ANDA

News & Analysis as of

Supreme Court Declines to Revisit Broad Personal Jurisdiction Over ANDA Filers

On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of...more

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

Federal District Court finds brand-name manufacturer’s alleged regulatory delay tactics a valid theory of attempted monopolization

In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory...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

Closed Case Is Reopened To Amend Induced Infringement Claims In ANDA Litigation Relating To Mitigare

Robinson, J. Plaintiff’s motion to reopen judgment and amend the complaint is granted. Plaintiff’s request for a preliminary injunction was denied and the denial was affirmed on appeal. On September 10, 2015, Takeda...more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...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

Judgment For Plaintiffs After Cyclobenzaprine ANDA Trial

Robinson, J. The court enters judgment against defendants following 2-day bench trial. Trial took place on November 16 and 17, 2015. The disputed product relates to cyclobenzaprine formulations with extend release...more

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

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

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