GlaxoSmithKline v. Teva - Not a Skinny Label?

Attorney: Richard D. Kelly
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

Supreme Court Declines to Hear Idenix Case: Dispute Surrounding the Enablement Standard for Biotechnology Patents Continues

Attorney: Lisa M. Mandrusiak
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

The "Skinny Label" - The Federal Circuit Has Second Thoughts

Attorney: Richard D. Kelly
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

USPTO: Proposed Changes to Terminal Disclaimer Practice in Joint Research Agreement Situations

Attorney: Marina I. Miller, Ph.D.
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

GSK v Teva – The Federal Circuit's First Look at Skinny Labels and 35 U.S.C. 271(b)

Attorney: Richard D. Kelly
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

Must a "Human Antibody" Be Entirely Human? Or May It Also Be "Partially Human?"

Attorney: Marina I. Miller, Ph.D.
October 16, 2020

This is a consolidated appeal from two Patent Trial and Appeal Board (“Board”) decisions in inter partes reviews (“IPRs”) of U.S. Patent 8,679,487 (“the ’487 patent”), owned by Immunex Corp. (“Immunex”). Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuti-cals, Inc. (“Sanofi”) challenged the ’487 patent. The Board invalidated all challenged claims in IPR 2017-01884. Immunex appealed, contesting the construction of the claim term “human antibodies.” The Court of Appeals for the Federal Circuit (“the Court”) agreed with the Board’s claim construction and affirmed the invalidity decision.<... Read more

Safe Harbor (35 U.S.C. 271(e)(1)) and Medical Devices

Attorney: Richard D. Kelly
October 13, 2020

In two decisions this year district courts have addressed the “safe harbor” provision of 35 U.S.C. § 271(e)(1) in motions to dismiss a patent infringement count. The first involved the display of artificial heart valves by Meril Life Sciences Pvt. Ltd. (Meril) at the 2019 Transcatheter Cardiovascular Therapeutics Conference (“TCT Conference”) in San Francisco, California. Edwards Life Sciences Corporation (Edwards) asserted that the display infringed its 5 patents on the displayed valves under §§ 271(a) and (g) by importing the valves made using its patented process. Meril defended by asserting that such display was protected by the safe harbor provision. The facts were not favorable. First, Meril did not have a marketing application pending with the FDA. While a pending application is unnecessary there must be evidence that the acts were calculated to lead to the possible submission of such evidence. See Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).    Alternatively, the activity was at least in part to attract clinical investigators for FDA trails. See Telectronics Pacing Systems, Inc. v. Ventritex, Inc., 982 F.2d 1520, 1523 (Fed. Cir. 1992). There was no evidence that defendants  recruited or could have recruited investigators for studies that could be submitted to the FDA. Edwards asserted that Meril’s sole objective was to promote sales in Europe. Thus, Teletronics was deemed irrelevant.<... Read more

GSK vs. Teva: Induced Infringement, Skinny Labels and Fat Damages

Attorney: Jeffrey B. McIntyre
October 6, 2020

Last week, in GlaxoSmithKline (GSK) v. Teva, the Federal Circuit reversed the district court's granting of judgment as a matter of law (JMOL) of no induced infringement by Teva. The JMOL had reversed a jury verdict finding of induced infringement by Teva. The Federal Circuit also sustained the jury's award of $234 million to GSK.... Read more

When are Recombinant Proteins Structurally Different Than Their Natural Counterparts?

Attorney: Daniel J. Pereira, Ph.D.
September 29, 2020

The answer to this question was central to the remand for a new trial on a judgement as a matter of law (JMOL) decision from the District Court overturning the jury verdict of anticipation in the Federal Circuit’s September 28, 2020 decision in Biogen MA Inc. v EMD Serono, Inv. Pfizer Inc. See http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-1133.OPINION.9-28-2020_1659873.pdf.<... Read more

Invalidity Based on Enablement: McRO, Inc. dba Planet Blue v. Bandai Namco Games America Inc., et al., No. 2019-1577 (Fed. Cir. May 20, 2020)

Attorney: Marina I. Miller, Ph.D.
September 1, 2020

McRO, Inc. (“McRO”) filed a lawsuit against multiple video game developers (“the Developers”), alleging that the Developers infringed three method claims of U.S. Patent No. 6,611,278 (“the ‘278 patent”), owned by McRO. The district court held the claims invalid for ineligibility under 35 U.S.C. § 101, but the Federal Circuit (“the Court”) reversed that holding in McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016) (McRO I). On remand, the district court held that the Developers were entitled to summary judgment of non-infringement, because the accused products do not practice the claimed methods and to summary judgment of invalidity because the specification fails to enable the full scope of the claims. McRO appealed.<... Read more