The Purple Book Continuity Act

Attorney: Richard D. Kelly
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  If a product’s license was withdrawn for safety, purity, or potency reasons the product must be removed from the list with notice published in the Federal Register.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

Small Entity Government Use License Exception: Amendment of the Rules of Practice in Patent Cases

Attorney: Marina I. Miller, Ph.D.
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

Should Companies Suspend Patent Rights on COVID-19 Vaccines?

Attorney: Lisa M. Mandrusiak
December 21, 2020

In early October, Moderna earned praise by announcing that it will not enforce patent rights related to its mRNA coronavirus vaccine during the pandemic. Other companies, notably Pfizer/BioNTech (also pursuing an mRNA-based vaccine), have not made the same promise.... 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

What is "About" All About?

Attorney: Daniel J. Pereira, Ph.D.
December 4, 2020

The meaning and scope of the term “about,” which was used to modify numerical ranges in patent claims was a central issue in Par Pharmaceutical, Inv v. Hospira (Fed. Cir. November 23, 2020). The two patents at issue (U.S. Patent Nos. 9,119,876 and 9,295,657) pertain to Par’s Adrenalin® products and methods using epinephrine and the case arose from Hospira’s ANDA to make and market the generic of Par’s product, which as one might expect caused Par to file suit against Hospira for patent infringement under 35 USC 271(e).<... Read more

Supreme Court Hears Oral Arguments on Affordable Care Act: Will Biosimilars Survive?

Attorney: Lisa M. Mandrusiak
November 10, 2020

Today the Supreme Court heard arguments in Texas v. Azar that the Affordable Care Act (ACA)’s individual coverage mandate is unconstitutional.  According to the ruling in the underlying case, in the absence of the individual mandate, the rest of the ACA cannot stand.<... Read more

Where Have All the Bio/Pharma IPRs Gone?

Attorney: Lisa M. Mandrusiak
October 27, 2020

The IPR program in general has been wildly successful in its intended purpose of providing a lower-cost alternative to patent litigation, and the number of filings has remained relatively steady (though there were somewhat less in 2019 and 2020 as compared to previous years). The same is not true of IPRs filed in the TC 1600 space.<... 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