO's case was argued by Beth Brinkman of the DOJ. In the original panel, the late Ken Bass has argued for Hyatt and Bill Jenks for the Government. Michael L. Martinez represented Hyatt in the civil action.

UPDATE: Investigating Patent Law’s Presumption of Validity

By Etan S. Chatlynne

Last year, I investigated the role that the presumption of validity, and the evidentiary standard for rebutting it, played in validity challenges adjudged at the Federal Circuit. In March 2010, Professor Crouch graciously published the study's results in the Patently-O Patent Law Journal. [Link]. In response to Microsoft's petition for certiorari challenging the Federal Circuit's hard-line application of a clear and convincing standard, please find updated statistics below that include Federal Circuit decisions through October 2010. To learn the methodology for collecting the data, and to read my understanding of what they suggest (and do not suggest), please refer to the original publication. A spreadsheet of the updated data is available. [Link].

At least eighty-eight of the one hundred nineteen (74%) patent challenges analyzed were evidentiary-standard independent. Of these determinations, forty-one (47%) were based on a granted motion for summary judgment, six (7%) were based on a granted motion for JMOL, twenty-four (27%) resulted from a jury trial, and seventeen (19%) resulted from a bench trial. Twenty-one (24%) determinations were reversals and seventy (80%) resulted in invalidation. The Federal Circuit mentioned the presumption or the evidentiary standard for rebutting it thirty-four times (39%) and expressly applied them eleven times (13%).

At most, thirty-one of the one hundred nineteen (26%) patent challenges may have been evidentiary standard dependent. Of these determinations twenty-three (74%) resulted from a jury trial and eight (26%) resulted from a bench trial. None of these challenges resulted in invalidation, and each was upheld at the Federal Circuit. The Federal Circuit mentioned the presumption of validity or the evidentiary standard twenty-one times (68%) and expressly applied them fifteen times (48%).

Thanks to Lucas Watkins and Steve Kenny for helping to create this update.

Guest Post: What Ultimately Matters In Deciding the “Gene Patenting” Issue?

By Jacqueline Wright Bonilla, PhD, JD. Ms. Bonilla is a partner at Foley & Lardner and filed an amicus brief supporting Myriad's position.

In entering the fray of this discussion, I note that I, along with two of my colleagues at Foley & Lardner LLP, submitted an amicus brief in the AMP v. PTO (a/k/a ACLU v. Myriad) "gene patenting" case on behalf of our clients Rosetta Genomics and George Mason University. In addition to our brief, other colleagues at our firm submitted a different amicus brief on behalf of a different client, Alnylam Pharmaceuticals. Both briefs, along with Myriad's brief and a number of other amicus briefs filed last week, support a reversal of the district court opinion as it pertains to "isolated DNA" composition claims. These briefs agree that such claims are patent eligible under current law, and should continue to meet the threshold of 35 U.S.C. § 101 as a matter of policy and social considerations. We are sensitive to dire consequence to biotech innovation in the face of a possible alternative outcome.

As it turns out, however, while such briefs agree on patent eligibility of "isolated DNA" claims, a number of briefs differ in viewpoints regarding applicable law, and even which cases are relevant versus not. As such, a reading of just the briefs filed with the Federal Circuit so far—even without considering the ACLU brief yet to be filed, much less amicus briefs filed in support of the ACLU's position—underscores a point worth mentioning.

The point is this: reasonable minds can differ on an interpretation of what constitutes relevant case law and how it should be interpreted in this case. This point is often missed in the hubbub we see in the press. For instance, many have commented on the amicus brief filed by the Department of Justice last week. Some have accused the DOJ of misreading the law entirely and attempting to eviscerate biotechnology innovation altogether. Such viewpoints misread the point of the DOJ brief, in my opinion.

Look what the DOJ brief actually says. It argues that the district court got it wrong in certain important respects. As stated in the DOJ brief:

… the district court erroneously cast doubt on the patent-eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA. Such compositions—e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and thus qualify as "'human-made inventions'" eligible for patent protection under section 101. [] The district court therefore erred in invalidating the challenged composition claims, such as claim 2 of the '282 patent, that are directed solely to cDNAs.

DOJ brief, pages 9-10 (citations omitted). As part of this discussion, the DOJ likewise agrees with our position that claims directed to recombinant vectors comprising any isolated DNA—even DNA having a sequence exactly as it exists in nature—constitutes patentable subject matter. See DOJ brief, page 16, discussing claim 8 of the '282 patent. Thus, unlike the district court opinion, the DOJ proposal does not throw the entire biotech baby out with the bath water.

That said, it appears that the DOJ may cut off a hand of the biotech baby. It argues that "isolated DNA" comprising a sequence from genomic DNA as it exists in a body does not constitute patentable subject matter. The DOJ brief (pages 10-11) argues that the "chemical structure of native human genes is a product of nature," even "when that structure is 'isolated' from its natural environment."

This position presents a slippery slope of considerable concern to those affiliated with biotech innovators responsible for actually getting medical products to patients. For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, "human made" inventions. These products simply do not exist without human intervention. Thus, how does one successfully distinguish what is really "human made"? Moreover, human involvement is needed to identify valuable isolated nucleic acid molecules, such as DNA vaccines, PCR probes, interfering or micro RNA, etc., and then isolate them. When exactly is the human involvement sufficient to meet § 101? An additional slippery slope in the DOJ position is that many non-nucleotide compositions also exist as "products of nature" in a human body or other natural physical state. These compositions include many valuable small molecule pharmaceuticals, proteins, antibodies, just to name a few. Such compositions could likewise be subject to the same legal reasoning propagated in the DOJ brief. In other words, the fallout of the DOJ's position has wide-sweeping implications, even if not as flabbergastingly debilitating as the district court opinion.

This all said, I propose that it does no good to simply assert that the DOJ (or any party or judge for that matter) incorrectly reads relevant case law and/or misunderstands the science wholesale. As mentioned already, reasonable minds can differ on case law interpretation in this case, and how to apply scientific facts to the law. The sheer number of briefs and differences in positions—see DOJ versus USPTO as just one example—indicates this phenomenon in vivid color.

Thus, at the end of the day, the Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social/economic considerations. The courts will consider case law, of course, but in reality may only apply it after the fact. I also believe that any precedential decision issued here, either way, will necessarily have at least some negative fallout. In fact, the patent system itself intends negative fallout to some people by virtue of granting a right to exclude others for a limited time. Thus, keeping the ideals of patent law in mind, it will be critical for courts to choose a course of action that provides the most amount of good, while causing the least amount of collateral damage. In other words, forget all the clever legal mumbo-jumbo—what do we want to happen here for the better collective good?

My understanding of the patent system is that it exists for the very purpose of stimulating innovation, as well as public disclosure of that innovation. As discussed at length in our amicus brief (and by others), abolishing patent eligibility of genetic inventions—not to mention inventions in other areas of health and medicine potentially impacted by a decision here—will have more of a dampening effect on research, development and innovation than any patent right could ever have.

My hope is that courts will remain ever conscious of slippery slopes created by any one interpretation of the law and application of science. No one wins if we inappropriately dampen incentives for innovators to discover, apply and provide innovation to the benefit of humans.

Documents:

• File Attachment: Myriad.CAFC.Amicus.RosettaGenetics.pdf (3443 KB)
• USG Brief

AstraZeneca v Apotex: Affirmance of a Preliminary Injunction

By Jason Rantanen

AstraZeneca LP v. Apotex, Inc. (Fed. Cir. 2010)
Panel: Rader, Bryson (dissenting in part), Linn (majority author),

Contrary to popular opinion, it's still possible to obtain a preliminary injunction in a patent case - it's just very difficult.  Astrazeneca v. Apotex provides an example of an affirmed preliminary injunction, and is significant for that reason alone.  It also raises some interesting inducement issues relating to intent that I'll discuss in a separate post.

Background
This case revolved around AstraZeneca's budesonide inhalation suspension drug product, which consists of a vial containing a single dose of budesonide suspended in a sterile liquid.  The drug is administered by squeezing the entire contents of the vial into a jet neubulizer, then inhaling the resulting mist through a mask attached to the nebulizer.  Because budesonide is an inhaled corticosteroid, the FDA requires that the label include a warning instructing patients to "titrate down" to the lowest effective dose of the medication to avoid any adverse effects from excessive use of the medication. 

The two patents at issue, Nos. 6,598,603 and 6,899,099, both contain method claims covering the once-daily use of the nebulized dose of a budesonide composition and product claims covering AstraZeneca's drug product kit.

Apotex sought approval to market a generic version of AstraZeneca's drug product.  As an ANDA applicant, it was well aware of AstraZeneca's patents, and sought to avoid the once-daily method claims by removing any mention of once-daily dosing from its labels.  While it succeeded in part, the FDA nevertheless required Apotex to keep the titration warning language in the generic product's label.

During the preliminary injunction proceedings, Apotex raised two principal arguments in response to the method claims.  First, it contended that they were anticipated; second, it contended that its distribution of the generic version of the drug would not induce infringement of AstraZeneca's method claims.  The district court rejected Apotex's arguments, and granted a preliminary injunction enjoining Apotex from marketing its product.

Note: The district court agreed with Apotex that the kit claims were invalid.  On appeal, the panel affirmed that determination. 

Anticipation
Apotex's first anticipation argument, involving a prior art patent, turned on a question of claim construction: whether the term "budesonide composition" encompassed budesonide encapsulated in liposomes (the '603 patent teaches dispersing budesonide in a solvent, either as a solution or a suspension that may include liposomes as an excipient).  The majority agreed with AstraZeneca's position, focusing on the discussion contained within the specification and buttressing its conclusions with extrinsic evidence (in this case, expert testimony).  Judge Bryson, dissenting on this point, reached the opposite conclusion: the claim term is not limited to budesonide directly dispresed in solvent, and thus the method claims are anticipated.

Apotex's also argued that a prior art British advertisement for AstraZeneca's product describing it as a twice-daily product anticipated the patents.  The majority again agreed with AstraZeneca that this reference did not anticipate the once-daily method claims, both because it did not disclose once daily dosing and because it was not enabled with respect to that type of dosing.  (Obviousness was apparently not in dispute, as at the time of the earlier reference no one recognized that the product could be administered once per day and still be effective).  Judge Bryson again disagreed, reading the prior art advertisement to suggest the administration of the drug once a day.

Inducement of Infringement
In challenging the district court's finding of inducement of infringement, Apotex focused on the subject of intent, arguing that its instructions did not demonstrate intent to cause the users of its product to engage in once-daily dosing and that it lacked specific intent to cause infringement of Apotex's patent.  The Federal Circuit rejected these arguments, affirming the district court's conclusion that the downward-titration instructions would necessarily result in some users engaging in once-daily dosing and noting that Apotex was well aware of the infringement problems raised by once-daily dosing, yet chose to proceed nonetheless.

Preliminary Injunction "Substantial Question of Invalidity" Standard
Although not playing a major role in the ultimate outcome of this appeal, the court's articulation of the "likelihood of success" standard, along with the subsidiary "substantial question of invalidity" element, is noteworthy given the divergent views on this subject, such as those expressed by Judges Newman and Gajarsa in Abbott Laboratories v. Sandoz, 544 F.3d 1341 (Fed. Cir. 2008).  AstraZeneca v. Apotex follows the approach of requiring a seemingly high threshold for patentees/low threshold for defendants on this issue:

For a patentee to establish that it is likely to succeed on the merits, it “must demonstrate that it will likely prove infringement of one or more claims of the patents-in-suit, and that at least one of those same allegedly infringed claims will also likely withstand the validity challenges presented by the accused infringer.” Ama-zon.com, 239 F.3d at 1351. When reviewing the grant of a preliminary injunction, this court “views the matter in light of the burdens and presumptions that will inhere at trial.” Titan Tire Corp., 566 F.3d at 1376 (citation omitted). A preliminary injunction should not issue if an alleged infringer raises a substantial question regarding either infringement or validity, i.e., the alleged infringer asserts an infringement or invalidity defense that the patentee has not shown lacks substantial merit. Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997).

Constitutional Inventors, First-Possession, and the Confusion of Bayh-Dole

Property law courses generally begin with the concept of first-possession as an originator of property rights. In patent law, the first-possession principle leads to a rule that potential patent rights are owned by the inventors unless and until they are assigned to another entity. See Crown Die & Tool Co. v. Nye Tool & Machine Works, 261 U.S. 24, 35-37 (1923). The legal basis for inventor rights is derived from constitutional principles that give Congress power to enact patent laws that grant exclusive rights "to inventors." US Constitution, Article I, § 8, cl. 8.

In Stanford v. Roche, Both Stanford and the US Government argue that that the Bayh-Dole Act of 1980 alters this original formula in the special case where an invention was either "conceived or first actually reduced to practice" with the use of US federal funding received by a university, non-profit, or small business. In that situation, the Bayh-Dole Act suggests that the funded-entity, the "contractor", automatically holds patent rights with a right to "elect to retain title to any subject invention." 35 U.S.C. § 202(a). If the contractor decides not to retain title, then, the funding federal agency "may receive title" or "may … grant requests for retention of rights by the inventor." 35 U.S.C. § 202(d). The Bayh-Dole Act includes a comparative-law clause making its provisions superior to those found in any other Act. "This chapter shall take precedence over any other Act which would require a disposition of rights in subject inventions of small business firms or nonprofit organizations contractors in a manner that is inconsistent with this chapter."

The Bayh-Dole language is somewhat confusing when examined through a first-possession framework. Namely, the statute indicates that the university might "retain title" and also that inventors can request "retention of rights." It is unclear from these provisions whether it is the university or the inventor that first holds rights. The US Constitution helps break this seeming conflict by focusing on inventors as the original recipient of rights. With this Constitutional backstop, there is no way that the university can be the original rights-holder. Rather, that designation must remain with the inventors.

This result may be important for the Stanford v. Roche case that was recently granted a writ of certiorari. Under a Constitutionally limited Bayh-Dole Act, Stanford cannot automatically claim first-possession rights to every invention & first reduction-to-practice that was materially supported by federal funding obtained by Stanford. At most, the Bayh-Dole law requires a transfer of rights from the inventor to the university. In the property framework, the question then focuses on the timing of the Bayh-Dole transfer (is it immediate or does it only occur upon the university's election of rights?) and on its impact on a prior transfer of patent rights to a third party.

Split Court Denies Rehearing En Banc in Sun Pharmaceuticals v. Eli Lilly

By Jason Rantanen

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. 2010) (denial of rehearing and rehearing en banc)

In Sun Pharmaceutical, a Federal Circuit panel affirmed a district court determination that Eli Lilly's patent for a method of using gemcitabine to treat cancer was invalid due for obviousness-type double patenting based on another application, filed the same day, claiming the compound gemcitabine and disclosing its use for treating cancer.  (The previous Patently-O write-up is here).  This morning the Federal Circuit issued an order denying Eli Lilly's petition for rehearing and rehearing en banc.  The court was closely split on the latter, with four of the nine currently sitting judges dissenting on the decision not to rehear the decision en banc.

The dissent's principal concern was that, in its view, the panel opinion involved a departure from precedent, thus creating an intra-circuit split.  According to the dissent,

the panel held the claims to the anticancer use to be invalid for double patenting because the anticancer use was mentioned (but not claimed) in the continuation-in-part specification that is not prior art, stating that “[t]he asserted claims of the later ’826 patent simply claim the anticancer use disclosed in the specification of the ’614 patent,” reported at 611 F.3d at 1389.

The dissent pointed out that this approach, which focused on the disclosure of the simultaneously filed patent, not its claims, was contrary to precedent:

Uniformly, unlike examination for obviousness based on prior art, the issue of obviousness-type double patenting is directed to whether the invention claimed in a later patent is an obvious variant of the invention claimed in an earlier patent. The panel opinion violates a vast body of precedent.

Furthermore, according to the dissent, expanding the doctrine of obviousness-type double patenting to the facts of this case serves no good policy purpose and creates a schism in the law - a schism that should be addressed by the court en banc:

A change of law “in ways that negatively impact the patentability of important later-discovered uses” serves no public purpose in areas in which commercial development requires patent protection. Id. If the majority of the court now believes, as a matter of policy, that the law should be changed in this new direction, en banc treatment is particu-larly appropriate, for the court’s rule is that the earlier precedent prevails unless overruled en banc. A situation in which the court ignores this rule, and applies whatever law the panel prefers, is an indictment of the ability of this court to provide stable law in the areas entrusted to us.

Comment: Given that there are currently only nine sitting Federal Circuit judges, it seems unlikely that the court will grant a rehearing en banc absent extraordinary circumstances - especially in cases where the panel decision was unanimous.  In that situation, in order for an appeal to be reheard en banc, at least five of the six judges who did not participate on the panel would need to vote to rehear the decision en banc.  Of course, there are instances when this would not apply, as senior judges and visiting judges frequently participate in panel determinations, but it is something to keep in mind for the near future.

Supreme Court to hear Bayh-Dole Patent Ownership Dispute: Stanford v. Roche

Bd. of Trustees of Leland Stanford Jr. University v. Roche Molecular Systems, 09-1159 (Supreme Court 2010)

The Supreme Court has granted Stanford's petition for a writ of certiorari in Stanford v. Roche on an issue of patent ownership. Although the case may turn on federal patent law statutes, it looks substantially like derivative title issues considered in the law of property. The rule of derivative title generally bars a property owner from transferring rights greater than his own. One exception to the rule of derivative title is that, in certain situations, a bona fide purchaser can take title free of prior claims to the property.

The patents in this case involve methods for using PCR techniques to measure HIV concentration in blood plasma. Stanford scientists first created the invention while subject to a contractual duty to assign any inventions to Stanford. After agreeing to assign rights, but prior to the invention, one of the inventors (Holodniy) assigned his rights in his future inventions to Cetus (who later became Roche). Rather than a promise-to-assign, the assignment to Roche was an actual assignment of future inventions. Thus, on the contracts, Holodniy first promised-to-assign rights to Stanford but first actually-assigned rights to Cetus. Stanford later filed for patent protection and then demanded a royalty from Roche. The Federal Circuit held that Roche could not be liable for infringement because it held ownership rights based on the Holodniy assignment.

On appeal to the Supreme Court, Stanford has argued that its receipt of federal funding for the research somehow results in a superior claim to title. Stanford framed the question as follows:

Whether a federal contractor university's statutory right under the Bayh-Dole Act, 35 U.S.C. §§ 200-212, in inventions arising from federally funded research can be terminated unilaterally by an individual inventor through a separate agreement purporting to assign the inventor's rights to a third party.

The US Department of Justice filed a brief supporting the petition and argues that the Bayh-Dole Act does indeed establish a "framework for determining ownership interests in federally funded inventions." The Government brief argues that the Bayh-Dole Act flips the normal statutory rule that patent rights first vest with the inventor. Instead, in their view, by virtue of receiving federal funding, the university or federal contractor automatically receives title to the invention and then may "elect" to not "retain title." Under that interpretation of the law, Stanford retains full title because it received federal funding for the research and elected to pursue patent protection. The Government frames the question as follows:

Whether an inventor who is employed by a [federal] contractor that elects to retain rights in an invention may defeat the contractor's right to retain title under the Bayh-Dole Act by contractually assigning his putative rights in the invention to a third party.

The Federal Circuit rejected these questions – holding instead that the Bayh-Dole Act was not designed to automatically void contractual transfers made by an inventor simply because the research received federal funded.

In addition to the Government Brief, additional petitions-stage briefs were filed by a number of universities and university-controlled organizations that all supported the petition.

Comment: The cause of Stanford's plight is the University's failure to negotiate a tight assignment agreement with its researchers and scientists. If it has not done so yet, Stanford could fix the issue by forcing its students and employees to agree to a new assignment agreement. Thus, this particular issue is solved by contract law. A real ongoing question that the Supreme Court should focus-on with this decision involves the rights of third-party inventors who are not under any contractual duty to assign rights to a university or federal contractor. Does that third party retain rights when the University can show that the invention process was at last partially federally funded. This issue arises in collaborative projects where the work of a subset of inventors receives federal funding.

• Revised Federal Circuit Opinion cited as Stanford v. Roche, 583 F.3d 832 (Fed. Cir. 2009)
• Crouch, Another University Patent Ownership Dispute: Stanford Loses Rights Based on Researcher's Side Agreement
• Government Brief