Dey v. Sunovion

By Jason Rantanen

Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013) Download 12-1428.Opinion.5-16-2013.1
Panel: Newman (dissenting), Bryson (author), O'Malley

Although decided under the "old" version of 35 U.S.C. 102, Dey v. Sunovion has broad ramifications for both current and future patents.  At issue was whether a clinical study – conducted by the accused infringer in this case – constituted an invalidating "public use."  All three judges agreed that the district court erred in granting summary judgment that the study was a public use. Judge Newman would have gone further and granted summary judgment that the study was not a public use.

A Classic Issue With a Twist: In the 1990s and 2000s, Dey and Sunovion both developed pharmaceutical products containing the compound formoterol for treating pulmonary disease.  Both filed for and obtained patents and both conducted clinical trials. 

In a twist on a classic issue, Sunovion – the accused infringer – asserted that its clinical trials were an invalidating public use against Dey's patents because they involved the accused formulation and took place well before Dey's 102(b) critical date.  During Sunovion's clinical trials, participants were given treatments to take home and self-administer twice daily.  Participants were also given some information about the study (but not the specific formulation) and signed a consent form stating that the medications must only be taken by the person for whom it was intended and that they would have to keep usage logs and return unused medications.  Test administrators signed a confidentiality agreement. The district court granted summary judgment in Sunovion's favor and Dey appealed.

The Law of Public Use: On appeal, the Federal Circuit applied the public use framework articulated in Invitrogen v. Biocrest:  "To decide whether a prior use constitutes an invalidating 'public use,' we ask 'whether the purported use: (1) was accessible to the public; or (2) was commercially exploited.'"  Slip Op. at 6, quoting 424 F.3d 1374, 1380 (Fed. Cir. 2005).  Here, the case turned on the "accessible to the public" form of public use, a fuzzy determination guided by the policies underlying the pubic use bar and a multi-factor analysis including "the nature of the activity that occurred in public; the public access to and knowledge of the public use; [and] whether there was any confidentiality obligation imposed on persons who observed the use."  Id., quoting Bernhardt v. Collezione Europa USA, 386 F.3d 1371, 1379 (Fed. Cir. 2004).  The court held that this approach applies equally to alleged third party public uses. 

Against this backdrop, the CAFC reversed the district court's grant of summary judgment of invalidity.  First, the majority viewed the issue of whether the use of Batch 3501A by study participants was "indisputably open and free" as opposed to "sufficiently controlled and restricted" as a factual determination.  "The fact that a tiny fraction of the thousands of vials were lost without penalizing the responsible test subject(s), or that the practicalities of the study required self-administration at home rather than physician administration in a closed facility, does not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted, rather than unfettered and public."  Id. at 9.  Similarly, the issue of the confidentiality obligations imposed in the study was open to dispute.  "Because a finder of fact could conclude that the study was conducted with a
reasonable expectation of confidentiality as to the nature of the formulations being tested, summary judgment on the public use issue was inappropriate."  Id. at 11.  

Public Use or Public Knowledge?: One of the main tensions in determining whether there has been an invalidating public use has long been the question of whether it is the use of the invention in public that matters or whether knowledge of the invention by the public is necessary.   In my classes, I use the classic case of Egbert v. Lippman to start the discussion: is it a public use because Samuel gave the corset springs to Frances without restriction or is it a public use because Frances wore the corset springs under her clothes in public?  Here, the court adopted the former view: what mattered in Egbert was the giving of the corset springs without restriction to the public (Frances), not the wearing of the springs in a concealed manner in public. 

In adopting this view, the majority rejected the approach of  New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1299 (Fed. Cir.2002), which quoted another classic case, City of Elizabeth v. American Nicholson" for the proposition that "the core issue is not public knowledge of the invention, but the public use of it":

The language quoted from New Railhead derives from the seminal “experimental use” case, City of Elizabeth v. American Nicholson Pavement Co., 97 U.S. 126, 136 (1877), and it makes good sense in that setting: During experimentation, the public might have knowledge of an invention (because they see it), but may not be using the invention within the meaning of the statute (because the inventor is experimenting).4 As for Egbert, although the invalidating use in that case was not visible to the general public, the case turned on the lack of control the inventor maintained over his invention.

4 In New Railhead, the invalidating public use took place at a public commercial job site, with the knowledge of the patentee inventor. 298 F.3d at 1293, 1298. “Commercial exploitation is a clear indication of public use,” even absent separate consideration of public accessibility,
Invitrogen, 424 F.3d at 1380, and “secret commercialization” by a third party is not public use, even if it might have resulted in forfeiture were the third party the one filing the patent application, W.L. Gore, 721 F.2d at 1550.

Slip Op. at 14-15. 

Consequences for Arguing the Issue of Public Use: One major consequence of this opinion is that is makes the argument against clinical trials being public uses much easier and simpler.   Rather than attempt to deal with the complexity of arguing that a clinical trial falls into the experimental use exception to public use (a challenging task, given Federal Circuit precedent over the last decade), Dey provides an excellent grounding for the argument that many clinical trials are not public uses at all. 

50 thoughts on “Dey v. Sunovion

  1. What do you think eBay touched on, the right or the remedy?

    Simple question, answer, please do provide.

    No “lengthy answer” required. Choose one word or the other – dazzle the readers here with your grasp of U.S. law.

  2. OK. No idea what is blocking my substantive post. I cannot see in it any naughty words. In frustration, I give up.

  3. How would your confusion be ‘determinative?’

    Even if you are confused, you might be able to reason from the simple answer to the simple question.

    Try it.

    Can we see a plain and direct answer from you? One that easily disposes of your attempt to obfuscate things by bringing in an inapposite case, on ethat needs no such ‘reconciliation’ for the point at hand.

    But then again, we both already knew that, didn’t we?

  4. Simple question. Agreed. But what I happen to think about it is not determinative for you, is it, if I’m as you say, confused.

    If you know I’m confused then you know the answer already, to your simple question.

    By the way, I’m still interested in your notion of a “Constitutional Directive”. Are you going to tell me how to reconcile it with eBay and its progeny?

  5. At least one of us indeed confused, MaxDrei.

    What do you think eBay touched on, the right or the remedy?

    Simple question, answer, please do provide.

  6. At least one of us is confused. We can agree on that, anon.

    Remedies: injunction, damages, account of profits, costs, order for deivery up, etc etc.

    Right: right to relief from damage, right to a reasonable royalty, or a right to exclude.

    Is the right a matter of discretion Y/N? Is the relief a matter of discretion Y/N?

  7. Ah yes, anon, the Constitutional Directive, that exclusive right.

    You know, I did think I got that. If you go to trial and your claim is found to be infringed and not invalid, you are entitled to enjoin the proven infringer. That is still the case where I sit.

    But then you had the EBay case, so now I am not at all sure that I “get” what “exclusive right” (or “directive”) means to you.

  8. You really do not get the Carrot AND Stick approach of U.S. jurisprudence, do you?

    You really do not get the constitutional directive of exclusive (and not only to exclude, but to whom that decision to exclude belongs to), do you?

    A mind open to understanding would have absorbed these simple lessons, but wait, this is MaxDrei, and he has a pretty soapbox he wants to climb up on: “be like EP”

    For lay people here, the opposite is what seems a nonsense and unfair, and the ass is those who want to go against the constitution (as has been traditionally understood). Astonishing yes, but not in the way that you think.

  9. What a great case to use as a template for discussing the changes brought in by the AIA, and the extent to which the AIA brings harmony between USA and ROW.

    Seems to me the District Court baulked at a finding that the prior use leaves untouched the novelty of the Claims. For lay People it would seem a nonsense, and unfair, and something that renders patent law a ass, that a party can be enjoined from continuing in good faith with the commercial use in EXACTLY the form it had already borought as far Forward as clinical Trials, even before the date of the claim.

    If this case had been decided under the AIA, the result in the USA and in Europe would have been the same. Right of continued use, yes. Claims novel, yes.

    I think it astonishing, that these Prior user questions are still open, even up to the moment the 1952 Act gets displaced.

  10. So why isn’t a clinical trial clearly an experimental use?

    In certain circumstances related to preparing information for an FDA submission, a public “experimental use” remains a defense to excuse acts that would otherwise be infringing. But if the issue is invalidity (the focus of this case) and the prior use is deemed to be “public” for the purposes of satisfying 102(b), whether that public use was “experimental” or not is moot.

  11. Why would a patent already be granted for something that needs experimenting to see if it has utility?

  12. So why isn’t a clinical trial clearly an experimental use? The whole thing is an experiment to see whether the drug works safely for the use.

  13. I was the first one on these boards to affirm that I post in a purely personal mode

    Weirdest. Blogtroll. Ever.

  14. LOL – you say I do not get these cases, but you cannot refute the points I make. I was the first one on these boards to affirm that I post in a purely personal mode – something you have never done (not could you, ethically).

    Your protest here rings hollow and completely ineffectual.

  15. Ned,

    My position is correct fully resting on the way the statute is written. Again, I reference you to how the NEW title of 102 is ACTUALLY written.

    Even for a Court that likes to find implicit words, rewriting a statute to add words directly taken out would be more than difficult (witness why Stevens lost his majority position in Bilski for example).

  16. anon, you know you still do not get Golan, just as you do not get Benson, or Alappat or Pennock or for that matter any other case.

    I know the reason why, too.

  17. annie, I think you are talking about the patentee’s owns tests. I don’t know why the experimental use exception should not apply.

    If you are talking about something else, please clarify.

  18. anon, at times the courts have been known to construe the statutes the way they are written as opposed to the self-interested statements of a few senators or their ghost writers.

  19. In the 007 movie Quantum of Solace, Bond was all for-moterol, he gave a can of it to Mr. Greene as he was sent out into the desert – but they said moterol was found in his stomach, not his lungs . . . .

  20. Shall?

    Ned – look now. What does the title, the new title of 102 say? What did it say?

    This is no accident. This was an intentional act of Congress.

  21. A non enabling “public use” is not prior art.

    That has been the law since the SC first considered the matter 200 years ago.

    This is equivalent to saying, in my view, that if a product does not disclose its specifications, its compositions, or methods of manufacture, and it is those things that are claimed or that are necessary to make and use, then the invention itself is not in public use even though it might be commercially exploited.

    Take the example of Coke one more time. Just because Coke is known, no one really knows how to reproduce it. The Coke product is non enabling, allowing, in my view, others to figure out how to reproduce Coke and to patented it.

    Now, some might say that give enough time and effort that the Coke formula might be discovered by reverse engineering. But I think that there has to be imposed on this concept some reasonableness. If it would cost the price of the Apollo program to accomplish this, I would submit such an effort is unreasonable and the later discovery of the formula by another should be eligible for patenting over the practically non reverse-engineerable Coke product.

  22. No Ned, I will not forget Golan for a second – that’s the point of the comment above.

    Why don’t you join in on the conversation about the point at hand? Engage in something other than ‘platitudes,’ for a change?

  23. 102 has been completely rewritten – with notice and intent from Congress. Even the title removing the personal bars has been scrapped.

  24. Anon, forget Golan for a second, and consider a non enabling “public use.” It it a public use in the first place if it does not really disclose the invention?

  25. LOL – figured it out just in time for 102 to have changed and recodified with the AIA and the personal bar to be removed.

  26. Learned Hand understood what the Federal Circuit today holds long long ago. Cf., Metallizing.

    An on sale bar is personal and not prior art to third parties. Public use is prior art and therefore invalidating to all. In order to be prior art, the prior use must be public. Pennock v. Dialogue. Confidential use is not public.

    It is a wonder that the Federal Circuit was ever confused on this point. It is good that they have figured it out.

    Regarding the Supreme Court case of Egbert V Lippmann, there is also a complicating factor that it was the patentee himself that was “using” the invention for its intended purpose. Whether the use was public or not is beside the point when the uses by the patentee. It is a bar if the use is not experimental.

    Thus I think the take that Dennis gives on this case is slightly misleading because he fails to take into consideration that the use was by the patentee. In the case of Pennock v. Dialogue, the Supreme Court made clear that any use by the patentee for the patented purpose was a public use within the meaning of the law. Congress in 1836 codified this case by adding “on sale” to the statute. Judge Learned Hand clearly understood what this case stood for in his holding in Metallizing when he said that third-party non-public use was not prior art, but use by the patentee was “prior art” to the patentee, making it a personal bar.

  27. Here, the situation is far less egregious

    …so Congress can eliminate this public domain constraint from patents if it so chooses…

    Is that what you are saying? (and yes, I recognize that such has not been actually chosen – I am just looking now at the possiblity that such could be chosen)

    Or are you saying that the policy of discouraging the removal from the public domain is still in full force (which clearly goes against what Golan teaches)?

    You cannot bend this particular nose of wax in both directions.

  28. No contradiction. Golan was about whether or not Congress can amend the copyright laws to temporarily remove from the p.d. something that was in the p.d. SCOTUS said it can. Here, the situation is far less egregious: Congress specifically said that public use means something isn’t patentable; but by wording it that way, it implied that in certain circumstances, a use isn’t considered public and therefore doesn’t negate the possibility of a patent.

  29. Still good law in light of Golan😕

    We have explained that the policies underlying the public use bar inform its scope and that one such policy is “discouraging the removal, from the public domain, of inventions that the public reasonably has come to believe are freely available.” Tone Bros., Inc. v. Sysco Corp., 28 F.3d 1192, 1198 (Fed. Cir. 1994).

  30. The slippers are MM’s line of comfort in using an anonymous name. Once in a while he jumps out from his anonymous positions and attacks, but then retreats back behind his slippers.

Comments are closed.