The Biotechnology Industry Organization (BIO) and the Pharmaceutical
Research and Manufacturers of America (PhRMA) have jointly filed an amici brief curiae brief urging the
Federal Circuit to grant en banc rehearing of Ariosa v. Sequenom. The
brief is available here. I am the
counsel of record.
BIO and PhRMA are concerned that the
development and commercialization of a range of biotechnology and
pharmaceutical innovations will be impeded if the Federal Circuit does not
address the mounting uncertainty currently afflicting patentable subject matter
jurisprudence. The brief points out the
critical importance of effective patent protection for biotechnology and
pharmaceutical innovators, and the current unprecedented level of uncertainty with
respect to the scope of patent eligible subject matter. This uncertainty is affecting both the patent
user community and the PTO, which has responded with an ongoing stream of
revised and re-revised non-final and interim guidance documents. With each new PTO Guidance, BIO members have
observed an increasing rate of claim rejections, affecting a diverse range of
biotechnology, including novel antibiotic molecules, industrial enzymes,
diagnostic processes, and crop production products.
The unsettled state of the law has also created doubt as to
whether issued patents will be able to withstand challenge. The brief points out that the
vast majority of judicial decisions addressing patent eligibility under the
recently articulated standards have resulted in a determination of
ineligibility. For example, Appendix 3
of the recent PTO “July 2015 Update: Subject Matter Eligibility,” identifies 24
post-Mayo subject matter eligibility cases decided by the
Federal Circuit, of which 22 held all
of the challenged claims to be patent ineligible.
The brief urges the court to clarify the
contours of both Step I and Step II of the
Mayo two-step test for patent eligibility.
It posits that the Supreme Court would not have articulated a
two-step test if it did not intend the first step to serve some meaningful
gatekeeping function, but that under the standard applied by the panel it is
difficult to see how any analytical
or detection method would ever not satisfy
Step I, so long as that method is designed to detect something that occurs
naturally. With regard to Step II, the
brief asks for clarification with regard to the proper application of the “inventive
concept” and “preemption” standards of patent eligibility. As an example, the brief discusses the
practical challenges facing the inventor of a new diagnostic test under the new
patent eligibility jurisprudence.
In its recent decisions the Supreme Court apparently assumed
the existence of limiting principles that would maintain patent eligibility for
truly meritorious inventions (this was Judge Linn’s characterization of Sequenom’s
claimed invention in his concurring opinion), even if that invention can be
deconstructed into a combination of natural phenomena and conventional
technology. The brief argues that en banc
reconsideration would allow the Federal Circuit to address the nature of these
limiting principles suggested in Mayo. Alternatively, if the court finds that
Supreme Court precedent does not provide for limiting principles that provide a
meaningful opportunity for patenting important biotechnology innovations, that would
suggest a need for the Supreme Court to readdress the contours of patent
eligibility in the context of biotechnology. Ariosa v. Sequenom would be an appropriate vehicle for alerting the Supreme Court to the
urgent need for this clarification.
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