News & Analysis as of

Mylan Pharmaceuticals

Health Care E-Note - April 2017

by Burr & Forman on

An often overlooked and under publicized provision of the False Claims Act (“FCA”) is the retaliatory discharge prohibition. This is probably because retaliatory discharge claims do not grab headlines by winning multimillion...more

PTAB Life Sciences Report -- Part II - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc. PTAB Petition: IPR2017-00853;...more

PTAB Life Sciences Report -- Part I - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more

Anaphylaxis Possible Risk of Recalled EpiPen Auto-Injector, Epi-Pen Jr Auto-Injector

A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need....more

Federal Circuit Patent Updates - April 2017

by WilmerHale on

Affirming judgment of noninfringement of one patent and reversing judgment of infringement of another patent. All asserted claims required a particular process step, construed as defined by one example in the specification,...more

PTAB Life Sciences Report -- Part IV

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Smith & Nephew, Inc. v. ConforMIS, Inc. PTAB Petition: IPR2017-00778; filed January 26,...more

The Medicines Company v. Mylan, Inc. (Fed. Cir. 2017)

The Federal Circuit returned to its consideration of the outcome in the District Court of The Medicines Company's ANDA litigation against Mylan and Bioniche Pharma over a proposed generic version of Medicines' bivalirudin...more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complex Innovations, LLC. v. AstraZeneca AB - PTAB Petition: IPR2017-00631; filed January 9,...more

PTAB Life Sciences Report -- Part II - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents....more

Mylan and Genentech Reach Settlement on Cabilly Patent IPR

by Goodwin on

As we reported yesterday, Mylan announced that it has reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. relating to trastuzumab, which extended to Mylan agreeing to withdraw its IPR challenge to U.S. Pat....more

Mylan Obtains Global License to Trastuzumab in IPR Settlement

by Goodwin on

Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As...more

IPR Tracker: Mylan and Genentech Settle Humanized Antibodies IPRs

by Goodwin on

We have been following the IPRs filed by Mylan against Genentech’s U.S. Patent No. 6,407,213, which relates to humanized antibody polypeptides and methods for their preparation and use. On Tuesday, March 7th, the parties...more

PTAB Life Sciences Report -- Part I - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. McKesson Corp. v. My Health, Inc. - PTAB Petition: IPR2017-00312; filed November 29,...more

Rx IP Update - February 2017

by Smart & Biggar on

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

FDA Accepts Mylan aBLA or Pegfilgrastim Biosimilar

by Goodwin on

Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim), for filing through the 351(k)...more

FDA Request for Justification Found to Provide a Mere Research Suggestion—Not Conception of Claimed Formulation

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower court’s holding that a patent covering a chelating-agent-free drug...more

As patients sue over insulin’s skyrocketing costs, Trump thunders, confuses

Just under a century ago, a team of Canadian scientists made the breakthrough that led to widely available insulin as an effective treatment for diabetes, which then was a deadly disease. The researchers, who won the Nobel...more

Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC (Fed. Cir. 2017)

The Federal Circuit had the opportunity to provide guidance on a question now in its twilight: what is the standard for determining who is the true inventor under pre-AIA 35 U.S.C. § 102(f), in Cumberland Pharmaceuticals...more

Mylan Institutional LLC v. Aurobindo Phama Ltd

by Robins Kaplan LLP on

Case Name: Mylan Institutional LLC v. Aurobindo Phama Ltd, 2:16-cv-00491-RWS-RSP, 2016 U.S. Dist. LEXIS 180551 (E.D. Tex. Nov. 21, 2016) (Payne, MJ). Drug Product and Patents-in-Suit: isosulfan blue; U.S. Patents Nos....more

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

FDA Accepts aBLA for Mylan-Biocon’s Proposed Herceptin® Biosimilar

by Goodwin on

As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its...more

Supreme Court Declines to Review Personal Jurisdiction Ruling in Drug Patent Case

by Goodwin on

In March 2016, a Federal Circuit panel issued a decision in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc. in which it held that Mylan was subject to specific personal jurisdiction in the District of Delaware because...more

Year In Review: Top Five Biosimilars Deals of 2016

by Goodwin on

After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: As we reported in January 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an...more

PTAB Life Sciences Report -- Part IV

About the PTAB Life Sciences Report: Each month (or more frequently) we will report on developments at the PTAB involving life sciences patents....more

20 states, U.S. take aim at collusion claims, soaring prices for generic drugs

If there ever were naïve wishes that parts of Big Pharma might work in more enlightened ways for patients, the attorney generals in 20 states and federal prosecutors, have dashed optimism about “white hat” drug makers. Led by...more

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