By Kevin E. Noonan —

On Monday, the Federal Circuit hears oral argument in Association of Molecular Pathology v. U.S. Patent and Trademark Office (aka the Myriad case).  In addition to the parties (Appellant Myriad Genetics and Appellees represented by the American Civil Liberties Union and the Public Patent Foundation), the Court has granted leave for the Solicitor General, Neal Katyal, to represent the government's views.  This portion of the proceedings will be the first opportunity for the government to explain the change in its position after ~30 years of the U.S. Patent and Trademark Office granting patents on isolated human (and other) DNA.

In advance of the argument, The Atlantic on Sunday published an article by Andrew Cohen entitled "Nature vs. Nurture: The Continuing Saga of the Gene Patenting Case."  The article contains a relatively balanced discussion of the issues, but cannot resist the provocative statement that "no one can patent a human being.  Not yet anyway"; the author is likely unaware that such an outcome is barred by the 13th Amendment.

The article does contain an idea that strikes at the heart of the important policy question raised by the controversy (but sadly lost in the hyperbole regarding purported efforts to determine "who owns you").  The relevant paragraphs are these, attributed to Gary Cohen, Vice President of Bioethics, Law and Policy at Foundation Medicine:

We've been accustomed to thinking of DNA as a molecule, a chemical entity (which, of course, it is).  But in this more sophisticated era, we understand that DNA is not "just" a molecule; it's an information-carrying molecule.  Genes are better thought of as packets of information, not mere molecules, Judge Sweet reasoned.  This reasoning is key to his decision — because the information encoded by a gene is the same, whether it's sitting amongst its natural neighbor genes, or in isolated form.  That's why researchers want to isolate genes — because they are useful in all sorts of ways, but only because the isolated form contains the same genetic instructions as the naturally occurring form.  Using this information paradigm, the judge reasoned that "isolation" does not render a naturally occurring gene something novel, something patentable.  This part of the ruling is what makes it so interesting — its very much consistent with "information age" thinking — bits, bytes, genetic base pairs, genes:  all information carriers.

Genes are not bits or bytes, of course, and there is no paradigm shift necessary regarding genes as chemical compounds the way they have traditionally been used:  as the means to produce biologic drugs like erythropoietin, tissue plasminogen activator, interferon, clotting factors, human growth hormone and insulin, to name but a few.  Judge Sweet didn't hear from any of the millions of patients whose lives have been saved or improved by these drugs.  And thus he was able to focus, as Mr. Cohen does, on the "informational" properties of DNA molecules (ignoring the inconvenient fact that the information is not patented).

The method claims in the case were summarily dismissed by Judge Sweet under the Federal Circuit's In re Bilski precedent (prior to the Supreme Court's clarification of the patent eligibility standards in Bilski v. Kappos).  But it is the distinct character of the diagnostic method claims at issue in this case (as they were in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. ("LabCorp"), Classen Immunotherapies, Inc. v. Biogen Idec, and Prometheus Laboratories, Inc. v. Mayo Collaborative Services) that raises the important issue:  how best to "promote the Progress . . . of the Useful Arts" for method claims that produce information (as opposed to traditional methods of making and methods of using tangible machines, manufactures, or compositions of matter).  This characteristic of diagnostic method claims is not limited to genetic or medical diagnoses; it arguably was the issue in Parker v. Flook and Diamond v. Diehr.  The answer depends on how the Constitutional mandate is considered.

If, as the Supreme Court frequently seems to believe, the focus on patent eligibility should be on restricting patent rights to private inventors, then a parsimonious approach to patenting (as advocated by plaintiffs in the Myriad case) might make sense.  But looking at the public interest in innovation, investment and commercialization of inventions, and disclosure, yields the opposite result.  For genetic diagnostic claims like those in Myriad's patents, the issue is whether the limited patent rights granted to patentees (which support commercialization of such diagnostic tests) are balanced by disclosure and thus the public's right to freely practice the invention when the patent expires.  (And the possible early dedication to the public of patent rights by those who fail to profitably commercialize such tests.)  The value in promoting disclosure is particularly important for inventions that are difficult to reverse-engineer, an example being the unpatented menopause drug Premarin®, for which no generic equivalent has ever been available.  The complexities of genetic diagnosis are sufficiently great that a subject matter eligibility ban on genetic diagnostic patents threatens an outcome similar to Premarin®:  failure to promote disclosure could lead to "monopolies" lasting far longer than the 20-years-from-earliest-filing-date term of U.S. patents.

None of these issues will be heard by the Federal Circuit on Monday.  But however these questions are ultimately decided will impact how broadly, how quickly, and how effectively genetic diagnostics (the long-promised "personalized medicine") will become a reality.

For information regarding this and other related topics, please see:

• "Curiouser and Curiouser," February 16, 2011
• "AMP v. USPTO — Briefing Update III," February 8, 2011
• "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "AMP v. USPTO — Briefing Update II," December 16, 2010
• "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
• "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
• "AMP v. USPTO — Briefing Update," December 14, 2010
• "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO — Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
• "AMP v. USPTO — Briefing Schedule Update," August 22, 2010
• "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
• "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
• "AMP v. USPTO: What Everyone Else Is Saying – Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th — Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010