Generic Drugs

News & Analysis as of

Another Decision Applying Bartlett Preemption to All Drugs

Just last month we collected all the favorable precedent applying impossibility preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to innovator drugs – although the precise subject of that post...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Court Report - October 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. United Therapeutics Corp. v. Watson Laboratories, Inc. 3:15-cv-05723; filed July 22, 2015 in the District Court of New...more

Divided Infringement Between Doctor and Patient

Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the...more

Guest Post -- The Biggest Side-effect of Making Medicine: How to Manage Intellectual Property and Patent Law

International intellectual property regulations are doing serious damage to the pharmaceutical industry and, by extension, to the health of people around the world. The core of the problem: growing global concern about how...more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part One of Two

On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada),...more

Solid "No Designer Liability" Decision in a Non-Pharma Case in the Eastern District of Pennsylvania

On September 13th, we, as Drug and Device Law Jews, celebrated Rosh Hashanah, the Jewish New Year. Normally, we host dinner for 20 or so members of our extended family. This year, the entire day before the holiday was...more

Inter Partes Review Proceedings: A Third Anniversary Report

When inter partes review (IPR) proceedings became effective in September 2012, few people would have predicted the transformative effect it would have on patents and the litigation landscape. Three years in, IPR has become...more

3D-Printed Prescription Drugs a Huge Stride Forward for Personalized Medicine

Advances in 3D printing (3DP) technology have paved the way for pharmaceutical companies to print prescription drugs. Aprecia Pharmaceuticals recently announced that the FDA has granted it approval to manufacture Spritam®...more

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

Court Report - September 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Senju Pharmaceutical Co. et al. v. Watson Laboratories, Inc. et al. 1:15-cv-05591; filed July 16, 2015 in the District...more

KMART Settles False Claims Act Allegations for $1.4 Million

The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

In the Wake of Trade Agenda Momentum, TPP Negotiations Continue

The United States made significant headway with the Administration's trade agenda in the summer of 2015. With the passage of Trade Promotion Authority, Congress has agreed to ensure trade agreements negotiated by the...more

Board Boots Bass Tecfidera IPR on the Merits

On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the...more

Patent Covering Safyral® and Beyaz® Found to Be Valid

The defendant sought to engage in the commercial exploitation of generic versions of Safyral® and Beyaz®, which are covered by plaintiff’s U.S. Patent No. 6,441,168 (the ‘168 patent). The parties stipulated to infringement...more

District Court Denies Motion to Dismiss for Lack of Personal Jurisdiction Where Plaintiff Sent ANDA Notice Letter

Defendants, Nang Kuang Pharmaceutical Co., Ltd. ("Nang Kuang") and CANDA NX-2, LLC ("CANDA") (collectively, "Defendants") filed a motion to dismiss, asserting that the patent infringement action filed by Plaintiffs, Eli Lilly...more

Sandoz’s Zarxio® Launches with 15% Wholesale Discount

On September 3, 2015, Sandoz Inc. (“Sandoz”) announced that it launched the first biosimilar in the United States, Zarxio® (filgrastim-sndz). Sandoz began marketing Zarxio® following a Federal Circuit Order to permit it to...more

Antitrust Implication of Recent FTC Patent Related Agreement

In recent years, the Federal Trade Commission (FTC) has refocused its efforts on the interplay between the patent system and antitrust law, particularly in the pharmaceutical industry. While most of this focus has manifested...more

Court Report - August 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Bristol-Myers Squibb Co. et al. v. Merck & Co., Inc. et al. 1:15-cv-00572; filed July 7, 2015 in the District Court of...more

Contract Manufacturing Is a Commercial Transaction for Purpose of “On-Sale” Bar - The Medicines Company v. Hospira, Inc.

Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted patent were invalid based on an agreement, dated more than one year prior to...more

Kyle Bass Loses Round 1 of IPR Attack Against Pharma/Biotech Patents

On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826,...more

Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion...more

PTAB Denies Institution of Kyle Bass's Ampyra Patent Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more

Generating Life Sciences Brand Names: 5 Key Tips

In the challenging and complex world of life sciences product development, choosing a brand that survives the US Patent and Trademark Office and US Food and Drug Administration clearance processes is critical. Brand names in...more

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