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

The Federal Circuit recently reversed a PTAB determination on remand that a patent was obvious over applicant admitted prior art (“AAPA”) in combination with prior art patents, holding that expressly designating AAPA as a “basis” for a ground is improper under 35 U.S.C. § 311(b). In doing so, the Court rejected the PTAB’s “blanket rule” that “AAPA used in combination with prior art patents or printed publications under § 311(b) is ipso facto not the basis or part of the basis of a ground.” Ultimately, while the case clarifies that expressly listing AAPA in an IPR ground is improper, the precise line between proper and improper uses of AAPA in other instances remains unclear.

In an appeal from an inter partes review, the Federal Circuit recently clarified that the enablement inquiry applied to prior art references in the context of an anticipation defense differs from the enablement inquiry applied when evaluating the claims of a patent.

The Northern District of Ohio denied a motion to compel the plaintiff to produce test results referenced in its initial disclosures and complaint. The court found that because the “test results are not facts but rather are opinions,” the information was protected as work product. Furthermore, because that testing would not be used as evidence in the litigation, the defendant was not prejudiced.

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.