New Academic Work Sheds Light on Big Pharma Patenting Activity
by Aaron F. Barkoff
People in academia seem more interested lately in the activities of the pharmaceutical industry. Kyle Jensen, a Research Affiliate at the Harvard-MIT Division of Health Sciences & Technology, and C. Scott Hemphill, an Associate Professor of Law at Columbia, recently contacted me and let me know about their work.
Dr. Jensen and his group analyzed drug approval and patent data since 1982 to learn how the pharmaceutical industry uses patents. Their findings include: most approved drugs are protected by very few patents (2.69 patents on average); "platform technologies" are rare (most patents cover only one approved drug); drug companies are generally self-sufficient (the NDA filer owns all of the patents listed for a given NDA 60% of the time), but collaboration is still necessary; and certain families of drugs are protected by "patent thickets." Dr. Jensen's work can be read by clicking here.
Prof. Hemphill is interested in reverse payment settlements of Hatch-Waxman litigation, in which the innovator company pays the generic company to delay launching its generic drug. Prof. Hemphill calls these "pay-for-delay" settlements. His analysis of the Hatch-Waxman Act reveals that certain features of the Act widen the potential for anticompetitive harm from pay-for-delay settlements and that the Act reflects a congressional preference for litigated patent challenges over negotiations between litigants. Prof. Hemphill reaches a conclusion that is even more strongly anti-settlement than the FTC's position: "a settlement should be accorded a presumption of illegality as an unreasonable restraint of trade if the settlement both restricts the generic firm's ability to market a competing drug and includes [any] compensation from the innovator to the generic firm." Prof. Hemphill's paper can be read by clicking here.
Both Dr. Jensen and Prof. Hemphill would welcome any feedback about their work.
(This article was published by BioHealth Investor with exclusive permission of the author Aaron F. Barkoff of OrangeBookBlog.com)
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People in academia seem more interested lately in the activities of the pharmaceutical industry. Kyle Jensen, a Research Affiliate at the Harvard-MIT Division of Health Sciences & Technology, and C. Scott Hemphill, an Associate Professor of Law at Columbia, recently contacted me and let me know about their work.
Dr. Jensen and his group analyzed drug approval and patent data since 1982 to learn how the pharmaceutical industry uses patents. Their findings include: most approved drugs are protected by very few patents (2.69 patents on average); "platform technologies" are rare (most patents cover only one approved drug); drug companies are generally self-sufficient (the NDA filer owns all of the patents listed for a given NDA 60% of the time), but collaboration is still necessary; and certain families of drugs are protected by "patent thickets." Dr. Jensen's work can be read by clicking here.
Prof. Hemphill is interested in reverse payment settlements of Hatch-Waxman litigation, in which the innovator company pays the generic company to delay launching its generic drug. Prof. Hemphill calls these "pay-for-delay" settlements. His analysis of the Hatch-Waxman Act reveals that certain features of the Act widen the potential for anticompetitive harm from pay-for-delay settlements and that the Act reflects a congressional preference for litigated patent challenges over negotiations between litigants. Prof. Hemphill reaches a conclusion that is even more strongly anti-settlement than the FTC's position: "a settlement should be accorded a presumption of illegality as an unreasonable restraint of trade if the settlement both restricts the generic firm's ability to market a competing drug and includes [any] compensation from the innovator to the generic firm." Prof. Hemphill's paper can be read by clicking here.
Both Dr. Jensen and Prof. Hemphill would welcome any feedback about their work.
(This article was published by BioHealth Investor with exclusive permission of the author Aaron F. Barkoff of OrangeBookBlog.com)
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