May 2006

Claim Construction: Similar Terms in Continuation Given Identical Meaning

AIPLATalk215Advanced Cardio and Guidant v. Medtronic (Fed. Cir. 2006, Nonprecedential).

On summary judgment, the lower court held that Medtronic’s vascular stent patents were not infringed.  On appeal, the CAFC made an interesting point about claim construction — holding that a disclaimer in the file history of a patent applied equally to construction of similar terms in all the family member cases.  The patentee had consciously chosen to use different claim language in later continuation applications —  perhaps to avoid the prior disclaimer.  The CAFC paid this no matter.

Medtronic correctly states that its claims do not all use the [disputed] term “end” to describe the connection. . . Instead, certain claims use “turn” or “curved member.” . . .  However, because the specification . . . uses “peaks” and “turns” synonymously, and “turn” and “curved member” are used in the []patent claims synonymously with “end,” we find that those claims embody the same “peak” or “end” limitation as the [parent], i.e., the disclaimer from the [parent] patent applies against the [child] patent. Our conclusion is further buttressed by the established rule of claim interpretation that dictates that like terms should be construed consistently across related claims.

According to the Court, Medtronic admitted that the varying claim language should be identically interpreted when it made the statement that the child claims were allowable “for at least the same reasons as the parent application.”

Scholarship: Patent Thickets See a New Light

Patent law professor Douglas Lichtman (and my good friend) has an interesting new short article (8 pages of text) about problems of “patent thickets.” 

Theorists have discussed patent thickets as an example of problematic over-ownership — A.K.A. the tragic “anti-commons.”  When a particular area of technology is blanketed by multiple patents owned by multiple parties, everyone blocks everyone else, and nothing gets done.

After all, the conventional literature on the tragedy of the anti-commons asserts that resources will be inefficiently under-used in the face of too many overlapping patent rights.

Lichtman turns this theory on its head and asserts that in actuality, a very thick thicket might result in less litigation.  His idea is in a case of multiple overlapping patents, each patent represents only a small piece of the pie.  And few patentees would be willing to go through litigation simply to recover such a small slice.

More patents means less money per patent holder. Less money, in turn, means less of an incentive for a firm to strategically delay in the hopes of being a patent holdout, and less of an incentive for an accidental patent holdout to actually bring suit.

A couple of weeks ago, I would have rejected Lichtman’s argument out of hand.  Under the old rule, every patent holder had a right to force large settlements based on its hold-up threat through injunction.  Now, post eBay, his ideas begin to make more sense. . .

Professor Kimberly Moore Receives Nomination to Federal Circuit Court of Appeals

KimpictureAs predicted, the White House has sent Professor Kimberly Moore’s name to the Senate as a nominee to be a United States Circuit Judge for the Federal Circuit — filling the spot of Judge Raymond C. Clevenger, III, who has retired.

This should make the CAFC Judicial Conference that starts on May 19 a bit more exciting.

Professor Moore has long been considered one of the handful of leading patent law professors, and is especially noted for her empirical research methods. In addition, Moore is co-author of a book on patent litigation along with CAFC Chief Judge Michel and she is the Editor-in-Chief of the Federal Circuit Bar Journal. 

Although not a registered patent attorney, Moore holds a BS and MS from MIT in electrical engineering.  Her masters thesis focused on chaos theory applied to electrical systems.  She received her JD from Georgetown.  Moore has been teaching law — and more specifically patent law — since completing her clerkship with Judge Archer at the CAFC.  She also has trial experience from her associate days at Kirkland & Ellis.

My two-cents — Professor Moore is an excellent nominee.  She is extremely intelligent, and has a complete understanding of the legal issues faced by the CAFC.  You will find that her decisions will be fair and quick, and, I believe that her vast knowledge of the CAFC and its history will help her to craft opinions that reconcile some of the internal cracks that have surfaced the past few years. I hope that the Patent Bar and will stand with me in putting its weight fully behind this nomination.

Congratulations to Professor Moore!

Patently-O Tidbits

Blog Notes:

  • www.OrangeBookBlog.com: Chicago Attorney Aaron Barkoff has started the Orange Book Blog: At the Intersection of Patent Law and FDA Law.  I know from experience that Aaron is a great writer (his office is next-door to mine) and I believe that you will learn from his posts.
  • I have also been very impressed lately with Gary Odom’s blog Patent Prospector.  Gary is not a lawyer, but he does lots of patent searching and analysis.  Like another patent searcher many of us know, Gary is not afraid to speak his mind or give an opinion.

Vote for Patently-O:

  • Patently-O is up for an @Award as the “Favorite Legal Blog” from TechnoLawyer. There is a two-step voting process:

CAFC Refines Function-Way-Result Test of Infringement

AIPLATalk208Applied Medical v. U.S. Surgical (Fed. Cir. 2006, 05–1314).

In a dispute over Applied Medical’s patented trocar, the district court granted summary judgment of non-infringement to U.S. Surgical. Specifically, the district court found that the recited means plus function language was not infringed.

A means plus function claim limitation is literally infringed when the relevant structure in the accused device perform the identical function recited in the claim and be identical or equivalent to the corresponding structure in the specification.

Once the relevant structure in the accused device has been identified, a party may prove it is equivalent to the disclosed structure by showing that the two perform the identical function in substantially the same way, with substantially the same result.

This test for infringement is known as the function-way-result test.  And, it was in applying the “way” portion of the test that the lower court erred.

Specifically, the district court looked at the “way” the accused structure operated in general and found that it was different from the “way” described in the specification.  The CAFC found this general approach to be wrong because it essentially imported additional limitations into the claims.

In this step, the inquiry should be restricted to the way in which the structure performs the properly-defined function and should not be influenced by the manner in which the structure performs other, extraneous functions. . . . [T]he district court improperly imported unclaimed functions when analyzing the way in which the disclosed embodiment performed the claimed function.

Summary judgment vacated.

Supreme Court Vacates eBay Injunction

EBayITIn a landmark unanimous decision, the U.S. Supreme Court has reportedly vacated the appellate court’s decision against eBay — putting an end to the “general rule” that a permanent injunction should follow a finding of infringement of a valid patent.  Rather, the opinion by Justice Clarence Thomas rules that the decision of “whether an injunction should issue” is within the trial court’s discretion. Concurring opinions by Chief Justice John Roberts and Justice Anthony Kennedy.

Background: At the district court, eBay was found to infringe MercExchange’s valid patent. However, the district court refused to issue an injunction to stop the ongoing infringement because MercExchange’s patent was a disfavored type (business method), because MercExchange was willing to provide a license, and because of the contentious nature of the litigation, any injunction would be difficult to enforce.  On appeal, the Federal Circuit (CAFC) reversed, finding that the lower court “did not provide any persuasive reason that this case is sufficiently exceptional to justify the denial of a permanent injunction.”  Most controversially, the CAFC concluded with its “general rule that courts will issue permanent injunctions against patent infringement absent exceptional circumstances.”

eBay v. MercExchange ___ U.S. ___, No. 05–131 (2006).

Unanimous Opinion: The decision relies on the traditional “four-factor test” for determining whether to issue a permanent injunction:

A plaintiff must demonstrate: (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction. . . . These familiar principles apply with equal force to disputes arising under the Patent Act.

The Court indicated that these factors must be applied on a case by case basis – noting that “traditional equitable principles do not permit such broad classifications.”

The Supreme Court flatly rejected the argument that patentee’s who only license should not qualify for injunctive relief — finding that “[s]uch patent holders may be able to satisfy the traditional four-factor test, and we see no basis for categorically denying them the opportunity to do so. To the extent that the District Court adopted such a categorical rule, then, its analysis cannot be squared with the principles of equity adopted by Congress.”

In its final word, the court emphasized that the “decision whether to grant or deny injunctive relief rests within the equitable discretion of the district courts, and that such discretion must be exercised consistent with traditional principles of equity.”

Roberts, CJ, Scalia, J, and Ginsberg, J, Concurring: Chief Justice Roberts provides a short concurring opinion that appears to caution district court judges in their “discretion.”

[T]here is a difference between exercising equitable discretion pursuant to the established four-factor test and writing on an entirely clean slate. .Discretion is not whim, and limiting discretion according to legal standards helps promote the basic principle of justice that like cases should be decided alike.

 The opinion notes that from “at least the early 19th century, courts have granted injunctive relief upon a finding of infringement in the vast majority of patent cases.”  According to the Chief Justice, this long tradition of injunctive relief should be awarded great weight.

Kennedy, J, Stevens, J, Souter, J, and Breyer, J, Concurring: These four Justices feel that times have changes, and that the tradition of injunctive relief might no longer be so compelling.  The Kennedy opinion is focused primarily on non-manufacturing patent holding companies and business method type patents:

In cases now arising trial courts should bear in mind that in many instances the nature of the patent being enforced and the economic function of the patent holder present considerations quite unlike earlier cases. An industry has developed in which firms use patents not as a basis for producing and selling goods but, instead, primarily for obtaining licensing fees. . . . For these firms, an injunction, and the potentially serious sanctions arising from its violation, can be employed as a bargaining tool to charge exorbitant fees to companies that seek to buy licenses to practice the patent. When the patented invention is but a small component of the product the companies seek to produce and the threat of an injunction is employed simply for undue leverage in negotiations, legal damages may well be sufficient to compensate for the infringement and an injunction may not serve the public interest. In addition injunctive relief may have different consequences for the burgeoning number of patents over business methods, which were not of much economic and legal significance in earlier times. The potential vagueness and suspect validity of some of these patents may affect the calculus under the four-factor test.

The equitable discretion over injunctions, granted by the Patent Act, is well suited to allow courts to adapt to the rapid technological and legal developments in the patent system. For these reasons it should be recognized that district courts must determine whether past practice fits the circumstances of the cases before them. With these observations, I join the opinion of the Court.

In the end: The court found problems with both the CAFC decision and the district court decision.  For those concerned about the actual parties (MercExchange and eBay), we’ll have to wait to see a new decision from the lower courts.

Crouch’s off the cuff analysis: I had predicted that the Court would apply equitable principles, but would announce that that injunctions should continue to issue in most cases.  [Prediction].  As it turns out, that decision is found in the Roberts Concurrence, but not in the majority. (Thus, I lost my $1 bet).  I also had not predicted that four Justices (Kennedy, Stevens, Souter, and Breyer) would come out so strongly against injunctions.  This decision may indicate a real shift in Patent Law and the strength of an individual patent.  My general advice to litigators: The injunction is now a big issue — make sure that you focus on evidence of irreparable harm from the beginning — including your cease & desist letter or initial complaint.  My colleague Tom Fairhall correctly points out that this decision adds yet another layer of uncertainty to patent litigation.

Based on this decision, it is now clear that the value of a patent does depend upon the identity of the owner. For instance, an industry competitor will be able to show irreparable injury much more easily than would a university or individual inventor who has no plans to manufacture a product.  Because the industry competitor has a higher likelihood of obtaining an injunction, it should be willing to pay more for the patent.  Interestingly, this valuation gap may spur more licenses and patent transfers.

Notes:

BPAI Decisions

ScreenShot029The USPTO has a new search engine for finding decisions of the Board of Patent Appeals and Interferences. (Link).  As far as I know, none of the 308 decisions filed in 2006 are precedential.  Rather, it seems the last precedential decision was Ex parte Lundgren from 2005. (Decision).

Traditionally, the vast majority of BPAI decisions involved underlying applications that remained secret.  With the advent of publication of applications, the BPAI has become a more public body and continues to move toward the goal of providing sound decisions that both adjudicate the particular issues in question and provide further guidance to other applicants and examiners.

For someone thinking of starting a new blog, I would suggest a BPAI blog in the mold of John Welch’s excellent TTABlog.

What is a patent troll?

Here’s my working definition of the confusing term: Patent Troll.

Definition: The patent troll does not research or develop the technology or any products related to its patent. Rather, the patent troll waits for others to independently develop the patented technology into useful products and to create a market for those products. Once the newcomers are locked-into the new technology, the patent troll seeks rents either through licensing or litigation.

Question: Is this type of activity bad?

Links:

Philips v. AWH Takes a Casualty: “interface” construed as “parallel bus interface.”

AIPLATalk207Inpro II v. T-Mobile (Fed. Cir. 2006, 05–1233).

Inpro accused T-Mobile and RIM of infringement of its patent relating to electronic devices having user-operable input means such as a thumb wheel. (Pat. No. 6,523,079). After claim construction, the parties stipulated to summary judgment of noninfringement. 

Inpro’s PDA design includes a thumbwheel controller with a host interface.  The “PDA is designed to run independently by its own [CPU] until it is connected to a host computer.  Upon connection to the host computer, the host CPU takes control and can access the memory and other functional units of the PDA. 

Inpro appealed the construction of the term “host interface.” Interestingly, the specification only discussed the interface as a parallel bus, and actually disparages serial busses. 

The appellate panel agreed the defendants that the term’s definition should be limited to parallel bus interfaces:

The description of a serial connection in the discussion of the expansion bus interface, and the lack of any such description in the discussion of the host interface, reinforce the interpretation of the host interface as requiring a parallel bus interface, for that is the only interface described for that purpose.

The real killer for the plaintiff was that the following line from the patent:

A very important feature of the PDA in an aspect of the present invention is a direct parallel bus interface . . .

Because RIM and T-Mobile use serial ports, they can’t infringe the patent, which is construed to require parallel ports.

Patent Drafting Commentary: This case reinforces the trend of intentional obscurity in patent drafting.  Based on this case and others, patent drafters would do well to ensure that nothing in the patent document is “important,” “essential,” “required,” or the like.  Those terms do help the patent readers better understand your preferred embodiment, but in court they will only limit your claim scope.

Additional views of Judge Newman: Judge Newman wrote the majority opinion, but added a separate addendum on her own. Judge Newman agreed that the court’s construction of “host interface” was dispositive in this case.  However, she argued that the court should have construed all three disputed terms.

I believe we have the obligation to review the construction of the three appealed terms, for the interests of the parties and the public, as well as judicial economy, require final disposition of the issues of claim construction that were decided by the district court, and raised on appeal. This panel’s resolution of this infringement action based solely on the construction of “host interface” does not resolve, or render moot, the interpretation of the other disputed terms. . . .

We should review and decide all three of the disputed claim terms that are presented on this appeal, lest our silence leave a cloud of uncertainty on the patent, its scope, and its validity. Our obligation to the system of patent-based innovation requires no less.

 Judge Newman’s view appears to be at odds with Judge Mayer’s recent dissent in Old Town Canoe.

Patents are Still “Very Important”

In Inpro v. T-Mobile, an applicant’s use of the phrase “very important feature” in the specification allowed the court to legitimately import the “important” limitation into the claims.  That result prompted a resourceful, but anonymous Patently-O reader to do some quick analysis to figure out: who still uses phrases like “very important?” The answer: Lots of people.

 

The following table shows the percentage of patents using the terms “important” or “very important” by month over the past twenty years.  As you can see, “important” features are alive and discussed in a significant number of applications.

 

Application Month

“important” %

“very important” %

Jan 1985

23.5

1.65

Jan 1990

24.0

1.80

Jan 1995

28.3

1.82

Jan 2000

29.6

2.08

Jan 2001

27.5

1.80

Jan 2002

27.0

1.78

Jan 2003

24.4

1.95

Jan 2003*

32.3

2.31

Jan 2004*

31.4

2.21

*Data taken from published patent applications, which may or may not also have issued as patents.

 

Of course, there are times when it is useful to talk about a “very important” feature of the invention — such as if you are attempting to avoid known prior art.  However, I would be cautious even on that point.

 

A few caveats to this data — some of these hits might be in the background saying “this problem is very important.”  Some of them might also be saying it is “not very important.”

Patently-O TidBits

  • Highway 101: Oracle and GWU are hosting a timely symposium on patentable subject matter in light of Lundgren and Metabolite.  For law school faculty, Oracle will sponsor your paper and travel expenses to the November conference in Washington DC. Conference Details PDF.
  • Fire of Genius: After regularly contributing to several blogs, Professor Joseph Miller at Lewis & Clark has started his own blog
  • TinyTechIP: Blaise Mouttet is also a long-time blog comment-writer.  His new blog focuses on nanotechnology patent developments.
  • PunchcardTechnoLawyer: I regularly receive the TechnoLawyer intellectual property newsletter, known as “IPMemes.” Last year, TechnoLawyer members picked Patently-O as the “Best Practice Area Blog” on the net.  This year, Patently-O is up for Favorite Legal Blog — Your vote would be appreciated.
    • How to vote (3 minute process):
    • Note — the one issue with TechnoLawyer is that they send quite a few e-mails — I would recommend using your yahoo or gmail account. (I setup a rule in outlook)

DJ Counterclaims Allow Adjudication of Invalidity Counterclaims Even After Noninfringement Decision

The Old Town Canoe Company: Our First Hundred YearsOld Town Canoe v. Confluence Holdings (Fed. Cir. 2006, 05–1123).

Old Town sued Confluence, asserting infringement of its patent covering layered polyethylene canoes. Confluence filed declaratory judgment counterclaims of invalidity and unenforceability.

After a few days of trial, the judge called it quits — first ruling that as a matter of law, the patents were not infringed, and the next day taking further arguments and ruling that the patents were not invalid and not unenforceable.

On appeal, the CAFC majority agreed that the claims were not infringed (based on claim construction) and then bit into the validity analysis.

Enablement: Because the time and temperature settings of the canoe manufacturing process were not disclosed, a jury could find that undue experimentation was required.

Best mode: Best mode requirement only applies to the claimed invention. However, the defendant’s evidence that a preferred mode had not been disclosed to the PTO was enough to overcome the Court’s judgment as a matter of law.

Inequitable Conduct: Without evidence of intent, the patentee’s failure to disclose the best mode is not “material” as a matter of law.

J. Mayer’s Dissent: Dissenting-in-part, Judge Mayer argued that after the district court decided that the defendant did not infringe, the declaratory judgment jurisdiction of the counterclaims vanished.  Those counterclaims became moot.  Thus, the lower court’s decision on validity and enforceability should be vacated.

Practice Strategy: This case is a prime example of why a defendant should include declaratory judgment counterclaims rather than just defenses.  With counterclaims, the plaintiff will need the defendant’s agreement to end the case.

Book Review: Pharmaceutical Patent Law

PharmPatentLawPharmaceutical Patent Law
by Professor John R. Thomas (Georgetown).
December 2005

$355 from Amazon.com

Professor Thomas has written an excellent treatise that will be very well regarded for years to come.  The book includes 600+ pages of text that is surprisingly readable plus a large appendix in CD form. 

This is not primarily a textbook for law students.  No, the book provides answers and focused analysis that a practitioner will find extremely useful. The focus of the book is clearly the interplay between patents and the FDA.  However, the book also details the pharmaceutical patent prosecution process and particular litigation issues that are important in pharmaceutical patent litigation. The review on Amazon (link above) does a good job of describing the contents.

I have found the book useful and would recommend it to you as well.

 

In re EchoStar: Opinion Waiver Does Not Extend To Work Product Never Communicated To The Client

In re EchoStar Communications (Fed. Cir. 2006, order).

In an order on mandamus, the CAFC has vacated a district court’s decision that would require EchoStar’s outside counsel (who provided an infringement opinion) to produce documents that were never communicated to EchoStar.

Before TiVo sued, EchoStar relied on the advice of its in-house counsel in continuing to produce its allegedly infringing product.  After the suit was filed, EchoStar hired Merchant & Gould (M&G), but decided not to rely on the IP Boutique’s advice.  Since EchoStar was relying on advice in defense of a willfulness charge, TiVo asked for any M&G opinions and associated work product.

The district court ordered production of M&G’s infringement opinions as well as “all work product . . . whether or not communicated to EchoStar.”  The non-communicated subject matter, according to the district court, might contain information disclosed to EchoStar — even if the documents themselves were not disclosed.

On appeal, the CAFC (Gajarsa) came to several conclusions:

  1. An in-house attorney providing an opinion to executives can be an “opinion of counsel.”  And, relying on that opinion in court will create a waiver of attorney-client privilege. According to the court, “[u]se of in-house counsel may affect the strength of the defense, but it does not affect the legal nature of the advice.”
  2. Attorney-Client privilege is distinct from Work-Product protection.  Waiver of one, does not necessarily waive the other.
  3. Here, “[w]ork-product waiver extends only so far as to inform the court of the infringer’s state of mind.”
  4. Importantly, “work product, which is never communicated to the client, is not discoverable” even after waiver of attorney-client privilege.

[I]f a legal opinion or mental impression was never communicated to the client, then it provides little if any assistance to the court in determining whether the accused knew it was infringing, and any relative value is outweighed by the policies supporting the work-product doctrine.

This case goes a long way in clarifying the scope of waiver, which has been in dispute in essentially every patent case where an opinion is asserted. The court also discusses how redaction should take place and gives rather easy guidlines for determining when a document would fall within the waiver.

Notes:

 

Blogger Defamation Litigation

VisitMaine AdvertisementWarren Kremer Paino v. Dunston (D. Maine)

There is an interesting controversy brewing about a blogger (Dunston) who has been sued for defamation and copyright violation by Maine’s tourism advertising firm (Warren Kremer).  Dunston reposted (and derided) one of Warren Kremer’s recent ads that mistakenly included the number to a phone-sex hotline.  The defamation claim is partially based on Dunston’s accusation that the ad firm is “pissing away” Maine’s tourism dollars.

Blogger Ron Coleman is one of the attorneys representing Dunston.

UPDATE: Warren Kremer dismissed the suit.

Links:

 

 

Editorial: The Orange Book Should Include Process Patents or Be Eliminated

By Aaron Barkoff

Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or “method of use” patents.  Such patents may cover the drug compound, specific formulations of the drug, or methods of treating certain diseases by administering the drug.  But “process patents,” which cover methods for making (chemically synthesizing) the drug compound, are not allowed to be listed in the Orange Book.  This inconsistency creates several problems for drug companies.

In ordinary circumstances, a patent owner trying to enforce its patent must first get the competitor’s product, look at it and test it, determine that it’s covered by the patent, and then file a lawsuit.  In most pharmaceutical patent cases, however, the patent owner need not bother with that.  Instead, if an innovator drug company lists its patent in the Orange Book, a generic drug company is required by law to notify the patent owner that it is making (and plans to sell) a drug that arguably infringes the patent.  Once notified, the patent owner can file a lawsuit for patent infringement.  But notice of possible infringement is required only with respect to patents that are listed in the Orange Book.  A patent might not be listed for in the Orange Book because either (a) it’s a process patent; or (b) the patent owner simply forgot to ask the FDA to include it in the Orange Book.

For generic drug companies, the Orange Book provides notice that there are patents out there covering FDA-approved drugs.  This relieves the generic drug company’s burden of searching for patents before it invests in research to develop a generic drug product.  But patent searching isn’t too difficult nowadays, and generic companies have to do it anyway because not all patents of concern are listed in the Orange Book.

For innovator drug companies, the Orange Book provides more valuable benefits.  First, the Orange Book relieves the innovator’s burden of monitoring the marketplace for new generic drugs that infringe its patents.  As long as an innovator drug company gets its patent listed in the Orange Book, a generic drug company that desires to make its own version of the drug must, under law, provide notice of possible infringement to the innovator.  Upon receiving notice, the innovator is free to file for patent infringement–without having to see the generic product or conduct expensive chemical testing on it.  Second (and probably more importantly to the innovator drug companies), the filing of a lawsuit based on a patent listed in the Orange Book automatically invokes a 30-month stay before the generic drug company can sell its drug.

But why can’t any patent relating to an FDA-approved drug be listed in the Orange Book?  The answer must be in some sort of bargain struck by lobbyists.  After all, the reasons for the Orange Book’s existence apply as well or better when it comes to process patents.  For example, to enforce its process patents, an innovator drug company has to monitor the marketplace, obtain a sample of the competitor’s product, test it, and establish a “good faith basis” for filing a patent infringement lawsuit.  In other words, the innovator drug company has to gather some evidence (usually the results of chemical testing) that the generic drug company uses the patented process to make the drug.  It is difficult and expensive to gather such evidence.  In fact, in most cases it would probably be easier to find chemical evidence that a generic drug company infringes a compound or formulation patent, yet because compound and formulation patents may be listed in the Orange book, such monitoring and evidence isn’t required.

Furthermore, owners of process patents must continue to monitor the marketplace even after they win in litigation.  Suppose an innovator drug company monitors the market, tests a new generic drug, suspects infringement of its process patent, files a lawsuit, and wins.  The generic drug company must then stop selling its drug.  However, the generic drug company is free to purchase API made differently, from a different source perhaps, and amend its drug application with the FDA.  The innovator drug company that already proved infringement won’t be given notice, and therefore must continue to monitor the market and test all new drugs for infringement of its process patents.  Such continuous monitoring isn’t necessary for owners of composition or method of use patents, because a generic company that loses in the first round of litigation will have to provide notice to the innovator company if it later files another drug application.  As long as composition or method of use patents are in the Orange Book, the generic drug company must provide notice.

Maybe the inconsistency that only some, but not all, kinds of pharmaceutical patents may be listed in the Orange Book is a minor issue.  Maybe the bigger problem is that the Orange Book exists at all.  Every other company has to continuously monitor the marketplace for potentially infringing products.  And monitoring and testing is expensive for all sorts of high tech industries.  What makes the drug companies special?  Moreover, because the FDA includes any composition or method of use patent in the Orange Book that an innovator company asks it to list, and does not question whether such listings are proper, many patents that don’t belong in the Orange Book are listed there.  This often leads to unnecessary litigation between drug companies.  Maybe a way to bring consistency to FDA regulations is to eliminate the Orange Book entirely.

Notes:

  • Post author: Aaron Barkoff is a patent litigator at the Chicago office of MBHB. He hold a PhD in Biochemistry from Wisconsin and a JD from the University of Chicago. 
  • Comments are welcome.

Patently-O TidBits

Here are three new patent papers that I found interesting:

  • AcademicEggHeadBeth Simone Noveck of New York Law School proposes a peer-to-patent system that would harness the public “collective intelligence” and allow members of the public to suggest references to the Examiner. [Link]
  • Stuart Minor Benjamin and Arti Rai of Duke Law School provide a useful framework for how the Administrative Procedures Act (APA) should be applied in post-grant reviews. [Link]
  • Margo Bagley of Emory Law School is worried that the prospect of patent rights forces researches to delay dissemination of their research. Professor Bagley proposes an opt-in filing delay that would allow a two-year grace period coupled with early publication of the patent application [Link] (Published in the Boston College Law Review).

Patent Blog Posts: The world of patent blogs is continuing to grow.  Here are

Patently-O Intellectual Property Schedule: I have started a new Google calendar to keep track of upcoming conferences and events in the patent world. The feed for the calendar is publicly available through these icons:   and is apparently best seen through any product that supports the iCal format (like iCal for Mac or Mozilla’s Sunbird).  Please send suggested events to patentcalendar@gmail.com.

Expert Testimony Not Required for Infringement Finding

Screenshot019Kyocera Wireless v. President Electronics and Tony Colida (Fed. Cir. 2006, unpublished).

In a DJ action, Kyocera was awarded summary judgment of noninfringement. On appeal, Colida argued that expert testimony is required for such a summary determination. The CAFC, however, affirmed its prior precedent that expert evidence is “not always necessary to resolve questions of patent infringement.”

While expert evidence may be necessary in cases involving complex technology, this is not such a case, and Mr. Colida does not explain how expert evidence would have been helpful.

Affirmed

Colida has been involved in several other CAFC decisions:

 

Should the Patent Office Kill Late Claiming?: Proposed Continuation Change

In January 2006, the PTO proposed dramatic changes to patent continuation practice that would essentially allow only one continuation (or CIP or RCE) per application. [Link]. 

Although the PTO has justified these changes based on a need to reduce examiner workload, the real controversy with extended continuations is what I call “late claiming.” 

There are many different ways to “claim” an invention in a patent application.  Often, an applicant may pursue one aspect of the invention in the original application, and then file continuations to obtain coverage for other aspects.  That practice is fine and legal, but can create business problems when the applicant waits until learning of a competitor product before adding claims that cover that new product.

Late claiming occurs when the applicant adds new claims to cover what has arisen in the marketplace since filing the original patent application.

According to the law, those new claims are generally legitimate so long as they are enabled by the original written description.  However, the possibility of late claiming creates another potential down-the-road liability for product developers.

Is late claiming a problem?
Will the PTO rule change reduce late claiming?