Pharmaceutical Manufacturers

News & Analysis as of

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

Applicability of the Entire Market Value Rule in Hatch-Waxman Cases - AstraZeneca AB, et al. v. Apotex Corp., et al.

Addressing damages issues in the Hatch-Waxman context, the U.S. Court of Appeals for the Federal Circuit provided important guidance regarding the application of the entire market value rule to pharmaceutical sales, and the...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

Court Report - May 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Laboratories FL Inc. et al. 1:15-cv-00393; filed May 15, 2015 in the District Court of...more

Permanent Injunction Against Medtronic

The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s...more

Is This The End of RICO?

The short answer is “no.” We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it...more

The Medicaid Fraud Control Units: Fiscal Year 2014 Report

The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs)...more

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

Sixth Circuit Holds That Cases Directly Filed in MDLs Are Governed By Law of Where Case Would Have Been Filed

On May 22, 2015, the United States Court of Appeals for the Sixth Circuit Court of Appeals addressed an important choice-of-law issue for parties involved in multidistrict litigation. When multidistrict litigation is...more

House Subcommittee Circulates Proposed Legislation Providing Insight on the Future of the 340B Drug Pricing Program

The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more

Liability for Statements of Opinion–New Clarity from the Supreme Court

The U.S. Supreme Court’s recent decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund resolved a clear split in the federal courts of appeal regarding when statements of opinion may give...more

CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D

In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more

What Does Pharmacogenomics Have To Do With Product Liability? – Potentially Everything

Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On...more

FDA releases additional draft guidance regarding implementation of BPCIA

On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of...more

Pharmaceutical Marketing and Unfair-Trade-Practices Claims

Lawsuits against pharmaceutical companies generally center on product-liability claims. A new trend in pharma cases, however, is to include a different kind of claim: a claim for unfair trade practices....more

Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

Health Care Update - May 2015 #3

In This Issue: - 21st Century Cures Markup; Full Committee to Take Up this Week - Senate Finance Committee Solicits Health Bills for Upcoming Markup - Implementation of the Affordable Care Act - Federal...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

Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015)

The Federal Circuit affirmed a decision by the U.S. District Court for the District of Massachusetts that it lacked subject matter jurisdiction under 35 U.S.C. § 146 pursuant to changes in the statute provided by the...more

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

FDA Issues Biosimilars Q&A Guidance Document

On May 13, the FDA released a draft question-and-answer guidance document, titled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” The...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

Senator Asks Department of Veteran Affairs to Break Patents on Hepatitis C Drugs

Last week, in a letter addressed to the Secretary of the U.S. Department of Veteran Affairs, Senator Bernard Sanders (I-VT) urged Secretary Robert McDonald to use his authority as Secretary "to break the patents on Hepatitis...more

Biosimilar Makers Turn to IPRs before Litigation under the BPCIA

A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to litigate the validity of patents that cover their proposed products prior to submission of their biosimilar applications to FDA. ...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

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