Supreme Court Expected to Determine Whether Early Drug Research Necessary for FDA Approval Can Constitute Patent Infringement.
Merck v. Integra LifeSciences, U.S. Supreme Court (Case No. 03-1237).
The appeal to the Supreme Court questions the limits of the safe harbor statute (35 USC 271(e)(1)) that permits a drug manufacturer to perform experiments needed to obtain FDA approval of their drugs without incurring liability for patent infringement, even if their activities infringe other’s patent rights.
Under the Fold: The Drug Price Competition and Patent Term Extension Act (Hatch-Waxman) created a safe harbor that permits drug manufacturers to perform the experiments needed to obtain FDA approval of their drugs without incurring liability for patent infringement, even if their activities infringe others patent rights.
However, the statute, codified at 35 USC § 271(e)(1), was limited by a 2003 decision by the Court of Appeals for the Federal Circuit. The Federal Circuit affirmed a lower court’s finding that the safe harbor against patent infringement does not apply to pre-clinical activities to identify and develop new drugs that will eventually be subject to FDA approval — and thus, that Merck was liable to Integra for patent infringement.
The Case: Integra alleged that Merck and Scripps infringed patents owned by Integra relating to peptides involved in interactions between cell surfaces and the extracellular matrix. Under contract from Merck, Scripps identified several potential anti-tumor peptide candidates and selected the most promising peptide by conducting in vivo and in vitro experiments to evaluate the specificity, efficacy, and toxicity of the peptide candidates for various diseases. Scripps also performed tests to assess the histopathology, toxicology, circulation, diffusion, plasma half-life, and proper mode of administering of the peptides candidates.
The Appeals Court held that these activities did not fall under the safe harbor (§ 271(e)(1)) because they were not done "solely for purposes reasonably related to the development and submission of information" to the FDA.
"the focus of the entire exemption is the provision of information to the FDA . . . [a]ctivities that do not directly produce information for the FDA are already straining the relationship to the central purpose of the safe harbor." (CAFC Opinion).
"Expansion of § 271(e)(1) to include the Scripps-Merck activities would effectively vitiate the exclusive rights of patentees owning biotechnology tool patents."
Supreme Court:
Merck has now appealed the case to the Supreme Court of the United States, petitioning the High Court to hear the question:
Under 35 U.S.C. 271(e)(1), it is generally not an act of infringement to use a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law” regulating the manufacture, use, or sale of drugs. The question presented is whether the court of appeals erred in limiting that exemption to clinical studies designed to provide information for Food and Drug Administration approval of a new drug.
On request from the Court, the Solicitor General of the U.S. submitted the Government’s view that the case should be heard. The Government brief makes two major points, one legal and the other social:
Gov’t Brief: The decision of the court of appeals reflects an incorrect view of the law, and is likely to restrict significantly the development of new drugs. Fairly read, the decision below holds that “pre-clinical” research regarding a potential new drug is not protected by the FDA exemption because that exemption is limited to “clinical” research necessary to obtain ultimate FDA approval of a new drug. That holding is inconsistent with the text of the FDA exemption, reflects a mistaken and unduly narrow view of the types of information relevant to the FDA’s two-step process for evaluating potential new drugs, and is in tension with this Court’s decision in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990). Moreover, the court of appeals’ decision poses a direct and substantial threat to new drug research by dramatically narrowing the scope of protections enacted by Congress in Section 271(e)(1). Although this case is not an ideal vehicle for considering the issue, see p. 18, infra, the potential impact of the court of appeals’ legal conclusion is sufficiently important that the petition for a writ of certiorari should be granted.
Eli Lilly and Co. was also granted leave to file a brief as amicus curiae in the case. Justice O’Connor and Justice Breyer took no part in the consideration or decision of the petition for writ of cert. It is reported that both Justices own stock in Merck.
Academics Take Sides: Judge Richard Posner (In Lessig Blog) has advocated the creation of a fair-use exception for patents on research tools:
Link: For example, a generic drug manufacturer is permitted to use the patented drug to demonstrate that its generic equivalent is indeed therapeutically equivalent (the "testing" exception created by the Hatch-Waxman Act). More broadly, an inventor can use the information in the patent to try to invent around the patent. And Landes and I advocate an expansion of the patent fair-use principle to allow scientists to use patented research tools (such as the oncomouse) without license–provided the scientists aren’t allowed to use the tools to produce their own patented products!
In response, Lichtman has noted that Judge Posner’s proposal "is problematic for the simple reason that, often, the key market for research tools is to sell those tools to other researchers. If a researcher’s use of patented research tool is fair use, that would significantly degrade the incentive to create those research tools inthe first place. Moreover, even if your approach works, it is in sharp conflict with the Bayh-Dole instinct that society might very well be better off in a world where academic researchers patent their work. As you know, that legislation was passed in response to evidence that university breakthroughts were sitting on the shelves both because (a) they could not be owned exclusively under old NIH rules; and (b) universities had too little incentive to bring their work to the attention of industry."
Links:
- AP Article by Hope Yen
- Supreme Court Website
- APLF Article on the Federal Circuit Decision
- Noonan, Greenfield, and Zuhn, Paradise Lost: The Uncertain Future of Research Tool Patents, 15 INTELL. PROP. & TECH. L.J. 1 (2003).
False Marking: The Supreme Court has denied certiorari in PubPat’s False Marking case. PubPat had challenged the AIA’s retroactive rejection of non-competitor qui tam suits for false marking. Public Patent Foundation, Inc. v. McNeil-PPC, Inc., Sct. No. 13-161.Prior Art Presumed Enabling: The Supreme Court has denied certiorari in the Finjan’s challenge to the PTO’s presumption that prior art is enabling. Finjan, Inc. v. U.S. Patent and Trademark Office, Sct. No. 12-1245.Good.
Subject Matter Eligibility: The Supreme Court has denied certiorari in the § 101 case challenging PerkinElmer’s patented “method for determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome.” Intema Ltd. v. PerkinElmer, Inc., Supreme Court No. 12-1372.I think PE’s claims should probably have gone down under a careful application of Prometheus. I’m guessing the Supremes saw that it was more of a dispute about facts and claim construction than anything else so they decided not to disturb the nightmare further.
Oops, I got this case confused with Aria Diagnostics (Fed Cir 2013; also a Downs detection case) where the case was remanded down by the Federal Circuit so the district court could reconsider whether a preliminary injunction was appropriate. Anyone know what the status is? I didn’t believe the preliminary injunction should be granted in Aria but I’m not sure what the judge decided. [update – the new hearing on the prelim injunction doesn’t look like it’s going to happen until January 2014 at the earliest]As for this Perkin Elmer case: the Federal Circuit got it right, and so did the Supremes.
link to patentdocs.org…Wherein the eligibility issue in this case is patiently explained to people who do not want to understand.
wherein the subject matter issue is reduced to nonsense by a person that doesn’t understand squat about information processingwherein the subject matter issue is resolved by a judge psychotically reciting the elements in the claim and ascribing whatever meaning pops into his head to the elements and chanting “does not add any structure… .”
wherein the subject matter issue is reduced to nonsense by a person that doesn’t understand squat about information processingThe only “information processing” in the claim is a mental step.does not add any structureThe only “information processing” in the claim is a mental step.
The only mental step is the one the Judge took. The machine is processing information which takes time, space, and energy. And is being processed by a MACHINE (not a brain.)And, let’s not forget that the Judge merely imagined how the machine would perform the step and did not perform the step himself.You love your little ’round and ’round games. It looks as though you either tired out anon or anon has been censored. I’d guess you tired him out like you have all the rest. My favorite was what’s her name? You remember her. The one that beat you to a pulp daily for about a year.I wonder when you will get your next admirer.
The machine is processing information which takes time, space, and energy.I don’t think we’re talking about the same case. What “machine” are you referring to?let’s not forget that the Judge merely imagined how the machine would perform the step and did not perform the step himself.What in the world are you talking about? Judges have to perform the claim steps in order to opine on them? What?My favorite was what’s her name? You remember her. The one that beat you to a pulp daily for about a year.I think you need to take a nap for a while. You’re losing it.
“I don’t think we’re talking about the same case.”Obviously not, NWPA was plainly ranting about some different case from the get go.
Plainly.
Plainly.Which case you were ranting about, and why did you choose to rant about it in response to a discussion about Perkin Elmer v. Intema?
NWPA,While a Crybaby Veto is most definitely in effect, I am also hampered by the new posting system (Disqus is not approved past my firm’s blocks and my iPhone browser will not work with allowing posts through Disqus either).But also in the category of things that make you go hmmm…:Malcolm continues (largely) unabated in his poor blogging techniques.It is true that some of the more egregious comments have been blocked – but it is interesting that I am followed by the moderator while Malcolm is not.Also, have you clicked on the little ‘community’ hyperlink? Note that in addition to Malcolm making his moniker ‘private’ which prevents anyone from seeing the list of his CRP, somehow he is not even listed as a community member. And yet, hoover over his icon next to his post and you can see that he has over 200 comments (and you can also see he has no followers). Malcolm tried a rather feeble attempt at deflecting the ‘private’ setting, and then descended into his rather typical Vinnie Barbarino “Huh, what?) ‘conversation’ mode.Also realize that only one single person has ever posted a hyperlink (now on the old threads which still have not been restored – but that’s another point) that took you to an internal comment location – which uses a website’s internal tags.Given the rest of the story, you can draw your own conclusions.
it is interesting that I am followed by the moderator while Malcolm is not.Right. And your firm’s issues with disqus and your iPhone settings were known prior to the change. Think about that for minute.
Nothing in anon’s post suggests that he thought that Dennis went to disqus to prevent anon from posting.
That petty shot was being ignored.
Maybe you don’t get listed as a community member because you are private?Maybe MM is not followed by Dennis because he is private.But, I agree that there is a definite possibility that MM is Dennis. But, I don’t believe that just because MM can be vulgar and write racial epithets. I don’t think Dennis would do that even under a nom de guerre.Although, one disturbing aspect of MM is that he does make horrible threats that appear to be threats of trying to hurt one beyond this board.My bet would be that MM is someone that Dennis knows and socializes with on occasion.
Oh, I do not think Malcolm and Prof. Crouch are the same person.And the private setting is not a ‘community’ filter, as Malcolm (and Leopold, the other main user who has that setting) were both listed in the community until recently (so it is something beyond the private setting) and Leopold is still listed.My beef with Malcolm is not his ‘threats,’ nor even his opinions. My beef is his intellectual dishonesty and the misstatements of facts, the misstatements of law, the misstatements of what others posts, his strawmen, his obfuscations, his dissembling, and his accuse-others-of-that-which-he-does. His admissions against interests prove that he knows that what he does is done fully knowingly and fully purposefully.
I agree completely with your post anon.
His admissions against interests prove that he knows that what he does is done fully knowingly and fully purposefully.Remember, Trollboy: try not to act like a “crazy person”. I know it’s difficult. But try real hard.
How does vacuous name-calling fit into a norm for discussions?
How does vacuous name-calling fit into a norm for discussions?You tell me. You were the one who popped off about my alleged “admissions against interest” and “intellectual dishonesty.”So go take a flying you know what at a rolling donut, you hypocritical ass.
How does vacuous name-calling fit into a norm for discussions?You tell me, TB. You were the one who popped off about my alleged “admissions against interest” and “intellectual dishonesty.”
MM can … write racial epithets.What in the world are you talking about?
Malcolm tried a rather feeble attempt at deflecting the ‘private’ settingHuh?
“And is being processed by a MACHINE (not a brain.)”There it is again: anthropomorphication.Plain and unassailable fact: machines do not think.Elsewhere Malcolm admitted that he thought machines really do think.Recently he modified that to call machines a ‘proxy’ for humans and human thinking.The problem that he has not addressed is that such a ‘proxy’ is fully patent eligible under the plain words of US patent law.The problem that he has is that mental steps, let alone ‘proxies’ of mental steps, are fully allowed as elements in a patent eligible claim. Witness how he perpetually attempts to twist any conversation on this point into a strawman of a claim comprised only and fully of mental steps – something that no one but he advances.He is not interested in a conversation that acknowledges and integrates this fact. He is not interested in a conversation at all. He is only interested in his soapbox.
“And is being processed by a MACHINE (not a brain.)”There it is again: anthropomorphication.You seem unaware that you are quoting NWPA (not me) and NWPA is talking about a completely different case (which one? who knows?) than the Perkin Elmer case, which does not recite an information processing machine.
The case that scares me the most is the Sony case that challenges Therasense. But, the Supreme Court could go a long way to helping the bar by clarifying inequitable conduct is an equitable doctrine founded in fraud, and that an element of fraud is that one through intentional, as opposed to negligent, misrepresentation obtained something he did not already have a right to obtain. This would permit, I think, a showing of lack of intent, or a lack of harm or the lack benefit. If a claim would have issued regardless of the alleged fraud because the claim is patentable, then there is no harm and no benefit. (E.g., I steal a car, but it turns out to by my own car.)In this view, the actions of the PTO in mandating certain disclosures cannot be enforced by holding the patent unenforceable, as this would effectively allow the PTO by rule to make law that is binding after the patent has issued, and this power they do not have.My fear, of course, is that the Supreme Court may find Rule 56 so enforceable.
“obtained something he did not already have a right to obtain.”I think you need to re-read the defintion of fraud my brosef.
6, I’m all ears. Please refer us to the Supreme Court case you had in mind.
Or you could just re-read the definition of fraud. Is your google button stuck or something?
6, did you have a point?Sent from Windows Mail
It is more of a suggestion than a point.
I think, a showing of lack of intent, or a lack of harm or the lack benefit. If a claim would have issued regardless of the alleged fraud because the claim is patentable, then there is no harm and no benefit. (E.g., I steal a car, but it turns out to by my own car.)I see a distinction between your example and the obtaining of a patent. As you note, when you “steal” your own car (by accident, because you meant to steal someone’s else’s car), there is no harm and no benefit. That’s because you already own the car. You owned it before you acted. You own it after you acted.In contrast, you don’t own a patent until it’s granted by the USPTO. Why should patents be granted to people who intended to deceive the PTO during prosecution and who acted with that intent, just because someone came up with a later argument (after the patent was granted) that “it wouldn’t have mattered anyway”? I’m referring to a case where there is evidence and testimony that (1) convinces a jury (or judge) that information was intentionally withheld or intentionally misrepresented to the PTO and (2) convinces a jury (or judge) that the patent “would have issued even had that evidence been presented because blah blah blah.” Why should the patent still be deemed enforceable under those circumstances? What policy is being promoted? It’s not the policy of deterring inequitable conduct, that’s for sure.Speaking of which, have you noticed the increasing calls for Rule 11 sanctions against patent trolls lately, even by the “pro-patent” folks? As the preferred solution relative to increased regulation? That seems rather strange given all the talk about “plagues” and “why can’t we all just get along?” when it came to the inequitable conduct defense.
You make a good point on intent. I’ll think about it.Sent from Windows Mail
Thanks!
Perkins Elmer is an interesting case where they went ahead and invalidated the claims under 101. IMO the court got that one right. link to cafc.uscourts.gov…
Agreed.
Any update on the request for the Solicitor General’s opinion in the Akamai v. Limelight case? How long does it usually take to get the SG’s input?
Dennis, the statute put the discretion, I believe, in whether to award attorneys fees when the case is exceptional. Whether it is exceptional seems to be without discretion.Now, the contrary view would be appropriate if the statute read,”the court may, in its discretion, find a case exceptional and award attorneys fees.”
The copyright holder in the case is Paula Petrella whose father Peter Petrella wrote two 1970s screenplays (one titled The Raging Bull) and a book about the life of boxer Jake LaMotta. A few years later(1980), Raging Bull became an Oscar winning movie. In 2009, Petrella sued MGM for copyright infringement. And 2009 was the first time Petrella or his estate ever asserted his copyrights against MGM? That is rather … odd. Seems like someone just wants a piece of MGM’s pie. Why would they wait so long?According to Scorcese, Robert De Niro gave him a copy of Jake LaMotta’s book “Raging Bull” (co-authored by Pete Savage and Joseph Carter) circa 1973-74, while Scorcese was filming Alice Doesn’t Live Here Anymore. LaMotta’s book was published in 1970 and the authors of that book were paid for the movie rights. Paul Schrader (among others) had written a script based on LaMotta’s book and Scorcese and De Niro re-worked Schrader’s script.
“Undoubtedly, the Supreme Court will reverse in Highmark and the reasons are well understood by the Federal Circuit judges.”That’s a pretty strong opinion, there, Dennis, but I’m not sure I’m following you. Why is there no doubt here?
I agree regarding the strong words. The problem with the Federal Circuit’s decision is that it gives no deference to the district court determination.
And 6 of 11 Federal Circuit judges said that this was OK, or at least not important enough to convene an en banc panel? I guess I should read the case…
Oh, and by the way, whatever you’ve done, keep doing it. The discussion on these boards has been much improved over the last week!
Such ‘improvement” is so very PC.I find it very interesting to note that the ability to hold posters accountable for what they say has been denigrated with the new software (the archives have yet to be restored, and the floating date notation prevents pinpoint citation to explicit remarks) and ‘procedurally’ (facts are viewed as ‘attacks’ and a clearly uneven application of ‘norms’ is in effect).I also find it interesting that only two people so far have chosen to make their monikers ‘private’ and thus block an easy way to see what exactly they have said.Take a guess Leopold as to just who those two posters are.I still find the irony of the exchange between Ned Heller and Prof. Crouch delicious: <ul>”“routine liars… I would point to their lie. Rub their noses in it like one does with a dog. Then I would expel them from my office with some intentionally rude remark.â€â€œNed is right to some extent – the beauty of our adversarial system of laws is that each side has a strong incentive to uncover any misstatements by their opponents.â€It appears that the beauty of (ad nauseum repetition of) drive-by rhetoric without ‘attacks’ for misstatements separates the ‘norm’ for blogs from a basic practice of law. Yes, your ‘version’ of ‘much improved’ is duly noted.</ul>
facts are viewed as ‘attacks’ and a clearly uneven application of ‘norms’ is in effectI haven’t noticed. Exactly what “facts” are viewed as “attacks” and what “norms” are being applied unevenly?
“I haven’t noticed”Yes, you have.
“I haven’t noticed”Yes, you have.Patent Jeebus now telling other people what they “actually” think! Bow down! Is there not limit to Patent Jeebus’ magical powers?Seriously, I have no idea what you are trolling on about. You wrote: “acts are viewed as ‘attacks’ and a clearly uneven application of ‘norms’ is in effect”. So tell everyone exactly what “facts” are viewed as “attacks” and what “norms” are being applied unevenly. Or is it the case that you are just full of cr*p and flinging insults at everyone “who deserves it” (which is everyone who disagrees with you about anything)? Just clear the air, TB. Try letting everyone exactly what you are talking about instead of ranting like a crazy person. Give it your best try.
Can you really be that obtuse to ignore the conversations that we have had, and to attempt to accuse me of something we both know you know?That you choose to do so is one thing. That you choose to do so in a religiously offensive manner sinks below any objective ‘norm’ for conversation.
I also find it interesting that only two people so far have chosen to make their monikers ‘private’Why are you reluctant to name them?And are you sure that you checked “everybody” who’s posted here so far?
Why do you attempt to spin this as ‘reluctant?’ That is so very accuse-others-of-that-which-you-are.And yes, I did check each of the posters on top posters list when I made that post.So Malcolm, why are you so concerned with secrecy of what you post?
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