ANDA

News & Analysis as of

FDA Is Evolving on Qualifications for 'New Chemical Entity'

The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

Claims are construed in ANDA case relating to crystalline modifications

Stark, J. Claim construction opinion issues regarding seven terms from four patents. A Markman hearing took place on October 19, 2016. The disputed technology relates to new crystalline modifications of hydrochloride...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

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more

Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc.

Case Name: Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc., Civ. No. 07-cv-1299 (SRC)(CLW), 2016 U.S. Dist. LEXIS 95789 (D.N.J. July 22, 2016) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Restoril®...more

Supreme Court Denies Cert in Lamictal Pay-For-Delay Litigation

Third Circuit has previously ruled that non-cash payments to settle patent litigation may violate antitrust laws. On November 7, 2016, the Supreme Court of the United States declined to hear the petition of...more

Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al

Case Name: Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al, Civ. No. 16-C-2988, 2016 U.S. Dist. LEXIS 96448 (N.D. Ill. July 25, 2016) (Pallmeyer, J.) - Drug Product and Patent(s)-in-Suit: Benicar®...more

UCB, Inc. v. Accord Healthcare, Inc.

Case Name: UCB, Inc. v. Accord Healthcare, Inc., Civ. No. 13-1206-LPS (Consolidated), 2016 U.S. Dist. LEXIS 109362 (D. Del. Aug. 12, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Vimpat® (lacosamide); U.S....more

Eli Lilly & Co. v. Perrigo Co.

Case Name: Eli Lilly & Co. v. Perrigo Co., Case No. 1:13-cv-00851-SEB-DKL (S.D. Ind. Aug. 22, 2016) - Drug Product and Patent(s)-in-Suit: Axiron® (testosterone metered transdermal solution); U.S. Patents Nos. 8,071,075...more

Vanda Pharm. Inc. v. Roxane Labs., Inc.

Case Name: Vanda Pharm. Inc. v. Roxane Labs., Inc., Civ. No. 14-757-GMS (Consolidated), 2016 U.S. Dist. LEXIS 113521 (D. Del. Aug. 25, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Fanapt® (iloperidone); U.S....more

Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more

Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC

Case Name: Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, Civ. No. 13-2088-GMS, 2016 U.S. Dist. LEXIS 114419 (D. Del. Aug 26, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: NuvaRing® (etonogestrel /...more

Claims Are Construed In An ANDA Case

Stark, C. J. Claim construction opinion issues regarding four terms from two patents. A Markman hearing took place on August 9, 2016. The disputed terms are related to controlled-release formulations of the drug...more

Sanofi v. Glenmark Pharms. Inc.

Case Name: Sanofi v. Glenmark Pharms. Inc., Civ. No. 14-264-RGA (Consolidated), 2016 U.S. Dist. LEXIS 116950 (D. Del. August 31, 2016) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Multaq® (dronedarone); U.S....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

ANDA Update - Volume 2, Number 3

On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...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

Allergan Sales, LLC v. Sandoz, Inc.

Case Name: Allergan Sales, LLC v. Sandoz, Inc., No. 12-cv-207-JRG, 15-cv-347-JRG, 2016 U.S. Dist. LEXIS 135088 (E.D. Tex. Sept. 30, 2016) (Gilstrap, J.) - Drug Product and Patent(s)-in-Suit: Combigan® (brimonidine...more

Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

Know the Rules! FDA’s New Regulations Change Responsibilities For ANDA Filers

On October 6, 2016, nearly thirteen years after passage of the Medicare Modernization Act (MMA), FDA published a final rule in the Federal Register implementing amendments and revisions to title 21 of the Code of Federal...more

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

FDA Issues Final Rule on Abbreviated New Drug and 505(b)(2) Applications

New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016. On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more

Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to...

The District Court of Delaware denied defendant Wockhardt’s motion to dismiss a patent infringement action based on the reasonable inference that plaintiff AstraZeneca may need to assert its patent rights in the future. On...more

369 Results
|
View per page
Page: of 15
JD Supra Readers' Choice 2016 Awards

"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 to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*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.
×