Biotechnology

Eye on Biotech, biotechnology, post-grant, IPREye on Biotech: Through the rise of biosimilars, the evolution of patent eligibility (Section 101), and the advent of hedge-fund challenges to pharma patents, Marshall Gerstein keeps a watchful eye on PTAB developments in the world of biotechnology and life sciences. Follow this industry-focused section of our blog to stay informed on post-grant proceedings and the related issues that matter most to your business.

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Mind The Gap: The PTAB Will Not Bridge It For You

Petitioners should beware gaps in their evidence and reasoning.  Two DepoMed patents recently survived their second IPR challenge because the petitioner failed to meet its burden of proof.  The PTAB rejected petitioner’s obviousness arguments as “overly vague and nonspecific,” concluding that petitioner failed to “explain persuasively why or how a person of ordinary skill in … Continue Reading

PTAB Denies Institution of Another Investment Fund IPR Petition, Refusing to Ignore Claim Limitation Under BRI Standard

Score another win for pharma against investment funds-turned-IPR petitioners. On September 21, 2015, the PTAB denied institution of Ferrum Ferro Capital, LLC’s (“FFC”) petition for IPR of an Allergan patent claim related to its Combigan® eye-drop product for treating glaucoma. This dispute has attracted publicity for having bled into the courts, where Allergan has sued … Continue Reading

PTAB Applies the Estoppel Provision of the AIA to Deny an IPR Petition

The PTAB recently denied institution of an inter partes review (IPR) on the basis of the estoppel provision of the AIA (35 USC § 315(e)). Apotex Inc. v. Wyeth LLC, IPR2015-00873, Paper 8 (PTAB Sept. 16, 2015). The decision is not appealable, and is significant because it offers guidance on how the PTAB will construe this … Continue Reading

PTAB Denies Institution of Two IPR Petitions Filed by Hedge Fund

As the patent community anxiously awaits the PTAB’s decision concerning whether the Coalition For Affordable Drugs (CFAD) should be sanctioned for filing an IPR petition against a Celgene patent¹, the PTAB recently denied institution of two IPR petitions² the CFAD filed concerning two Acorda patents that cover Ampyra, a billion-dollar drug for treating multiple sclerosis.  The … Continue Reading

Gamble At Your Own Risk – The Danger Of Petition Overkill

Boehringer Ingelheim filed the petition at issue in IPR2015-00417 concurrently with the petitions at issue in IPR2015-00415 and IPR2015-00418 to challenge patents protecting methodologies for treating rheumatoid arthritis (RA) with rituximab, an FDA-approved antibody for treating certain cancers.  The IPR2015-00417 petition specifically challenged the fourteen claims of U.S. Patent No. 7,976,838, which are drawn to … Continue Reading

Grinning Patentees Get A Mulligan

Filed concurrently with the petitions at issue in IPR2015-00417 and IPR2015-00418, Boehringer Ingelheim filed the petition at issue in IPR2015-00415 seeking review of U.S. Patent No. 7,820,161 owned by Genentech and Biogen Idec.  The Board’s institution decision steadily whittled down Boehringer’s varied attacks on the patent.  Ultimately, IPR was granted on 2 of the 36 … Continue Reading

PTAB Denies Institution in Cepheid v. Roche: PCR Primers Found Not Inherently Anticipated

On June 11, 2015, the PTAB denied institution of Cepheid’s petition seeking inter partes review of Patent No. 5,643,723 directed to methods of detecting tuberculosis in humans (IPR2015-00255). To defeat institution, the patent owner successfully used its preliminary response to persuade the Board to (a) narrowly construe claim terms (despite the broadest-reasonable-construction standard), and (b) … Continue Reading

Pharma Patent Owner Attacks Bass IPR Petitions by Requesting Discovery of Real Parties-In-Interest

A picture can be worth a thousand words. This one illustrates the complex web of actual and potential real parties-in-interest (RPIs) that a pharmaceutical patent owner is attempting to pierce for two IPR petitions recently filed by Coalition For Affordable Drugs II—one of several similarly-named creations of hedge-fund manager Kyle Bass and his Hayman Credes … Continue Reading

Hatch-Waxman and BPCIA Patents May Be Exempted from Post-Grant Proceedings Under Pending Senate Legislation

On Thursday, June 4, the Senate Judiciary Committee approved the Protecting American Talent and Entrepreneurship (PATENT) Act. We previously reported the significant provisions of the bill. Several members of the Judiciary Committee expressed support for a further proposal that would exempt from PTO post-grant proceedings patents that are subject to the Hatch-Waxman or Biologics Price … Continue Reading
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