Greenblum & Bernstein, P.L.C.
PRACTICE GROUP NEWSLETTER
Recent News in Intellectual Property
In This Issue
· Federal Circuit Affirms District Court Finding That Lilly’s Alimta® Patent Is Not Invalid For Obviousness-Type Double Patenting
· DC District Court Orders FDA To Approve Watson’s Actos® ANDA
Federal Circuit Affirms District Court Finding That Lilly’s Alimta® Patent Is Not Invalid For Obviousness-Type Double Patenting
In Eli Lilly & Co. v. Teva Parenteral Medicines, the Federal Circuit affirmed the U.S. District Court for the District of Delaware’s ruling that Lilly's anticancer drug Alimta® (pemetrexed) was not invalid for obviousness-type double patenting. Alimta® is approved for the treatment of mesothelioma and non-small cell lung cancer, and U.S. Patent No. 5,344,932 (the ‘932 patent), which is owned by Princeton University and licensed exclusively to Lilly, is listed in the Orange Book for the drug.
In 2008, Teva, Barr and APP filed ANDAs asserting that the ‘932 patent was invalid, and seeking approval to market generic versions of Alimta®. Specifically, Defendants alleged that asserted claim 3 of the '932 patent was invalid for obviousness-type double patenting over two patents in the patent family; namely, expired U.S. Patent Nos. 5,028,608 (the ‘608 patent) and 5,248,775 (the ‘775 patent). The '932 patent, however, does not expire until July 24, 2016.
Defendants first argued, based upon Amgen Inc. v. Hoffman La-Roche, that only the differences between the claims at-issue were relevant to the analysis, such that any common features between the claims should be ignored. The Federal Circuit rejected this argument noting that in Amgen, the Court merely held that, once the differences between claims were established, an obviousness-type double patenting analysis required considering "whether the differences in subject matter between the claims render the claims patentably distinct," but that the claims must be viewed in the context of the patent - not in the abstract.
The Federal Circuit further noted that, in chemical cases, obviousness-type double patenting requires a motivating reason to modify the earlier claimed compound into the subsequently claimed compound with a reasonable expectation of success, and that the Delaware district court correctly considered both parties’ expert testimony in accepting Lilly’s expert testimony in ruling that "the ways in which a person of ordinary skill in the art would modify [the compound claimed in the '608 patent] would not result in pemetrexed."
The second argument was that pemetrexed is not patentably distinct from a compound claimed in the '775 patent. Specifically, Defendants argued that the '775 patent disclosed a pemetrexed intermediate thereby rendering claim 3 of the ‘932 patent invalid for obviousness-type double patenting based upon Sun Pharm. Indus. v. Eli Lilly & Co. and Pfizer v. Teva. The Federal Circuit again rejected this argument noting that Defendants’ cases were an exception to the rule, not the rule. That is, the cases "address the situation in which an earlier patent claims a compound, disclosing the utility of that compound in the specification, and a later patent claims a method of using that compound for a particular use described in the specification of the earlier patent [and that] in each of those cases, the claims held to be patentably indistinct had in common the same compound or composition." The Federal Circuit then explained that the instant fact pattern was different in that the claims at-issue were directed to separate and distinct chemical compounds; namely the '775 patent claimed an intermediate, whereas the ‘932 patent claimed, a different compound, pemetrexed itself.
DC District Court Orders FDA To Approve Watson’s Actos® ANDA
In a matter that has been on-going for nearly a decade, the U.S. District Court for the District of DC recently ordered the FDA, for the first time, to approve an ANDA product for marketing despite extant first-to-file market exclusivity.
The first ANDAs for Actos® (pioglitazone HCl) tablets were submitted by Watson, Mylan, and Ranbaxy on July 15, 2003, and were thus subject to the pre-Medicare Modernization Act, which provided for market exclusivity on a patent-by-patent basis that could be shared by respective ANDA filers. Thereafter, the FDA required Watson to amend its Paragraph IV certification to include “section viii” statements to certain patents-in-suit. The NDA holder Takeda then filed a patent infringement litigation, which was ultimately settled. Under the settlement, Watson and Mylan received a non-exclusive license to the Takeda Orange Book patents-in-suit effective August 17, 2012. (See G&B Updates, March 2007, July and December 2008 and October 2010).
As the license effective date approached, Watson and Mylan were required to amend the ANDAs to replace the section viii statements with Paragraph IV certifications. Mylan did so first and was awarded the first-to-file exclusivity by the FDA resulting in the instant case, which Watson filed on August 15, 2012. Watson sought an injunction to prevent the FDA from granting final approval to any other ANDA, including Mylan, prior to granting such approval to Watson’s ANDA. The DC District Court denied Watson’s request for an injunction, and the FDA granted final approval to Mylan on August 17 as well as awarded the 180-day exclusivity.
Watson then filed an Amended Complaint, accompanied by a summary judgment motion seeking a court order directing the FDA to ignore Mylan’s the 180-day market exclusivity and approve Watson’s ANDA. The FDA, in response, argued that “Watson filed certifications to the relevant patents and patent claims two years after Mylan filed its certifications, and it is Watson’s own delay that led to its loss of a right to exclusivity.”
The DC District Court was not persuaded by the FDA’s argument and concluded, based upon the plain language of the statute, that the FDA’s decision was arbitrary, capricious and contrary to the statute. The Court specifically noted that the statute provides that “if the application contains a paragraph IV certification and it is for a drug for which there was a previous application containing such a certification, approval of the application is delayed for 180 days. Here, when Watson filed its application containing a paragraph IV certification for the drug composition/use patents on July 15, 2003, there was no previous application containing such a certification on file for that drug. Mylan’s application came in on the same day.” The DC District Court further observed that “FDA’s decision to deny Watson shared exclusivity in this circumstance is arbitrary and capricious because it produces absurd results that are contrary to the purpose of the Hatch-Waxman Amendments and the exclusivity provision in particular. . . . Here, although denial of shared exclusivity to Watson does not mean that generic pioglitazone cannot be marketed at all . . . the result is still at odds with the sole purpose of the exclusivity provision: to encourage generic applicants to file paragraph IV certifications and incur the risks and costs of patent litigation necessary to clear the patents out of the way and facilitate the entry of generics into the market.”
Although the ruling is under appeal and may be factually limited, it will be interesting to see how this long-running dispute is finally resolved, and how it impacts (if at all) any current approval/market exclusivity issues after appellate review.