Drug Manufacturers

News & Analysis as of

Cymbalta Class Certification Denied Again

Is there a tougher federal district judge than Stephen Wilson in Los Angeles? By “tougher,” we do not mean in the usual sense when applied to judges: handing out long criminal sentences – though that certainly does apply to...more

Court Report - July 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Hetero Labs Ltd, Unit V et al. v. Pharmacia & Upjohn Co. LLC 1:15-cv-05396; filed June 18, 2015 in the Northern District...more

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule...more

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

Also In The News - Health Headlines - July 2015

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

A Fractured Federal Circuit Panel Interprets The Biosimilars Patent Resolution Procedures

On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more

Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery...

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more

Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

A Couple of Law Review Articles We Actually Like

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

Changes to Google Ad Policy to Affect Pharmaceutical Industry; Requires Immediate Action to Paid Search Ads

Google has announced a new advertising policy for pharmaceutical companies that presents significant issues and dictates immediate changes. Effective July 20, pharmaceutical companies can no longer run pharmaceutical ads in...more

Is Your SEM FDA Compliant? New Google SEM Policy Forces Pharmaceutical Industry to Adjust Paid Search Advertisements

Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it...more

The Medicines Company v. Hospira (Fed. Cir. 2015)

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

Court Report - July 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Fresenius Kabi USA, LLC. v. Par Sterile Products, LLC et al. 2:15-cv-03852; filed June 9, 2015 in the District Court of...more

The Medicines Company v. Hospira - Preparation of validation batches by a contract manufacturer for FDA submission creates an...

On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA created an invalidating...more

Disclosure Requirements Under the BPCIA

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...more

The Elephant in the Room in Alabama

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and...more

Final Drug Shortage Reporting Rules Will Go Into Effect September 2015

Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological...more

Evening The Score On Off-Label Use Information

Two stories in 360 yesterday – the timing was pure coincidence – have us thinking again about the FDA’s muddled and increasingly untenable position on truthful off-label “promotion” – broadly defined as any accurate...more

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy

The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will...more

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act. Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

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