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.
Malcolm,
How do you arrive at “The point is that without the delay, you get no patent at all.” Are you saying the patentee added new matter?
30 years of extended term? I don’t know much about term extensions, since I don’t practice in the pharmaceutical area. Is the term extension calculated from the patent grant date?
Lolz Sunshine – you callin anyones a “coward hiding behinds a sock”
How did the patentee get the market for itself longer via the delay?
The product was approved for marketing in 1999. The patent term was “reduced” because 35 USC 156 caps the extension to 14 total years of post-approval term, which would have gone to 2013. Not that maxing out one’s term extension isn’t a benefit in and of itself.
Guess what? The patent expires in 2014. Had it issued promptly in 1984, do you think they would have gotten 30 years of extended term?
“It appears the only reason prosecution was delayed was so the patentee could have the market to itself for longer and thereby make more money.”
But they said upthread that the claim term was reduced by the delay, and it was ye aulde submarine patent. How did the patentee get the market for itself longer via the delay?
So, regardless of the delay, the infringer could still argue lack of conception, if that truly applies in this case. Is that not correct?
If it applies, sure. But that depends on all kinds of complicated facts the defendant might not have, and it’s only one possible explanation for the delay. Notably, in this case the rejection was ultimate answered by information that was available at the time of filing, plus caselaw from 1969. It appears the only reason prosecution was delayed was so the patentee could have the market to itself for longer and thereby make more money.
The delay itself is the problem, and the damage, and it should be enough to invalidate or unenforce the patent unless the patentee can show cause why the delay was justified.
In the unpredictable arts, if you don’t have the data showing that your method has the beneficial effect that you are claiming, then there is a compelling argument that you aren’t in possession of the method.
I think the applicable term of art is lack of conception.
“In some instances, such as the discovery of genes or chemicals, an inventor is unable to establish a conception until he has reduced the invention to practice through a successful experiment.” The Regents of the University of California v. Synbiotics Co., 849 F.Supp. 740, 742 (S.D.Cal., 1994) (citing Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206 (Fed. Cir. 1991)).
So, regardless of the delay, the infringer could still argue lack of conception, if that truly applies in this case. Is that not correct?
Lionel If I keep filing continuations then I am simnply losing time on my patent.
The point is that without the delay, you get no patent at all.
I guess that’s what still confuses about this case. In the unpredictable arts, if you don’t have the data showing that your method has the beneficial effect that you are claiming, then there is a compelling argument that you aren’t in possession of the method.
EG: The “egregious” days of the Lemelson “submarine” patents are basically over.
That’s true, of course, but I’m not sure why the court thought it was relevant to this particular case of an actual submarine patent from those days. “We shouldn’t punish this particular wrongdoer, because people don’t do what he did wrong anymore.”
Ned: an infringer who was not prejudiced at all by whatever violation of patent office rules that may have occurred.
Isn’t anyone prejudiced who might want to compete with the patentee during the final 9 years of term? Aren’t those final 9 years the patentee’s true ill-gotten gains, and can it truly be said that those gains did not come at anybody else’s expense?
Ned: But I do not believe they have the authority to specify rules that have the force of law such that their violation would render the patent unenforceable.
So why shouldn’t the Federal Circuit stick to the old Rule 56, if they prefer it as a standard for inequitable conduct?
replace “wold” with “wolf”
Posted by: Anon
Replace Anon with “coward hiding behind a sock”
Paul, I take this case as one more example that the mere violation of patent office rules does not render a patent unenforceable. In this particular case, the defense was asserted by an infringer who was not prejudiced at all by whatever violation of patent office rules that may have occurred. I think the result is quite proper.
I do not think this case stands at all for any proposition that the patent office cannot control patent office prosecution. They can. They can specify rules that are not themselves ultra vires — or a violation of the statutes. But I do not believe they have the authority to specify rules that have the force of law such that their violation would render the patent unenforceable. I think that is just beyond the pale – because that would effectively give them the power they do not have and that is to enact substantive law binding after the patent issues.
“Given the 20 year lifespan from filing I am much less concerned with this delay.”
Lionel,
I concur. In fact, the majority opinion pointed out that the patent applicant was using up its effective term by filing these continuations. And I also agree that if you have “intervening rights” then you have “prejudice” and prosecution laches should apply. The “egregious” days of the Lemelson “submarine” patents are basically over.
No surprise who is championing the “rights” of infringers
No surprise who is championing the “rights” of people who hold invalid patents.
You mean, if the applicant’s widespread publication of data where the PTO can’t/doesn’t search while withholding same from the PTO prompted an inference as a matter of law that the applicant wasn’t trying to hide anything, he just didn’t really understand the relevance of his own publication to his own work?
replace “wold” with “wolf”
No surprise who is championing the “rights” of infringers – everyone’s favorite wold in sheep’s clothing.
Yet one more panel decision that applies a specific intent requirement as follows:
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.
Is there anyone who thinks that McKesson and the other cases that have led to reference dumping would have been decided differently if the requirement for specific intent had been properly enforced?
The allegedly effective cancer treatment that arose out of the instant case was a red herring that appears to have confused the judges.
That happens a lot. Look at Prometheus and Arrhythmia, where the Federal Circuit went on about what a wonderful life-saving treatment the spec described, and then upheld the claims that didn’t actually cover the treatment.
Given the 20 year lifespan from filing I am much less concerned with this delay.
If I keep filing continuations then I am simnply losing time on my patent. I do not get to extend it farther.
I agree with the majority that laches should apply where there are intervening rights. If I keep delaying and in the meantime someone else develops an otherwise infringing product, then my patent should be unenforceable due to laches.
Once again, Newman gets it right.
Good point, Paul. It seems that after the second or third continuation is filed with no apparent good faith attempt to prosecute, the PTO should simply pull the plug.
At that point, the offending party can appeal if it wishes and explain why the delaying of prosecution is not simply for the purposes of delaing prosecution.
The allegedly effective cancer treatment that arose out of the instant case was a red herring that appears to have confused the judges.
I’m troubled by what effect this Cancer Research decision might be argued to have on PTO control over deliberate long prosecution delays by applicants, which has been a serious issue for many years. [The PTO continues to spring some “submarine” patents on the public that have been pending for many, many, years due to multiple serial continuations and other unchallenged and unexcused applicant delays.]
The PTO has always had the inherent authority [and duty] to prevent this, before, above, and beyond the two prior Federal Circuit Lemelson decisions on prosecution laches.* But the PTO has rarely done so.
This decision is troubling for the PTO because clearly knowledge of “intervening rights” requires third party information that the PTO has no access to, and no means to obtain. There is no recognition of that reality in this panel decision.
*This decision does at least reconfirm that in: “In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002),” … “We upheld the PTO’s authority to sanction undue delay under the Administrative Procedure Act, 5 U.S.C. § 706,..”
EG, I reiterate my remarks posted elsewhere that when a patentee extends his term “for business purposes” that purpose is inherently to profit at the expense of potential infringers.
What’s more, this is a pharma case, where we all know that would-be infringers line up to swarm into the market the very moment a patent expires. I don’t think one would have to have a particular infringer in mind before it could be said that one was deliberately depriving potential infringers of nine years of sales.
Prost says in dissent: “Neither the Supreme Court nor this court has required a defendant to establish prejudice to assert prosecution laches.”
That’s not correct. In the 2005 Symbol case, the Federal Circuit specifically pointed to the potential adverse effects on other businesses and intervening rights for upholding the district court ruling that prosecution laches had occurred. Whether Prost likes it or not, “prejudice” is part of the doctrine of laches, including prosecution laches in litigation. That’s made clear by Aukerman, the seminal case on laches.
Also, Symbol makes clear that prosecution laches “should be applied only in egregious cases of misuse of the statutory patent system.” In Symbol, we had the ultimate submarine patent Admiral in Lemelson who thoroughly abused the system. In Bogese, the applicant was specifically warned that if they didn’t provide a substantive response, prosecution laches would be imposed. I see nothing this case that the applicant was given such a warning.
Prost’s statement that the patent applicant was “stalling prosecution for its own business purposes” would have had more traction under Symbol if that “stalling” was for the purpose of snaring potential infringers. But nothing in these facts says that.
Admittedly, the patent applicant “played with fire” and potentially set themselves up for a fatal prosecution laches defense. But the circumstances are simply not “egregious” in the Symbol sense, nor was there “prejudice” specifically to Barr from the delay.
LOLZ Malcolm, – evidence of intent be even more laughable than intent with a world wide publication.
Look – let me set this out for EVERYONE – see, I am intending to HIDE this.
Ya better off chasin your windmills bright boy.
we were speaking about intent here people.
Actually, I was speaking about evidence of intent.
…we were speaking about intent here people.
Keep up please.
“You can get EPO file histories on the internet, you know. No need to disclose those, right?”
Unfortunately you have to because the oh-so-well-trained-and-technically-savvy USPTO examining corps is incapable of looking them up themselves.
But they’re all overworked and underpaid.
Lulz
MB Only on Patently-O can a world wide publication be considered an intent to conceal from the government organization.
I guess when you post something this stoopit it makes sense to use a sockpuppet.
Only on Patently-O can a world wide publication be considered an intent to conceal from the government organization.
So, in court for example, you would argue with a straight face that there was no intent to conceal undisclosed prior art … because it was prior art?
What about inconsistent arguments made before the EPO? You can get EPO file histories on the internet, you know. No need to disclose those, right?
Only on Patently-O can a world wide publication be considered an intent to conceal from the government organization.
Moocow How is publication of the material information in multiple scientific journals consistent with an intent to conceal? How can one even argue that with a straight face?
We’re talking about concealing information from the PTO. If I have put material before the PTO saying “X works great for treating this” and I am publishing in some British journal a report that says “X sometimes works but the side effects make it unsuitable for treatment at the present time”, that seems like an intent to conceal information from the PTO.
A better question is this: would you recommend to a client NOT disclosing a publication with negative or contradictory data to the PTO simply because “it’s published, therefore there is no intent to conceal”? I think that strategy assumes a lot. Certainly it is “risky”, which some commentators here equate with malpractice.
the first brain cancer treatment in decades
Where did you dig this up?
But prior to the change in law, how is it unethical to maximize the protection available under the law in performing as the initial counsel performed?
How can it possibly be unethical to do something legal? I can’t imagine.
“This case is a great example of why the law was changed.”
Fair enough.
But prior to the change in law, how is it unethical to maximize the protection available under the law in performing as the initial counsel performed?
Answer: it’s not.
Do you think that 4-5 years of patent protection is good enough for the first brain cancer treatment in decades,
If it was that special, I’m sure they could have made a pretty penny in 4-5 years. If not, take it up with the FDA. It’s neither the patent system’s fault nor its responsibility that FDA approval took 16 years.
Anyway, since when does the patent term depend on how awesome the invention is? Everybody gets the same term, and it’s up to the patentee to make what money he can before it expires. I’d like to say that you can charge more for curing someone’s brain cancer than for an 18-year supply of coffee, but given the price of coffee these days I’m not so sure.
IANAE – you don’t have sympathy for a drug company that needs an extra 9 years to line its pockets? Why don’t you read the case first? The companies needed 16 years of clinical development before they got FDA approval. Do you think that 4-5 years of patent protection is good enough for the first brain cancer treatment in decades, when you can get 18 years of effective patent life for an espresso machine? Honestly, I don’t care if plenty of other drugs “get by” on the standard patent term. THIS drug didn’t.
Here, though, the applicant was trying to string its application along for as long as it could until it found an investor capable of bringing its drug to market.
Yup. This case is a great example of why the law was changed.
Dan Feigelson: Here, though, the applicant was trying to string its application along for as long as it could until it found an investor capable of bringing its drug to market (i.e. managing and financing the extensive clinical trials required by the FDA, as well as post-approval marketing of the drug to physicians), because the costs involved in developing a new drug product are staggering. There’s nothing wrong with that. As Jason (and the majority noted), had the applicants not had a pending patent application in the late 1980’s (i.e. had they secured issuance in early on), they never would have gotten investment in the first place – no one’s interested in drug patent that going to expire too early.
By that rationale, we should allow any conduct by the patentee that is demonstrably in his own economic interest?
As you appear to recognize, the economic impact of extending the patent term is far more significant in pharmaceuticals than in, say, software. That’s why when there’s a fight over PTA or continuation practice it’s always by someone like Glaxo or Wyeth and never by IBM or Microsoft. For them, even one day sooner is “too early”. That means the public has a correspondingly much greater interest in those last nine years of term.
The patent is not a guarantee that one’s product will make it to market. It’s only a head start. Drugs are expensive to develop, but plenty of other drugs get by just fine on the standard 20-plus-PTA. They make their profit on whatever happens to be left of their term when they hit the market, and it’s usually enough to pay for not only the cost of that drug but all the others along the way that never made it. I don’t have any sympathy for a drug company that “needs” an extra 9 years to line its own pockets.
When I do get to speak to the Judges in FIRST PERSON, I will ask them if hindsight is 20/20, Then think about it why did you even question why I was charged for things, after Loffler tried to hold on to the Claims? Even though he told me to get lost. Maybe he was being threatened by the Japanese Imoshimo Mafia. Any other charge after that was obviously Fraud. And Hal is calling me a LIAR. LOLOLOLLULLLZZZZ.
Why even the letter from Moatz telling me to pound sand that what Tamai did was just tuff tooties. And I still couldn’t get legal help. We shall see. LULLLZZZZZ
How is publication of the material information in multiple scientific journals consistent with an intent to conceal? How can one even argue that with a straight face?
“There’s nothing wrong with that”
Basing your rationale on “money, money, money” is more than just a slippery slope, and one the patent right should not depend on in any degree. Their is no guarantee of money in the patent right.
And waiting for you to bury, steal or deny what I have is no longer a wait and see. I am now just going to DO! Game on!
(?) I hope that was a DC Judge.So he gets a real heads up of what’s coming.
Classic case where “one size fits all” doesn’t work in the patent world. If this had been a software or business method case, I’d agree the patent should be unenforceable for prosecution laches, because in those cases a product embodying the invention can be brought to market quickly. Here, though, the applicant was trying to string its application along for as long as it could until it found an investor capable of bringing its drug to market (i.e. managing and financing the extensive clinical trials required by the FDA, as well as post-approval marketing of the drug to physicians), because the costs involved in developing a new drug product are staggering. There’s nothing wrong with that. As Jason (and the majority noted), had the applicants not had a pending patent application in the late 1980’s (i.e. had they secured issuance in early on), they never would have gotten investment in the first place – no one’s interested in drug patent that going to expire too early. Once big pharma was on board, they moved things along and got issuance in reasonable time. And the world got a new cancer drug that it wouldn’t otherwise have had.
Doesn’t appear to be anything new here. Dennis, am I missing something?
Abraxis BioScience v. Navinta
/media/docs/2011/03/09-1539.pdf
Well it didn’t take too long.
Just three years ago, the Federal Circuit held that the issue of whether an assignment was a present assignment or an obligation to assign was to be decided as a matter of federal law when standing was at issue. In this case, the majority held that as a matter of federal law, a complex series of transactions was only an obligation to assign and that on the date of filing the lawsuit the plaintiff did not have title to the patents. The dissent, in contrast, sided with the District Court in its holding that as a matter of New York law the plaintiff did have legal title, and that the subsequent assignments were only confirmatory nature, in essence urging that the master agreement between the parties was controlling, and it agreement vested title in the plaintiff’s prior to filing the lawsuit.
Obviously, I think this situation has to be resolved by Supreme Court. Just because standing is a jurisdictional issue does not justify deciding that issue based upon federal law as opposed to state law. The obligations of contracts is, under Erie Railroad v. Tompkins, a matter of state law.
I always misspell laches before having to go back and correct it.
Me too (although I’m a little surprised you have very many opportunities to misspell it in the first place). I just enjoyed your unintentional pun when you said “sounds like latches.”
It appears that the issue of “intervening rights” in connection with prosecution delays is an issue of first impression for the Federal Circuit. I am heartened to see that the Federal Circuit extensively reviewed relevant Supreme Court precedent and decided the case consistent with that precedent.
Bravo!
I don’t have any air jxrdans to sell today. 😉
That almost made me choke on my drink. Good one.
Thanks for the link Malcolm.
Dennis may have a different approach, but I tend to only actively moderate comments such as advertisements for shoes, etc.
-Jason
Fair enough, Jason. I missed that it was your post. I don’t have any air jxrdans to sell today. 😉
IANAE – I’ll have to think about the points you raise. I think this public harm issues in this case are particularly complicated (more so than either opinion really discussed), given the underlying questions of whether or not the commercial embodiment would have been created absent the patent or the additional nine years, the timing issues you suggest (i.e.: what is the relevant time period for the laches question), and the possibility that, even under Judge Prost’s approach, future innovator incentives might not be affected given the fact that these types of continuations aren’t available for post-1995 filings.
anything at all that Malcolm has to say
Dennis, I would love to know what merit you find in this crxp.
Speaking of which, I think the oral arguments for Therasense were today or maybe tomorrow …?
Arguments were today, in fact. There is a write-up here:
link to paulhastings.com
I found this interesting:
“Judge Newman pointed out that the public interest resides not only in avoiding enforcement of patents obtained by inequitable conduct, but also in avoiding the “profound” burden on patentees of defending against routine charges of inequitable conduct.”
Was the charge of inequitable conduct in CRT v. Barr Labs “routine”? What about the charge in Therasense? In each of those cases, a district court and at least one Federal Circuit judge was convinced that the patents had been obtained by deceptive intent.
And does “the public” really care about how much patentees spend to “defend” their patents against inequitable conduct? What exactly is “the public interest” exactly in lowering the cost of enforcing a patent by some small amount? Seems to me that “the public” is at risk of being sued every time a patent is issued and the vast majority of “the public” will never own a patent. Relative to the social costs of issuing deceptively obtained patents, the nominal increase in defending against inequitable conduct charges (which most defendants do successfully) seems “profoundly” trivial.
Malcolm – the oral arguments for TheraSense (and also Tivo v. Echostar) were scheduled for this morning.
Dennis may have a different approach, but I tend to only actively moderate comments such as advertisements for shoes, etc.
-Jason
I am going to make a neat little package and hand deliver it.
Dennis, I would love to know what merit you find in this crxp.
IANAE must be DUDAS? Do you want to see my proof? You will anyway. I am going to make a neat little package and hand deliver it. It will also show just how the filter on my computer is different so those that need to see what i am writing don’t see it. BUT THEY WILLLLLLL!
From the majority opinion: Also, Stevens did not selectively withhold information; the withheld information includes both positive and negative data regarding the claimed tetrazine derivatives.
That is beyond pathetic.
Accordingly, an equally reasonable inference to draw from the evidence is that Stevens viewed publication of all the data as important to his career as a scientist but did not appreciate their potential importance to the patentability of the tetrazine derivatives patent claims.
The majority just plain ignores the judge’s credibility findings and uses Star Scientific to substitute its own finding of fact. What a joke.
who waz the jokers prosecutin this app?
In hindsight, they chose the correct approach, didn’t they? Simply delay prosecution on the merits until the desired results are obtained, and then provide the desired results and only the desired results.
A better question might be: which jokerz *don’t* prosecute this way? I mean, do you want a patent or not? Most of the time the dirty laundry is never aired.
Speaking of which, I think the oral arguments for Therasense were today or maybe tomorrow …?
Indeed so. I always misspell laches before having to go back and correct it.
Lulz, sounds like latches to me.
It may sound like it, but it’s not spelled like it. Lulz, indeed.
“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. ”
Lulz, sounds like latches to me. I’ll give em out, and warnings thereof, like candy btches. You stall up my prosecution latches is coming out.
Course in this case, they may have simply made a deal with the examiner.
“Are you flippin kidding?”
I kno right? Who would do this?
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.
I don’t have a problem with the patent never being enforceable. The argument is that the patent should have issued (or not) nine years earlier but for the intentional delay by the applicant. It’s silly to say that without the patent the patentee would never have developed the drug, notably because the patentee fully developed the drug to the point that it was testing on humans before obtaining a patent.
The proper comparison is between a patent timely obtained and a patent obtained with delay, not between a patent and no patent. Had the application been disposed of in a timely manner, it would have been enforceable for its entire term. The harm to the public is the extra 9 years of patent term during which the public would have had access to a generic version of the drug. Unenforceability is an appropriate remedy, and the standard one when the patentee unfairly obtains from the patent office more than he is due.
What I do have a problem with is the idea that prosecution laches is an infringer-specific defense. Prosecution laches occurs entirely between the applicant and the PTO, and its determination should result in unenforceability vel non of the patent. This isn’t a case of a specific defendant relying on the patentee’s delay in suing him personally. Maybe the panel was confused because both of those things are called “laches”.
What’s more, if the applicant was unwilling or unable to advance any evidence at all of utility at the time of filing, perhaps he wasn’t entitled to his priority date.
Equal bashin time – who waz the jokers prosecutin this app?
“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.”
Are you flippin kidding?
Comments are closed.