Category: Intellectual Property

Video Now Available: Responsibility and Integrity in the Pharmaceutical Industry

The Petrie-Flom Center Staff Leave a comment

On November 21, the Petrie-Flom Center hosted a lecture by Neil Flanzraich on responsible pricing strategy, access to care, clinical trial design, outsourcing, and other topics that raise thorny but crucial issues for pharmaceutical and biotechnology companies.  (You can read a summary of the lecture here.) You can now view the lecture online.

Mr. Flanzraich graduated from HLS in 1968, and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012. He is the Executive Chairman of Kirax Corporation and the Executive Chairman of ParinGenix, Inc., both of which are privately owned biotech companies. He previously served as the Vice Chairman and President of Ivax Corporation, an international pharmaceutical company, which was sold to Teva in 2006 for an enterprise value of $10 billion.

Resources on the Future of Gene Patenting

Leslie Francis Leave a comment

By Leslie Francis

At the University of Utah, our Center on Law and Biomedical Sciences was fortunate to be able to hold a recent symposium on the future of gene patenting. Our speakers included Ken Chahine and Amelia Rinehart, both faculty at the College of Law, presenting accounts of the science and patent law; Brian Dawson, co-director of the molecular genetics lab at the Mayo Clinic, and Elaine Lyon, co-director of pharmacogenomics at ARUP and incoming president of the Association of Molecular Pathologists, speaking from the perspectives of laboratory directors and the Association of Molecular Pathologists; John Meija, legal director of the ACLU of Utah, speaking on patients’ rights; Wendy Kohlmann, manager of genetic counseling at the Huntsman Cancer Center, considering the ethical dilemmas for genetic counselors confronted by intellectual property restrictions; and Benjamin Jackson, senior director of legal affairs at Myriad Genetics, speaking from the perspective of Myriad. A recording of the symposium can be found here.

For those wishing to follow ongoing developments in gene patenting, we have prepared a libguide with resources on the Myriad decision and ongoing gene patenting cases.

[Leslie Francis]

[This is a cross-post from the HealthLawProf blog.]

Big relief for Big Pharma: Indian Patent Office rejects application for compulsory license

agupta Leave a comment

Aditya Gupta

By a detailed order passed last week, the Indian Patent Office rejected an application for compulsory license filed by a generic drug manufacturer BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) seeking a license of Bristol Myers Squibb’s (“BMS”) Indian patent for an anti-cancer drug. The Indian Patent Office found that BDR had not made out a prima facie case for grant of a compulsory license since it had not made efforts to obtain a voluntary license from BMS on reasonable terms and conditions.

Though the Indian Patent Office did not go into the merits of BDR’s application and rejected it on preliminary grounds, this victory will help restore pharmaceutical companies’ faith in the Indian patent system.

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Expanding Access to Clinical Trial Data Responsibly

The Petrie-Flom Center Staff Leave a comment

[Ed. Note: This report stems from the “Issues in Clinical Data Sharing Conference” co-sponsored by MRCT and Petrie-Flom last May.]

Press Release: A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients’ privacy and weighing pharmaceutical companies’ business interests. Recently, the European Medicines Agency (EMA) announced it will provide public access to participant-level data submitted in applications for marketing approval in Europe, prompting questions about whether the U.S. Food and Drug Administration should follow suit. Data releases by the EMA have spurred litigation by drug companies and heated debate about whether clinical trial data should be protected as proprietary information or widely shared.

The report, published online October 21, 2013 in The New England Journal of Medicine, was released to coincide with the first meeting of the Institute of Medicine’s Committee on Strategies for Responsible Sharing of Clinical Trial Data on October 23. The Institute of Medicine convened the committee on an accelerated timetable to develop a framework for expanded public access to clinical trial data. An initial report is expected in January 2014.

“Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data,” said Michelle Mello, professor of law and public health at the Harvard School of Public Health and lead author of the report. “The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants’ privacy, avoiding ‘junk science,’ and minimizing burdens on trial sponsors?”

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10/21: Open Access Week 2013: Promoting Access to Federally Funded Research

The Petrie-Flom Center Staff Leave a comment

Open Access Week 2013: Promoting Access to Federally Funded Research

Monday, October 21st, 12pm-1pm.

Wasserstein Hall 4063. Lunch will be served.

2013 has seen many milestones towards improving access to biomedical research. In February, President Obama issued an Executive Order requiring most federal research agencies to implement public access policies; official guidance in this respect is expected from the Office of Science and Technology Policy early next year.  This spring, the NIH began implementing the enhanced compliance requirements for its Public Access Policy announced in December 2012. State level open access bills have been passed in Illinois and are pending in California and New York.

In celebration of Open Access Week 2013, please join us for an overview of these recent developments, featuring comments by Peter Suber, Director of the Harvard Office of Scholarly Communications and author of Open Access. Scott Lapinski, HMS Digital Resources and Services Librarian and Open Access Liaison, will be discussing how these enhanced requirements impact medical researchers and how authors can ensure that their publications are in compliance.

Download the event poster here.

Co-sponsored by the Universities Allied for Essential Medicines, HLS Advocates for Human Rights, Office for Scholarly Communication, the Right to Research Coalition, the Berkman Center for Internet and Society, and the Petrie-Flom Center.

Dov Fox on the question of “designer babies”

Dov Fox Leave a comment

Bill of Health blogger Dov Fox was quoted in the recent article “Genetic-testing patent raises concerns about ‘designer babies’.”

“‘Some people might say this is in some respects similar to dating websites to the extent you look for traits in somebody you want to have children with,’ said Dov Fox, a law professor at the University of San Diego. But the important question, he said, is whether the accuracy from the genetic testing, albeit imperfect, makes 23andMe’s service more troubling.”

View the full article here.