Washington Legal Foundation Files Amicus Brief in Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co.

By Kevin E. Noonan --

The Washington Legal Foundation (WLF), a self-styled "non-profit public interest law and policy center that regularly appears before federal and state courts to promote economic liberty, free enterprise, and a limited and accountable government," filed an amicus curiae brief on September 8th, urging the Federal Circuit to rehear en banc Eli Lilly's appeal of the Court's affirmance of an invalidity finding of U.S. Patent 5,464,826.  The Federal Circuit affirmed a District Court determination that the claims of the '826 patent were invalid over the claims of Lilly's U.S. Patent No. 4,808,614 under the judicially-created doctrine of obviousness-type double patenting.  The '826 patent claimed methods for using gemcitabine (sold by Lilly under the name GEMZAR®) for treating cancer, and the earlier '614 patent disclosed but did not claim this use.  The lawsuit between the parties arose after Sun filed an ANDA for generic gemcitabine, and Sun Pharmaceuticals filed a declaratory judgment action that the '614 and '826 patents (both of which were listed in the FDA's Orange Book) were invalid.

The Federal Circuit in its panel decision based affirmance on its earlier decisions in Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), that the only type of applications that qualify for the "safe harbor" provisions of 35 U.S.C. § 121 were divisional applications, i.e., applications filed in response to a Patent Office-promulgated restriction requirement.  Restriction is proper if the Office determines that an application claims more than one patentably-distinct invention, and the safe harbor protects applicants from inconsistent determinations from the Office that the claims are patentably-distinct for restriction purposes but fall within the scope of the obviousness-type double patenting doctrine.

Here, the '614 patent was a continuation-in-part of an earlier-filed application whose description of methods of using gemcitabine were limited to the compound's antiviral activities.  The '826 patent, which arose from an application filed on the same day as the '614 patent, claimed the use of gemcitabine for treating cancer.  The District Court's obviouness-type double patenting determination as well as the Federal Circuit's affirmance were ultimately grounded in the policy considerations enunciated in Pfizer and Geneva Pharm.:

It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patent upon each of the uses to which it may be adapted.

Pfizer, 518 F.3d at 1368 n.8; Geneva Pharm., 349 F.3d at 1386.

The WLF objects to this "expansion" of the obviousness-type double patenting doctrine in its amicus brief.  The group argues that the Court's decisions threaten to lower the incentive to innovate by limiting a patentee's ability to protect improvements in their inventions.  Citing Miller v. Eagle Mfg. Co., 151 U.S. 186, 198 (1894), the brief argues that it is settled law that "an inventor may obtain 'a separate patent' for a 'new improvement on his own invention.'"  Id. at 199.  Indeed, the brief argues that "[h]ad anyone other than Eli Lilly discovered this method of treating cancer with gemcitabine, quite clearly they would have been entitled to a patent," citing Lilly's brief in support of its petition for rehearing en banc.  WLF's brief also argues that "Miller specifically precludes the possibility that a patent that merely describes a separately patentable invention renders another patent claiming that invention invalid under the doctrine of double patenting." 151 U.S. at 198, an interpretation directly contrary to the panel decision here.

The brief recognizes that the panel believes that its decision was consistent with the Geneva Pharm. decision, but distinguished this case by characterizing the panel decision here as "extending" the holding in Geneva Pharm -- specifically, asserting that in that case, a compound and its "only" use were not patentably distinct, whereas gemcitabine had "two separate methods of use," making Takeda v. Doll, 561 F.3d 1372 (Fed. Cir. 2009), the appropriate prior precedent.  In the Takeda case, the Court held that a later-claimed method of making a claimed pharmaceutical was patentably distinct provided that "a second method of making the same pharmaceutical was discovered before the filing of the application that led to the second patent."  Id. at 1377.  Since the application leading to the '826 patent was filed on the same day as the invalidating '614 patent, "the new method necessarily was discovered prior to the filing of either patent" (emphasis in original).  Thus, the brief concludes, "discovery of the second method of using the compound should have rendered both the new method and the older method patentably distinct from the compound."

The brief also notes that the Court's decision here is contrary to Patent Office restriction practice, which "categorically barred an applicant from presenting claims to a compound and two distinct methods of using that compound.  37 C.F.R. §§ 1.141(a)-(b) (1984)."  Had Lilly presented claims to both methods of use in the same patent, the brief argues that the application would have been subject to a restriction requirement, which would have forced these claims to be pursued in two separate patents.  This part of the brief implies strongly that it is equally "a shock to a sense of justice" to have substantive rights so influenced by procedural details of whether the claims are presented in the same or separate applications (an argument that depends on the unique facts here that the '614 and '826 application were effectively filed on the same day), in view of these established rules of practice.  The brief argues that the en banc Court should solicit the PTO's views on this question.

Comments

[6]

"It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patent upon each of the uses to which it may be adapted."

I still agree with that, but yet they still have done nothing about software being patented even though it shocks one's sense of justice.

""[h]ad anyone other than Eli Lilly discovered this method of treating cancer with gemcitabine, quite clearly they would have been entitled to a patent"

Assuming they filed their app the exact day that Lilly filed theirs. Otherwise there might just be some prior art situations created from one case to the other or vice versa.

[6]

"Had Lilly presented claims to both methods of use in the same patent, the brief argues that the application would have been subject to a restriction requirement, which would have forced these claims to be pursued in two separate patents. This part of the brief implies strongly that it is equally "a shock to a sense of justice" to have substantive rights so influenced by procedural details of whether the claims are presented in the same or separate applications"

Interesting. So, they knew that they needed to get 121 protection by getting a restriction req and yet summarily choose not to do that.

I think the PO's position is going to be pretty simple. The law isn't terribly confusing, and neither is the DP caselaw.

While I agree with them on the whole substantive matters hanging on procedural issues. These kinds of things happen all the time in patent law. If you wait until after 6mo to file a response, for example, you might just get some substantive matters that hang on a procedural issue.

[Kevin E. Noonan]

Dear 6:

Software isn't my area. Don't know enough to opine on whether it should be patentable or not.

Correct about the prior art, but the point is that the '614 and '826 patents were filed on the same day. So the point WLF is making is disproportional treatment of Lilly as opposed to anyone else.

Thanks for the comment.

[Kevin E. Noonan]

Dear 6:

I would say that having applicants jump through these kinds of otherwise meaningless procedural hoops is inefficient in both the practical and economic senses. Does it make sense to make the PTO go through the time and effort to promulgate a restriction requirement etc.? Wouldn't it make more sense to interpret the law the way WLF suggests?

Thanks for the comment.

[6]

dude odp rejections are in place for a reason.

"The group argues that the Court's decisions threaten to lower the incentive to innovate by limiting a patentee's ability to protect improvements in their inventions. Citing Miller v. Eagle Mfg. Co., 151 U.S. 186, 198 (1894), the brief argues that it is settled law that "an inventor may obtain 'a separate patent' for a 'new improvement on his own invention.'" Id. at 199. "

That is the way they want to interpret the law, and yes, it would make sense, except for one small issue. What is going on in this case isn't just the patentee getting a patent on his improvement. It is him getting a distinct patent for an "obvious" improvement. And, I'm pretty sure, odp is there to prevent things like getting outrageous PTA extension.

The procedural things are there for a reason or two Kev, and I agree, they're inefficient and we could do better. Even so, there's no reason presented in this case for us to get rid of the procedure or ignoring what the ramifications of not following it are.

Besides, non-stat ODP is kind of easy to get around isn't it? Maybe I'm thinking of the wrong thing here, but isn't a terminal disclaimer all you need? Can you not file one after the patent issues and have everything be cool?

[Kevin E. Noonan]

Dear 6:

I think it is the "obviousness" of the improvement that is the issue. If this were a typical case, and patent 1 was filed at time 1 (and included the anticancer use), and then patent 2 was filed at later time 2, then I would tend to agree that a use called out in patent 1 but patented in patent 2 would be subject to obviousness-type double patenting without the safe harbor of Sec. 121.

But here, patent 1 and patent 2 were filed on the same day. It is merely an anomaly of the change in the law that they were granted at different times; indeed, there is a principle that if patent 2 were to grant before patent 1 (patent 1 being filed earlier), then patent 1 would not be subject to ODP, because the later grant was due to PTO "inefficiency" (go figure :)).

So while I think you and the panel may be correct 99 and 44/100ths of the time, here I think we have an exception. And the "policy" rationale that we want to limit the term of patents on drugs isn't sufficient in my view to justify ignoring the exceptional facts in this case.

Thanks for the comment.