CAFC Upholds Validity of Lilly’s Alimta Compound Patent


Earlier today, the United States Court of Appeals for the Federal Circuit affirmed an earlier District Court decision regarding the validity of Eli Lilly’s compound patent for Alimta® (pemetrexed). The compound patent provides protection for Alimta in the U.S. through January of 2017 and, as the result of this Federal Circuit decision, the relevant claims have had their validity confirmed.  See Eli Lilly Co. v. Teva Parenteral Medicines, Inc. et al (August 24, 2012).

“We are pleased with today’s ruling from the Court of Appeals affirming the validity of the compound patent for Alimta,” said Robert A. Armitage, senior vice president and general counsel for Lilly. “By affirming the district court ruling, we believe that the Court fairly applied long-standing patent law principles. Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the physicians and patients we serve, as these rights help support the development of the next generation of innovative medicines to treat unmet medical needs.”

This dispute arose when Teva Parenteral Medicines, Inc., Barr Laboratories, Inc., and APP Pharmaceuticals, LLC filed abbreviated new drug applications (“ANDAs”) seeking approval to manufacture and sell generic versions of Alimta® before the expiration of the ’932 patent. Those ANDAs each included a Paragraph IV certification asserting that the ’932 patent was invalid, unenforceable, or would not be infringed by the proposed generic products. When a Paragraph IV certification is made, the patent owner is allowed by law to treat the mere filing of the ANDA as an act of patent infringement.

The ’932 patent issued on September 6, 1994, from an application filed on March 22, 1991, claiming priority from the ’742 application through a series of continuations. U.S. Patent 5,028,608 (the “’608 patent”) and U.S. Patent 5,248,775 (the “’775 patent”) share a common familial history with the ‘932 patent.

The ’932, ’608, and ’775 patents were assigned to the Trustees of Princeton University and exclusively licensed to Eli Lilly. The ’608 and ’775 patents have expired, but the ’932 patent remains in effect until July 24, 2016, due to a patent term extension of over four years to compensate for delays in the regulatory approval of Alimta®. See 35 U.S.C. § 156. Lilly holds a further six months of market exclusivity over pemetrexed pursuant to 21 U.S.C. § 355a.

During the proceedings, Teva conceded infringement, but maintained that the asserted claims of the ’932 patent were invalid for obviousness-type double patenting over two earlier-issued claims: (1) claim 3 of the ’608 patent, which claims the ’608 Compound, and (2) claim 7 of the ’775 patent, which claims the ’775 Intermediate. Teva, Barr and APP all appealed from the judgment of the United States District Court for the District of Delaware holding that U.S. Patent 5,344,932 is not invalid for obviousness-type double patenting.

Before announcing its decision, the Federal Circuit, per Judge Lourie, briefly explained the doctrine of obviousness-type double patenting:

The doctrine of obviousness-type double patenting is intended to “prevent the extension of the term of a patent… by prohibiting the issuance of the claims in a second patent not patentably distinct from the claims of the first patent.” In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985). “A later patent claim is not patentably distinct from an earlier claim if the later claim is obvious over, or anticipated by, the earlier claim.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001). As with statutory obviousness under 35 U.S.C. § 103, obviousness-type double patenting is an issue of law premised on underlying factual inquiries. Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1290 (Fed. Cir. 2012).

The primary argument that the claims of the ‘932 patent were invalid for obviousness-type double patenting insofar as the ‘608 compound was concerned was whether the District Court applied the appropriate legal standard for making the determination. Relying on Amgen Inc. v. Hoffmann-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), Teva/Barr/APP contended that the correct analysis involves only the differences between the claims at issue, so that any features held in common between the claims—in this case, all but the aryl regions of the ’608 Compound and pemetrexed—would be excluded from consideration.

On this, the Federal Circuit explained that there was no discernible error and complemented the District Court for its thorough analysis. Judge Lourie went on to write:

Moreover, a complicated compound such as the ’608 Compound pro- vides many opportunities for modification, but the district court did not find that substituting a phenyl group into the aryl position was the one, among all the possibilities, that would have been successfully pursued. Thus, absent any motivation to derive pemetrexed from the ’608 Compound or reason to expect success in doing so, the district court correctly concluded that the asserted claims were not invalid for obviousness-type double patenting over the ’608 Compound.

Teva similarly contended that pemetrexed is not patentably distinct from the ’775 Intermediate.

The Federal Circuit opinion explained the relevant law:

As a general rule, obviousness-type double patenting determinations turn on a comparison between a patentee’s earlier and later claims, with the earlier patent’s written description considered only to the extent necessary to construe its claims. E.g., In re Avery, 518 F.2d 1228, 1232 (CCPA 1975). This is so because the non-claim portion of the earlier patent ordinarily does not qualify as prior art against the patentee and because obviousness-type double patenting is concerned with the improper extension of exclusive rights—rights conferred and defined by the claims. The focus of the obviousness-type double patenting doctrine thus rests on preventing a patentee from claiming an obvious variant of what it has previously claimed, not what it has previously disclosed. See generally Gen. Foods, 972 F.2d at 1280–82.

Judge Lourie went on to explain that the ’775 Intermediate and pemetrexed differ from each other in four respects, which alone suffices to undermine Teva’s argument regarding the ’775 Intermediate. More specifically, in distinguishing the long line of cases Teva/Barr/APP cited to support their assertions, Judge Lourie explained that because Lilly’s original claim to the ’775 Intermediate offered no protection for pemetrexed and did not incorporate or require use of the ’775 Intermediate, the “particular concerns motivating our prior decisions are thus absent here.”

Written by Gene Quinn of

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