FDA INCREASES TRANSPARENCY THROUGH EXPANDED PARAGRAPH IV PATENT CERTIFICATIONS LIST

On June 18, 2019, the FDA announced plans to expand its Paragraph IV Patent Certifications List, a database used to list information about applications for generic drug approval.  The changes are part of the FDA’s on-going efforts “to provide the industry with greater transparency in order to provide greater certainty around timing of market entry […]

TERM Act Would Presume All Patents Covering a Branded Pharmaceutical Product Are Not Patentably Distinct

On June 11, a bipartisan group of Representatives including Hakeem Jeffries (D-N.Y.), Doug Collins (R-Ga.), Ben Cline (R-Va.), and Debbie Mucarsel-Powell (D-Fla.) introduced a new bill to address the rising cost of branded prescription drugs. The Terminating the Extension of Rights Misappropriated (TERM) Act of 2019, H.R. 3199, 116th Cong. (2019), aims to prevent pharmaceutical [...]

PATENTS ARE AWARDED FOR INVENTIONS, NOT RESEARCH PLANS

In a recent decision, the Federal Circuit reversed the District of New Jersey’s final judgment that two patents directed to methods of administering NSAIDs were adequately described under § 112. Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc., 2019 U.S. App. LEXIS 14345 (Fed. Cir. 2019). Both of the asserted patents are […]

Federal Circuit Confirms Collateral Estoppel Does Not Apply to Issues that Could Have Been Raised Previously

Recently, the Federal Circuit affirmed a decision from the United States Patent and Trademark Office Patent Trial and Appeal Board (“the Board”) finding claims of Purdue’s latest abuse deterrent, extended release oxycodone patent, U.S. Patent No. 9,034,376 (“the ’376 patent”), obvious over reference combinations including Pub. No. US 2002/0187192 A1 (“Joshi”).  Purdue Pharma L.P., et […]

District of Delaware Applies IPR Estoppel Even Though the Final Written Decision Did Not Issue Until After Trial

The District of Delaware recently weighed in on the scope of IPR estoppel in Novartis Pharmaceuticals Corp. v. Par Pharmaceutical, Inc., 14-cv-01289 (D. Del. Apr. 11, 2019).  Describing the issue before it as a matter of first impression, the Court held that “IPR estoppel will still apply post-trial where the Court has not entered a […]

PTAB Quashes Compound Patent After Rethinking Lead Compound Analysis

Last week the Patent Trial and Appeal Board invalidated Concert Pharmaceuticals’ patent covering modified ruxolitinib compounds in a final inter partes review decision, despite having initially denied institution of the underlying petition.  The Board found all claims of U.S. Patent No. 9,249,149 obvious over the prior art.  Ruxolitinib is the active ingredient in Concert’s Jakafi® […]

PTAB DENIES INTER PARTES REVIEW IN VIEW OF PETITIONER’S INCONSISTENT CLAIM CONSTRUCTION POSITIONS

The PTAB recently denied a petitioner’s request for inter partes review of a competitor’s surgical device patent, stating that the petitioner failed to provide a claim construction necessary to meet its burden to show a reasonable likelihood that at least one claim is unpatentable.  OrthoPediatrics Corp. v. K2M, Inc., IPR2018-01548, Paper 9 (P.T.A.B. March 1, […]

Athena Diagnostics v. Mayo – Federal Circuit Rejects Subject Matter Eligibility of Diagnostic Method Claims Requiring Man-Made Molecules

Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Massachusetts holding claims directed to methods for diagnosing neurological disorders invalid for lack of subject matter eligibility under 35 U.S.C. § 101. Athena Diagnostics, Inc. v. Mayo Collaborative Servs , LLC, 2019 U.S. App. LEXIS 3645 (Fed. Cir. 2019).  […]

Federal Circuit Confirms that Blocking-Patents Can Kill Secondary Considerations

The Federal Circuit recently refused to rehear a panel decision that affirmed a district court’s finding that the existence of a blocking patent negated the patent owner’s argument that commercial success, failure of others, and long-felt but unmet need showed the patents-in-suit were non-obvious. Acorda Therapeutics, Inc. et al. v. Roxane Labs., Inc. et al. (original […]