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December 18, 2014

Myriad II – Basic Methods Of Biotechnology Now Patent Ineligible

The Federal Circuit has just invalidated, as patent ineligible “abstract ideas,” certain method claims common in biotechnology patents. The case, In re BRCA1– and BRCA2-based Hereditary Cancer Test Patent Litigation (2014), is certain to upset the biotechnology industry, perhaps even more than the 2013 case, AMP v. Myriad Genetics Inc. (Myriad I).  In Myriad I, the Supreme Court held, contrary to decades of U.S. Patent Office practice, that certain DNA claims are patent ineligible.


Myriad II


But Myriad was not without recourse.  While some DNA claims were invalid, Myriad still had method claims that should adequately cover the Myriad’s BRCA genetic testing.  When certain companies began offering BRCA gene tests after Myriad I, Myriad sued (Myriad II) asserting its method claims.  The method claims are drawn to “detecting a germline alteration” and include standard assay steps such as “hybridizing a . . . gene probe which specifically hybridizes to an allele of one of said alterations” and “amplifying all or part of [the] gene.” The alleged infringer attacked the claims as analogous to Mayo Collaborative Services v. Prometheus Laboratories(2012) another controversial case which held that certain diagnostic methods (using concentrations of certain metabolites in a patient to determine the proper dosage of medicine) as patent ineligible.  The Prometheus court concluded this diagnostic method was merely a bare recitation of the natural law.


The patent owner dodged this attack but ran into a surprise attack, based on Alice Corporation(2014), a recent Supreme Court decision holding that a business method of lowering “settlement risk” was a patent ineligible “abstract idea.”

The low threshold is not so low anymore


Lets briefly review of the underlying law.  U.S. patent law has a threshold requirement that inventions fall within certain broad categories, e.g. a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. This has been considered a low threshold. That is, the scope of patent eligible subject matter was thought to be very broad. The only categories of patent ineligible subject matter were “abstract ideas,” “laws of nature” such as the famous formula E=mc², “natural phenomena” such as the elements of the periodic table and inventions that violate certain basic laws of science, as perpetual motion machines which violate the laws of thermodynamics.  Most inventions easily avoided these categories.  Recent cases, however have dramatically changed the landscape, carving away subject matter that was, until very recently, considered well over the low threshold of patent eligibility.


Ambry v. Myriad Genetics is the latest example.  It contains a double surprise.  Not only that certain basic methods of biotechnology may now be patent ineligible, but that the court usedAlice Corporation in its reasoning.  Alice Corporation is considered a business methods case, not a biotechnology case.  Alice Corp. cautioned methods of doing business, without more, were abstract ideas.  Inventors must do more then just claim steps of a business method together with simple, pro forma computer computation steps. The computer must perform some substantial role in the method to transform a traditional, performed by human business method into a patent eligible business method.  It was quite a surprise, therefore, when the Federal Circuit, the chief patent law court in the U.S., used Alice Corporation in the biotechnology context.

High school science in the federal courts


The underlying issue bothering the court, I believe, was this.  Since DNA claims are ineligible then all uses of DNA should be ineligible, as a matter of public policy. The court divided the claims into a “comparison” part and a “techniques used in the comparison” part. The comparison part was invalid as “patent-ineligible abstract idea of comparing [gene] sequences.”  The techniques were invalid because they do not provide a “further inventive concept.”  What were these techniques?  As mentioned above, DNA hybridization and DNA amplification.  The court dismissed them as “well-understood, routine and conventional activity engaged in by scientists at the time of Myriad’s patent applications.”


This is a problem.  The high school level understanding of science on display is inappropriate for any advanced technical field and certainly inadequate for biotechnology.  So you say DNA hybridization is merely a “routine and conventional activity” that does not “further an inventive concept.” This is a very odd statement.  In fact, DNA hybridization techniques, properly understood, were major breakthroughs in molecular biology and now form the foundation for virtually the entire field of biotechnology.  Look back at two pioneers in this field, Roy J. Britten and David Kohne and their citation classic, “Repeated sequences in DNA,” Science 161:529-40, 1968.  All literate molecular biologists study “Britten and Kohne.” In 1968 no one new what would happen after you separated a double stranded stretch of DNA into two complementary single strands.  Indeed, before their research, Britten and Kohne thought it could take months for two single strands to re-anneal. Their research transformed this field. They discovered the rate at which two single stranded DNA molecules reassociate into a double stranded DNA is function of DNA concentration “Co” and time “T” in their “CoT analysis.” This insight, as well as their protocols, were significant breakthroughs that form the foundation of all modern DNA hybridization techniques.  This highly significant, pioneering research is now deemed by the Federal Circuit, the nations expert patent court, as not furthering an inventive concept.


What about DNA amplification?  For this discovery, Kary Mullis was awarded U.S. Pat, No. 4,683,202 and the 1993 Nobel prize in Chemistry!  But never mind, in the court’s opinion it no longer furthers an inventive concept because everyone uses this technique.


Patent law is supposed to serve it’s inventors.  To do so, the technical aspects of patent law must reflect the level of knowledge of the inventors working in the field.  Sadly, the court uses simplistic “high school” level science in its reasoning and brushes aside, in few brief paragraphs, the works of Britten, Kohne and Mullis and other pioneers of molecular biology.  The court poorly serves the biotechnology community.

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