By Kevin E. Noonan --
There is a great cultural divide that has been illuminated by the Myriad case (AMP v. Myriad Genetics), between producers of technology and its consumers, governments and non-government organizations such as patient groups who are goal-driven to reduce present costs (especially in healthcare) regardless of future disadvantages, and the more general schism between those who understand science and technology and those who don't. There is also the problem of bright, educated, ambitious, and motivated graduates of America's best colleges and universities who have the natural propensity of their class and age to think they have better answers than their elders who have actually tackled the problems of investment and commercialization. This becomes a problem, of course, when many of these folks go into government, resulting in the Justice Department's "magic microscope" as but one example.
Another consequence is that briefs for both sides of the "gene patenting" question repeat the same arguments based on the same policy rationales to come to the same conclusions. The AIPLA's amicus brief in the Myriad case illustrates the issue. The brief sets forth the following propositions:
I. MYRIAD'S CLAIMED DNA MOLECULES ARE NOT PRODUCTS OF
A. Human DNA Is Complex in Both Structure and Function
B. Myriad Claims Isolated DNA Molecules, Not Found in Humans, That Can Perform New Functions
II. THE FEDERAL CIRCUIT APPLIED THE CORRECT TEST
A. Patent Eligibility of Isolated DNA Molecules, Which Are Compositions of Matter, Must Be Analyzed Under the Applicable Precedents
B. Prometheus Applies to Method Claims, Not to the Isolated DNA Molecule Claims at Issue Here
C. Myriad's Claims May Not Be Patentable, But That Does Not Make Them Patent-Ineligible Under Section 101
III. PATENT PREEMPTION DOES NOT PRECLUDE THE PATENTABILITY OF THE CLAIMED SUBJECT MATTER
A. The Importance of Broad Patent Eligibility
B. The Experimental Use Exception Allows For Some Uses of the Claimed DNA Molecules
IV. CONGRESS HAS RECOGNIZED THE PATENT ELIGIBILITY OF ISOLATED DNA MOLECULES
A. Moral and Ethical Considerations Are for Congress, Not the Courts
There is not an incorrect statement of the law in any of this, nor the science. (There are a few aspects that bear closer scrutiny, as set forth below.) But it is true that the science of DNA does not resemble either the pointedly incorrect analogies set forth by the petitioners (DNA as a kidney, or a leaf, or a mineral) or the equally inapt analogies by courts (such as the distinctions between a tree and a baseball bat or a statue and a piece of marble). Ignoring the facts makes it easy to misapply the law; indeed, the old aphorism may need to be updated to read "Bad analogies make bad law." The distinctions set forth in Section I of the AIPLA's brief are not news to anyone who understands the scientific basis of isolated DNA. But generalist lawyers and judges can be understood (if not forgiven) to have believed that the ways scientists have tried to explain DNA (as a library or a book or a code or software) are in fact what DNA actually is. "A gene is but a chemical compound, albeit a complex one" is the proper measure of what is encompassed in claims to isolated DNA, and the conflation of the patent-eligible molecule for the patent-ineligible sequence has made it easier for petitioners to convince some judges and the public that patents for human genes are a bad idea.
Nor is the brief incorrect on the law, setting forth the "applicable precedents" of Chakrabarty, Funk Bros., and J.E.M. Ag Supply to support the proposition that isolated human DNA satisfies the requirements for the "hand of man" and new utilities of isolated natural products. Unfortunately, the matter is before the Court because the patent eligibility of isolated human DNA has not been decided before, despite the 30 years and thousands of patents in this area. And the brief is also correct that the principles enunciated in Benson, Flook, Diehr, Bilski, and Mayo do not directly apply, as those were method claims embodying laws of nature, not composition or manufacture claims directed to isolated "products of nature." The brief goes somewhat astray in making this argument categorically, i.e., based on the statutory category of invention rather than, for example, on the differences in scope of the two types of claims. This is nicely illustrated by the Myriad claims at issue, which are limited to DNA molecules that encode a specific amino acid sequence. Unlike the broad reach of claims to a "law of nature," Myriad's claims are extremely narrow. Think: if a putatively infringing DNA molecule encodes a protein that differs by even a single amino acid, that DNA molecule does not literally infringe. This point is even sharper when it is recognized that the one amino acid difference could be a valine to isoleucine change, which is equivalent to the addition or subtraction of a single methylene group – (-CH2-) – in a protein molecule comprising 60,000-100,000 atoms. Never has so small a change had so large an effect on claim scope, and yet the AIPLA misses the opportunity to inform the Court that petitioners' claims about the scope of preemption occasioned by permitting isolated human DNA to be patented are grossly exaggerated. Also in this section of the brief the AIPLA appears to agree that Myriad's claims may not even be patentable, a curious position for a brief in favor of patent eligibility. Mayo showed clearly that the Court believes that its Section 101 jurisprudence is "well established" and a better vehicle for preventing patenting of claims that should not be patented -- why give them a reason to think that Myriad's claims might not be worth the effort?
The brief's section on preemption is where questions are raised about the focus of the brief and its potential vel non for persuasiveness. First, rather than addressing the argument, the brief takes the position that "broad patent eligibility" is necessary, thereby to a degree conceding to petitioners the point that these claims broadly preempt use of human genes for research. The brief then posits the existence of an "experimental use exception" for basic research that, frankly, does not exist. While there are some 19th Century district court cases that support the proposition, for most, the Federal Circuit's decision in Madey v. Duke Univ., 307 F.3d 1351, 1361-62 (Fed. Cir. 2002), foreclosed any such broad protection against patent infringement liability for university research. This is because the Federal Circuit recognized that university research was not for "philosophical experiments" or "gratifying a philosophical taste, or curiosity, or for mere amusement." The brief correctly identifies the "safe harbor" provisions of the Hatch-Waxman Act, codified under 35 U.S.C. § 271(e)(1), but while broadly interpreted by the Supreme Court (Medtronic v. Eli Lilly & Co., Merck v. Integra) this is of limited usefulness for most inventions including isolated human DNA. And the brief's citation of In re Rosuvastatin Calcium Patent Litig., __ F.3d___, 2012 WL 6217356, at *12 (Fed. Cir. Dec. 14, 2012), misses the mark because while "patenting does not deprive the public of the right to experiment with and improve upon the patented subject matter" and "[i]t is not necessary to wait for the patent to expire before the knowledge contained in the patent can be touched," the case does not stand for the proposition that a three-judge panel of the Court sua sponte created a research exception sufficient to protect university research on isolated, patented human DNA. (It is somewhat amusing that one of the citations set forth in the brief to support the existence of a experimental use exception is L.C. Bruzzone, The Research Exemption: A Proposal, 21 AIPLA Q.J. 52 (1993), which is, on its face, a proposal.) The better argument, of course, is that there has never been patent infringement litigation against basic research, even by Myriad: indeed, more than 10,000 research papers have been published since the BRCA gene patents were granted. This statistic is much more persuasive than an argument that bolsters the proposition that basic science research is at risk of patent infringement liability but for the tenuous existence of a experimental use/research exemption.
Finally, as has been discussed in previous posts, it is a waste of paper to argue to this Court deference to Congress on such matters, particularly when it is inaction, rather than affirmative action, that is the basis for the argument.
Oral argument is set for April 15th, and Patent Docs will be posting on additional amicus briefs in the interim and oral argument in due course.