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

Two-Step Eligibility for Genomic Analysis Systems

Attorney: Daniel J. Pereira, Ph.D.
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

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

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

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

Can One Have Too Many Patents?

Attorney: Richard D. Kelly
July 7, 2020

As is common with a blockbuster drug, AbbVie's Humira faced an antitrust challenge from third-party payers. The third-party payers filed an antitrust action claiming AbbVie's patent strategy stifled competition by forcing prospective competitors to settle on terms allowing Humira to enjoy a monopoly long after patent protection should have ended. The complaint alleges that AbbVie cornered the market for Humira and its biosimilars by obtaining a thicket of patents which allowed it to gain the market power it needed to prevent competitors from entering the U.S. market (violation of Sherman Act section 2). It used this market power to enter into settlement agreements with potential competitors to keep their products out of the U.S. market in return for early launch dates in Europe, also an important market which they termed a pay-for delay and market division (violation of Sherman Act section 1). Judge Shah, of the Northern District of Illinois, dismissed the complaint without prejudice on June 8, 2020. The opinion begins with a discussion of three reasons Humira might hold its commanding position foreshadowing his decision. First, the more than one hundred Humira-related patents made it difficult if not impossible to seek a non-infringing competing product.... Read more

Requirements Under COVID-19 Prioritized Examination Pilot Program

Attorney: Marina I. Miller, Ph.D.
June 8, 2020

The USPTO has launched a new Covid-19 Prioritized Examination Pilot Program to help small and micro entities. The USPTO will accept requests for prioritized examination of up to 500 qualifying patent applications without requiring payment of certain fees associated with prioritized examination. Under this pilot, the USPTO will advance out of turn certain patent applications related to COVID-19 for examination, resulting in their prioritized examination. The USPTO aims to provide final disposition of patent applications in the pilot in one year or less after it grants prioritized status. <... Read more

CAFC Affirms Invalidation of Replacement Heart Valve Patent – Reiterates that Reasonable Expectation of Success is not Absolute Certainty for Success

Attorney: Grace Kim
May 08, 2020

           The Federal Circuit issued a public opinion in Boston Scientific Scimed, Inc., v. Andrei Iancu, No. 2018-2004 (Fed. Cir. May 6, 2020) (sealed opinion was previously issued on April 27, 2020), affirming the PTAB’s final written decision in IPR 2017-00060. The CAFC upheld that challenged claims 1-4 of U.S. Patent No. 8,992,608 to Boston Scientific are invalid as being obvious over prior art.<... Read more

CAFC Issues Another Precedential Decision on Standing

Attorney: Grace Kim
May 07, 2020

The Federal Circuit issued a precedential decision addressing standing requirements in Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., No. 2018-2273, slip op. (Fed. Cir. April 23, 2020).<... Read more

PTAB Issues Two New Precedential and One Informative Opinions on Section 325(d)

Attorney: Lisa M. Mandrusiak
April 17, 2020

The PTAB recently designated two decisions as precedential and one decision as informative with respect to 35 U.S.C. § 325(d). These cases discuss the Board's process for deciding when to use their discretion to deny institution because a Petition raises issues that the Patent Office previously considered in other proceedings (e.g., during prosecution, prior reexams).... Read more