News & Analysis as of

PTAB Update -- Biopharmaceutical Edition

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more

The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

Pharmaceutical Patent Score a Win - Amneal Pharms., LLC v. Supernus Pharms., Inc.

In three separate but related final written decisions in the first successful defense of a pharmaceutical patent in an inter partes review (IPR), the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board...more

Petitioners Denied Second Bite at IPR Petition - Biodelivery Sciences Int’l, Inc. v. RB Pharms. Ltd.; Standard Innovation Corp. v....

In two separate but similar written decisions involving challenged patents that were already the subject of instituted proceedings, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) denied...more

Court Report - February 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...more

Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc

Case Name: Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc., Nos. 2014-1439, 2014-1441, 2014-1444, 2014-1445, 2014-1446, 2014 U.S. App. LEXIS 21946 (Fed. Cir. Nov. 18, 2014) (Circuit Judges Lourie, Reyna and Taranto...more

Court Report - February 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis AG et al. v. Ezra Ventures LLC. 1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware. •...more

Teva receives license to three patents covering oxycodone dosage forms

Purdue Pharma L.P. et al. v. Teva Pharmaceuticals USA, Inc.; Purdue Pharma L.P. et al. v. Teva Pharmaceuticals USA, Inc. Case Number: 1:13-cv-04606-SHS; 1:14-cv-02357-SHS - Teva settled with plaintiffs in two...more

Sandoz Inc. v. Amgen Inc.,

Case Name: Sandoz Inc. v. Amgen Inc., No. 2014-1693, 2014 U.S. App. LEXIS 22903 (Fed. Cir. Dec. 5, 2014) (Circuit Judges Dyk, Taranto, and Chen presiding; Opinion by Taranto, J.) (appeal from N.D. Cal, Chesney, J.) (A...more

Mylan Pharms., Inc. v. FDA

Case Name: Mylan Pharms., Inc. v. FDA, Civ. Nos. 14-1522, 14-1529, 14-1593, 2014 U.S. App. LEXIS 24022 (4th Cir. Dec. 16, 2014) (Circuit Judges Wilkinson, Shedd, and Wynn presiding; Opinion by Wynn, J.) (Appeal from N.D....more

Biosimilars Update

Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics...more

Court Report - February 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc. 1:15-cv-00128; filed February 5, 2015 in the District...more

Production of prosecuting attorney’s memorandum about prior art waives privilege

Regeneron Pharmaceuticals, Inc. v. Merus B.V. Case Number: 1:14-cv-01650-KBF Judge Forrest, having determined that Regeneron’s production of a memorandum discussing prior art was a waiver of attorney-client...more

Supreme Court: Claim Construction Is Subject to Hybrid Review - Teva Pharmaceuticals USA v. Sandoz, Inc.

In a 7–2 decision penned by Justice Breyer, the Supreme Court of the United States overturned the de novo standard as the sole standard of review issues arising in claim construction. Teva Pharmaceuticals USA v. Sandoz,...more

Teva and Its Potential Impact on Patent Litigation

The Supreme Court recently handed down its 7-2 opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. The case involved a Federal Circuit review of a district court’s determination that Teva’s patent claims were not...more

Patent Claim Construction Subject to Hybrid Review Standard

Teva Pharmaceuticals USA v. Sandoz, Inc., U.S. No. 13-854 (Jan. 20, 2015) - Answering the long debated question of what deference the Court of Appeals for the Federal Circuit should give in reviewing district court...more

Why Did the Supreme Court GVR the Shire Lialda Case?

On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA,...more

Supreme Court Cuts Out a Slice of the Federal Circuit’s De Novo Pie

Recently, the Supreme Court changed the standard of review the Federal Circuit must use when reviewing district court claim construction decisions in patent cases. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. ___...more

The Supreme Court Clarifies the Standard for Reviewing Fact-finding in Claims Construction

On January 20, 2015, the Supreme Court issued its long-awaited decision on the standard of review of factual findings by the trial court in construing patent claims. The Court ruled that factual findings in the context of...more

Claims Are Construed Relating To Polysorbate Patents

Andrews, J. Claim construction opinion issues. The court considers 17 terms from five patents regarding formulation and device patents relating to polysorbates....more

Supreme Court Permits Appeal To Go Forward in LIBOR Antitrust Lawsuit

On January 21, 2015, the Supreme Court decided a narrow but important issue of appellate jurisdiction in cases that have been consolidated for pretrial proceedings by the Judicial Panel on Multidistrict Litigation. A...more

Supreme Court Orders Federal Circuit To Defer To District Court Factual Findings During Patent Claim Construction: Will Markman...

On January 20, 2015, the U.S. Supreme Court handed down its first patent decision of the current term, rejecting the U.S. Court of Appeals for the Federal Circuit’s long-standing practice of reviewing district court patent...more

Teva Decision Will Be Felt in Future Patent Claim Construction Hearings

On January 20, 2015, the Supreme Court issued its opinion in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Case No. 13-854), which changed the level of deference the Federal Circuit must show to district court claim...more

Teva v. Sandoz (USSC) – Standard for Appellate Review of Claim Construction Rulings

On Jan. 20, 2015, the U.S. Supreme Court issued a decision setting forth a new standard for appellate review of a district court’s claim construction ruling.  Teva Pharmas. USA, Inc. v. Sandoz, Inc., No. 13-854, slip op., 574...more

Court Report - January 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Par Pharmaceutical Inc. et al. 1:15-cv-00068; filed January 21, 2015 in the District Court of...more

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