By Kevin E. Noonan --
The rift that has arisen between the U.S. Patent and Trademark Office and the Justice Department over the question of patent-eligibility for isolated genes seems to be continuing. Last Thursday, the Acting Solicitor General sent a letter to the Federal Circuit, requesting to opportunity to present oral argument to the Court in support of the Justice Department's amicus curiae brief in Association of Molecular Pathology v. U.S. Patent and Trademark Office (aka the Myriad case). This brief has already exposed deep divisions between the two Cabinet departments (Justice and Commerce), with the patent solicitor evidently being completely excluded from any participation in preparing the "government's" brief. Now, the specter is raised of one part of the Executive Branch arguing to the Court that the considered judgment and almost three-decade history of practice of another department of that same government has been (and continues to be) wrong in granting patents not only on isolated human genes but also on any isolated biological (or "natural") product.
The letter, from ASG Neal Katyal (at left), informs the Court that he intends to argue the "government's" position himself, and that the parties will not oppose his motion to participate. He asks the Court to accommodate his schedule, by calendaring the argument on April 4th, to permit him to participate in oral argument before the Supreme Court (on global warming) and before the 4th Circuit (on the Affordable Care Act). Despite this busy schedule, the ASG asks the Court to grant his motion to personally participate in the Myriad argument, indicating how important the administration evidently believes this issue to be.
This scenario of one part of the Executive branch arguing against another smacks of a "gang-that-couldn't-shoot-straight" administration, and if the consequences were not so significant it might pass for political theater to the enjoyment of President Obama's political opponents but without great effect on the national polity. But the "government's" position, that natural products cannot be patent-eligible, has real-world and deleterious consequences far beyond the limited scope of patent eligibility for isolated human genes (the overwhelming majority of which will be outside the reach of patent protection in a little less than ten years). The very property the government's brief argues makes isolated genomic DNA patent-ineligible -- that it is a "product of nature" -- applies with even greater force for all other valuable and useful "products of nature" including almost all biologic drugs. There is typically substantially less modification involved in isolating these compounds, which are in fact merely isolated (separated from other impurities) rather than chemically changed (by breaking covalent bonds that hold the DNA molecule together). Simply put, the government's position would prevent patent protection (and thus retard commercialization) of any useful compound found in plants, microorganisms, animals, etc. This rationale also applies to products of genetic engineering, because while methods, cells for producing biologic drugs, and other components of the chain of production may be patentable, the drug itself will be less patentable the more closely it mimics the "natural product." Since differences between synthetically produced biologic drugs and the compounds as they exist in nature carry the risks of differences in stability, in vivo half-life, biological activity, and immunogenicity, the "government's" position that ASG Kaytal is so anxious to argue disincentives biologic drug production, by putting drugs that are closest in stability, in vivo half-life, biological activity, and immunogenicity to the "natural product" in the most jeopardy of failing to be eligible for patent protection. Estimates (even the "government's" estimates from the Federal Trade Commission) of the investment costs for bringing a biological drug to market are in the $1 billion range. It is unlikely that such an investment will be made in the uncertain environment that would result from the Court adopting the "government's" views on patent eligibility for such "natural products."
Looking on the bright side, the possibility exists that, under the kind of piercing questioning that ASG Kaytal is likely to face from whatever Federal Circuit panel hears this argument, he will begin to have a glimmer of an understanding on how completely the "government" has botched the opportunity to benefit from the experience of senior PTO officials and experienced legal staff, and that merely being the latest installment of the "best and brightest" isn't always enough. In instances such as these, involving questions having such real-world consequences, operating from "first principles" and attempting to impose a political solution that satisfies as many of your supporters' constituencies as possible is almost certain to involve unexpected and unintended consequences. Regardless of whether ASG Kaytal experiences his own personal epiphany on these matters, it is also possible that the Supreme Court will come to appreciate the deficiencies in the "government's" arguments, and that this will make it less likely to grant certiorari on the question of patent eligibility for isolated genes should the Federal Circuit reverse the District Court on the merits. That would be an outcome deserving of the political theater the ASG's day before the Federal Circuit is certain to become.
Patent Docs thanks Hal Wegner for alerting us to and providing a copy of ASG Kaytal's letter.
For information regarding this and other related topics, please see:
• "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