January 1, 1970 (Vol. , No. )

Rod Raynovich

This Super Session on Monday afternoon at BIO focused on issues involving the core asset for every biotechnology Company – Intellectual Property. A strong underlying concern during the duration of the 2009 BIO International Meeting were the pending House bills for Follow-on Biologics (Biosimilars)and the broader bill for Patent Reform. The key policy issues consider the impact of the biggest proposed changes in patent laws in over 50 years plus the proposal for an abbreviated FDA regulatory pathway for generic biologics.

One thing for certain, if you look at all the pending legislation that will affect Biotechnology and healthcare in general the bull market will be for legal fees in and around Washington D.C.

H.R. 1260 The Patent Reform Act of 2009 is being sponsored by Rep. John Conyers(D) of MI and has been referred to committee as a first step and because of its far reaching consequences in unlikely to make it out of committee. S.515 sponsored by Sen.Patrick Leahy (D) VT and has been recommended by committee,and could get BIO support.

Another bill H.R. 1548 sponsored by Rep. Anna Eshoo (R) of CA proposes to establish a pathway for the licensure of biosimilar biological products and for other purposes. This bill prohibits approval of an application for licensure of a biologic product similar to an existing licensed product for a maximum period of 12-14.5 years. This is in contrast to a Rep. Henry Waxman(D) CA bill H.R 1427 which provides only 5 years of exclusivity and only if the “major substance” had not been previously approved. The major issue is the need to link patent protection with data protection.

A working paper by Duke University economist Dr. Henry Grabowski identifies 12.9 to 16.9 years of data exclusivity as necessary to sustain investment in the R&D of new biologics.

BIO has already commented on the Waxman bill saying that the H.R. 1427 bill “sets a path that jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases such as multiple sclerosis, HIV/AIDS and Alzheimer’s”. Bio has focused on the bill’s shortcomings with respect to safeguarding patient safety.

In summary the intersection of the patent system with the regulatory system presents complicated issues and patent reform has strong opposing constituencies. Many see the patent system as job related with may jobs lost with radical reform.

Among the organizations against the Patent Reform are labor, VC’s, high tech and biotech industries, small business and engineers.

Among the organizations for Patent reform are primarily the Business Software Alliance (BSA) with companies such as Adobe, Amazon, Apple, H-P ,Microsoft and Google who claim that patents are too broad and lawsuits stifle innovation.

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