Monday, October 19, 2009
Debate exhaustion and exhiliration
I just posted on Madisonian.net a short comment on a terrific debate on ScotusCast about the exhausation doctrine after the Supreme Court's Quanta v. LG decision. Worth listening to, a fabulous format for public edification and education, and almost nothing said in my post about patentable subject matter for a change.
Monday, October 12, 2009
Bilski, What is Patentable, and the Constitution
I recently filed an amicus brief in the pending Supreme Court case, Bilski v. Kappos, about whether business methods are patent eligible “inventions,” on behalf of eleven law professors and AARP (for whom I filed an amicus brief in the LabCorp v. Metabolite case about diagnostic methods). Although the Bilski brief focuses on business methods (and the legal category of unpatentable “abstract ideas”), it also explains how to draw the line between the patentable inventions and unpatentable science and nature. In addition, the brief explains why these concerns are of Constitutional stature, and not just questions of how far Congress has legislated and whether it has sought to extend the patent system beyond its historic contours.
As the brief argued, the patent system does not apply to science, nature, and abstract ideas, whether claimed “as such” (familiar terminology to Europeans under the EPC) or claimed without “invention in their application.” The reason for excluding science, nature, and ideas as such is based on historic beliefs (reflected in the Constitution) that such foundational information should be “free for all to use,” and that those who discover such information have a moral duty to freely disseminate it. The reason to prohibit claims lacking invention in the application (i.e., to go beyond claiming such public domain science, nature, and ideas as such) is that once such information is treated as public domain information, a patent without any additional inventive contribution (i.e., creative technological advance) would both improperly reward the scientific discovery with exclusive rights and overcompensate the discoverer for disclosing only what is supposed to be free for all to use. Stated differently, without “invention in the application,” there is simply no patent-eligible invention to patent; the claim is no more than a mere application of the public domain information, which may be new and a human creation but is not an invention.
Allowing patents for such claims would permit the public domain to be appropriated in a piecemeal fashion, rather than in one large bite (“as such”), but adds nothing to the store of technological knowledge (assuming again that the disclosed science itself is treated as if already known). Of course, scientists and others might -- absent patent protection for science, nature, and ideas “as such” or without additional invention -- choose to withhold such information from the public because they cannot turn it into their private property. But as Lord Camden stated over two Centuries ago, “[t]hey forget their Creator, as well as their fellow creatures, who wish to monopolize his noblest gifts and greatest benefits.” The law should neither encourage nor reward such withholding behaviors. (On alternative incentives and funding for scientific discovery, see below.) Whether one has the same, different, or no religious beliefs, patentable subject matter thus raises important moral concerns (and not just of utilitarian morality).
Because all countries prohibit patenting science, nature, and ideas as such, the approach suggested by the brief is quite similar to the approach in many other countries. This includes the “technical effect” approach of Europe, the Japanese requirement for “creation of technical ideasutilizing laws of nature,” and the requirement for industrial application reflected in, among other things, the TRIPS Agreement (recited along with novelty and inventive step patentability requirements, given the treaty’s notable lack of a definition for “invention”). The approach adopted by the brief, however, does not define the minimum threshold of what constitutes an invention (i.e., a creative technological advance), and countries may differ in where they set that threshold – as well as in regard to the qualitative degree of creativity that they believe would justify granting a patent (the subject of the inventive step requirement).
Instead, the brief sketches important and relevant patent law cases from the last two-plus centuries to show how the “invention in the application” test of eligibility has been applied, providing concrete examples of that minimum threshold. The “invention in the application” test thus provides analytic clarity regarding both the history and the theory of patent law in the U.S. and thus should be of help to the courts, the PTO, and the patent system as a whole. By articulating and analyzing the “invention in the application” test, the brief explains how patentable subject matter determinations differ from novelty, non-obviousness, and adequate disclosure patentability requirements, how it generates the “machine or transformation” precedents, and why those precedents establish a (possibly) necessary but (necessarily) insufficient condition for patent eligibility. The brief also explains why “preemption” of science, nature, and ideas is not the test of eligibility (which it would be if science, nature, and ideas were only prohibited from being claimed “as such”), but rather is the consequence of improperly claiming science, nature, and ideas without invention in the application (or any other meaningful limitation on claiming science, nature, and ideas “as such”).
The brief also argues that protecting the public domain of science, nature, and ideas is a constitutional, not just a legislative, requirement. Although originalism is always a difficult position, one need not be an originalist to believe that the value of protecting the public domain of science, nature, and ideas from encroachment is so important that it should continue to receive constitutional protection, and thus should not be subject to legislative override. The brief thus articulated three grounds (in less detail than in the amicus brief filed in the Court of Appeals below) for why the Constitution restricts legislative power, and explains why a broad interpretation of the statute (of Section 101 alone or in conjunction with Section 273) should not be adopted, as to do so would raise constitutional conflicts that should be avoided. These are: (1) that “Inventors” and “Discoveries” excludes science, nature, and ideas (which either are not human creations or are not the kinds of things that are properly subjected to private ownership); (2) that “useful Arts” imposes limits by requiring that patents be for technological advances, and eliminating the requirement for invention in the application extends the patent system beyond technology – however defined; and (3) that patents on the fundamental infrastructure of science, nature, and ideas impedes rather than “promote[s] the Progress of [both] Science and useful Arts.” Although I don’t expect the Court to rule on constitutional grounds, as Section 101 (alone or in conjunction with Section 273) can readily be construed to avoid violating such constitutional limits (and the brief argues that the statute should be interpreted to do so), I still hope the Court will reach the constitutional issues. It would be good for the Court at least to provide a clear statement on the meaning and limits (if any) of the Authors and Inventors Clause. Following Eldred, the statement in Graham that the Constitution limits legislative power may be widely viewed as repudiated dicta. A clear statement of the Constitution’s limits would potentially restrain Congress (and lobbyists) from testing those limits, as well as reinforce the constitutional policies behind those limits and provide guidance for future courts in assessing the constitutional validity of any future legislation that tests the limits.
Finally, in tardy response to comments of Anonymous and by Richard Aron Osman on my earlier post on the ACLU challenge to gene patents, I agree that we don’t want to “destroy this potential” for funding biotechnological advances, and that gene patents are an “easy target” whereas natural pharmaceuticals may make for harder cases. But the fact that hard cases may exist should not deter the courts from ruling on them, even if they may sometimes make mistakes. And permitting patents where there is “invention in the application” will preserve patents for some pharmaceuticals (and not just “minor follow-ups”), even if it denies patents for many pharmaceuticals that reflect no creative technological advance beyond the natural discovery. I also agree with Osman that we should be reluctant to prohibit patents on such medical advances without providing adequate funding for their scientific discovery. But I don’t think we are in serious danger of doing so if the prohibition on patenting science, nature, and ideas were made clearer. Rather, I think the justification for government funding would be easier to make (and the funds would become easier to obtain). Similarly, I think that personal incentives to engage in scientific (and other fundamental) discovery already exist, and that we don't need to provide patent incentives for them. But if we do need something more than already exists, there are better alternative than exclusive patents rights for providing them (e.g., prize funds, greater publicity and social recognition, more job security, etc.). Lastly, whether or not we wish to provide broad patent incentives for “pioneering” inventions is a complicated issue. The brief notes that some patents on non-inventive applications of science, nature, and ideas also may fail under Section 112 disclosure doctrines. But not all scientific, natural, and abstract discoveries are “pioneering.” For broadly applicable and important scientific discoveries, it is precisely their status as pioneering and foundational that suggests why (on utilitarian grounds) they should not be the subject of private exclusive rights. But even for patentable technological inventions, broad “pioneering” genus claims may sometimes do more harm than good, and I do not believe in granting broad patent rights to effectuate a "prospect theory" of the role of patents. The best discussion of this issue that I have seen is in Merges and Nelson’s On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839 (1990), which I believe is a strong repudiation of the prospect theory of granting broad patent rights in order to control the development of sequential innovation. But I’ll have more to say about pioneering inventions and genus and species claims soon, after our IP Clinic files an amicus brief in the Ariad v. Lilly written description case….
As the brief argued, the patent system does not apply to science, nature, and abstract ideas, whether claimed “as such” (familiar terminology to Europeans under the EPC) or claimed without “invention in their application.” The reason for excluding science, nature, and ideas as such is based on historic beliefs (reflected in the Constitution) that such foundational information should be “free for all to use,” and that those who discover such information have a moral duty to freely disseminate it. The reason to prohibit claims lacking invention in the application (i.e., to go beyond claiming such public domain science, nature, and ideas as such) is that once such information is treated as public domain information, a patent without any additional inventive contribution (i.e., creative technological advance) would both improperly reward the scientific discovery with exclusive rights and overcompensate the discoverer for disclosing only what is supposed to be free for all to use. Stated differently, without “invention in the application,” there is simply no patent-eligible invention to patent; the claim is no more than a mere application of the public domain information, which may be new and a human creation but is not an invention.
Allowing patents for such claims would permit the public domain to be appropriated in a piecemeal fashion, rather than in one large bite (“as such”), but adds nothing to the store of technological knowledge (assuming again that the disclosed science itself is treated as if already known). Of course, scientists and others might -- absent patent protection for science, nature, and ideas “as such” or without additional invention -- choose to withhold such information from the public because they cannot turn it into their private property. But as Lord Camden stated over two Centuries ago, “[t]hey forget their Creator, as well as their fellow creatures, who wish to monopolize his noblest gifts and greatest benefits.” The law should neither encourage nor reward such withholding behaviors. (On alternative incentives and funding for scientific discovery, see below.) Whether one has the same, different, or no religious beliefs, patentable subject matter thus raises important moral concerns (and not just of utilitarian morality).
Because all countries prohibit patenting science, nature, and ideas as such, the approach suggested by the brief is quite similar to the approach in many other countries. This includes the “technical effect” approach of Europe, the Japanese requirement for “creation of technical ideasutilizing laws of nature,” and the requirement for industrial application reflected in, among other things, the TRIPS Agreement (recited along with novelty and inventive step patentability requirements, given the treaty’s notable lack of a definition for “invention”). The approach adopted by the brief, however, does not define the minimum threshold of what constitutes an invention (i.e., a creative technological advance), and countries may differ in where they set that threshold – as well as in regard to the qualitative degree of creativity that they believe would justify granting a patent (the subject of the inventive step requirement).
Instead, the brief sketches important and relevant patent law cases from the last two-plus centuries to show how the “invention in the application” test of eligibility has been applied, providing concrete examples of that minimum threshold. The “invention in the application” test thus provides analytic clarity regarding both the history and the theory of patent law in the U.S. and thus should be of help to the courts, the PTO, and the patent system as a whole. By articulating and analyzing the “invention in the application” test, the brief explains how patentable subject matter determinations differ from novelty, non-obviousness, and adequate disclosure patentability requirements, how it generates the “machine or transformation” precedents, and why those precedents establish a (possibly) necessary but (necessarily) insufficient condition for patent eligibility. The brief also explains why “preemption” of science, nature, and ideas is not the test of eligibility (which it would be if science, nature, and ideas were only prohibited from being claimed “as such”), but rather is the consequence of improperly claiming science, nature, and ideas without invention in the application (or any other meaningful limitation on claiming science, nature, and ideas “as such”).
The brief also argues that protecting the public domain of science, nature, and ideas is a constitutional, not just a legislative, requirement. Although originalism is always a difficult position, one need not be an originalist to believe that the value of protecting the public domain of science, nature, and ideas from encroachment is so important that it should continue to receive constitutional protection, and thus should not be subject to legislative override. The brief thus articulated three grounds (in less detail than in the amicus brief filed in the Court of Appeals below) for why the Constitution restricts legislative power, and explains why a broad interpretation of the statute (of Section 101 alone or in conjunction with Section 273) should not be adopted, as to do so would raise constitutional conflicts that should be avoided. These are: (1) that “Inventors” and “Discoveries” excludes science, nature, and ideas (which either are not human creations or are not the kinds of things that are properly subjected to private ownership); (2) that “useful Arts” imposes limits by requiring that patents be for technological advances, and eliminating the requirement for invention in the application extends the patent system beyond technology – however defined; and (3) that patents on the fundamental infrastructure of science, nature, and ideas impedes rather than “promote[s] the Progress of [both] Science and useful Arts.” Although I don’t expect the Court to rule on constitutional grounds, as Section 101 (alone or in conjunction with Section 273) can readily be construed to avoid violating such constitutional limits (and the brief argues that the statute should be interpreted to do so), I still hope the Court will reach the constitutional issues. It would be good for the Court at least to provide a clear statement on the meaning and limits (if any) of the Authors and Inventors Clause. Following Eldred, the statement in Graham that the Constitution limits legislative power may be widely viewed as repudiated dicta. A clear statement of the Constitution’s limits would potentially restrain Congress (and lobbyists) from testing those limits, as well as reinforce the constitutional policies behind those limits and provide guidance for future courts in assessing the constitutional validity of any future legislation that tests the limits.
Finally, in tardy response to comments of Anonymous and by Richard Aron Osman on my earlier post on the ACLU challenge to gene patents, I agree that we don’t want to “destroy this potential” for funding biotechnological advances, and that gene patents are an “easy target” whereas natural pharmaceuticals may make for harder cases. But the fact that hard cases may exist should not deter the courts from ruling on them, even if they may sometimes make mistakes. And permitting patents where there is “invention in the application” will preserve patents for some pharmaceuticals (and not just “minor follow-ups”), even if it denies patents for many pharmaceuticals that reflect no creative technological advance beyond the natural discovery. I also agree with Osman that we should be reluctant to prohibit patents on such medical advances without providing adequate funding for their scientific discovery. But I don’t think we are in serious danger of doing so if the prohibition on patenting science, nature, and ideas were made clearer. Rather, I think the justification for government funding would be easier to make (and the funds would become easier to obtain). Similarly, I think that personal incentives to engage in scientific (and other fundamental) discovery already exist, and that we don't need to provide patent incentives for them. But if we do need something more than already exists, there are better alternative than exclusive patents rights for providing them (e.g., prize funds, greater publicity and social recognition, more job security, etc.). Lastly, whether or not we wish to provide broad patent incentives for “pioneering” inventions is a complicated issue. The brief notes that some patents on non-inventive applications of science, nature, and ideas also may fail under Section 112 disclosure doctrines. But not all scientific, natural, and abstract discoveries are “pioneering.” For broadly applicable and important scientific discoveries, it is precisely their status as pioneering and foundational that suggests why (on utilitarian grounds) they should not be the subject of private exclusive rights. But even for patentable technological inventions, broad “pioneering” genus claims may sometimes do more harm than good, and I do not believe in granting broad patent rights to effectuate a "prospect theory" of the role of patents. The best discussion of this issue that I have seen is in Merges and Nelson’s On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839 (1990), which I believe is a strong repudiation of the prospect theory of granting broad patent rights in order to control the development of sequential innovation. But I’ll have more to say about pioneering inventions and genus and species claims soon, after our IP Clinic files an amicus brief in the Ariad v. Lilly written description case….
Saturday, September 19, 2009
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.
Thursday, August 27, 2009
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 23Berkeley
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?
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
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?
Friday, August 14, 2009
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!
Friday, June 5, 2009
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.
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.
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