The Financial Times' Take on Gene Patenting

By Kevin E. Noonan --

The staid Financial Times (London) has an article today on the gene patenting debate, and while there are things to criticize in it, the article (perhaps predictably) takes a carefully measured, dispassionate (and welcome) tone ("Who steals the gene from off the common"; free registration required).

The paper's conservative bona fides are established on its website:

First published in 1888 as a four-page newspaper, the Financial Times' initial readership was the financial community of the City of London.  The Financial Times soon established itself as the sober but reliable "stockbroker's Bible", with its only rival being the slightly older and more daring Financial News.  In 1893, the FT turned salmon pink -- a masterstroke that made it immediately distinguishable from its competitor.  From their initial rivalry, the two papers merged in 1945 to form a single six-page newspaper.  The Financial Times brought with it a higher circulation, while the Financial News provided enormous editorial talent.

And it is with a "sober" voice that the article by James Boyle, William Neal Reynolds Professor at Law, Duke Law School addresses a frequently emotional subject.  He cites critics of gene patenting as describing a "'genetic land grab' that promised to privatize the common heritage of mankind," and characterizes their arguments as "frankly moral, protesting the hubris and in some eyes, heresy, of claiming to own the human genome."  He contrasts this with arguments that "patents over genes [are] necessary to spur investment and jump start biotech innovation."  And he includes the third part of the debate, whether gene patents "spur innovation" or slow it, by "introducing a tangle of property rights into the most fundamental building blocks of research science."

Although evenhanded, the piece suffers from the common misconception that genetic information is patented (Judge Sweet's view), rather than isolated nucleic acids themselves as chemical compounds (which, despite Judge Dyks' recent pronouncements, has been the Federal Circuit's view).  This deficiency also informs the article's discussion of what the author calls a "new consensus," patterned on the recent publicity regarding the Alzheimer's Disease Initiative.  As previously reported in The New York Times, this is an effort by the National Institutes of Health joined with academic and "commercial" researchers "to unlock the secrets of that debilitating disease."  The key development, cited in this article as well as the original Times piece, was that the data from the collaboration would be made public "immediately," and that "no one would own the data" (and no one would file any patent applications, although "private companies would ultimately profit from any drugs or imaging tests developed as a result of the effort").  Professor Boyle hails this development as one where "all parties . . . are better off."  He attributes (without attribution) to private companies "who had watched their drug pipelines dry up" the fear that "the old model of in-house development and jealous guarding of data" would not be able to "unlock such complex biological mysteries" as the motivation for joining the initiative.

Perhaps.  It is also good to remember that a great deal of the initial research from the Initiative (like much initial research) was unlikely to lead to any patentable subject matter in the first place.  Patents protect inventions, not data.  As the Federal Circuit said in Ariad v. Eli Lilly:

Ariad complains that the doctrine disadvantages universities to the extent that basic research cannot be patented.  But the patent law has always been directed to the "useful Arts," U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical use, see Brenner v. Manson, 383 U.S. 519, 532-36 (1966).  Much university research relates to basic research, including research into scientific principles and mechanisms of action, see, e.g., Rochester, 358 F.3d 916, and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered.  That is no failure of the law's interpretation, but its intention.  Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.  "[A] patent is not a hunting license.  It is not a reward for the search, but compensation for its successful conclusion."  Id. at 930 n.10 (quoting Brenner, 383 U.S. at 536).  Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of "invention" -- that is, conceive of the complete and final invention with all its claimed limitations -- and disclose the fruits of that effort to the public.

That research hypotheses do not qualify for patent protection possibly results in some loss of incentive, although Ariad presents no evidence of any discernable impact on the pace of innovation or the number of patents obtained by universities.  But claims to research plans also impose costs on downstream research, discouraging later invention.  The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not "attempt[s] to preempt the future before it has arrived."  Fiers, 984 F.2d at 1171.  As this court has repeatedly stated, the purpose of the written description requirement is to "ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification."  Rochester, 358 F.3d at 920 (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)).  It is part of the quid pro quo of the patent grant and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.  Enzo, 323 F.3d at 970.

And it is also well to remember that the reason for the extensive collaboration between scientists (who heretofore guarded their pre-publication Alzheimer's disease research results just as jealously as any commercial enterprise) is precisely because Alzheimer's disease has proven so intractable.  In today's New York Times is an article bemoaning the lack of progress at developing an effective treatment for the disease, in the face of 30 years effort (and 10 years of that same Alzheimer's Disease Initiative so praised by Professor Boyle).  So while it is evident that at least some of the participants were happy (and self-satisfied) to paraphrase Quincy Jones by proclaiming that they "left their intellectual property at the door," it is less evident that anything of commercial value (or any intellectual property) was put at risk by what was publicly disclosed by the Initiative.  (Recognition of this reality explains as well as the Professor's speculation does why commercial entities were willing to participate in the Initiative.)

Being the Financial Times, the article is quick to point out that "[t]he idea is not to give up property rights," because "these will be essential in the development of therapies down the line."  Rather, Professor Boyle contends that "science -- and commerce -- will benefit from the establishment of a pre-competitive commons, a pool of information from which all can draw," using the NIH as an "honest broker."  As evidence of a trend, he cites the Bermuda Accords guiding the public prong of the Human Genome Project, the Sage Bionetworks project, as well as the Science Commons (which organization had Professor Boyle as one of its founders).  He suggests that the economic tools exist to ascertain the best ways to "jump-start commercial innovation" while at the same time recognizing that the task of deciding where sharing should end and privatization and property rights begin is complex.  Refreshingly, he says that this enterprise "is not an ideological war but a pragmatic process of design."

The article charmingly analogizes the gene patenting debate to enclosure of the English commons over 500 years ago, and in doing so returns the analogy from the "anticommons" rhetoric that usually accompanies discussions of this debate.  The article begins and ends with part of a poem regarding this ancient argument:

The law locks up the man or woman
Who steals the goose from off the common
But leaves the greater villain loose
Who steals the common from off the goose
And geese will still a common lack,
Til' they go and steal it back.

However the gene patenting debate is resolved, it would be well if the same benefits garnered from enclosing the common -- providing the greatest benefits to the greatest number -- are the result.

Comments

[S. Pelech - Kinexus]

With the sequencing of the human genome completed a decade ago and the genomes of hundreds of other organisms at hand, is it not rather late to get worked up about patenting genes. The vast majority of gene sequence information has been generated at public expense. It has been very difficult to argue that the discovery or elucidation of the nucleotide sequence of a gene represents an "invention." Moreover, the huge length of time it actually takes to successfully generate and test a drug from initial determination of the sequence of a gene for a drug target makes it quite impractical to go through the enormous energy and expense required to file and maintain a gene sequence patent in all of the major jurisdictions in the world.

The situation was very different 15 years ago. Private enterprise was willing to make the huge investments necessary to undertake the sequencing of genomes in exchange for some guarantee that a return on their investment might be realized. This spurned on the growth of the biotechnology industry around the turn of the last century. The problem is that once a race began between governments and industry to sequence the human genome and this information became rapidly accessible, the value of these genomics companies plummeted, and so did the industry as a whole. It has not really recovered since then.

I suspect that had governments and disease charities not devoted a major part of their biomedical research budgets to gene sequencing and distributed their funding more widely, we would be further along in our understanding of cellular biochemistry and physiology than we are today. Basic researchers would still have had access to the sequences of human genes from the industrial effort, probably with more value added. Finally, in this new decade, all of the gene sequence patents would have expired and all of this information would have been freely available for anyone to use.

[6]

When does the appeal get underway Kev? You wanna come down the CAFC for the oral arguments?

[Kevin E. Noonan]

Well, 6, Myriad's brief is due October 22, so I don't see the oral hearing until some time in 2011. Decision by next summer.

[Mike]

The point is moot. The Myriad patents will have expired before the appeal is finished...
The first patent US5747282 has a priority date of 8/12/1994 and an issue date of 5/5/1998. Because it was filed on 6/7/1995 it expires either 20 years from priority date - 8/12/2014, or 17 years from issue date - 5/5/2015. The CAFC may make their decision in the next year, but will the Supreme Court be able to get through the case before May 5, 2015? Assuming the ACLU appeals the CAFC opinion which should give Judge Sweet a kind lesson in patentable subject matter. He doesn't even address patent claims until 1/2 way through the opinion. Of course he also spends less time on the claims than he does on the credentials of the people who admitted to clinically copying Myriads tests in their research institutions. I digres...

[6]

crp man, that is such a long time. I don't know how you lawyers put up with so much delay in the courts.