IP Law Daily, PATENT—Fed. Cir.: Pfizer lacked standing to appeal IPR decisions finding protein-purification methods patentable, (Apr 27, 2020)

By Thomas Long, J.D.

Pfizer failed to show that it was at risk of being accused of infringement for using the patented methods to make a drug product, or that it otherwise sustained injury giving it Article III standing.

Biopharmaceutical company Pfizer Inc. lacked standing to appeal two Patent Trial and Appeal Board decisions in inter partes review proceedings over patents related to methods for purifying proteins, in which the Board held that Pfizer did not prove that any of the challenged claims were unpatentable. According to the U.S. Court of Appeals for the Federal Circuit, Pfizer failed to establish that it was suffering a cognizable injury at all stages of the appeals sufficient to give it Article III standing to seek relief in the appellate court. Although Pfizer filed its notice of appeal on January 30, 2019, it could not have incurred a risk of infringement liability until much later that year, when it announced that it would be selling a drug product that purportedly used production methods covered by the patents at issue. Nor did Pfizer show that it actually had practiced, or planned to practice, the patented methods in producing its product (Pfizer Inc. v. Chugai Pharmaceutical Co., Ltd., April 27, 2020, Bryson, W.).

The patents at issue—U.S. Patent Nos. 7,332,289 ("the ’289 patent") and 7,927,815 ("the ’815 patent")—were owned by Chugai Pharmaceutical Co., Ltd. The patents described methods for purifying proteins by "removing contaminant DNA from a sample containing a physiologically active protein."

Pfizer petitioned for inter partes review (IPR) of claims 1–8 and 13 of the ’289 patent and claims 1–7, 12, and 13 of the ’815 patent. Although the Board instituted IPR of all the challenged claims on all the grounds that were asserted, the Board determined that Pfizer did not prove that any claims were unpatentable. Pfizer appealed to the Federal Circuit.

The court noted that any person or entity may petition the Patent and Trademark Office to institute an IPR proceeding, even if they do not have Article III standing. Parties bringing appeals to the Federal Circuit, however, must have Article III standing or the court lacks jurisdiction to hear the case. To establish Article III standing, an appellant must show that it has suffered an injury in fact that is fairly traceable to the challenged conduct of the defendant, and that is likely to be redressed by a favorable judicial decision. Moreover, an "actual case or controversy" must exist at all stages of review. In cases involving an IPR appeal in which the appellant is not currently engaging in infringing activity, the appellant generally must show that it has concrete plans for future activity that would put it at substantial risk of being accused of infringement.

According to the court, Pfizer did not establish that it had suffered a concrete and particularized injury in fact at the beginning of this appeal. Pfizer contended that it sustained an injury in fact stemming from its launch of its product Ruxience® in January 2020, a biosimilar product to a rituximab drug made by its competitor, Genentech. Pfizer asserted that Genentech was a wholly owned subsidiary of the Roche Group and that F. Hoffman-La Roche Ltd. was the majority owner of Chugai. Pfizer entered into a settlement agreement with Genentech, authorizing Pfizer to begin selling Ruxience®; Chugai was not a party to that agreement, and Pfizer did not get a license from Chugai for the patents at issue. Pfizer contended that Chugai was likely to accuse Pfizer’s rituximab biosimilar product of infringing the patents at issue because Pfizer’s product used protein A chromatography, and the ’289 and ’815 patents concerned methods of purifying proteins involving the use of protein A chromatography.

However, the court said, Pfizer did not address in its briefing or supplemental evidence when the purported risk of an infringement suit arose. Pfizer filed its notice of appeal on January 30, 2019. Yet the Food and Drug Administration did not approve its rituximab biosimilar product until July 2019, and Pfizer announced at the end of October 2019 that it would begin selling the product in January 2020. Pfizer cited no evidence of its activities or plans relating to the product before July 2019. Therefore, Pfizer failed to show that it was suffering from an injury-in-fact when the appeal began. Nor did Pfizer provide evidence that would allow the court to evaluate whether it practiced or planned to practice the patented methods in the course of making its biosimilar product.

Accordingly, the court dismissed Pfizer’s appeals.

This case is Nos. 19-1513 and 19-1514.

Attorneys: John P. Scheibeler (White & Case LLP) for Pfizer Inc. Jon Steven Baughman (Paul, Weiss, Rifkind, Wharton & Garrison LLP) for Chugai Pharmaceutical Co., Ltd.

Companies: Pfizer Inc.; Chugai Pharmaceutical Co., Ltd.

Cases: Patent GCNNews FedCirNews