Hedge Fund IPR Challenges to Pharma Patents: Latest Developments and Strategies to Strengthen Patents

Lessons From PTAB Denial of Acorda Therapeutics IPR, Celgene's Sanctions Motion, and More

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Monday, October 12, 2015

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Program Materials

This CLE webinar will provide patent counsel with guidance on the recent inter partes review (IPR) challenges by hedge funds to pharmaceutical patents, examining the patents that are being attacked and the grounds for attack. The panel will discuss the lessons learned from these challenges and will offer strategies for strengthening patents to withstand attack.

Description

On Aug. 24, 2015, the PTAB declined to institute two hedge fund IPRs on the merits, leaving the issue of real party in interest for another day. There are now 22 IPR petitions that have been filed against pharmaceutical patent holders. For those who thought pharma patents were going to be generally immune from IPRs, the flurry of recent IPR petitions filed by hedge funds is a clear message that, so far at least, they were wrong.

In October, the PTAB instituted the first IPR petitions filed by a hedge fund. These latest developments may potentially change the landscape for both patent owners and hedge funds. This decision, in addition to the Board's denial of Celgene's sanctions motion against a hedge fund, demonstrates, at least for now, the Board's acceptance of hedge funds' ability to challenge patent in IPRs.

AIA post-grant proceedings were heralded by many as an effort to legislatively address the perceived problem of “bad” patents. It was widely considered to be a tool that would be used primarily in the computer and electronic industries, where most of those “bad” patents were thought to exist.

These recent IPRs have set off a great deal of controversy and confusion. For example, there are current lobbying efforts attempting to limit, perhaps legislatively, the ability of third parties to file IPR petitions. As of now, however, there is no standing requirement for filing an IPR petition.

The goal of this program is not to assess or debate standing or whether non-practicing entity (NPE) IPR petitioners are good, bad or indifferent. Rather, the goal is to report objectively what is being done in these IPRs, i.e., what kinds of pharma patents are being challenged, how those challenges are expressed, patent owner’s responses so far, and PTAB’s decisions to date.

Against this background, pharma patent owners can assess what is happening and what pharma patent owners can do now to strengthen patents against IPR attack, no matter the identity of the petitioner. According to reports in the media, at least one of these petitioners is not planning to settle in any IPR. (“We are going to challenge and invalidate patents through the IPR process ... (and) we are not going to settle,” Reuters.com, Jan. 7, 2015).

Listen as our expert panel, with extensive experience drafting, prosecuting and litigating patents before PTAB and federal courts, provides an analysis of the kinds of patents that have been attacked so far and the grounds of the attacks. The panel will also provide insight on what lessons innovative pharma patent owners can take away.

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Outline

  1. Overview of IPRs in pharma, including IPRs filed by NPEs
  2. Analysis of pharma patents attacked so far by NPEs
    1. Pharma technology involved
    2. Prior publications and patent grounds asserted
    3. What types of claims in the patents are under attack?
  3. Patent owner responses so far
    1. Real-party-in-interest
    2. Substantive arguments
    3. Motions for sanctions
    4. Motions for additional discovery
  4. What can innovative pharma do today to strengthen their patents to enhance the chance of survival in IPR, irrespective of the identity of the petitioner

Benefits

The panel will provide answers to the following and other key questions:

  • What types of pharma patents are being challenged by hedge funds in IPR?
  • What grounds are being asserted?
  • What can be learned from the PTAB’s Aug. 24, 2015, decision declining to institute two hedge fund IPRs?
  • What message is the PTAB sending by choosing not to take a position on whether a third party’s filing status is determinative of a petition’s ability to be taken up?
  • What can the pharma patent owner do to strengthen their patents to enhance the chance of survival in IPR, irrespective of the identity of the petitioner?

Faculty

Kerry Flynn
Kerry Flynn
Vice President, Chief IP Counsel
Vertex Pharmaceuticals

Ms. Flynn is a highly experienced licensing and intellectual property attorney with over 30 years of experience in both...  |  Read More

Irving, Thomas
Thomas L. Irving
Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

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