Generic Drugs The United States Food and Drug Administration

News & Analysis as of

Searching for Causation in ACTOS Complaint

How explicitly must a complaint sounding in antitrust allege causation? At oral argument last week, the Court of Appeals for the Second Circuit evaluated the sufficiency of the plaintiffs’ allegations that certain Takeda...more

Product Liability Update: April 2016

Massachusetts Superior Court Rejects “Innovator Liability” Failureto-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant’s...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

A Banner Week For Buckman Preemption

There used to be a TV show called “That Was the Week That Was.” It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career. Without an ounce of...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

Helsinn Healthcare S.A. v. Hospira, Inc.

Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more

Genzyme Corp. v. Dr. Reddy’s Labs., Ltd.

Case Name: Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., C.A. No. 13-1506-(GMS), 2016 U.S. Dist. LEXIS 62056 (D. Del. May 11, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Mozobil® (plerixafor solution); U.S. Pat....more

Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp.

Case Name: Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp., Civ. No. 14-1268-SLR, 2016 U.S. Dist. LEXIS 65317 (D. Del. May 18, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S....more

Ferring B.V. v. Actavis, Inc.

Case Name: Ferring B.V. v. Actavis, Inc., Civil No. 15-4222 (SRC)(CLW), 2016 U.S. Dist. LEXIS 69328 (D.N.J. May 26, 2016) (Chesler, J.) - Drug Product and Patents-in-Suit: Lysteda® (tranexamic acid); U.S. Patent No....more

Intendis GMBH et al. v. Glenmark Pharms. Inc., USA

Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.) - Drug...more

Spectrum Pharms., Inc. v. Burwell

Case Name: Spectrum Pharms., Inc. v. Burwell, No. 15-5166, 2016 U.S. App. LEXIS 10095 (D.C. Cir. June 3, 2016) (Circuit Judges Griffith, Cavanaugh, and Wilkins presiding; Opinion by Griffith) (Appeal from D.D.C., Lamberth,...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

FDA Draft Guidance on Updating Generic Labels When RLD Withdrawn

On Friday, the FDA issued a draft guidance document intended to provide ANDA holders with information about how and when to propose any necessary labeling updates to their drugs when the reference-listed drug (RLD) upon which...more

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more

Federal Circuit Rules on Biosimilar Notice Requirement

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

Fed Circuit’s “Amgen v. Apotex” Decision: Clarification of a BPCIA Riddle (Unless, of course, the Supreme Court Steps In)

On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No....more

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