Generic Drugs Pharmaceutical Industry

News & Analysis as of

King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp. (3rd Cir. 2015)

Ever since the Supreme Court's decision in FTC v. Actavis in 2013, courts (predominantly district courts) have grappled with the scope of the decision. It was evident that the presence of a large cash payment from the...more

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Cardinal Health to Acquire The Harvard Drug Group for $1.1 Billion

Ohio-based Cardinal Health (CAH) has agreed to buy Michigan-headquartered The Harvard Drug Group (THDG) for $1.12 billion. According to press releases, THDG, which is currently owned by Court Square Capital Partners, is a...more

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)

Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more

Court Report - June 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al. 1:15-cv-00438; filed May 29, 2015 in the District Court...more

Japan’s Ministry of Health Revisits Generics

The Ministry of Health, Labor and Welfare (MHLW) has announced a new policy regarding generic pharmaceuticals in an attempt to stem the rise of health care costs. Japan spends JPY50 trillion (of which approximately one fifth...more

California Supreme Court Decision in Cipro Highlights the Lack of Predictability in Antitrust Jurisprudence and Counseling

On May 7, 2015, the Supreme Court of California issued an opinion in In re Cipro Cases I & II, a case centered on pay-to-delay settlements between drug makers and generic manufacturers. The Court found the existence of an...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Court Report - June 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Idenix Pharmaceuticals LLC et al. v. Gilead Pharmasset LLC 1:15-cv-00416; filed May 21, 2015 in the District Court of...more

Product Liability Hopping & the FDA’s Generic Drug Proposal – Awful Together

A major basis for our criticism of the FDA’s still pending generic drug labeling proposal, and why we prefer industry’s EAR (“Expedited Agency Review”) system better, is that the FDA’s proposal would create festival-seating...more

REMS and Antitrust: Latest Litigation Lessons

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

OIG Releases Mid-Year Update to its Work Plan

On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...more

Second Circuit Holds a Hard Switch Between Drugs Is an Unlawful Product Hop Under Section 2

On May 22, 2015, in a much-watched case, the Second Circuit upheld a preliminary injunction against Actavis PLC and its wholly owned subsidiary, Forest Laboratories, LLC (collectively “Actavis” or “Forest”), finding that...more

Otsuka Suit Results in Victory for FDA

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

Second Circuit Becomes First Court of Appeals to Address Pharmaceutical “Product Hopping” Under Antitrust Laws in Decision Barring...

Few courts have addressed antitrust challenges to pharmaceutical “product hopping,” i.e., the practice of shifting customers from a drug nearing the end of its patent protection to a modified version that is covered by newer...more

Life Sciences Litigation Update - May 2015

Trends in Post-grant Review of Orange Book Patents. The America Invents Act’s post-grant challenges (“AIA proceedings”) continue to grow as an option for companies challenging a patent’s validity. In the first full fiscal...more

District Court Decision Opens Door to Five-Year NCE Exclusivity for Single Components of Previously FDA-Approved Multi-Component...

On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's (FDA) administrative decision denying five years of new chemical entity exclusivity for Amarin...more

Newton’s Third Law: The Alabama Legislature Supersedes Weeks v. Wyeth and Disallows Innovator Liability in Product Liability Cases

Sir Isaac Newton’s Third Law of Motion states, loosely, that for every action there is an equal and opposite reaction. A force exerted by one body upon another causes an equal reaction by the second body. Want an...more

FTC’s $1.2 Billion Disgorgement Settlement With Cephalon: Heightened Scrutiny of Hatch-Waxman Settlements

On May 28, 2015, the Federal Trade Commission (FTC) announced the settlement of its 2008 lawsuit against Cephalon, Inc. (now owned by Teva Pharmaceutical Industries, Ltd.), which alleged that Cephalon had made “reverse...more

Motivation to Combine Reviewable for Clear Error - Insite Vision Inc. v. Sandoz, Inc.

Reviewing the district court’s framing of the obviousness inquiry and determination of no motivation to combine for clear error, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s determination...more

Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical...

A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more

Sweet Home No More, Innovator Liability Leaves Alabama

On May 1, 2015, Alabama Gov. Robert Bentley signed into law a bill to “provide that a manufacturer is not liable ... for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by state...more

Status of Pay-for-Delay Cases Nearly Two Years After Actavis – “It ain’t over ’til it’s over.”

Nearly two years ago the Supreme Court issued its opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013), holding that a reverse payment made by a brand manufacturer to a generic manufacturer to resolve pending patent litigation...more

Court Report - May 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Pharma, Inc. et al. v. Actavis Laboratories FL., Inc. et al. 3:15-cv-03322; filed May 13, 2015 in the District...more

Analysis of Inter Partes Review and Post-Grant Review in the Life Sciences Industry Through First Quarter 2015

The recently established inter partes review (IPR) and post-grant review (PGR) of the America Invents Act have been in the spotlight lately, especially now that the life sciences industry has begun to utilize these...more

178 Results
|
View per page
Page: of 8

"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*

*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.
×