Cross-blogging -- IP, India, and Cultural Anthropology

I was recently invited to join the Madisonian.net blog as a contributor. For my first post there, I decided to discuss a recent meeting in Kolkata, India, hosted by a good friend Professor Shamnad Basheer of the National University of Juridical Sciences and the founder of the SpicyIP blog, that considered pending legislation to regulate ownership of inventions created with government funding, similar to the U.S. Bayh-Dole Act. As suggested in the post, more attention needs to be paid to cultural considerations in the regulation of the creation and use of intellectual property.

ACLU gene patents challenge -- Bilski preview

Lori Andrews and I today filed a motion and an amicus brief on behalf of the American Medical Association, the American Society of Human Genetics, the American College of Obstetricians and Gynecologists, the American College of Embryology, and the Medical Society of the State of New York in Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, et al., No. 09 Civ. 4515 (RWS) -- the lawsuit filed by the ACLU and the Public Patent Foundation challenging the BRCA1 and BRCA2 gene patents owned by Myriad Genetics. ( I discussed the case earlier this summer on the Kojo Nnamde Show, with Hans Sauer of the Biotechnology Industry Organization and Shobita Parthasarathy of the U. of Michigan.) The case will provide a good opportunity for the courts to resolve whether isolated natural materials and discovered medical phenomena are patentable subject matter. We argued that in a series of cases over the past 150 years, the Supreme Court has held that one cannot patent (1) products of nature, or materials isolated from products of nature if those materials behave in the same way they would in nature, or (2) discovered laws of nature or mathematics, or applications of those laws lacking significant (i.e., creative) “post-solution activity.” We also explained how some of the claims at issue (the sequence claims) cover the natural materials and being "isolated" does not change them nor give them new properties, and how other claims (the correlation claims) cover the mental act of recognizing or comparing information, however obtained. Finally, we explained how these patents have interfered with our clients' research and have prevented proper medical care, and why they violate both medical and scientific ethical tenets.

The brief is a good preview for my forthcoming Supreme Court amicus brief in Bilski v. Doll, as it demonstrates in the contexts of products of nature and natural phenomena the relevant patentable subject matter requirement that there must be invention in the application of scientific principles, naturally occuring materials, and abstract ideas. Historic ethical obligations required treating previously known or newly discovered science, nature, and ideas as not only "free for all to use" but also as if they were already in the prior art (once disclosed, e.g., in a patent application). Thus, in order for there to be any patent-eligible "invention" there must necessarily be some other "inventive concept" (using the terminology of Parker v. Flook) in the application itself of the discovered science, nature, and ideas, even if the application is novel. Simply isolating the natural genetic material is not sufficient to be called "invention," given that the discovery of the natural material must be treated as if it were already known. Similarly, claiming the isolated genetic sequence information or variants of it (in mutations) is not an invention once that information is requiredto be treated as public domain information (as natural phenomena). And claiming the acts of comparing the actual genetic sequence disclosed in the patent to another (potentially mutated) sequence is not an invention, given that there is no creativity in doing so once the sequence information is treated as in the public domain -- recognizing that one of these things is not like the others is trivial even if highly useful. (It also destroys the quid pro quo of the patent system -- an enabling disclosure where people can use the information -- if not the physical implementation -- in exchange for patent rights. Note that this is different from but the mirror image of the bargain-destroying problem caused by the lack of a meaningful research exception, when people can't use the information disclosed in the patent to sequentially innovate because they can't use physical embodiments that are necessary to research. Although combinatorial chemistry and biology may minimize that problem, some of the patents at issue in the AMP v. PTO case actually prohibit "analyzing" sequence information, however it might be obtained.)

Chris Holman (a friend and a colleague on a recent paper entitled Recent Developments Affecting the Enforcement, Procurement, and Licensing of Research Tool Patents, the draft of which is on SSRN and the final is published at 23 Berkeley Tech. L. J. 1299 (2008)) has provided a good short summary of the ACLU's motion for summary judgment that our amicus brief supports on his Holman's Biotech IP Blog. Chris appears to recognize that the Supreme Court precedents before Diamond v. Chakrabarty (which as discussed in our amicus brief did not change the law in this regard) require more than "mere isolation" in order to claim a patent-eligible application of a product of nature. Chris also correctly notes that the Patent Office has for a long time treated mere isolation as sufficient human creativity and difference from the natural material to constitute a patent-eligible invention. So we will have to see if the District Court (and ultimately perhaps the Supreme Court) is willing to disregard various appellate court decisions (pre-dating and of the Federal Circuit) and the PTO policies that contravene the Supreme Court precedents, when the consequence is to eliminate thousands of claims in a very important industry. For the reasons explained in the medical association amicus brief, there are good policy reasons to do so because these patents cause real harm.

This case also reflects another "industry battle," this time not IT or generics against pioneering PhRMA, but the medical treatment/scientific research community (and the patient and consumer community as the ultimate beneficiaries) against the biotech/scientific research community. And it is precisely the tension in the scientific community (which spans both industries) that makes this so fascinating. As the amicus brief discusses, scientists had an ethical duty (deriving from the morality of religion) not to subject to private property rights their discoveries of nature -- which duty remains reflected in the patent law requirement that such discoveries must be treated as prior art if disclosed. As William Robinson stated over a century ago in his celebrated Patent Law treatise, "To benefit by the discoveries of his fellow-men is thus not only a natural right, it is also the natural duty which every man owes to himself and to society; and the mutual universal progress thence resulting is the fulfillment of the earthly destiny of the human race.” As Lord Camden said a century earlier, scientists are "entrusted by Providence with the delegated power of imparting to their fellow creatures that instruction which heaven meant for universal benefit; they must not be niggards to the world, or hoard up for themselves the common stock." Are scientists who seek to (and often successfully) patent their natural discoveries bad people?

SCOTUScast debate on Bilski -- Shedding light, not heat

I had the pleasure this summer of debating Michael Risch, with Adam Mossoff hosting, regarding patentable subject matter and the Supreme Court's upcoming decision in Bilski for the Federalist Society's terrific SCOTUScast blog series of commentaries on recent and upcoming Supreme Court cases. Not only are Michael and Adam very knowledgeable and insightful, particularly regarding centuries of history of patent law, they are terrific analysts and interlocutors (and just good people). Michael cogently presented the case for broad patentable subject matter, as a matter of innovation policy, legislative interpretation, and history, while I made the case for keeping certain areas free from private property rights as a matter of industrial policy, history, and judicial construction of legislation and the Constitution. I highly recommend the podcast for all who want to better understand the legal and policy issues, as well as Michael's recent amicus briefs in the Federal Circuit and the Supreme Court and his recent article on patentable subject matter history, as well as my recent amicus brief in the Federal Circuit and draft article -- the Supreme Court brief is coming so stay tuned!

Welcome to Inherently Sarnoff

This is my first post, so I'll say a little about what I have been doing for the last few years (outside of the home and my teaching of patent law and IP Clinic).

Following some earlier work that I had done in the IP Clinic for the Public Interest Intellectual Property Advisors on the consistency of disclosure of origin requirements with international IP treaties, I was asked by the United Nations Conference on Trade and Development (UNCTAD) in 2005 to draft a report with Carlos Correa for the Eight Conference of the Parties to the Convention on Biological Diversity on the relationship between the intellectual property sytem (particularly patents) and the access and benefit sharing requirements of the CBD. The report discusses the nature and scope of a potential disclosure of origin requirement for genetic or biological resources and associated traditional knowledge, how it could be implemented by national governments and the international IP system, and what issues would need to be resolved in reaching international agreement on such a system.

Around the same time, I was involved in patent law reform issues, including submitting comments for a coalition of law professors on draft patent reform legislation. In 2007, I focused the law of obviousness (inventive step) by filing an amicus brief in the KSR v. Teleflex case in the U.S. Supreme Court and writing an article about the case and presumptions of validity, comparing U.S. and Indian law.

I have also been focused on the history of what can be patented, particularly in the United States (although tracing back to the English patent custom and looking comparatively to Europe and elsewhere). When the U.S. Supreme Court granted certiorari in the LabCorp. v. Metabolite case, I filed an amicus brief for AARP in December of 2005 that argued for the unpatentability of a medical diagnostic claim to a newly identified correlation, based on the exclusions from patentability for science, nature, and ideas, and why scientific discoveries of natural phenomena (there a medical correlation) should not be patented. This made me wonder about the history of this doctrine, which I thought at the time must have been related to the idea of nature as a common heritage resource (tracing that idea to Grotius).

I was then asked by George Washington University Law School/Oracle Corp. to write a paper on patentable subject matter that I presented at the “What’s Ahead on Highway 101?” symposium held at GWU on November 3, 2006. I subsequently developed a much longer draft of the history, Shaking the Foundations of Patentable Subject Matter. and when the U.S. Court of Appeals for the Federal Circuit granted en banc review of In re Bilski, I filed an amicus brief explaining the constitutional concerns with construing Section 101 of the Patent Act broadly (or finding an implied ratification of the broad State Street Bank approach under Section 273) so as to find the busines method claim at issue to be patentable.

More recently, with Lori Andrews and Jonathan Kahn, I filed comments with the Australian Senate in their inquiry on gene patents, explaining why the law in the US has not authorized patents on isolated and purified gene sequences and why the thousands of patents that have issued for such sequences are invalid. We also submitted comments with the US Department of Health and Human Services on a public consultation draft report of the Secretary's Advisory Committee on Genetics, Health and Society on gene patents and licensing and their effects on patient access to genetic tests. I recently appeared on the Kojo Nnamde radio show to discuss the ACLU's and Public Patent Foundation's judicial challenge to the breast cancer gene patents issued by the U.S. PTO and licensed to Myriad Genetics.

I am now working on a Supreme Court amicus brief in Bilski v. Doll, and a book entitled Patents and Morality: Religion, Science, Nature and the Law, discussing the history of and modern moral concerns with patenting science and nature. I am also involved in discussions of patents, technology transfer, climate change, and human rights. So, more to come on patentable subject matter, and on other patent law and environment issues.