1. AMP v. US PTO: Section 101 and DNA Sequence Patents Joshua D. Sarnoff DePaul U. College of Law 25 E. Jackson Blvd. Chicago, IL, 60604 01-312-362-6326 jsarnoff@depaul.edu AIPLA Teleconference 09-22-11

2. Overview Court of Appeals Holding and Opinions Petition for Rehearing Additional Concerns Questions (afterwards)

3. Court of Appeals Majority Lourie opinion – focus on eligibility as novelty alone -- structural differences and covalent bond-breaking as distinguishing “isolated sequences” and cDNA from products of nature and “purified” chemicals Moore concurrence – focus on function rather than mere novelty of structure: “Even though an invention did not previously exist in nature in exactly the claimed state, however, does not automatically mean it is patentable subject matter.”; cDNA sequences “are the creation of man’ and ‘have a distinctive name, character, and use, with markedly different chemical characteristics”; isolatd DNA sequences that include ‘most or all of a gene’ only based on settled expectations/extensive property rights

4. Court of Appeals Bryson dissent – cDNA claims eligible; isolated DNA inelgible – rejected that chemically cleaving covalent bonds “turns the isolated genes into ‘different materials,’” any more than collecting portions of a wild plant “by chemical means or by scissors’ makes the portion a ‘human-made invention’”; “the structural differences [of isolated DNA]... are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form.... Indeed, that identity of function in the isolated gene is the key to its value.” Moore comment: Judge Bryson’s analogy to the eligibility of a baseball bat based on selection of the parts of the wood would similarly apply to these sequences

5. Court of Appeals Failure by all judges to appreciate the existence (as products of nature) of cytoplasmic, isolated and excised single-stranded sequences and to provide useful guidance as to when new functions warrant treating identical or similar novel creations as eligible inventions Fractured opinions reflects continued uncertainty Method claims invalid – unanimous holding; the “comparing” and “analyzing” claims “claim only abstract mental processes” and “Limiting the comparison to just the BRCA genes or … to just the identification of particular alterations, fails to render the claimed process patent eligible” Distinguished claims from Prometheus – administering and determining steps transformative; Claim 20 of ‘282 eligible – a method of drug screening using BRCA1 altered cells

6. Rehearing Petitions – Denied Plaintiffs’ argue that the majority and concurrence improperly relied on structural difference (novelty) rather than functional similarity, and that similar chemical structures exist Plaintiffs’ argue that organizational standing exists for Am. Coll. of Medical Genetics (based on Dr. Ostrer’s membership) and for Ellen Matloff, Yale, based on conversations with Myriad Defendants argue that the case is moot because Dr. Ostrer has moved from NYU and any communications were directed at NYU and not Ostrer personally Defendants ask for dismissal without vacatur

7. Additional Concerns How much of what kind of functional change should be sufficient – Ansonia “non-analogous use” standard and 101 Relationship to Prometheus “determine and infer” claims – does prior treatment and data gathering make a difference? Relationship to constitutional concerns – will Golan v. Holder make any difference (withdrawing knowledge from the public domain)? Non-doctrinal concerns – should we have these kinds of patents (and likely inability to restrict their eligibility by legislation; pressures for experimental use and compulsory licensing for particular conduct)

8. Asserted Harms of Medical Groups/Patients Plaintiffs BRCA1 and BRCA2 restrictive licensing, high costs, foregone research, clinical, and diagnostic activity: Failure of Myriad and prohibition on others to perform known tests for additional mutations (¶89) Inability to obtain independent lab. second opinions (¶90) Specific people who cannot afford the $3000 test (¶93) Although Myriad has occasionally permitted research on BRCA1 and BRCA2, it has no policy of and has not publicized doing so and researchers have been chilled from performing research on these and other genes with which they may interact (¶¶97-98) Myriad will only permit other labs to perform testing to a very limited extent (¶99) District Court recited allegations but did not resolve facts

9. Conclusions & Questions Continued controversy over proper approach to 101 Fine scientific distinctions that may not match public values regarding what should/should not be eligible Failure to consider prior art treatment of ineligible discoveries (Law Professors Amicus in Prometheus) Controversy will be further fueled by recent legislative treatment of tax liability methods as prior art for sections 102 and 103 in the new patent act Uncertain conclusions on certiorari Resurrection of constitutional claims if decision affirmed and case is not moot Questions? (afterwards)