Split Court Denies Rehearing En Banc in Sun Pharmaceuticals v. Eli Lilly

By Jason Rantanen

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. 2010) (denial of rehearing and rehearing en banc)

In Sun Pharmaceutical, a Federal Circuit panel affirmed a district court determination that Eli Lilly's patent for a method of using gemcitabine to treat cancer was invalid due for obviousness-type double patenting based on another application, filed the same day, claiming the compound gemcitabine and disclosing its use for treating cancer.  (The previous Patently-O write-up is here).  This morning the Federal Circuit issued an order denying Eli Lilly's petition for rehearing and rehearing en banc.  The court was closely split on the latter, with four of the nine currently sitting judges dissenting on the decision not to rehear the decision en banc.

The dissent's principal concern was that, in its view, the panel opinion involved a departure from precedent, thus creating an intra-circuit split.  According to the dissent,

the panel held the claims to the anticancer use to be invalid for double patenting because the anticancer use was mentioned (but not claimed) in the continuation-in-part specification that is not prior art, stating that “[t]he asserted claims of the later ’826 patent simply claim the anticancer use disclosed in the specification of the ’614 patent,” reported at 611 F.3d at 1389.

The dissent pointed out that this approach, which focused on the disclosure of the simultaneously filed patent, not its claims, was contrary to precedent:

Uniformly, unlike examination for obviousness based on prior art, the issue of obviousness-type double patenting is directed to whether the invention claimed in a later patent is an obvious variant of the invention claimed in an earlier patent. The panel opinion violates a vast body of precedent.

Furthermore, according to the dissent, expanding the doctrine of obviousness-type double patenting to the facts of this case serves no good policy purpose and creates a schism in the law – a schism that should be addressed by the court en banc:

A change of law “in ways that negatively impact the patentability of important later-discovered uses” serves no public purpose in areas in which commercial development requires patent protection. Id. If the majority of the court now believes, as a matter of policy, that the law should be changed in this new direction, en banc treatment is particu-larly appropriate, for the court’s rule is that the earlier precedent prevails unless overruled en banc. A situation in which the court ignores this rule, and applies whatever law the panel prefers, is an indictment of the ability of this court to provide stable law in the areas entrusted to us.

Comment: Given that there are currently only nine sitting Federal Circuit judges, it seems unlikely that the court will grant a rehearing en banc absent extraordinary circumstances – especially in cases where the panel decision was unanimous.  In that situation, in order for an appeal to be reheard en banc, at least five of the six judges who did not participate on the panel would need to vote to rehear the decision en banc.  Of course, there are instances when this would not apply, as senior judges and visiting judges frequently participate in panel determinations, but it is something to keep in mind for the near future.

34 thoughts on “Split Court Denies Rehearing En Banc in Sun Pharmaceuticals v. Eli Lilly

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  2. What I take from this case on further consideration is that one cannot disclose a compound that has a number of disclosed uses and then, absent a restriction, present claims for those uses in different applications that have potentially different owners and different expiration dates.

    I think this is right.

  3. RE: Title 35> Part 1> Chapter3> Statute 32

    Context:

    The Director may … suspend or exclude from further practice before the Patent and Trademark Office, any … attorney … who shall, by … circular, letter … threaten any … other person having immediate or prospective business before the Office.

  4. Title 35> Part 1> Chapter3> Statute 32?
    I was threatened. But his name is still holding as Attorney? still? I told his Bar? nothing! I told the USPTO? nothing!
    Even with the switch…. Who is really listed now? I will find out, I assure you!

  5. Imagine having the Power to put the words This is a Continuation of -,—,— on the Fake one. but it is not in the Continuity of the Case itself. It just gets better and better.

  6. OT,

    I see why Malcolm’s been so persnickity of late.

    From the Eskimo’s site:

    As the evening moves forward it is increasingly apparent that the Republicans are having an excellent night, and exactly what the vast majority of pundits have predicted seems to be coming true. The Republicans are poised at this hour to take control of the United States House of Representatives by margins larger than the last so-called Republican Revolution, which swept Republicans to power in 1994. The Republicans are also poised to gain substantial numbers in the United States Senate, although it seems likely they will fall short of the 10 needed to take control of the Senate, as widely predicted. Republican Governors seem to be fairing exceptionally well, as are Republican State Representatives and State Senators, which has long-term implications with redistricting on the agenda over the next several years. Not withstanding the potentially historic nature of this election, there will be plenty of time to consider what the election results mean in general, for business and for a variety of issues important to families; the so-called kitchen-table issues.

    link to ipwatchdog.com

    Malcolm’s bad decade continues. Those undies must be seriously bunched.

  7. Me too, assuming two different owners, it still bothers me that the patent office cannot set up an interference where the first patent application with a first invented entity discloses the compound as a cure for cancer and the second application, filed on the same day, but with a different invented entity, not only discloses, but claims the use of the compound as a cure for cancer.

    The Phantom count would be compound X, for all disclosed uses, including the use of compound X as a cure for cancer.

    The disclosure of the use of compound X for use as a cure for cancer in the application of another invented entity raises inventorship issues which I think the patent office needs to resolve.

  8. are you suggesting that you agree with the absurdity of this case?

    No, I’m stating that I don’t have a problem with the conclusion. In fact, I applaud it.

  9. metoo the CIP which briefly mentioned cancer treatment was filed ON THE SAME DAY as the patent invalidated.

    Thanks. And what is the earliest priority date claimed in each case? 1984, correct?

    metoo: There is no “28 year priority claim” in this case.

    There would have been in 2012 had the patent not been invalidated. Hence my comment upthread.

    Following along now?

  10. Are you saying that the patent that was set to expire in 2012 doesn’t claim priority back to the original 1984 filing?

    Sure it does. But who cares? That’s not a “28 year priority claim.”

    In any event, are you suggesting that you agree with the absurdity of this case?

  11. Was there data supporting the cancer treatment in the CIP where cancer treatment was ‘briefly mentioned’? Was that prior application ever published? How does the publication of the prior application compare with the date of the filing which contains the supporting data?

    Gee, are you even bothering to follow along here? the CIP which briefly mentioned cancer treatment was filed ON THE SAME DAY as the patent invalidated. Good grief.

  12. lcolm, here’s a suggestion for you–why not attempt to read the case before you make yourself look foolish. There is no “28 year priority claim” in this case. For the life of me, I have no idea where you pulled that from.

    2012-1984 = 28.

    Are you saying that the patent that was set to expire in 2012 doesn’t claim priority back to the original 1984 filing?

  13. Malcolm, here’s a suggestion for you–why not attempt to read the case before you make yourself look foolish. There is no “28 year priority claim” in this case. For the life of me, I have no idea where you pulled that from.

  14. If ya got a claim to the compund, what care you for the uses of the compund – all the uses fall to the compound itself.

    Didn’t you learn that a new use for an old compound is patentable in your introduction to patent law course? While you might be infringing a patent on the compound if you practice your new use, you could still get a patent on the new use and enforce it against anyone who practices the new use, including the entity who has a patent on the compound.

  15. the cancer treatment was not disclosed in the original parent.

    the earlier issued patent briefly mentions using the compound to treat cancer,

    The rejection is for double-patenting over a claim to the compound with a disclosure that the compound is useful for treating cancer. You won’t get any closer to the answer by quibbling over the semantics of the word “original”.

  16. the earlier issued patent briefly mentions using the compound to treat cancer, while the later issued patent (declared invalid here) is directed to a method of treating cancer using the compound.

    Was there data supporting the cancer treatment in the CIP where cancer treatment was ‘briefly mentioned’? Was that prior application ever published? How does the publication of the prior application compare with the date of the filing which contains the supporting data?

    Frankly, a 28 year priority claim is ridiculous so I’m glad to see the patent tanked. Good riddance.

  17. IANAE, the cancer treatment was not disclosed in the original parent. The two patents addressed in this case have the same effective filing date. the earlier issued patent briefly mentions using the compound to treat cancer, while the later issued patent (declared invalid here) is directed to a method of treating cancer using the compound. This decision is just flat out wrong.

  18. ping If ya got a claim to the compund, what care you for the uses of the compund – all the uses fall to the compound itself.

    They do, except that if I buy the compound from the patentee, I can do with it whatever I want, including sell it to another person. If that person sells it with a label saying “useful for treating cancer”, the patentee can’t sue the person for inducing infringement of the composition claim, just because the specification teaches such a use.

    But the legal reasoning underlying the holding in this case would arguably permit that absurdity.

  19. Bottom line, if you file 30 patent applications claiming feature of the same complex product, those 30 patents likely may expire on the same day under this new approach to Obviousness-type double patenting, even if some are C-I-Ps.

    cepts, of course, for PTA…(and yes we’ve seen a messy lawsuit on that particular item)

    The real question in my mind is whether it’s appropriate to construe a claim to a compound in light of the spec to include “use of the compound for all utilities disclosed in the spec”. That feels like a mixing of statutory classes, which we all know is only permitted in the software arts.

    Ya see, IANAE, ya lose yourself in the weeds when you let your jealosy get the best of ya. If ya got a claim to the compund, what care you for the uses of the compund – all the uses fall to the compound itself. In your haste to reach and slam software, ya gettin sloppy.

  20. The method of using gemcitabine to treat cancer is not obvious over the disclosure of gemcitabine and its use as an antiviral.

    It would appear that the use to treat cancer was also disclosed in the original application.

    The real question in my mind is whether it’s appropriate to construe a claim to a compound in light of the spec to include “use of the compound for all utilities disclosed in the spec”. That feels like a mixing of statutory classes, which we all know is only permitted in the software arts.

  21. For Malcolm: the claim is to a sequence. The sequence is the same sequence that is admittedly old or patented to another. The only differences are obvious modifications to the prior art sequence, which are artifacts of a known process.

    The ball is in your court examiner. Do you reject under section 103?

  22. Ned: Not necessarily. The method of using gemcitabine to treat cancer is not obvious over the disclosure of gemcitabine and its use as an antiviral. The district court actually held that was the case. So in an interference, you could end up with both parties having valid claims, depending on who invented what and when. Of course that would also assume that both parties have overlapping claims–which is not the case here. If one patentee only claimed the antiviral method and the other only claimed the method of treating cancer, there would be no interference.

    And for an interesting twist on this case, what if the earlier issued patent (filed on the same day as the patent in suit) had merely incorporated by reference the disclosure of the patent in suit? Wouldn’t the same outcome result, at least in the flawed logic of the original panel?

  23. J, true, but since one is obvious over the other, I think there would be an inherent 102(g)/103 problem. Not so?

    I think an interference of some sort would sort that out.

  24. A single entity now gets penalized for making two inventions. If these two inventions were made by separate entities and filed on the same day, no ODP can exist.

  25. Bottom line, if you file 30 patent applications claiming feature of the same complex product, those 30 patents likely may expire on the same day under this new approach to Obviousness-type double patenting, even if some are C-I-Ps.

    =========================

    OK, here is the hub bub.

    The applications leading to both the ‘826 patent and the ‘614 patent (a C-I-P of and the ‘826 patent) were filed on the same day, December 4, 1984. The ‘614 patent expired on May 15, 2010, while the ‘826 patent does not expire until November 7, 2012. Lilly sued on the ‘826 patent. If the ‘826 patent is double patenting, then a terminal disclaimer should have been filed and the ‘826 patent would have expired on May 15, 2010 and plaintiff Lilly would not have been able to bring its lawsuit.

    In double patenting, the claims of the ‘614 patent are treated as “the specification” and that scant text can be mixed and matched to see if the ‘826 patent claims are obvious in view of the mixed and matched text of the ‘614 patent. Bizzare? Yea, but that is the way it normally is done.

    In this case, the court additionally used the very detailed text of the entire ‘614 C-I-P patent to mix and match to see if the ‘826 patent claims are obvious.

    That spells trouble for a lot of companies since it is standard practice to use the same or similar patent application text in multiple applications that related to a similar product. Each application will have additional text not included in the other applications, but in a double patenting obvious analysis, that isn’t going to matter much ’cause the examiner can use your other patents against you and fill in the gaps via a computer search of the 6,000,000+ other patents in the US data base.

    Bottom line, if you file 30 patent applications claiming feature of the same complex product, those 30 patents likely may expire on the same day under this new approach to Obviousness-type double patenting, even if some are C-I-Ps.

  26. Courtenay: bingo.

    The only thing that saves the applicant’s bacon from these nematode dp examiners is that you can force the nimrod to specify which claim is obvious in view of which other claim. Now, it appears, that is out the window. I wouldn’t even know what to argue in view of this mess.

    One sometimes gets the feeling money is changing hands where it shouldn’t be.

  27. Wow, more vitriol, directed this time at the CAFC.

    Hey Americans, don’t neglect to vote today.

  28. The panel’s decision was b.s., and the denial of en banc rehearing is a more b.s. Heck, the whole institution of o.t.d.p. should have been thrown out with the adoption of 20-years-from-earliest filing. The dissent is absolutely right that per precedent, the correct comparision is between the claims of the issued patent and the pending application. Get your s–t together, CAFC.

  29. Obviousness-type double patenting is a morass. The issue used to come up rarely, usually in genus-species situations. Now Examiners cite every application by the same Applicant even if the claims recite mutually exclusive methods or components, and the Federal Circuit hasn’t really illuminated the law much.

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