U.S. – China Trade Agreement: China Agrees to Make Changes That Could Benefit U.S. Drug Companies Doing Business in China

In a precedential opinion, the Federal Circuit definitively held that the Patent Trial and Appeal Board has jurisdiction over IPRs that concern expired patents.

In a patent infringement litigation in the U.S. District Court for the Eastern District of Texas, Judge Rodney Gilstrap denied a joint motion to stay the litigation pending resolution of inter partes review when it was uncertain that all defendants would be bound by the statutory estoppel provision of 35 U.S.C. § 315(e).

A district court recently dismissed a patent infringement complaint for improper venue under 28 U.S.C. § 1400(b), finding that the storage and distribution of products from an Amazon warehouse was not sufficient to establish that warehouse as a regular and established place of business in the district.

The Federal Circuit affirmed a District of Delaware finding of non-infringement in an ANDA litigation due to the patentee’s clear and unmistakable disavowal of claim scope during prosecution. Specifically, the court held that statements made during prosecution of a parent application before the asserted claims were allowed amounted to a prosecution disclaimer that extended to subsequent patents in the family. In reaching this conclusion, the court rejected an attempt by the patentee to resurrect the claim scope through a unilateral, self-serving statement made in later applications in the family.

The Federal Circuit recently affirmed a district court’s holding that patent term extension (PTE) for a reissued patent was properly based on the issue date of the original patent and not that of the reissued patent. The Federal Circuit concluded that, where both the original and reissued patents claimed a drug product under regulatory review, using the issue date of the original patent to calculate PTE comports with both the purpose of the Hatch-Waxman Act and the related statutory context.

The Patent Trial and Appeal Board recently declined to institute a petition for IPR that was filed on the same day that the petitioner filed another petition challenging the same claims of the same patent. The board was not persuaded by petitioner’s arguments that a second petition was needed due to alleged claim construction issues or the number, length or scope differences of the challenged claims.

The USPTO Director vacated the board’s decision to institute inter partes review based on an erroneous application of the Fintiv factors. Specifically, the Director found that the board placed too much emphasis on Petitioner’s Sotera stipulation, and not enough emphasis on the investment in the parallel litigation. Weighing the factors as a whole, the Director determined that institution should be denied.

In an institution decision following the USPTO’s withdrawal of its Fintiv Memo, the board addressed discretionary denial of an IPR under Fintiv in view of a parallel ITC investigation. The board noted it would not consider the now-rescinded June 2022 memo from then-director Vidal which instructed that the PTAB would not deny institution of an IPR or PGR under Fintiv when the request is based on a parallel ITC investigation. The board conducted a Fintiv analysis in view of the ITC investigation, but ultimately determined that discretionary denial was not warranted in this particular situation.