Tag Archives: Pharma / ANDA

PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent

IPRs are an attractive option for biosimilar applicants to clear the patent landscape before delving into litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which is still in its infancy.  Roche’s Herceptin® (trastuzumab) is a prime target for biosimilar makers, accounting for sales of over $6.5 billion in 2015.  Mylan, Celltrion, … Continue Reading

Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules

 The House of Representatives recently sent to the Senate its bill (H.R.5) that combines six previous regulatory reform bills, including, as Title II of the bill, the “Separation of Powers Restoration Act.”  Section 202 of the bill effectively removes the option for courts to apply Chevron deference to agency rulemaking and interpretations.  Thus, rather than deciding … Continue Reading

Another VIMOVO® Patent Survives Challenge by Coalition for Affordable Drugs – Updating the CFAD Scorecard

In the spirit of “if at first you don’t succeed, try, try again,” the Coalition for Affordable Drugs (CFAD) challenged a fourth Orange Book-listed patent relating to VIVOMO®, Horizon Pharma’s naproxen/ esomeprazole product.  While denying CFAD’s previous three petitions, the PTAB instituted inter partes review for U.S. Patent No. 8,945,621.  Despite CFAD’s success at the … Continue Reading

Purdue Not Estopped From Raising Invalidity Contentions at Trial That Were Submitted But Not Instituted During IPR

Recently, the Federal District Court for the District of New Jersey allowed Purdue Pharma to assert invalidity arguments in the litigation that were previously submitted in an IPR petition, but upon which IPR review was not instituted. See Depomed Inc. v Purdue Pharma LP, Civil Action 13-571, Order (D.N.J. Nov. 4, 2016). The Court rejected … Continue Reading

PTAB Cancels Gattax® Patent Claims in Coalition for Affordable Drugs IPRs

In two final written decisions (IPR2015-01093 and IPR2015-00990), the PTAB found that challenged claims in Shire’s U.S. Patent No. 7,056,886 (the ’886 patent) were invalid as obvious.  The decisions highlight potential issues related to patents directed to pharmaceutical formulations that petitioners and patent owners alike may want to consider if confronted with an IPR related … Continue Reading

“Providing . . . information” Step Given No Patentable Weight

The PTAB recently addressed the limits on strategies to patent drug labeling, canceling claims directed to a method of supplying a pharmaceutical product where the method includes a step of providing certain “information” to the medical provider. According to the PTAB, the claimed step of providing the information is entitled to no patentable weight under … Continue Reading

The Possibility of Inconsistent Results Inherent to Congress’s Design of AIA Trial Reviews

In Cuozzo Speed Technologies, LLC v. Lee, the Supreme Court recognized that a “district court may find a patent claim to be valid, and the agency may later cancel that claim in its own review.”  The Court also recognized that because of the different evidentiary burdens in court versus before the agency—the Patent Office—“the possibility … Continue Reading

Status Report on IPR Statistics for the Biotech/Pharma Technology Center

On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided a status report on Inter Partes Review/Post Grant Review in the Biotechnology and Chemical Technology Center 1600 during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference.  The statistics discussed during this BCP Conference are current as of May 31, 2016. … Continue Reading

Rare Grant of Rehearing of Denial of Petition for Inter Partes Review

The Board initially denied institution of Mylan Pharmaceuticals’ petition for inter partes review of U.S. Patent No. RE44,186, owned by AstraZeneca.  After a rare grant of Mylan’s request for rehearing, the Board reconsidered the record and decided to institute the IPR.  The decision to institute focused on the content of Mylan’s expert testimony; and although … Continue Reading

Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties

In a recent order by the magistrate judge in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (NJD, Jan. 22, 2016), defendants Amneal Pharmaceuticals and Par Pharmaceuticals were reprimanded and threatened with sanctions and monetary fines for trying to use confidential information from the litigation to move for additional discovery in a related IPR proceedings.  The judge … Continue Reading

PTAB Warns Again That Prosecution Declarations Without Depositions May Be Given Little or No Weight

If you rely in an IPR on a declaration submitted during prosecution, the PTAB may give it little or no weight if your opponent cannot cross-examine the declarant. In Praxair Distribution, Inc. v. INO Therapeutics LLC, the PTAB instituted inter partes review of U.S. Patent No. 8,846,112, directed to methods of providing nitric oxide gas … Continue Reading

Broader is Better for the Petitioner, but Inherency is Intrinsically Difficult

Two recent PTAB final written decisions highlight the benefits that the “broadest reasonable interpretation” standard for claim construction provides to Petitioners, as well as the difficulty Petitioners face in proving inherent anticipation.  The PTAB instituted two IPRs on the same patent: one on an anticipation ground, and another on an obviousness ground.  The Petitioner failed … Continue Reading

Pharma industry continues efforts to exempt patents from IPR

The pharmaceutical industry continues its efforts to exempt pharmaceutical and biotechnology patents from inter partes review (IPR). Neither the House’s Innovation Act nor the Senate’s PATENT Act currently contain any provisions that would exempt particular patents from these proceedings. But as we reported in June, some members of the Senate judiciary committee appear sympathetic to … Continue Reading

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

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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