News & Analysis as of

Generic Drugs

Double Preemption Win in Amiodarone Litigation

by Reed Smith on

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in...more

Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and...more

Federal Court releases new guidelines for actions under the amended PMNOC Regulations

by DLA Piper on

On September 21, 2017, the Federal Court released the Guidelines for Actions under the Amended PMNOC Regulations (the “Guidelines”) to coincide with the coming-into-force of the amended PMNOC Regulations (“PMNOC...more

JAMA Publishes Response to Article on Obstacles to Biosimilar Adoption

by Goodwin on

The Journal of the American Medical Association (JAMA) recently published a response to “Obstacles to the Adoption of Biosimilars for Chronic Diseases,” a JAMA article we summarized in the spring. In a letter to the editor...more

District of Delaware “Clips”- Off Venue-Discovery for Medical Device Company but Allows It for Pharmaceutical Company

by Orrick - IP Landscape on

Boston Sci. Corp. v. Cook Grp., Inc., No. 15-980-LPS-CJB, 2017 U.S. Dist. LEXIS 146126, at *2 (D. Del. Sep. 11, 2017); Bristol-Myers Squibb Co. v. Mylan Pharm., Inc., No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372, at *3 (D....more

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

by Bennett Jones LLP on

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry – Recommendations on Changes to Public Policy -- Part...

In the first three installments of this series, we've explained the general purpose of the study, and gone through the sections of patents, marketing authorizations and strategic behavior of the study published on August 9,...more

FDA Implements a New “Concept of Operations” for Drug Inspections

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

Pharma advertising in Italy – Online publication of OTC medicinal products list, prices and reimbursability

by Hogan Lovells on

The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more

Third Circuit Holds No Sham Litigation or Unlawful Reverse Payment in Wellbutrin XL Litigation

The Third Circuit recently affirmed the grant of summary judgment to GlaxoSmithKline (“GSK”) in the nearly 10-year-old Wellbutrin XL Antitrust Litigation, which challenged the lawfulness of settlement agreements resolving...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part III

In the first and second installments of this series, we've explained the general purpose and the patents and marketing authorizations sections of the study published on August 9, 2017 by the Federal Commission for Economic...more

Excessive Pricing in Generic Drug Markets

by Ropes & Gray LLP on

EU and UK antitrust laws make it illegal for dominant firms to charge unfair or excessive prices. These laws have most often been applied in markets that feature high barriers to entry or expansion, which enable a dominant...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

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part II

In the first installment of this series, we outlined the general contents of the study published on August 9, 2017 by the Federal Commission for Economic Competition, highlighting that the Antitrust authority is calling for...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

by Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

News from Abroad -- Mexican Antitrust Authority Issues Broad Study on Generic Drug Entry into Mexican Market -- Part I

Study Suggests Several Changes to Legislation on Patents, Marketing Authorizations, and Government Procurement - In July of 2016, the Federal Commission for Economic Competition announced a broad ranging study on the entry...more

Innovator Liability Fails Again

by Reed Smith on

As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws...more

Considerations for Developing a Global Patent Term Extension Strategy

Many jurisdictions provide for the extension of the term of the patents that cover a regulated product. Patent term extension (PTE) is particularly important in the bio/pharma industry given that development of an innovative...more

Patent Term Extension Considerations for BioPharma Patents

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...more

Alza Corp. v. Amneal Pharmaceuticals of New York, LLC

by Robins Kaplan LLP on

Case Name: Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 53551 (D. Del. Apr. 7, 2017) (Andrews, J.)....more

Par Pharm., Inc. v. Luitpold Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., 2017 U.S. Dist. LEXIS 62020 (D.N.J. Apr. 24 2017) (Walls, J.)....more

Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc.

by Robins Kaplan LLP on

Case Name: Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc., No. 14-7992 (NLH/AMD) (D.N.J. May 12, 2017) (Hillman, J.)....more

Teva Pharms. USA, Inc. v. Sandoz Inc.

by Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....more

GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA

by Robins Kaplan LLP on

Case Name: GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, 2017 U.S. Dist. LEXIS 82534 (D. Del. May 23, 2017) (Burke, M.J.)....more

Federal Circuit upholds Millennium’s Patent on Velcade®

by Knobbe Martens on

MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more

761 Results
|
View per page
Page: of 31
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.