Friday, September 16, 2011

Weldon Amendment Welded Onto The Patent Act

In 2004, the Consolidated Appropriations Act (Public Law Number 108-199, Section 199) was passed with the "Weldon Amendment" (named for its sponsor, former Republican Congressman Dr. Dave Weldon), a rider stipulating that "[n]one of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism."  On September 16, 2011, when President Barack Obama signed into the law the America Invents Act, the Weldon Amendment became an integral part of the Patent Act.  Effective immediately, here is what this new patent law requires:
(a) LIMITATION.-Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
(1) IN GENERAL.-Subsection (a) shall apply to any application for patent that is pending on, or filed on or after, the date of the enactment of this Act.
(2) PRIOR APPLICATIONS.-Subsection (a) shall not affect the validity of any patent issued on an application to which paragraph (1) does not apply.
No one yet knows what "directed to or encompassing a human organism" means.  The United States Patent and Trademark Office will have the first opportunity to apply this restriction as the initial arbiter of patent applications.  Inevitably, the federal courts will weigh in to provide more authoritative interpretations.  Eventually, Congress may have to amend this provision to clarify it.  Meanwhile, the inclusion of this restriction on patenting "a human organism" directly within the patent statute strongly signals that at least some biotechnological advances have unsettled both Congress and the President.