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

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

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

Battle of the Biologics: Lilly's IPRs Clear Six Teva Patents

Attorney: Lisa M. Mandrusiak
March 5, 2020

Several companies have received FDA approval for antagonist antibodies against calcitonin gene-related peptides. These so-called anti-CGRP biologic drugs are a relatively new type of injectable medication for preventing migraines without side effects.<... Read more

Motions to Amend in Inter Partes Review: Why did Ethicon Cut Against the Grain?

December 9, 2019

Motions to amend (MTAs) are generally disfavored. The prevailing approach calls for patentees to file an MTA in Inter Partes Review (IPR) only in limited circumstances. In particular, most patentees are moving to narrow or clarify claim scope via an MTA only in cases where (i) there is no related application pending at the Office and (ii) the specter of lost past damages due to intervening rights outweighs the risk of an invalidity finding. At first glance, neither (i) nor (ii) appears to be true in the case of Intuitive Surgical, Inc. v. Ethicon, LLC, (IPRs2018-00933, 00934, and 00935), yet Ethicon elected to pursue an MTA in each of the IPRs and was successful in doing so.... Read more

The Flip Side of Reasonable Expectation of Success is Unpredictability

Attorney: Daniel J. Pereira, Ph.D.
October 11, 2019

The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:... Read more

SOVEREIGN IMMUNITY AND IPR'S: AND NOW, THE REST OF THE STORY

Attorney: J. Derek Mason, Ph.D., CLP
June 14, 2019

Radio great Paul Harvey would always leave listeners hanging during his broadcast, then return from a commercial with "the rest of the story". Previously, I wrote on the Federal Circuit ruling with respect to Tribal Immunity (https://www.oblon.com/publications/tribal-immunity-in-ipr-is-dealt-a-death-blow-by-the-federal-circuit). At the end of that article I stated: "I note, however, that in the final sentence of their analysis, the Federal Circuit explicitly stated that this decision did NOT address whether there is any reason to treat state sovereign immunity differently with respect to IPR proceedings. That will remain to be seen…"... Read more