Transcript WIPO Open Forum on the Draft Substantive Patent Law Treaty (SPLT)

AIPLA Teleconference 09-22-11
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
[email protected]
Overview
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Court of Appeals Holding and Opinions
Petition for Rehearing
Additional Concerns
Questions (afterwards)
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
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
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
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
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)
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
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)