Genetics Institute v. Novartis Vaccines

By Jason Rantanen

Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc. (Fed. Cir. 2011)
Panel: Lourie (author), Plager, Dyk (dissenting in part)

The Science: In the 1980's, scientists raced to develop a truncated version of Factor VIII, an essential blood-clotting protein.  Two companies, Genetics and Novartis, successfully developed and patented truncated versions of this 2,332 amino acid protein.  Genetics' patent, with a 1985 priority date, included claims directed at a version of the protein that removed between 581 and 949 amino acids in the region between amino acid 740 and 1690, while Novartis's patents, with a 1986 priority date, retained amino acids 1 to 740 and 1649 to 2332.  The retention of amino acids 1649 to 1689 later turned out to be significant because this range binds to von Willebrand factor ("vWF"), an association that is critical for the optimal regulation of the blood coagulation.

Procedural Background: In 2008, Genetics sued Novartis to determine priority of invention under 35 U.S.C. § 291.  Novartis argued that the district court lacked subject matter jurisdiction because the PTO's extension of the patent term from 2006 to 2010 under 35 U.S.C. § 156 applied to fewer than all of the patent claims, and that there was no interference-in-fact.  The district court rejected Novartis's jurisdictional challenge but agreed there was no interference.

Appellate jurisdiction: Seeking to terminate the appeal at the outset, Novartis contended that the CAFC itself lacked subject matter jurisdiction because the Genetics patent expired three days after the district court's entry of judgment.  None of the judges were persuaded.  Distinguishing an earlier case in which the court held that it lacked subject matter jurisdiction because of a claim disclaimer, the CAFC held that the expiration of Genetics' patent "following the district court's final decision does not strip our court of jurisdiction over the present appeal." 

Section 156 extension applies to the entire patent: The panel likewise affirmed the district court's finding of subject matter jurisdiction, rejecting Novartis's argument regarding the scope of the patent term extension.  Although Section 156(b) limits the effect of the extension, it does not limit the extension to specific claims.  "A patent as a whole is extended even though its effect may be limited to certain of its claims."  Slip Op. at 17 (emphasis added).

No prima facie case of obviousness: To determine whether an interference-in-fact exists, courts apply a two-way validity test, i.e.: whether the claims of one patent invalidate the claims of the other and vice-versa.  Both directions must be established.  In this case, the court focused on whether the claims of Genetics' patent rendered obvious the claims of Novartis's patents. 

Judge Lourie, joined by Judge Plager, concluded that they did not, as the lack of any reason to create a truncated protein that incorporated the 1649-1689 region supported the district court's finding of no prima facie case of obviousness.  Any motivation, they reasoned, would have been in the opposite direction – to create a shorter protein and eliminate more amino acids, not to create a longer protein.  Nor was the mere existence of a cleavage site (a natural point for cutting proteins) sufficient to provide the requisite reason to cut the protein at that point to make the claimed truncated protein.

Judge Dyk disagreed, pointing to cases holding that structural relationships may provide the requisite reason to modify compounds and can give rise to a case of prima facie obviousness.  "[T]he truncated Factor VIII proteins of the Novartis patents are not merely homologs, analogs, or isomers – they are all variants of the exact same protein, exhibiting the exact same procoagulant functions."  Dissent at 5 (emphasis in original). 

The use of post-invention "unexpected results": The majority further supported their conclusion by citing to the unexpected result of the 1649-1689 region binding to vWF.  The problem, however, lay in the lack of appreciation of this role until well after the priority date of Novartis's patents.  Undisuaded, the majority pressed on, holding that such evidence was nonetheless relevant to nonobviousness: "[E]very property of a claimed compound need not be fully recognized as of hte filing date of a patent application to be relevant to nonobviousness."  Slip Op. at 29.  In other words, "evidence of unexpected results may be used to rebut a case of prima facie obviousness even if that evidence was obtained after the patent's filing or issue date."  Id.

Again, Judge Dyk disagreed.  "The majority's finding of nonobviousness is based entirely on hindsight and happenstance, and not on what the inventors knew at the time the Novartis patents were filed.  See 35 U.S.C. § 103(a) (stating that an invention cannot be patented if 'the subject matter as a whole would have been obvious at the time the invention was made')."  Dissent at 10 (emphasis in quotation).  In Judge Dyk's view, the "unexpected properties must either be set forth in the specification or contemporaneously known to the inventors, rather than being discovered long after the fact."  Id. at 12.

Judge Dyk's citation of Section 103 notwithstanding, it seems reasonable to look to post-filing or issuance evidence with respect to at least some secondary indicia of nonobviousness.  Commercial success, for instance, would be difficult to establish if only pre-filing evidence were able to be considered.  But I think he's right on the question of unexpected results.  In my mind, a valid distinction can be drawn between discoveries of unexpected results – which really go to the fundamental question of obviousness – and commercial success, which must necessarily rely on the invention's post-filing success in the marketplace.

Practice note: Infringement defense attorneys writing discovery requests may want to take note of the majority's holding on unexpected results to press for either post-filing/issuance discovery on this point or a stipulation that such evidence will not be relied upon by the patent holder.

  

41 thoughts on “Genetics Institute v. Novartis Vaccines

  1. BTW, Jason was incorrect in his assertion that evidence of commercial success must necessarily rely on the invention’s post-filing success in the marketplace.

  2. “Because there are too many invalid patents issuing, or not enough?”

    Just to be the devil’s advocate here.

    What is wrong with creating a patent policy primarily based on its economic impact, and not based on whether or not the policy makes logical sense? Isn’t the economic impact the final goal? If the patent policy achieves the desired economic goal, isn’t that sufficient?

    I’m just curious to find out what people think…

  3. “But proceed anyway, because the process you will go through will reveal some of the ways in which the current formulation of obviousness is inadequate to support this task, and that revelation by itself has value, for the lack of a coherent and logical formulation of obviousness is one of the greatest fundamental deficiencies in patent law today.”

    I think you are being way more optimistic than I can ever be.

  4. IBP the lack of a coherent and logical formulation of obviousness is one of the greatest fundamental deficiencies in patent law today

    Because there are too many invalid patents issuing, or not enough?

  5. Now I get it JD. You S@iT on mine so you could steal it with the other side of the Oreo. And who ever you sold it too helped Sh@t on mine so they could have something valuable that they could file elsewhere.
    So JD I now know what you and him did along with the wonder boy that makes sure what he Steals is worthless in a court of law. Oh but the inequitable Conduct in getting it from me, and the fact that I was PROSE! I don’t think you are going to get away with it JD!!!!!!!!

  6. I’m not going to go into this at length like I usually do, unless somebody asks specifically.

    Suffice it to say that given the current understanding of “obviousness” that has emerged from the jurisprudence, this discussion will dead-end with disagreement over the fundamental nature of obviousness itself, even if disagreements over S-M and timing are satisfactorily resolved.

    The real issue here is one of how the most basic rules of evidence determine what is and what is not evidence regarding a non-obviousness rebuttal argument made in response to a PF case of obviousness under 103.

    What is and what is not such evidence must be based upon the basic ideas of evidence such as relevance, and the various elements of 103 such as the S-M, timing, and obviousness.

    To arrive at a meaningful answer to the question of whether evidence of commercial success or unexpected results is evidence of non-obviousness, there must be basic agreement on the basic propositions under debate, and that requires agreement of the basic elements of S-M, timing, and obviousness.

    Since there is not currently any good understanding of precisely what is meant by obviousness, any inquiry into secondary factors will not arrive at any meaningful answer, even if disagreements over S-M and timing are satisfactorily resolved..

    But proceed anyway, because the process you will go through will reveal some of the ways in which the current formulation of obviousness is inadequate to support this task, and that revelation by itself has value, for the lack of a coherent and logical formulation of obviousness is one of the greatest fundamental deficiencies in patent law today.

    It is, unfortunately, an excellent example of how the appellate courts have decided, and continue to decide cases before them without considering the big picture of patent law.

  7. Two Edges : the compounds are different or they are not.

    If the composition at issue is identical to a prior art composition, that’s called anticipation (heard of it), which is a completely different legal situation and one for which “secondary factors” and the contemporanous recognition thereof are utterly irrelevant.

    I’ll ask the question again: What if your composition is prima facie obvious and someone else finds out that it cures cancer years after your “discovery” of the composition but while your patent is pending — now you can get the composition claim granted?

    In case you are not aware or incapable of understanding, this is a very routine situation in the chem/bio area. Answer the question.

  8. “the secondary indicia might be used to examine the origin of the subject matter.”

    What are we looking for when we examine the origins of the subject matter?

    I’m not disagreeing with you. I think evidence of post-filing-date unexpected results have no bearing on the non-obviousness issue.

    However, I’m trying to understand what the SCOTUS was getting at when they said that it is OK to use secondary indica to examine “the origins” of the subject matter. What are we looking for?

  9. We’re talking about the non-obviousness of compositions…What if your composition is prima facie obvious

    You are assuming the very point of the argument you need to prove – that “prima facia” level is enough to be sustained to deny patentability when it is shown to be deficient.

    If indeed the level of obviousness is merely “prima facia,” then the actual case of obviousness – as required by law beyond the prima facia level – is not enough because obviously the prima facia level was not sufficient to show that the two compounds are indeed not different.

    Once again, the compounds are different or they are not.

    What the compound can “inherently do” does not change if that “what it can do” is discovered later. What you have merely done is discovered that your “prima facia” obviousness was in error as to the actual obviousness.

  10. now you can get the composition claim granted?

    Nice strawman, as no one is saying that.

    You are very confused.

  11. If I happen to be the first to discover that compound X cures cancer, I can get a patent on X for the treatment of cancer

    We’re talking about the non-obviousness of compositions, fxxxtxrd. What if your composition is prima facie obvious and someone else finds out that it cures cancer years after your discovery but while you’re patent is pending — now you can get the composition claim granted?

    Try to keep up. You’re falling behind and you look like a fxxl, as usual.

  12. Quite frankly, the inherent properties of a compound claim just do not need to be understood for the compound claim to be fully legitimate.

    accord:

    It is well established in patent law that one can patent an invention even without understanding why it works the way it works. If I happen to be the first to discover that compound X cures cancer, I can get a patent on X for the treatment of cancer (provided the discovery wasn’t obvious to the person skilled in the art), even when I have no clue whatsoever why X cures cancer.

    link to ipkitten.blogspot.com

  13. Good morning folks and I’m sure some of you are watching hurricane Irene’s movements especially if you live on the east coast. …………. I have a post called “Lancaster on 2 wheels” today on Amish Stories where i tour the Amish country side taking pictures and observations which I’ve just posted…………….Enjoy your weekend everyone and i hope your out of Irene’s path and safe. Richard from Amish Stories.

  14. I also have this special Idea I think should be looked at by congress. It is relationship to the destruction of the Forest. I don’t want to go any further fearing being more Troll Bait. But as I see it this should even produce a Law. And Fines if whoever allows it doesn’t follow the letter of the Law. Making the Red Tape to do this more problematic than bothering to do it at all.
    As soon as I am free I hope to get started on this by Petition after I start production. That Idea is number 3 of a winning combination getting people back to work. I guarantee each of These to be home runs.

  15. Must be nice to simply waive your hands like that and expect everyone to agree with you.

    Oh wait – no one in their right mind does.

    You have now postulated two different people as using “strawmen” without regards to the fact that the actual points being addressed are, indeed, not straw at all.

    The requirement of utility does not demand ALL utility or even THE BEST utility. Utility itself need not be novel. Quite frankly, the inherent properties of a compound claim just do not need to be understood for the compound claim to be fully legitimate.

    As to your “handwaiving” pronouncement of “prima facia obvious AND legally obvious as of the filing date,” you are going to have to do a lot more to establish these conditions than your usual mere blowhard words. In fact, these words (with your tag-on of “at the filing date” point out that not only is someone arguing to the contrary of the point of “The “criticality” did not become so merely because it was later discovered, but that someone is YOU.

    Ned is much closer on point with the written description requirement – that the inventor must be writing about his invention. However, given the fact that other utility is sufficient, and inherent properties of a claimed compound are legitimately “along for the ride,” even Ned’s point cannot prevent an inherent characteristic from being “what it is” and if that characteristic is the one that makes the compound itself patentable by overcoming obviousness, then the invention does merit a patent.

    It is as simple as that.

  16. tatetts: The “criticality” did not become so merely because it was later discovered.

    Nice strawman. Is anyone arguing to the contrary.

    The issue is whether the non-obviousness of a composition can be evidenced by presenting data about properties of the composition that were unknown to the applicant (or anyone else) until years after claims to the composition were filed.

    Note that there would seem to be nothing in the decision prohibiting an applicant from arguing non-obviousness using data that was obtained by *others* years after their filing date.

    The majority’s ruling in this case encourages applicants in the chem/bio area to file on any and all structures that have minimal utility for eligibility, even though the compositions are prima facie obvious AND legally obvious as of the filing date, and then wait for someone else to discover the “unexpected” use and voila! thanks for doing the work, we’ll pursue our composition claim now.

  17. True. But is there an issues concerning conception and written description?

    There are cases that hold that one does not conceive of an invention until one recognizes its utility regardless that one knows of the structure of the invention.

    With regard to written description, if the inventor had no conception of the utility until later, how can his later conception be imported into a prior filed patent?

  18. The “criticality” did not become so merely because it was later discovered.

    It was or it was not.

  19. Let me understand.

    Reference discloses a range of 1-9. The claim is to 1-10. The application/patent discloses no criticality for 10.

    According to Dyk, 1-10 would be obvious. The majority says no, it is not, relying on the later discovery of the criticality of 10 that make it better than 1-9. Without the later discovery, I presume that Dyk’s position is correct that the non critical variation by extending the range to 10 was merely a design choice. Had that later discovery not been made, the claim to 1-10 would not have made it out of the PTO.

    The question is what does 103 require when it says “at the time of the invention?”

    Regardless of Graham, I don’t think that case ever addressed the precise point at issue here. It is one of statutory construction.

    On its face the Feds seem to have gotten it wrong by allowing post filing evidence of criticality to affect the determination of what would have been obvious at the time of the invention.

  20. Broadly stating that only pre-filing-date evidence can ever be used to defend 103 unobviousness is both illogical

    Why is it illogical, Paul?

    and inconsistent with Graham v. John Deere Co. and other decisions of the Fed. Cir. itself.

    Those decisions also provide no logical basis for proving non-obviousness with data that was unknown and unpredictable prior to the filing date.

  21. I’m not arguing for the validity of such an approach–I used the scenario merely as an illustration of one condition that could be applied to the conditional use of the factual inquiries. I did not mean to suggest that it WAS actually applied thereto, or that it SHOULD be applied thereto.

  22. So commercial success evidence for 103 unobviousness should be limited to only those inventors who gave up all there foriegn patent rights and created other risks by delaying filing their patent application for a year after their commercial product launch? Has any case law ever suggested that in any of the numerous Fed. Cir. cases in which commercial success has been argued over the years?
    Broadly stating that only pre-filing-date evidence can ever be used to defend 103 unobviousness is both illogical and inconsistent with Graham v. John Deere Co. and other decisions of the Fed. Cir. itself.

  23. Like I said, the chances of proving that to an OBP standard is essentially zero–and I do believe that it must be proved logically in a trial, as an essential component of a secondary-indicia-based rebuttal to a finding of obviousness.

    And Mooney, your tea stuff is getting old. Nobody else has bought into your lexicon, so it’s not really working as you probably intended. Just thought I’d let you know.

  24. I know the USPTO has plenty. I also know the USPTO knows about the B FILE page and the fact that it was changed.
    And I am sure they also know that PATRICK from Century Telephone took me outside my house in Finger after he set up the Fax line, and he showed me a wire that had all the same connections as the one inside. And I quote!
    If you ever have trouble with the inside line. Bring the fax Machine out here and plug it in. It will also work the same way! So if you are telling me I sent it. You know and I know it was a lie. Because Berkenstock was not my Lawyer until Dec 18, 1996. So how could he do that legally and with out the 100.00 check. Last time I looked you could not Fax a check.So you need to ask Patrick or the Cherry’s if it came off my Line!!!!!!!
    And again I draw your attention (to the charge for firing Loffler on my “Nov Bill” full of fraud!…) but never filed. I was only charged fraudulently for fraudulently pretending to Fire him! Elementary!
    And if that’s a double negative blame Ms.Olsen!

  25. For those who say that post-filing discovery of unexpected results would show non-obviousness, does it follow that you also think that post-filing discovery of predictable results show obviousness? So I show that, after a wheel is invented, the result (that it rolls and effectuates transportation) is completely predictable. Now that is evidence of obviousness?

  26. Scenario

    And if the creammmeee filling of the OREO just happened to be there, and the creameeee filling grabbed the Fax in question and used another lawyers office… then wouldn’t that Lawyer defend himself from the creameeee filling?

  27. On the other hand, evidence of post-grant commercial success, when combined with the belief that all commercial opportunities are exploited

    I guess that’s in one of early chapters of the Patent Txxbxxgxrs Bible.

  28. Are you saying my Application was not finished until Sept 25, 1996 LOLOLOL.
    My Photographs dated and my Dairy that was stolen say a whole different thing. So if you are saying that, again LOLOLOL.
    If you are not even discussing my eaten Post..sorry.
    And as for what Ralph has been shown.. have at it!

  29. On the other hand, evidence of post-grant commercial success, when combined with the belief that all commercial opportunities are exploited, suggests that “the particular result could [not] have been accomplished by anyone familiar with the art” (Hotchkiss), because if it COULD have been, it WOULD have been.

    Of course, there is much other evidence required to make any such suggestion credible, but the logic is probably sound, as long as all of its limitations are recognized, and as long as any conclusion drawn therefrom is taken for what it is worth considering the evidence that is proferred.

    So it’s logical, but should be usually unsuccessful, and usually weak even if successful.

  30. The opinion in Graham said that:

    “Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy. See Note, Subtests of “Nonobviousness”: A Nontechnical Approach to Patent Validity, 112 U.Pa.L.Rev. 1169 (1964).”

    First, the secondary indicia might be used to examine “the origin of the subject matter”. The ORIGIN of the S-M, NOT the S-M itself–for the essence of any “obviousness” inquiry, is mental rather than physical. This is what led me to formulate my own interpretation of obviousness, with which I won’t burden anybody here, but which elegantly resolves the basic issues presented in this case.

    Second, the factual inquiries MAY have relevancy, and MIGHT be utilized. I would point out that there can be up to 1-year of commercialization of patentable S-M before the application needs to be filed, so it is possible that commercial success could be restricted to this period, especially if the S-M was still being modified and final reduction to practice didn’t conclusively occur until the filing date.

  31. In not some secondary indica of obviousness that is not necessary available as of the filing date established by Graham v. John Deere Co., 383 U.S. 1, 13-18 (1966)?

  32. the majority pressed on, holding that such evidence was nonetheless relevant to nonobviousness: “[E]very property of a claimed compound need not be fully recognized as of the filing date of a patent application to be relevant to nonobviousness.”

    The majority created a nice strawman. The issue was not whether “every property” of Novartis’ composition had been “fully recognized” as of its filing date. The issue was whether the non-obviousness of a composition as of its filing date could be determined by submitting facts about the composition that were not known to the applicants until years later. The majority’s rule in this case essentially encourages applicants and patentees to dream up new “features” of the composition that can be used to show non-obviousness. This is not a terribly difficult task in an unpredictable art, depending on your audience and your experts. After all, these new features will be so unexpected that not even the applicants knew about them until recently! Ugh.

  33. Happensance? Is someone being his/her own lexicographer? Happenchance or happenstance? Maybe I’m missing the obvious.

  34. Judge Dyk’s citation of Section 103 notwithstanding, it seems reasonable to look to post-filing or issuance evidence with respect to at least some secondary indicia of nonobviousness. Commercial success, for instance, would be difficult to establish if only pre-filing evidence were able to be considered.

    I disagree entirely and note that the use of “commercial success” as an “indicia” off non-obviousness never made any sense in the first place (except in the minds of those who benefitted from such evidence).

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