Pharmaceutical Manufacturers

News & Analysis as of

Ascertainability Saps Plaintiffs’ Energy in Dietary Supplement Class Action

In the recent decision Mirabella v. Vital Pharmaceuticals, Inc., Case No. 12-62086-CIV-ZLOCH (S.D. Fl. Feb. 27, 2015) the plaintiffs attempted, but failed, to certify a nationwide class of all purchasers of an energy drink...more

State Medicaid Programs May Be Leaving Revenue From Drug Rebates on the Table

The recent release of a New York State Office of the State Comptroller audit report serves as an example of state Medicaid programs that may not be maximizing their collection of revenue from drug rebates for Medicaid managed...more

Guest Post: $2.6 Billion Per Drug: Is Your Patent Portfolio Strong Enough to Protect Your Investment?

Late last year, the Tufts Center for the Study of Drug Development (CSDD) released a number that would cause jaws to drop all around the healthcare world.  The estimated cost for developing a new drug was an astounding $2.558...more

The Top 5 Trends in Canadian Intellectual Property Law for 2015

Last year promised significant changes in Canadian IP law; some of which will be realized in 2015. As the first quarter draws to a close, this year’s trends in IP law are emerging. Canada’s international trade negotiations...more

340B in the Spotlight This Thursday: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

Thursday, March 5th at 10:00 a.m. EST, the House Energy & Commerce Health Subcommittee on Health will hold a hearing entitled, “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the...more

Federal Circuit Review - February 2015

More Deference to District Courts in Claim Construction - In TEVA PHARMACEUTICALS USA, INC. v. SANDOZ, INC., No. 13-854, the Supreme Court held that factual findings underpinning claim construction rulings are reviewed...more

Court Report - March 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Shire LLC v. Par Pharmaceutical, Inc. et al. 1:15-cv-01454; filed February 25, 2015 in the District Court of...more

PTAB Update -- Biopharmaceutical Edition

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more

Africa Update - February 2015

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News - Excerpt from Leading the...more

The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

Supreme Court Announces Standard of Review for Factual Issues Underlying Patent Claim Construction: Implications Beyond Patent Law

The United States Supreme Court, clarifying the proper standard of review of factual findings arising during a court’s construction of patent claims, held that such “evidentiary underpinnings” should be reviewed for clear...more

The Court’s Decision in the FLANAX US Trademark Dispute Gives Bayer a Headache

On February 6, the United States District Court for the Eastern District of Virginia reversed the US Trademark Trial and Appeal Board’s ruling in Bayer Consumer Care AG v. Belmora LLC, 110 USPQ2d 1623 (TTAB 2014) holding that...more

Pharmaceutical Patent Score a Win - Amneal Pharms., LLC v. Supernus Pharms., Inc.

In three separate but related final written decisions in the first successful defense of a pharmaceutical patent in an inter partes review (IPR), the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board...more

Generic Drug Price Hike Investigations Target Lannett

Since we last reported on state and federal investigations into recent generic drug price increases, the investigations have moved forward against Philadelphia-based Lannett Co. On November 20, a Senate healthcare...more

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

Pharmaceutical Uses Acquisition To Make Itself More Competitive

For companies looking to become more competitive in the marketplace, maintaining a lookout for potentially valuable acquisitions is an important task. Acquisitions, when entered into strategically and with proper legal...more

Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp.,

Case Name: Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp., Civ. No. 14-1268-SLR, 2014 U.S. Dist. LEXIS 155981 (D. Del. Nov. 4, 2014) (Robinson, J.) (Given statements made in the accused product’s proposed labeling,...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

False Claims Act – 2014 Year in Review

The False Claims Act (FCA) imposes liability on individuals and companies who defraud or submit false claims to the federal government. The FCA allows the federal government to seek treble damages, civil penalties and...more

Petitioners Denied Second Bite at IPR Petition - Biodelivery Sciences Int’l, Inc. v. RB Pharms. Ltd.; Standard Innovation Corp. v....

In two separate but similar written decisions involving challenged patents that were already the subject of instituted proceedings, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) denied...more

Court Report - February 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...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

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

DOJ Settles False Claims Act Allegations Against Pharmaceutical Manufacturer

On February 11, the DOJ announced a $7.9 million settlement with a Delaware-based pharmaceutical manufacturer for allegedly violating the False Claims Act by engaging in a kickback scheme with a pharmacy benefits manager...more

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