Cancer Research Technology Limited and Schering v. Barr Laboratories

625 F.3d 724, 96 U.S.P.Q. 2d (BNA) 1937, 2010 U.S. App. LEXIS 23214, 2010 WL 4455839
CourtCourt of Appeals for the Federal Circuit
DecidedNovember 9, 2010
Docket2010-1204
StatusPublished
Cited by32 cases

This text of 625 F.3d 724 (Cancer Research Technology Limited and Schering v. Barr Laboratories) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Cancer Research Technology Limited and Schering v. Barr Laboratories, 625 F.3d 724, 96 U.S.P.Q. 2d (BNA) 1937, 2010 U.S. App. LEXIS 23214, 2010 WL 4455839 (Fed. Cir. 2010).

Opinions

Opinion for the court filed by Circuit Judge LOURIE, in which Circuit Judge NEWMAN joins. Dissenting opinion filed by Circuit Judge PROST.

LOURIE, Circuit Judge.

Cancer Research Technology Limited and Schering Corporation (collectively, “Cancer Research”) appeal from the final decision of the United States District Court for the District of Delaware holding U.S. Patent 5,260,291 (“the '291 patent”) unenforceable for prosecution laches and inequitable conduct. Cancer Research Tech. v. Barr Labs., Inc., 679 F.Supp.2d 560 (D.Del.2010). We reverse.

Background

The '291 patent claims a genus of tetra-zine derivative compounds and methods for treating cancer by administering those compounds. One claimed compound, temozolomide, is the active ingredient in the drug Temodar®, approved by the Food and Drug Administration (“FDA”) for the treatment of two types of brain cancer— refractory anaplastic astrocytoma and newly diagnosed glioblastoma multiforme.

The application for the '291 patent was filed in the United States on August 23, 1982, by a British pharmaceutical company. The original specification identifies and characterizes thirteen “[ijmportant” tetrazine derivative compounds, designated A through M, and it identifies three of the thirteen compounds, including temozolomide (designated as A) and mitozolomide (designated as C), as having “particular importance.” '291 patent col.4 1.57, col.5 11.17-18. The specification states that the new tetrazine derivatives “possess valuable antineoplastic activity, for example against carcinomas, melanomas, sarcomas, lymphomas and leukaemias” and “have proved particularly active” in several different mouse tumor models. Id. col.4 11.29-56. The specification goes on to disclose positive data from those animal models. Id.

In the first substantive office action dated November 18, 1983, the examiner, Examiner Ford, rejected original claim 31 directed to a method of treating leukemia by administering a tetrazine compound because “[t]he treatment of leukaemia is not a believable utility on its face” and objected to the composition claims “pending clarification of utility.” A2394-96. The examiner wrote that utility could be established “by clinical reports and data, the acceptance of the drug employed by the Food and Drug Administration and by the American Medical Association Council on Pharmacy,” citing Ex parte Timmis, 123 U.S.P.Q. 581 (POBA 1959). A2395. The applicants did not respond to the office action but instead filed a continuation application on March 6, 1984, and abandoned the original application. On October 24, 1984, Examiner Ford again rejected claim 31 for lack of utility and objected to the composition claims pending clarification of utility. Again, the applicants, rather than respond to the office action, filed a continuation application and abandoned the pending application. This pattern repeated itself eight more times, with the examiner ultimately rejecting all the pending claims for lack of utility.

On March 25, 1991, ownership of the patent application changed hands, with Cancer Research receiving an absolute assignment of rights. On October 18, 1991, Cancer Research filed another continuation application, but for the first time challenged the examiner’s utility rejection, arguing that the disclosure of animal data in the original specification sufficed to establish utility in humans. In the next office action, a new examiner, Examiner Richter, modified the utility rejection, stating that [727]*727the disclosure established utility but only for claims limited to the specific antineoplastic activity listed and tested in the specification. In response, Cancer Research again argued patentability based on the animal testing disclosed in the original specification, relying on a quote from In re Buting, 57 C.C.P.A. 777, 418 F.2d 540 (CCPA 1969), that “[s]ubstantiating evidence may be in the form of animal tests which constitute recognized screening procedures with clear relevance to utility in humans.” A2086. Subsequently, a third examiner, Examiner Dentz, found the claims allowable, and the '291 patent issued on November 9,1993.

During the prosecution of the '291 patent, the applicants continued to study tetrazine derivatives as a treatment for cancer, and inventor Dr. Malcolm Stevens coauthored numerous articles reporting both animal and human clinical data to the scientific community. One of the tetrazine compounds described in the '291 patent as having “particular importance,” mitozolomide, showed broad spectrum antitumor activity in mice and was advanced to human clinical trials in 1983. Phase I and II human trials showed mitozolomide to have toxic side effects and little activity against many cancers. In light of mitozolomide’s toxic side effects, further studies with the compound were halted. Instead, a second tetrazine compound of “particular importance,” temozolomide, entered Phase I human testing in 1987. By 1989, reports showed that temozolomide was safe and had some anti-cancer activity. Clinical testing of temozolomide continued after the issuance of the '291 patent, and the FDA approved Temodar® for the treatment of refractory anaplastic astrocytoma in August 1999, and for the treatment of newly diagnosed glioblastoma multiforme in March 2005. In October 1999, Sehering Corp., the new exclusive licensee under the patent, filed for a patent term extension under 35 U.S.C. § 156, which added 1,006 days to the '291 patent’s term. The patent also was granted a pediatric exclusivity period and will expire in February 2014.

On March 19, 2007, Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc. (collectively, “Barr”) filed an Abbreviated New Drug Application (“ANDA”) with a Paragraph IV certification under the Hatch-Waxman Act, 21 U.S.C. § 355, challenging the validity of the '291 patent and seeking FDA approval for generic Temodar®. Cancer Research sued Barr for patent infringement in the United States District Court for the District of Delaware on July 20, 2007. The parties stipulated to infringement and validity of claim 13 directed to temozolomide, leaving only Barr’s counterclaims that the patent was unenforceable for prosecution laches and for inequitable conduct.

After a bench trial, the district court held the '291 patent unenforceable for prosecution laches. The district court first decided that under Symbol Technologies, Inc. v. Lemelson Medical, 422 F.3d 1378 (Fed.Cir.2005) (“Symbol Techs. II ”), prosecution laches did not require a showing of intervening rights but rather turned on whether under the totality of the circumstances Cancer Research’s delay in prosecution in light of the PTO’s utility rejections was unreasonable and unexplained. Cancer Research, 679 F.Supp.2d at 572-73. The court then found that even assuming, as Cancer Research claimed, that the PTO’s rejections required the submission of human clinical data to establish utility in humans, and thus patentability, Cancer Research could have attempted to traverse the rejection based on then-existing case law holding that such utility could be shown by animal tests, but waited until doing so benefited it commercially. Id. at 574. Furthermore, according to the district court, even if the examiner had re[728]

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625 F.3d 724, 96 U.S.P.Q. 2d (BNA) 1937, 2010 U.S. App. LEXIS 23214, 2010 WL 4455839, Counsel Stack Legal Research, https://law.counselstack.com/opinion/cancer-research-technology-limited-and-schering-v-barr-laboratories-cafc-2010.