Patent Pending: Corporations, the Constitution, and the Human Gene
|Written by Professor Robin Feldman
U.C. Hastings College of Law
Posted: March 3, 2013 @ 12:17 pm
I began by describing the facts of the Myriad case, which is currently before the Supreme Court, and the science behind the issues, as well as introducing the panelists. I then began the discussion by asking the panelists if genetic sequence and cDNA patents interfere with scientific research and with those who provide health care. Vern Norviel of Wilson Sonsini argued that it does not matter either way with regards to patents and new biotech product innovations. Mr. Norviel pointed out that the entire human genome was already mapped and the company who mapped it was not sued. More importantly, he argued, is that human genes are limited and it would be a very small bit of information that could be determined to not be patentable. He did, however, caution that the Court should try and restrain itself and not go too far such that it destroys what is currently a massive and successful life sciences industry. The bottom line is that regardless of whether a patent exists, professors and researchers will continue to do the research. Dr. James Mullen of Morrison & Foerster further argued that patents encourage research and innovation as venture capitalists want to know if (1) the research does what it is claimed to do and (2) if the party owns that research.
The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene. Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.
The conversation then shifted towards where the dividing line should be between scientific observations/laws of nature and patentable subject matter as it relates to the structure of DNA versus a genetic sequence. Dr. Mullen stated that the shape of DNA, i.e. the double helix, is clearly not patentable, but that individual genes are a different breed. I posed the question along the lines of isolation purification and if discovering something that could be of practical use is a better distinction. This question remained unanswered by the panel, but Mr. Noviel argued in the amicus brief he filed in this case on behalf of Harvard University, that this was merely a screw up by the PTO on the question of novelty.
For a non-legal perspective, the question of patents harming patient care was raised next. Dr. Megan Allyse of Stanford University stated there indeed is an effect on patient care as Myriad has been very aggressive in enforcing its patent rights. As a result of this aggression, patients have developed cancer that has gone undetected, where it may have been caught had Myriad simply licensed its patents on BRCA1 and BRCA2 out. She compared Myriad to the University of Montana and its non-exclusive licensing program for the patent it holds on cystic fibrosis genes, allowing others to develop tests and new products. Judge Kozinski made the point that the patent enforcement issue on life science patents could be resolved with a mandatory licensing scheme developed by Congress, as exists for music. Dr. Allyse pointed out that a similar scheme does exist in Europe and that some gene patents are not allowed in Europe, which Dr. Mullen clarified as only pertaining to method and treatment patents, not composition of matter patents. In a moment of widespread agreement among the panel was the belief that had Myriad licensed more generously, these diagnosis gene patents generally would not be in trouble.
Straying briefly from the question of patentable subject matter and in one of the more contentious moments of the evening, Judge Kozinski pointedly asked what the novelty of the patents in this case is. Dr. Mullen stated it was discovering the propensity of having the mutated gene and higher risks of ovarian and breast cancer to which Judge Kozinksi responded by asking how this is any different than finding a virus that causes the flu. Judge Kozinski pressed the lawyers on the panel to articulate a reason that these patents represent a contribution beyond discovering information about nature. Wes Overson of Morrison & Foerster chimed in by pointing out that this case is unique in that the Supreme Court is considering cutting off an entire class of subject matter, rather than looking at the traditional points of inquiry such as novelty, prior art, or non-obviousness. His primary concern was that these cases are often handled by juries and that if the initial question of whether something is patentable subject matter is submitted to juries, in addition to the already long list of complex questions they consider, there is a potential harm lurking in inconsistent verdicts. He additionally feared that one of the effects of this case could mean that private companies lose the incentive to try and continue researching new cures instead of leaving it up to the government and universities. It would be unwise, Mr. Overson argued, for the Court to simply say that 30 years of research and subject matter everyone thought was initially patentable—the government and universities included—is not actually the case.
Professor Winickoff countered this parade of horribles by saying that he does not believe a slight tightening up of subject matter patentability will not bring down the patent system. He argued that in the past 30 years the patent system has greatly increased in scope and there are those in academia who do not believe this is a positive as it furthers the tragedy of the anti-commons. Dr. Mullen responded by pointing out that this case is a matter of law, not policy, and that the Supreme Court should try to avoid the policy arguments and let Congress handle that if it should so desire. On the legal issue and the dividing line of what is patentable subject matter, Mr. Overson points out that both sides argue that Congress’ inaction means that they should win—Myriad claiming the new AIA did not speak on the issue when Congress had the chance and the ACLU stating that the lack of discussion means the Court can intervene and set the line.
On the question of what the Supreme Court will actually do, all six panelists agreed, as do I, that human genes will be declared outside of patentable subject matter. Judge Kozinski stated that the message of Prometheus was that the Court was saying you cannot take something out of nature and claim it simply because there is a better way of counting it. Dr. Allyse believes the Court may be trying to force Congress’ hand to get a definitive statement either way on the issue and that by ruling on this case, it will achieve that end.
In the first question from the audience, it was posited whether parents are necessary for innovation and if venture capital truly will leave the biotech field. Mr. Norviel definitively stated that this is in fact the case. He works with companies who, when the cost is $1.4 Billion to get a drug to market, will simply not develop new products if the funding does not exist and that venture capitalists will not invest if the ability to make a profit via a patent monopoly ceases to exist. Mr. Overson also pointed out that this industry does not have trade secrets and thus patents need to exist.
Professor Rory Little asked whether the Court would consider ruling in this case on a narrower question and the panel agreed uniformly that it wrote this particular question and will answer it. Judge Kozinski wondered, however, if the recent trend of the Supreme Court ruling against the Federal Circuit on patent cases is a result of the Federal Circuit’s exclusive jurisdiction on the subject making them captive to the industry they are regulating. Dr. Mullen agreed with Judge Kozinski and Dr. Allyse chimed in by saying that many consider the Federal Circuit to be teleological in its decisions, making up the logic after the fact.
When asked about the value of gene patents and how that affects judicial decisions, Judge Kozinski discussed how judges are not unilateral beings and that they shouldn’t be. The value bestowed on these patents by the market is a valid consideration and judges should recognize the life-saving work that results from them.
Following on an earlier discussion, a discussion took place regarding why companies should be able to patent genetic sequences, if scientists who study the stars cannot patent the information they learn by staring at the skies. I noted that the question is slightly different in the two cases. For example, if we were able to separate a star from the sky and do something different with it in a lab, would we then grant a patent on the invention?
On questioning regarding the discovery involved with the patents of this case, the panel digressed into a discussion of judicial philosophizing in decisions. Professor Winickoff and Dr. Allyse pointed out that individual justices simply are throwing around their own ideas of causation as it relates to discovery before ruling on patent cases and Dr. Mullen seconded that notion by highlighting that §101 at issue in Myriad invites this philosophizing when it was solely meant to be a threshold issue.
Assuming the Court strikes down the patentability of human genes, Dr. Mullen stated that he will simply retool his claims language to enable his clients to get the desired result, regardless of the language the Court uses. He noted that he can simply write claims to a vector containing the relevant sequence. The panel agreed broadly that the Court should try and construe its opinion narrowly to avoid the problem of loose lips sink ships. Professor Winickoff briefly added that while he thinks some language on patentable subject matter should be changed and amended to raise the baseline a small bit, the CDNA claims in this case should not be barred.
A follow-up question was raised about international patent rights as relates to Myriad and future research. The panel agreed that companies and researchers will simply go to the jurisdictions where the research is allowed or where they can get patents that have not been barred in the United States. Biotechnological progress likely would not slow as each country has its own regulations on what is and is not patentable. Professor Winickoff then pointed out that what is important is the moral judgments that go into choosing patentability in each jurisdiction and how these cases are a good lens to viewOn February 20, the
About the Author
Robin Feldman is a Professor of Law at U.C. Hastings, Director of the UC Hastings LAB Project, and has served as the Chair of the Antitrust Section of the American Association of Law Schools. Professor Feldman’s first book, The Role of Science in Law, was published by Oxford University Press in 2009. Her second book, Rethinking Patent Law, is forthcoming in 2012 from Harvard University Press. Professor Feldman received a bachelor's degree from Stanford University graduating Phi Beta Kappa, and a J.D. from Stanford Law School, graduating the Order of the Coif and receiving the Urban A. Sontheimer Award for graduating second in the class.