IP News

Helsinn and MGI announced the agreements in a joint press release, and MGI also reported the agreement in a Securities and Exchange Commission (SEC) filings. Neither the SEC filing nor the press releases disclosed the specific dosage formulations covered by the agreements.

On January 30, 2003, nearly two years after Helsinn and MGI entered into the agreements, Helsinn filed a provisional patent application covering the 0.25 mg and 0.75 mg doses of palonosetron. Helsinn filed four more patent applications over the years that claimed priority to this provisional application. The fourth, a continuation-in-part of an earlier application, was filed in May 2013, and issued as U. S. Patent No. 8,598,219 (the '219 patent) with claims covering a fixed dose of 0.25 mg of palonosetron in a 5 ml solution. By virtue of its May 2013 effective date, the '219 patent is governed by the America Invents Act (AIA).

In 2011, Teva Pharmaceutical Industries, Ltd., and Teva Pharmaceuticals USA, Inc. (Teva), sought approval from the FDA to market a generic 0.25 mg palonosetron product. Helsinn then sued Teva for infringing its patents, including the '219 patent. In defense, Teva asserted that the '219 patent was invalid because the 0.25 mg dose was “on sale” more than one year before Helsinn filed the provisional patent application covering that dose in January 2003.

The district court determined that, under AIA 35 U. S. C. §102(a)(1), an invention is not “on sale” unless the sale or offer in question made the claimed invention “available to the public.” Because the companies' public disclosure of the agreements between Helsinn and MGI did not disclose the 0.25 mg dose, the district court concluded that the invention was not “on sale” before the effective filing date under AIA 35 U. S. C. §102(a)(1).

The Federal Circuit reversed; concluding that the details of an invention need not be publicly disclosed in the terms of sale to fall within the AIA's on-sale bar. 855 F. 3d 1356, 1360 (2017). The Supreme Court granted certiorari.

The Supreme Court's analysis began by noting that every patent statute since 1836 has been subject to an on-sale bar, and that immediately prior to the AIA, 35 U. S. C. §102(b) barred patents on inventions on-sale in the United States more than one year prior to the date of the application for patent. Slip Op. at 5-6. The Court further pointed to a significant body of case law pertaining to the on-sale bar that had developed by the time Congress enacted the AIA in 2011. For instance ,the Court cited its 1998 decision, in Pfaff v. Wells Electronics, Inc., 525 U. S. 55, 67 (1998), holding that the pre-AIA on-sale bar applies if the product sought to be patented was the subject of a commercial offer for sale and was ready for patenting.

While the Court acknowledged that it had never squarely addressed whether the sale needed to make the invention available to the public, the Court found that its prior decisions suggested it did not. Further, the Court noted that more recent decisions by the Federal Circuit had “made explicit what was implicit in our precedents,” i.e., that “secret sales” can invalidate a patent. Slip Op. at 5-7.

In light of this settled pre-AIA precedent on the meaning of “on sale,” and the fact that the new §102 retained the exact language used in its predecessor statute, adding only a new catchall clause, the Court concluded that Congress, by reenacting the same language in the AIA, adopted the earlier judicial construction of that phrase.

The new §102 retained the exact language used in its predecessor statute (“on sale”) and, as relevant here, added only a new catchall clause (“or otherwise available to the public”). Given the settled meaning of “on sale” prior to the AIA, the Court was unwilling to conclude that Congress intended to alter the meaning.

The Court dismissed Helsinn's contention that the associated-words canon required the added phrase, “otherwise available to the public,” be read to limit the preceding “on sale” term to sales that make the claimed invention available to the public. Rather, the Court concluded that this catchall phrase merely captures material that does not fit neatly into the statute's enumerated categories.

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New York District Judge Extends Estoppel Under §315(e) to Grounds Not Raised in Petition for Inter Partes Review

On Jan. 30, 2019, U.S. District Court Judge Kiyo A. Matsumoto of the Eastern District of New York issued an opinion and order in Am. Tech. Ceramics Corp. v. Presidio Components, Inc., No. 14-CV-6544, (E.D.N.Y. Jan. 30, 2019), holding that Presidio was estopped from raising invalidity grounds that it did not include in its petition for inter partes review (IPR).

American Technical Ceramics Corp. and AVX Corporation (collectively “plaintiffs”) sued Presidio for infringement of certain patents, including U.S. Patent No. 6,144,547 (the '547 patent), in November 2014. Presidio subsequently petitioned for, and obtained, inter partes review of each of the asserted patents, including the '547 patent. A final written decision in the IPR for the '547 patent issued on Dec. 1, 2016 confirming the patentability of claims 1–5 and 7–12 (IPR2015-01332, Paper 43). On Nov. 2, 2018, Judge Matsumoto issued an order construing a term in the confirmed claims of the '547 patent.

After this claim construction order, Presidio requested to supplement its invalidity contentions as to the '547 patent. Plaintiffs objected; arguing that Presidio was estopped, under 35 U.S.C. §315(e)(2), from raising any invalidity ground it “raised or reasonably could have raised” during its IPR of the '547 patent. Presidio responded by relying on Shaw Indus. Grp., Inc. v. Automated Creel Sys., Inc., 817 F.3d 1293 (Fed. Cir. 2016), to argue that because it did not petition the Patent Trial and Appeal Board (PTAB) on the invalidity grounds it sought to amend to its invalidity contentions, it necessarily could not have raised the grounds during the IPR and is thus not estopped.

Judge Matsumoto opinion first analyzes the legislative history of the AIA and 35 U.S.C. §315(e), and concludes that “Congress intended IPR to serve as a complete substitute for litigating the validity of patent claims in the district court.” Slip Op. at 6.

Judge Matsumoto next considered the Federal Circuit's decision in Shaw that estoppel under 35 U.S.C. §315(e)(2) does not apply to rejected grounds that were not instituted by the PTAB as part of an IPR. Shaw Indus. Grp. Inc., 817 F.3d at 1300. The court determined that the Shaw was not controlling, because it did not address the circumstances where a litigant seeks to argue invalidity on grounds that it never included or raised in its IPR petition but reasonably could have. The court, did, however, acknowledge that the Federal Circuit, in Shaw, held that an IPR does not begin until it is instituted, so a ground that is not instituted by the PTAB could not have been reasonably raised during an IPR.

After acknowledging a split among district courts' interpretation of 35 U.S.C. §315(e)(2) in the wake of Shaw — some barring invalidity grounds that were not presented to the PTAB but that reasonably could have been, and others permitting these grounds since they were never subject of an instituted IPR — Judge Matsumoto denied Presidio's request to supplement its invalidity contentions with grounds it reasonably could have raised in its IPR petition. Ruling otherwise, according to the court would “render the estoppel provision meaningless.” Slip Op. at 12. In support of its decision, the court cited policy goals of the AIA, including efficiency and reduced the burden on federal courts, and noted that “a petitioner that chooses not to raise certain invalidity grounds in its IPR petition only has itself to blame.” Slip Op. at 14-15.

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Jeffrey S. Ginsberg is the Assistant Editor of this newsletter and a partner with Patterson Belknap Webb & Tyler LLP.