Drug Manufacturers Generic Drugs

News & Analysis as of

California Supreme Court Details Antitrust Analysis of "Reverse Payment" Patent Settlements

Last week, in In re Cipro Cases I & II, Case No. S198616, the Supreme Court of California adopted the United States Supreme Court's application of the Rule of Reason to the antitrust analysis of so-called "reverse payment"...more

Alabama Legislature Says No to Innovator Liability

On April 29, 2015, the Alabama Senate passed a bill, SB80, “to provide that a manufacturer is not liable . . . for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by Senator Cam...more

Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds

On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Out-of-Market Divestiture Required to Resolve Competitive Concerns

On January 30, 2015, the Federal Trade Commission (FTC) announced a settlement of its investigation into Sun Pharmaceutical Industries Ltd.’s (Sun) acquisition of Ranbaxy Laboratories Ltd. (Ranbaxy) from Daiichi Sankyo Co.,...more

PTAB Update -- Hatch-Waxman-Watch Edition

The pharmaceutical industry has been closing watching the proceedings at the Patent Trial and Appeal Board ("PTAB" or "Board") to see if inter partes review ("IPR") will be a viable option for generic drug companies seeking...more

FDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers

On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to...more

Emerging Impact of Inter Partes Review on Hatch Waxman Litigation – A Primer

Hatch-Waxman Litigation in a Nutshell - Hatch-Waxman litigation refers to pharmaceutical patent litigation between a brand drug manufacturer and a generic drug manufacturer under the Hatch-Waxman Act (“Act”). The Act...more

Innovator Liability Finds Sweet Home In Ala.

Earlier this month, the Supreme Court of Alabama confirmed its January 2013 holding in Weeks v. Wyeth Inc. that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Though the recent ruling puts...more

Weeks II: Innovator Liability Finds a Sweet Home in Alabama

Last week, the Supreme Court of Alabama confirmed its January 2013 holding that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15,...more

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal

Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust...more

OIG Issues Advisory Bulletin Impacting Independent Charity Patient Assistance Programs

On May 21, 2014, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued its “Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs” (SSAB) to...more

Hoffman-La Roche Inc. v. Apotex Inc. (Fed. Cir. 2014)

Last Friday, the Federal Circuit issued an opinion in Hoffman La-Roche Inc. v. Apotex Inc. that is a cautionary tale of patent lifecycle and the difficulties those seeking to extend patent protection face -- namely the...more

Closing the Loop-Holes in Generic Drug Warnings

The Food and Drug Administration is considering some very important changes to its internal rules that would help to eliminate a loophole in accountability for defective drugs. Under current law, only the brand name...more

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the...more

Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014? [Video]

What is the climate for getting generic drugs to market in 2014 and what are the obstacles? Polsinelli Shareholder Gary Hood leads the firm's pharmaceutical/Hatch-Waxman patent litigation practice. He has experience in a...more

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

U.S. Supreme Court Bartlett Decision in Favor of Generic Drug Manufacturers

In a 5-4 decision, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug's...more

Supreme Court Hears Bartlett, Will Resolve Liability Questions for “Design-Defect” of Generic Drugs

In March, the U.S. Supreme Court held oral argument in Mutual Pharmaceutical Co. v. Bartlett, concerning whether design-defect claims against generic drug companies are preempted by federal law. Although the case addresses...more

Court Report - April 28, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayo Foundation for Medical Education and Research v. ARUP Laboratories, Inc. - Infringement of U.S. Patent Nos....more

Intellectual Property Bulletin - Winter 2013

In This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the §...more

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