yellow capsules on a blue background.

Fatty Acids, Skinny Labels: Fish Oil Patent Battle Back in Court

By Gregory Curfman

An ongoing patent battle over omega-3 fatty acids, colloquially known as as fish oils, may have broad implications for the marketing of generic drugs.

Icosapent ethyl (Vascepa®) is an omega-3 fatty acid preparation used to treat high triglycerides.  It was explicitly designed to be different from most other omega-3 fatty acid preparations — instead of containing a mixture two fatty acids (docosahexaenoic acid and eicosapentaenoic acid), it is a purified preparation of just the latter, and it is a much higher dose than what is typically used.

On the basis of the ANCHOR and MARINE clinical trials, in 2012 the Food and Drug Administration (FDA) approved Vascepa for the treatment of persons with severe hypertriglyceridemia.

In 2015, Hikma Pharmaceuticals, a generic drug company, filed an abbreviated new drug application (ANDA) for its generic formulation of icosapent ethyl.

The manufacturer of branded Vascepa, Amarin Corporation, promptly filed a patent infringement lawsuit citing six method of use patents (the ‘728, ‘715, ‘677, ‘652, ‘560, ‘929 patents) on Vascepa that the company believed were infringed by Hikma’s ANDA.

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image of the US Supreme Court

The Patent Trial and Appeal Board Again Survives Supreme Court Review

By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

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U.S. Supreme Court

The Patent Trial and Appeal Board Returns to the Supreme Court  

By Gregory Curfman

For the second time in the span of just three years, the Patent Trial and Appeal Board (PTAB) within the U.S. Patent and Trademark Office (USPTO) is under scrutiny by the Supreme Court.

How the Supreme Court decides this latest PTAB case, United States v. Arthrex, will have important implications for patent law and for administrative law more generally.

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Gavel surrounded by piles of money.

3 Challenges to Patents on Therapeutic Monoclonal Antibodies

By Gregory Curfman

Three new developments — two based on litigation and one based on a federal statute — may have significant effects on pharmaceutical manufacturers’ use of patents to fend off competition and maintain high prices for therapeutic monoclonal antibodies.

Highly specific monoclonal antibodies have played an increasingly important role as precision therapies for a growing number of diseases, including malignant, cardiovascular, and inflammatory conditions. As therapies derived from research and development, therapeutic monoclonal antibodies may be — and usually are — patented, providing manufacturers with protection from competition and the prospect of high revenues.

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Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation

By Blake N. Shultz and Gregory Curfman

Despite a troubling history, rofecoxib (Vioxx) may be making a comeback.

The voluntary withdrawal of rofecoxib (Vioxx) from the market in September 2004 marked the end of a controversial era for a once highly profitable and widely used drug. It also marked the beginning of years of high-profile product-liability litigation that would cost Merck billions.

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All-Payer Claims Databases After Gobeille

By Gregory Curfman

This new post by Gregory Curfman appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

With health care spending approaching 20 percent of Gross Domestic Product (GDP), controlling health care costs is a top priority not only for the federal government, but also the individual states. To develop successful strategies for cost control, states need comprehensive data on utilization of and spending on health care services. Medicare data are valuable but not representative of the entire national population or of the prices that private payers pay. In private insurance, prices are not under administrative control as they are in Medicare, and they vary widely in different geographic regions.

All-payer claims databases (APCDs) were developed, first in Maryland in 1995, to provide comprehensive state-level data on health-care utilization and spending, and there are now 16 APCDs nationwide. As the name implies, APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services. Thus, APCDs are a valuable source of information for state health policymakers and health services researchers. For example, in Massachusetts, the Health Policy Commission uses the state’s APCD to set state-wide health care spending targets, which have been important in achieving state cost control. […]

Read the full post here!

LIVE ONLINE TODAY @ NOON: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

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Webinar: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

Monday, December 19, 2016, 12:00 – 1:00pm

WATCH LIVE ONLINE!: http://petrieflom.law.harvard.edu/events/details/president-elect-trumps-health-policy-agenda

Submit your questions to the panelists via Twitter @PetrieFlom.

Please join the Petrie-Flom Center for a live webinar to address what health care reform may look like under the new administration. Expert panelists will address the future of the Affordable Care Act under a “repeal and replace” strategy, alternative approaches to insurance coverage and access to care, the problem of high drug prices, innovation policy, support for scientific research, and other topics. The panel will discuss opportunities and obstacles relevant to President-elect Trump’s proposals, as well as hopes and concerns for health policy over the next four years. Webinar participants will have the opportunity to submit questions to the panelists for discussion.

Panelists

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • Lanhee J. Chen, David and Diane Steffy Research Fellow, Hoover Institution; Director of Domestic Policy Studies and Lecturer, Public Policy Program; affiliate, Freeman Spogli Institute for International Studies, Stanford University
  • Douglas Holtz-Eakin, President, American Action Forum
  • Moderator:Gregory Curfman, Editor-in-Chief, Harvard Health Publications

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Medical Device Tax: Back in the News Post-King

By Gregory Curfman

Just when the Affordable Care Act (ACA) has won a second major Supreme Court victory in King v. Burwell, conservative critics of the ACA are back on the attack, this time directing their ire towards the medical device tax. Having lost the battle on subsidies, they are now focusing on the device tax as the prime target in their attempt to overturn parts of the ACA. This 2.3% excise tax levied on the medical device industry is stipulated as one of the tax provisions in the ACA. The rationale is that since the ACA provides coverage for many more people, thus bringing more business to the industry, it is reasonable to ask the industry to pay something back to support the programmatic mission of the ACA.

From the beginning, the medical device industry has strongly objected to the excise tax, claiming it will stifle innovation by taking away funds that would otherwise be used for new product research and development. For example, Dr. Thomas Stossel of Harvard Medical School, a conservative voice on health issues, recently wrote: “A 2.3 percent tax on sales can easily mean the difference between commercial success and bankruptcy: borderline profits become losses and investors flee to less risky ventures. Brute force taxes destabilize the fragile innovation ecosystem.” Read More

King v. Burwell And A Right To Health Care

By Gregory Curfman

Bill of Health contributor Gregory Curfman has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision in King v. Burwell in the broader context of Americans’ right to care. From the piece:

Do Americans have a fundamental right to health care? This oft-debated question is timely given the Supreme Court’s stunning ruling yesterday in King v. Burwell, in which health insurance subsidies on the federal exchange were upheld in a 6-3 decision.

Here I will place the King v. Burwell opinion in the larger context of to what extent Americans are provided a right to care. The Constitution itself does not stipulate a general right to health care, but a patchwork of rights to certain aspects of health care have emerged over time from both constitutional and statutory law.

Read the full piece at the Health Affairs Blog!

Health Law Year in P/Review: Until Next Year

By Holly F. Lynch, I. Glenn Cohen, and Gregory Curfman

This new post by Holly F. Lynch, I. Glenn Cohen, and Gregory Curfman appears on the Health Affairs Blog as the final entry in a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

It’s been our great pleasure to collaborate with the Health Affairs Blog on this series stemming from theThird Annual Health Law Year in P/Review symposium at Harvard Law School. This annual event takes a look back over the prior year and previews the year to come with regard to hot topics in health law.

After the symposium, we asked our speakers to keep the conversation going online by expanding on their topics from different angles or by honing in on particularly intriguing features. These pieces were published on the Health Affairs Blog through the spring and into summer.

We heard more from Kevin Outterson on how to promote innovation in the development of new antibiotics, from Rachel Sachs on whether the Food and Drug Administration’s proposal to regulate laboratory-developed tests will really stifle innovation, and from Claire Laporte on the impact of recent Supreme Court decisions on bio-IP.

George Annas weighed in on the Ebola outbreak, which has already almost faded from public consciousness but offers important public health lessons, while Wendy Parmet and Andrew Sussman tackled important developments in tobacco control. […]

Read the full post here.