April 6, 2021
The NHK-Fintiv rule allows the Patent Trial and Appeal Board (PTAB) to deny institution of an inter partes review petition based on the progress of a parallel U.S. district court proceeding of the same patent. The rule was established under former USPTO director Andrei Iancu in 2018, in NHK Spring v. Intri-Plex., No. IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) (precedential). As a result of the restrictions opposed by the NHK-Fintiv Rule, many petitioners have been facing increasing challenges in seeking review at the PTAB for patents where there is a parallel district court proceeding.<... Read more
March 8, 2021
Torrent Pharmaceuticals and Indoco Remedies Ltd. (Defendant-Appellant) appealed from the district court’s final judgment on Takeda’s (Plaintiffs-Appellees) invalidity challenges to claims 4 and 12 of U.S. Patent No. 7,807,689, owned by Takeda. In a non-precedential opinion, the Federal Circuit (“the Court”) affirmed the district court’s final judgment that Torrent and Indoco had failed to prove that the claims asserted by Takeda were invalid for statutory obviousness or non-statutory obviousness-type double patenting.<... Read more
March 1, 2021
The decision in GlaxoSmithKline LLC. V Teva Pharms. (976 F.3d 1347 (Fed. Cir. 2020) has caused panic in the generic industry because it has been interpreted as killing the “skinny label” approach to generic drug approval. A “skinny label” allows a generic company where there are multiple approved indications for a drug and some are protected by patent and others are not, to omit the patented indications from its label and avoid the need for a paragraph (iv) certification and 35 U.S.C. 217(e)(2) litigation. During the oral argument on February 23, 2021, on remand to the original panel, it became clear that the skinny label exception is not under attack although you wouldn’t know it from the Federal Circuit’s decision or the press reports.<... Read more
February 12, 2021
On January 19, 2021, the Supreme Court denied a petition for certiorari to hear the Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. case (941 F.3d 1149 (Fed. Cir. 2019)). In the underlying district court litigation, the jury found the Idenix patents were infringed, awarding it $2.5 billion in damages. But, the district court overturned the verdict and granted judgement as a matter of law finding the patents invalid for lack of enablement, and the Federal Circuit affirmed. To revive its damages claim, Idenix filed a petition to reverse the Federal Circuit's decision. The petition addressed whether a genus claim is not enabled if it encompasses a large number of compounds or whether, as the Supreme Court has previously recognized, enablement is a context-specific jury question (as well as a related written description issue that will not be discussed further).... Read more
February 10, 2021
On Tuesday the Federal Circuit vacated its decision in GlaxoSmithKline LLC. V. Teva Parma., USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020) in response to GSK’s request for rehearing en banc. In vacating the decision and deciding to rehear the case, the panel limited the rehearing to Teva’s question in its en banc petition as “whether there was substantial evidence to support the jury’s verdict of induced infringement.”<... Read more
February 4, 2021
For practitioners at the USPTO, the reversal of a 101 rejection in Ex parte Patil (PTAB January 7, 2021), APJs Grimes, Scneider and Valek, in Appeal 2020-002775 should be interesting if not provide some light on the dance floor for doing the two-step with the USPTO.
The invention focused on assessing genetic variability with a system including databases and processors and as recited in Claim 27 U.S. 15/169,498:<... Read more
February 1, 2021
The USPTO proposes to modify the rules of practice when certain types of patent applicants and patentees may obtain or enforce a second patent for an invention that is similar (i.e., patentably indistinct) to a first patent. Generally, an application for a second patent covering a similar invention would be rejected. The proposed rule change is limited to the situation where owners of the first and second patents or patent applications are different but have an agreement to conduct research together (i.e., a joint research agreement or JRA). The proposed rule change would increase the ability to file a terminal disclaimer (TD) that ties the rights of a second patent to the first patent. The proposed rule change intends to expand when a TD can be filed in the JRA situation by eliminating the requirement that the second patent or patent application be filed later than the first patent or patent application. The USPTO also proposes to amend the rules to explicitly state existing practices in the rules regarding when certain affidavits and declarations, as well as TDs, may be filed.<... Read more
January 8, 2021
The Congress passed and President on December 22 signed into law the “Further Extension of Continuing Appropriations Act, 2021”; despite its name it was chock full of goodies having nothing to do the nation’s need for a budget to pay its bills. One of the unrelated measures was the “Purple Book Continuity Act of 2019” (aka H.R. 1520). While the official text hasn’t been released yet, the Act’s content can be gleaned from the House report on H.R. 1520. The Act requires the FDA within 180 days to create in electronic format a searchable compendium of all licensed biologic products containing the license number, its date of approval, the marketing or license status. It requires updates every 30 days to include newly licensed products in the preceding 30 days. The FDA is also required to list each exclusivity period for a listed product that is applicable and has not expired. If a product’s license was withdrawn for safety, purity, or potency reasons the product must be removed from the list with notice published in the Federal Register.<... Read more
January 4, 2021
The USPTO is amending the rules of practice in patent cases to clarify and expand exceptions to the rule pertaining to government use licenses and their effect on small entity status for purposes of paying reduced patent fees. The USPTO explained that the rule change is designed to support independent inventors, small business concerns, and nonprofit organizations in filing patent applications and to encourage collaboration with the Federal Government by expanding the opportunities to qualify for the small entity patent fees discount for inventions made during the course of federally funded or federally supported research.<... Read more
December 7, 2020
In GSK v Teva the Federal Circuit reversed the district court’s JMOL and reinstated the jury’s verdict awarding $235 million in damages to GSK for Teva’s sale of $75 million dollars of carvedilol the generic equivalent of GSK’s Coreg®, even though the patents on the drug and all but one of its uses had expired.<... Read more