Mylan Pharmaceuticals

News & Analysis as of

FDA Accepts Mylan aBLA or Pegfilgrastim Biosimilar

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

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

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

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

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

Price Fixing Charges Brought Against Generic Drug Companies and Former Executives

Generic drug manufacturers have come under increasing scrutiny recently from state and federal regulators for price increases and alleged price collusion. Over the past year, drug pricing has faced sharp criticism from...more

Supreme Court Corner - Q4 2016

CASES WE ARE WATCHING Lenz v. Universal Music Corp. - COPYRIGHT – Cert. Pending ISSUE: Whether, in sending a takedown notice under the DMCA, the copyright holder’s “good faith belief” of copyright infringement may be...more

IPR Tracker: Genentech Files Preliminary Responses in IPR2016-01693 and IPR2016-01694

On December 16, 2016, Genentech filed preliminary responses in IPR2016-01693 and IPR2016-01694. Mylan filed both IPR petitions in August against patent 6,407,213, which covers humanized antibody polypeptides and methods for...more

PTAB Life Sciences Report -- December 2016 #2

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

Your Daily Dose of Financial News

Rupert Murdoch and 21st Century Fox have fulfilled a mission derailed five years ago by a UK phone hacking scandal and have taken full control of British satellite TV giant Sky. Fox paid just shy of $15 billion to acquire the...more

PTAB Life Sciences Report -- Part I December 2016

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

Mylan-Biocon Publish Positive Results for Proposed Trastuzumab Biosimilar

Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American...more

Forest Labs. Holdings Ltd. v. Mylan Inc.

Case Name: Forest Labs. Holdings Ltd. v. Mylan Inc., No. 13–1602–SLR (Consolidated), 2016 U.S. Dist. LEXIS 89268 (D. Del. July 11, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Savella® (milnacipran...more

Mylan and Mabion Reach Agreement on Rituximab Biosimilar

According to a Mabion press release, Mylan recently reached a deal with Mabion, a Polish biotech firm, for the exclusive right to commercialize Mabion’s rituximab biosimilar candidate in EU countries and non-EU Balkan states....more

Mylan and Biocon Partnership Updates

On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in...more

NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more

3rd Circuit Weighs In On Product-Hopping

On Sept. 28, 2016, in Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Limited Co. (Doryx), the Third Circuit affirmed the lower court’s grant of summary judgment rejecting antitrust claims brought against Warner Chilcott...more

Hatch-Waxman Venue Update: Will SCOTUS Limit Where Brands Can Sue Generics?

Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more

PTAB Life Sciences Report - October 2016

About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...more

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