District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage

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 The board noted it would not consider the now-rescinded June 2022 memo from then-director Vidal which instructed that the PTAB would not deny institution of an IPR or PGR under Fintiv when the request is based on a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.

The Federal Circuit recently refused to apply collateral estoppel to claims of a patent asserted in district court litigation based on a Patent Trial and Appeal Board (PTAB) decision finding similar claims from the same patent unpatentable because the PTAB applied a lower burden of proof than what is required to invalidate claims in district court.

The Central District of California denied a defendant’s motion to dismiss or transfer plaintiff’s first-filed declaratory judgment action based on defendant’s later-filed patent infringement suit in Wisconsin.  Though suit was seemingly imminent when defendant advised plaintiff it might be infringing defendant’s patents, plaintiff responded by requesting a licensing agreement in lieu of litigation. The court found that plaintiff’s action was not anticipatory forum-shopping litigation because plaintiff only filed suit after defendant neglected to respond to its licensing offer.

The District of Delaware recently denied in part a motion to compel production of documents and testimony between a patentee and potential investors, valuation firms and an international bank based on the common interest exception. In so doing, the court reaffirmed that disclosure of privileged information to third parties will generally waive privilege unless it can be shown that the parties’ interests are identical and the communications are legal, not solely commercial.

The Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) final written decision holding that the prior art exception of AIA Section 102(b)(2)(B) does not apply to a prior sale by an inventor when the sale is conducted in private. According to the Federal Circuit, a sale must disclose the relevant aspects of the invention to the public to qualify for the prior art exception of Section 102(b)(2)(B).