The Challenge of Biotech Patent Eligibility in the United States: Strategies Moving Forward Dr. Michael D. Hammer JMB Davis Ben-David June, 2016

Patent Eligible Subject Matter Exclusions Laws of Nature Natural Phenomenon (Products of Nature) The reasoning behind these exclusions is the belief that allowing a patent on such things would inhibit invention by others, and go against the constitutional mandate of “promoting progress in science and the useful arts” In the cases that we will discuss today, the challengers to the patents attempted (and as we will see, succeeded) to have the Court expand these exclusions to sweep in the challenged patent claims. Abstract Ideas

Court and USPTO Changes to Subject Matter Eligibility Bilsky v. Kappos (2010) – “Machine or Transformation” test Mayo v. Prometheus (2012) – Medical Diagnostic Methods AMP vs. Myriad Genetics (2013) – Isolated DNA Alice Corp. v. CLS Bank Intl. (2014) – Computer Implemented Methods USPTO Interim Guidance on Subject Matter Eligibility (2014 - 2016)

Sequenom v. Ariosa Question Presented for Certiorari at the US Supreme Court (denied, June 27, 2016): Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?

Mayo/Alice/USPTO Examination Guidelines Two step test: Is the claim as a whole directed to excluded subject matter? Does the claim recite one or more elements that make it “significantly more” than the subject matter exception?

Methods of Medical Diagnosis General test plus correlation claims are invalid – “only” a restatement of a law of nature Diagnostic test must include unique detecting agents or be carried out by unique apparatus Can the diagnostic method be covered by a method of detection? Can diagnostic method be turned into a novel method of treatment?

Isolated DNA Isolated genomic sequence is not patent eligible But…. cDNA might be

Biological Materials - Considerations Is the material synthetic? Does the material appear in nature in the same form? Has the material been processed? Or is it combined with a non-natural compound? Does purification change the structure of the material? If the material is a combination, do the components appear together in nature? If the material is a combination, does the combination produce a product with different properties from the individual components?

What can I do with a patent application filed before Mayo and Myriad? Hint: A US problem may be open to a US-specific solution

FTO Issues (a possible silver lining) The current standards for patent eligibility apply to all issued patents. The validity of thousands of patents is now questionable. Blocking and licensed patents should be evaluated in view of current case law. The USPTO guidelines do not have force of law. Until a category of subject matter is ruled by a court as ineligible, it must be considered valid.

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