By Kevin E. Noonan —

The Biotechnology Industry Organization (BIO) has joined the chorus of amici urging the Federal Circuit to rehear en banc (and overturn) a panel decision affirming an invalidity finding of Eli Lilly's U.S. Patent No. 6,464,826.  The panel affirmed the District Court's 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 thereafter filing a declaratory judgment action that the '614 and '826 patents (both of which were listed in the FDA's Orange Book) were invalid.

The panel based its decision 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 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.

In its brief, BIO argued that it was settled law that the claims, not the disclosure, be used to perform an obviousness-type double patenting assessment:  double patenting is based on what is claimed, not what is disclosed in the earlier-filed application, citing General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992) as "the law" on how the double patenting analysis must be conducted.  In addition to the law, the brief asserts sound policy reasons for this:  it would be inequitable to have the patentee's own disclosure used to support an obviousness rejection of any kind.  The panel's error, according to the brief, was to "extend the doctrine beyond its policy roots, depart from the authority of Geneva and General Foods, and conflict with the express provisions of the statutory law."

The brief cites extensive Federal Circuit precedent that the specification of an earlier-filed patent cannot be used to support an obviousness-type double patenting rejection, including In re Braat, 937 F.2d 589 (Fed. Cir. 1991), and In re Vogel, 422 F.2d 438 (C.C.P.A. 1970), as well as Geneva Pharm., which the brief says "acknowledged that General Foods constitutes the standard [that] . . . an earlier patent's disclosure is not available to show nonstatutory double patenting."  The brief distinguishes the Court's Geneva Pharm. decision as involving a "special situation" where the specification needed to be consulted "in order to determine whether a later-claimed method of using a compound was patentably distinct."  The brief contends that the situation was similar in Pfizer v. Teva:  the earlier patent contained claims merely to pharmaceutical compositions without regard to methods of use.  Under such circumstances, the specification can be consulted to construe the utility of the earlier-claimed compounds.  In Geneva Pharm. and Pfizer v. Teva, this understanding was used to determine that the later-claimed methods merely recited the methods disclosed as the (only) utility of the claimed compounds.

In the instant case, the brief argues that the '614 patent disclosed and claimed methods for using the claimed compounds for their antiviral utility.  Here, there was no need to consult the specification, because the claims of the '614 patent are self-evident (i.e., it is not necessary to consult the specification to construe what is claimed):  the utility of the antiviral claims of the '614 patent was "apparent on the face of the claims."  The brief asserts forcefully that the panel's "justification" for its reliance on the specification "does not withstand serious scrutiny."

Citing Geneva Pharm., the brief notes that the panel considered the (sole) utility of the compound claimed in the patent in that case was "an essential part of a single invention" and thus could not be patentably distinct in as later-claimed method.  Here, the anticancer utility claimed in the '826 patent was first disclosed only after the "underlying" application (Serial No. 473,833) was filed.  Thus, the anticancer utility could not be "an essential part of a single invention" as claimed in the '614 patent because that utility was not disclosed in the priority ('833) application.

Using this logic, BIO also contends that the panel's decision conflicts with the patent statute.  Under 35 U.S.C. § 120, the '614 patent is entitled to priority to the '833 application "provided that" the claims are supported by disclosure that satisfies 35 U.S.C. § 112, first paragraph.  The brief concludes that the grant of the antiviral claims in the '614 patent is an indication that these claims satisfied the § 112 requirements, and that the "later-added disclosure [of the anticancer activity] should be deemed immaterial."  This the panel did not do, the brief argues, "giving no regard to the different dates of invention" but "treated the later invented new use as [if] it were present in the priority application for the purpose of a purported double patenting analysis."  This is contrary to the statute, the brief argues, because "the Panel as rendered unpatentable a new use that was discovered after the priority date of the earlier patent."

The brief closes with the policy argument that "[a]ny . . . expansion [of law not rooted in the statute] should be consistent with the statute as a whole, and be supported by a public policy rational that creates proper incentives for continuing research and timely public disclosure."  The panel decision "elevates form over substance," BIO argues, as evidenced by the "simplicity with which double patenting could have been avoided," i.e., by "the simple ministerial act of filing a continuation application."  The panel decision "furthers no public policy," according to BIO's brief, and provides incentives for applicants to "minimize" patent disclosure (contrary to the proper public policy of the Patent Act).  In this case, Lilly added the anticancer aspect and disclosure thereof ("follow-on research" as termed in the brief) to its detriment.  This is contrary to the statutory purpose to promote disclosure in BIO"s view.

Finally, the brief reminds the Federal Circuit of the Supreme Court's admonition ("on more than one occasion") that changes in patent law should be made "in a manner that [does not] risk 'destroying the legitimate expectations of inventors in their property'" and "the settled expectations of the inventing community," citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002).

The District Court's obviousness-type double patenting determination, 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.  This sentiment echoes in some ways the justifications other panels have supplied for expanding the scope of inequitable conduct, another unsettled area of patent law that should be clarified by impending en banc review in Therasense v. Becton Dickinson.  It also evinces a Court that in some instances, for "good reasons," fails to apply settled law in contradiction to the precedential force of prior CCPA, panel or en banc decisions; these decisions are stare decisis and binding on later panels unless overturned by an en banc decision by the Court.  Too often, it seems that particular panels feel justified in ignoring these rubrics to reach the "right" or "just" decision in the matter at hand.  Justified or not, this pattern has resulted in the Court straying from the consistent principles established during its first two decades of decisions by such lions of patent law as Judge Rich and Judge Markey.  It has also necessitated en banc review in several areas of the law:  claim construction (Phillips v. AWH Corp.), written description (Ariad v. Eli Lilly), obviousness-type double patenting (Abbott Laboratories v. Sandoz), patentable subject matter (In re Bilski), inequitable conduct (Therasense), and the scope of district court review of PTO determinations (Hyatt v. Kappos).  While this spate of en banc review may be expected to settle the law in these important areas, they will do little unless each panel applies the settled law consistently.  That hasn't happened at the Court recently, a trend that renders difficult if not impossible the proper exercise of the Court's mandate to bring uniformity to U.S. patent law.