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June 29, 2016


Captain: Hard to get patent coverage for worthy inventions thanks to Alice/Mayo/Myriad?

Co-pilot: check.

Captain: Legislation to reduced term of exclusivity for biologic drugs?

Co-pilot: check.

Captain: Roger that, prepare to invest money in other industries and to bid new drug development adieu.

It took more than 25years for the Congress to pass a biologics equivalent of Hatch Waxman, and took a lot of input from the various stake holders to get the BCPIA passed (as part of Obamacare). The 12 year term was an important feature to compensate for the heightened regulatory barriers and lack of patent based protection.

6 years later, many of the same people who passed the BCPIA (I checked their votes) are now seeking to deliberately reverse a key feature of the law. This seems destined to generate bad faith with industry.

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