News & Analysis as of

Mylan Pharmaceuticals

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation

by Morgan Lewis on

There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more

EMA Accepts Applications for Two Mylan and Biocon Biosimilars

by Goodwin on

On Friday, Biocon and Mylan announced that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars. As we previously reported, Biocon had earlier requested...more

FDA Approves Ogivri, Mylan’s Biosimilar Version of Herceptin

by Goodwin on

Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of...more

Are EpiPens Friend or Foe?

7 Deaths Associated With Medical Device - EpiPens exist to save lives or stave off severe allergic reactions to drugs, foods, insect bites and other causes of anaphylaxis. They are pocket-sized cylindrical devices that, in...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

Price-Fixing Allegations Against Generic Drug Manufacturers Broaden as State Attorneys General Seek Amended Complaint

by Arnall Golden Gregory LLP on

On October 31, 2017, the Attorneys General of forty-five states and the District of Columbia (the “State AGs”) moved to amend a December 2016 complaint alleging a broad price-fixing scheme among key players in the generic...more

Mylan Resubmits EMA Applications for Trastuzumab and Pegfilgrastim

by Goodwin on

As we previously reported, earlier this year Biocon requested withdrawal and re-submission of its Marketing Authorization Applications for its trastuzumab and pegfilgrastim biosimilars with the European Medicines Agency...more

Bristol-Myers Squibb Co. v. Mylan Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., Civ. No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372 (D. Del. Sept. 11, 2017) (Stark, J.)... Drug Product and U.S. Patent: Eliquis® (apixaban); U.S. Patents Nos....more

Momenta’s Orencia (abatacept) biosimilar candidate M834 does not meet primary endpoints in Phase I study

by Goodwin on

Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and...more

Anticipated Acts of Infringement May Establish Venue for Hatch-Waxman

by McDermott Will & Emery on

Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...more

Missouri Senator Introduces Bill to Abrogate Native American Sovereignty for Inter Partes Review Petitions

by Orrick - IP Landscape on

S.1948 – A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents. Allergan, Inc. and The Saint Regis Mohawk Tribe v. Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals,...more

Senators and court complain of ‘anti-competitive’ transfer of patent rights to American Indian tribe

We have previously discussed antitrust implications of pharmaceutical companies’ efforts to maximize patent protection for their drugs. Consumers and generic drug makers, for instance, have alleged antitrust violations based...more

US FDA Issues CRL For Biocon and Mylan’s Pegfilgrastim Biosimilar

by Goodwin on

As we posted previously, Biocon and Mylan are jointly developing a pegfilgrastim biosimilar, and have sought marketing authorization in the US. On October 10, Biocon reported that the FDA issued a Complete Response Letter...more

The Restasis Patents and Tribal Sovereign Immunity: New Developments

by Polsinelli on

The battle between Mylan and Allergan over the six Orange Book patents covering Restasis has taken a next formal step. On Sept. 22, the new patent-owner, the Saint Regis Mohawk Tribe, moved to dismiss Mylan’s requests for...more

Amgen Files Infringement Suit Against Mylan Over Neulasta Biosimilar

Amgen has filed patent infringement claims against Mylan and its subsidiaries over Mylan’s proposed biosimilar version of Neulasta (pegfilgrastim). Neulasta, a long-acting version of Amgen’s Neupogen (filgrastim), is a...more

New BPCIA Litigation: Amgen v. Mylan (W.D. Pa.)

by Goodwin on

On Friday, Amgen filed a complaint for patent infringement under the BPCIA against yet another developer of a biosimilar of Neulasta® (pegfilgrastim). Amgen has sued Mylan in the Western District of Pennsylvania for...more

Recent Trends on the U.S. Doctrine of Equivalents

U.S. courts have long recognized that a product or process which does not literally infringe a patent can nevertheless infringe under the "doctrine of equivalents" if it is equivalent to the claimed invention. The percentage...more

Mylan Pharm. v. AstraZeneca AB (PTAB 2017)

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office recently issued a Final Written Decision in an inter partes review styled Mylan Pharm. v. AstraZeneca AB affirming the patentability of all challenged...more

US FDA Delays Approval of Biocon and Mylan’s Biosimilar for Trastuzumab

by Goodwin on

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European...more

The Four Things That Surprised Us in the EpiPen False Claims Settlement

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Mylan will pay $465 million to federal authorities to resolve claims that it overcharged the Medicaid program by millions for its EpiPen products. Though large, the figure represents about a third of the estimated...more

Biocon Requests Withdrawal and Re-Submission of EMA Applications for it's Trastuzumab and Pegfilgrastim Biosimilars

by Goodwin on

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing authorization in the European...more

The Medicines Co. v. Mylan, Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Mylan Inc., Civ. No. 11-cv-1285, 2017 U.S. Dist. LEXIS 99898 (N.D. Ill. June 28, 2017) (St. Eve, J.)....more

The Medicines Co. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Mylan, Inc., No. 2015-1113, -1151, -1181 (Fed. Cir. Apr. 6, 2017) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Dyk, J.) (appeal from N.D. Ill., St. Eve, J.)....more

Mylan Institutional LLC v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: Mylan Institutional LLC v. Aurobindo Pharma Ltd., 2017-1645, 2017 U.S. App. LEXIS 8792 (Fed. Cir. May 19, 2017) (Circuit Judges Lourie, Moore, and Reyna presiding; Opinion by Lourie, J.) (appeal from E.D. Tex.,...more

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