In an amicus brief filed on Wednesday, September 8th, 2010 in support of Eli Lilly & Company’s (“Lilly”) petition for an en banc hearing of Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., trade organization Biotechnology Industry Organization (“BIO”) alleged that failure to clarify the law surrounding patent specifications as grounds for nonstatutory double-patenting rejection may disincentivize research of new uses for various biotechnological discoveries.
In Sun Pharm., a Federal Circuit affirmed a lower court’s finding that claims from Lilly’s U.S. Patent No. 5,464,826 (“the ‘826 patent”) were invalid for obviousness-type double patenting over U.S. Patent No. 4,808,614 (“the ‘614 patent”). Lilly’s ‘614 patent was a continuation-in-part (“CIP”) of the earlier Lilly U.S. Application No. 06/473,883 (“the ‘833 patent), which claimed anti-viral activities of the nucleoside gemcitabine. Although the ‘614 application was intended to expand upon the ‘833 patent by disclosing methods for use of gemcitabine as an antiviral therapy, the specification also included a brief statement asserting that “certain compounds of the present invention have also demonstrated excellent oncolytic activity in standard cancer screens.” The same day that Lilly filed the application for the ‘614 patent, it also filed an application for the ‘826 patent, claiming methods of using gemcitabine for treating cancer. The ‘826 patent was set to expire November 12, 2012 (approximate two and a half years following the expiration of the ‘833 patent) and could have severely limited Lilly’s period of market exclusivity. In rendering the ‘826 patent invalid, the circuit and district courts relied on decisions from Geneva Pharm., Inc. v. GlaxoSmithKline PLC, and Pfizer, Inc. v. Teva Pharm. USA, Inc.
Rejecting the validity of a patent for nonstatutory obviousness-type double patenting is appropriate where two conflicting claims are not identical, but at least one application clam is not “patently distinct” from the reference claim because the application claim is either anticipated by or rendered obvious by the application claim. Explaining the policy rationale behind such rejections, the court in Pfizer and Geneva concluded that “[i]t 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.
BIO asserts that these same cases illustrate the notion that a court cannot use a patents specification in deciding whether a subsequent claim should be invalid for being indistinct from a previous claim, unless the utility of that previous patented invention can only be ascertained via that compound’s specification. BIO argues that the ‘833 patent’s utility was obvious on its face, as its claims of explicitly discussed methods of use in treating the Herpes virus. BIO therefore contends that the courts inquiry into the later filed ‘614 patent specification sets new precedent: allowing courts to compare new patent claims to the specifications of a previously issued patent. This is a departure from standard jurisprudence, which traditionally compares the “essential utility” of the compound’s claims to the newly requested patent.
In its brief, BIO argues that any expansion of the law should be supported by public policy rationale. Regarding patents, the court should apply the law in a way such that inventors are incentivized to not only create new inventions but also continue to research potential new uses of prior inventions. By erring on the side of disclosure in its CIP specification, Lilly essentially “invalidated legitimate patent rights otherwise in full compliance with patent statutes.” As a result of this new shift in jurisprudence, biotechnology companies must now be on notice that any uses described in subsequent patent specifications could inhibit their ability to successfully obtain a patent for that use. BIO maintains that the uncertainty produced by the court’s expansion of the obvious-type double patenting doctrine will likely make biotechnology companies reluctant to further research granted patents to determine additional uses. In the interests of public policy, BIO argues, Eli Lilly’s petition for en banc hearing of Sun Pharma v. Lilly should be granted and the jurisprudence surrounding the double-patenting doctrine clarified.