17 June 2011

Roche Beats Stanford

On Monday, June 6, the U.S. Supreme Court issued a fascinating patent-law decision, STANFORD UNIVERSITY v. ROCHE, in which it held that title to the intellectual property in a federally-funded invention does not necessarily vest in the institution receiving those federal funds.

In so doing, the Court limited the scope of some of the language of the University and Small Business Patent Procedures Act of 1980, also known as the Bayh-Dole Act.

The IP in question is to a diagnostic test for HIV involving a polymerase chain reaction (PCR), developed by a Stanford research fellow named Mark Holodniy. Under the Bayh-Dole Act, in a provision that was designed precisely to encourage federally-funded universities to engage in cutting-edge research, the rights to the PCR diagnostic would have been Stanford's, but for a contract Holodniy signed with Cetus, a company where he was a visiting scientist, in which he said he does "hereby assign" his rights to Cetus.

The great thing about PCR is that it does more than simply discover the presence of HIV. It measures the amount of the virus in a patient's blood stream, thus determining whether and to what degree he is benefitting from therapy.

In 1991 Cetus was acquired by, and its rights passed to, Roche.

In 2005, Stanford brought a lawsuit contending that Roche was illegally selling HIV test kits that infringed on Stanford's patents. Roche responded that it was a co-owner of the procedure. The matter went to the Supreme Court, with Stanford claiming that Holoniy had no right to assign to Cetus/Roche, because the right belonged by law to Stanford, so the document in which he purports to make that assignation is void.

U.S. patent law gives the initial IP right to the inventor. The inventor can then assign it away, to one party or another or no one, as he deems best. Indeed, the Constitution gives Congress the authority to secure "to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." It does not give the Congress the authority to secure that exclusive right to an institution employing the authors and inventors. The rather stark individualistic language refers to the authors and inventors themselves.

This decision was not in a strict sense a constitutional decision. It interpreted the language in Bayh-Dodd in such a way as to avoid any conflict with the relevant clause of the constitution. But it certainly did invoke the policy that the majority sees the document's language as endorsing.

Institutions such as Stanford will not suffer any great wound from this decision. They simply have to tighten up the language of their own employment contracts for their postdocs and others to make sure they have the assignation rights from the Holodniys of the world before anyone else puts a well-drafted document in front of any of them. Yet a principle is affirmed, by virtue of the fact that Stanford takes this loss and has to rework its contracts, the principle that the choice, in the first instance, must lie with the Holodniys.

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Knowledge is warranted belief -- it is the body of belief that we build up because, while living in this world, we've developed good reasons for believing it. What we know, then, is what works -- and it is, necessarily, what has worked for us, each of us individually, as a first approximation. For my other blog, on the struggles for control in the corporate suites, see www.proxypartisans.blogspot.com.