Drug Manufacturers

News & Analysis as of

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

Patent fundamentals for researchers, manufacturers

Patent laws function much the same way no matter the technology at issue. But there are some aspects of patent law that affect particular industries in specific ways. My Thompson Coburn colleague Steve Ritchey looked at some...more

Compounding Problems

In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders...more

Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications

In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices. On March 3, 2014, the Food and Drug Administration (FDA) released a...more

HSR Act Allows Pharmaceutical Licensing Transactions To Be Subject to Unique Reporting Requirements, FTC Tells Court

The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...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

FDA Seeks Public Comment on Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved...

On March 3, 2014, the U.S. Food and Drug Administration ("FDA") made available for comment a revised draft of its "Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended...more

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

FDA Proposes Policy Change Concerning 5-Year NCE Exclusivity for Certain Fixed-Combination Drugs

Prompted by citizen petitions filed by Ropes & Gray and by two other companies, FDA issued draft guidance proposed a change in the Agency’s interpretation of 5-year new chemical entity (“NCE”) exclusivity as applied to...more

FDA Issues Revised Draft Reprints Guidance

On February 28, 2014, the Food and Drug Administration (“FDA”) released a revised draft guidance for industry entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“Revised...more

Federal Appeals Court Rejects False Claims Act Suit Based on Drug Packaging cGMP Violations

Last Friday, the U.S. Court of Appeals for the Fourth Circuit affirmed the dismissal of a False Claims Act (“FCA”) case brought against Omnicare. United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, 2014 WL 661351...more

CMS Proposes Significant Rate Cuts and Other Changes to Medicare Advantage and Prescription Drug Plans

The Advance Notice ("Advance Notice") of Methodological Changes for Calendar Year ("CY") 2015 for Medicare Advantage ("MA") Capitation Rates, Part C and Part D Payment Policies and 2015 Call Letter was released by the Centers...more

A Look at the FDA’s New Social Media Guidance

Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age. On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more

Drug and Device Manufacturers Beware: Comments Could Result in FDA Troubles

After appearing on CNBC television show Fast Money, the CEO of Aegerion Pharmaceuticals received a warning letter from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion. The agency...more

HHS-OIG Criticizes 340B Drug Discount Program

I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...more

Pennsylvania Supreme Court Rules on Whether Drug Company Has Expanded Duties

On January 21, 2014, the Pennsylvania Supreme Court held in a 4–2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face...more

Clash Of Titans over Biosimilars at FTC Workshop

On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars. During highly informative...more

Federal Court Finds Actavis Applies Only To Settlements Involving Monetary Payments

A United States district court judge sitting in the District of New Jersey has held that only patent litigation settlements involving monetary payments from branded to generic pharmaceutical manufacturers are subject to the...more

FDA Publishes New Guidance on Letters from Manufacturers to Health Care Providers

The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP...more

Lance v. Wyeth: A New Cause of Action in Pennsylvania?

Issuing an opinion over two years after oral argument, the Pennsylvania Supreme Court ruled last week in Lance v. Wyeth that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs....more

FDA Issues Draft Guidance Relating to Social Media Promotion by Drug and Biologics Manufacturers

On January 13, 2014, the Food and Drug Administration (“FDA”) issued a draft guidance document outlining the circumstances under which a manufacturer of a prescription drug or biological product may be accountable for content...more

340B Drug Pricing Program Developments in the New Year

On January 9, 2014, the Health Resources and Services Administration (HRSA) posted an update on its current and anticipated 340B drug pricing program (340B) program integrity efforts.1 The update includes a discussion of...more

The District of Delaware Stops Exela’s Bid To Market Generic Orimev

In the District of Delaware, Judge Leonard Stark recently issued a final judgment and permanent injunction in Cadence Pharms., Inc. v. Exela Pharma. Scis., LLC, No 11-733, 2013 U.S. Dist. LEXIS 166097 (D. Del. Nov. 14, 2013),...more

Bayer Continues To Settle Yaz/Yasmin/Ocella Cases

To date, settlements in thousands of Yaz, Yasmin and Ocella cases have been reached and it is estimated that Bayer, the drug manufacturer, has paid out over $1 Billion to more than 6,000 injured women across the country, for...more

Trade Secrets Trend To Watch In 2014: Government Regulations Requiring Public Disclosure Of Proprietary Information

In the New Year, one of the trade secret trends we’re watching is the ongoing tension between a company’s interest in preserving its proprietary information and the public’s demand to know more about the goods or services it...more

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