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?

Attorney: Todd W. Baker
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

Written Description In Provisional Application: Perdue Pharma L.P. v. Andrei Iancu.

Attorney: Marina I. Miller, Ph.D.
May 28, 2019

Amneal Pharmaceuticals, LLC. ("Amneal") filed two petitions for inter partes review of claims 1–13 and 16–19 of U.S. Patent No. 9,034,376 ("the '376 patent") of Purdue Pharma L.P., P.F. Laboratories, Inc. and Purdue Pharmaceuticals L.P. ("Purdue"). In the petitions, Amneal argued that claims 1–13 and 16–19 were unpatentable for obviousness over the combinations of multiple prior art references including US 2002/0187192 A1 ("Joshi").... Read more

PTAB Issues Two New Precedential Opinions On Discretion to Deny Review - Implications for Generics

Attorney: Lisa M. Mandrusiak
May 9, 2019

The PTAB designated two decisions as precedential this week (in addition to several in previous weeks), both relevant to the Board's discretion to deny review. These cases illustrate that the PTO is in the process of designating precedential opinions on a number of issues, in line with revised Standard Operating Procedure 2 for designating precedential and informative decisions. See my previous posts on other recent precedential decisions here and here.... Read more