Six months ago, the United States Supreme Court shook up the
biotechnology industry by ruling that genetic sequences are not
patent eligible "simply because they have been isolated."
AMP v. Myriad Genetics, 569 U.S. 12-398
(June 13, 2013). While providing little practical guidance, the
Court succeeded in raising many new questions at the core of
biotechnology patenting. For example, what characteristics are
required to make natural nucleic acids patent eligible? What about
other natural products, such as stem cells, polypeptides,
antibodies, purified enzymes, and hormones?
The U.S. Patent and Trademark Office (USPTO) is still developing
comprehensive guidance for applying Myriad. Based on
preliminary guidance and current USPTO practice, Myriad is
being applied strictly to nucleic acids, but generally not to other
natural products. For now, sequence variations (e.g., 95%
or greater identity) or point mutations may not be enough to make a
natural nucleic acid patent eligible. See, e.g.,
Prosecution History of USSN 13/350,372. On the other hand,
"isolation" is still apparently sufficient to make other
natural products, for example polypeptides, patent eligible.
See, e.g., Prosecution History of USSN 13/543,049. This
may change, however, with the USPTO's comprehensive guidance,
which is expected soon. In the meantime, Myriad-based
rejections may vary by examiner due to a lack of clear
standards.
A number of pending lawsuits should provide insight into the
standards for patent eligibility under Myriad.
Myriad only invalidated claims to isolated, natural
nucleic acids, leaving Myriad's claims to diagnostic
methods and synthetic, non-natural nucleic acids
apparently untouched. On the basis of these claims, Myriad filed
suit against Ambry, Gene-by-Gene, Quest Diagnostics, GeneDx,
Invitae, and LabCorp. Therefore, at least for now, Myriad
has not eliminated genetic diagnostic patents. But,
questions remain on how diagnostic methods, and synthetic
sequences, based on natural nucleic acid sequences will be analyzed
after Myriad. For example, will all synthetic nucleic
acid compositions be patent eligible, including those with
naturally occurring sequence information, or will non-natural
sequence information also be required?
There are also pending cases which should provide insight into
whether Myriad applies to other natural products. Although
legal precedent would seem to dictate that "isolation"
makes natural compounds such as polypeptides and small molecules
patent eligible, that precedent also applied to nucleic acids but
failed under the Myriad analysis. The Consumer
Watchdog v. WARF appeal to the Federal Circuit should provide
some answers to the question of patent eligibility of purified
stem cells. Similarly, the St. Jude suits against
Xcovery (Civil Action No. 3:13-cv-01143, M.D.
Tenn.) and Novartis (Civil Action No.
2:13-cv-02802, W.D. Tenn.) should provide some answers to the
question of patent eligibility for isolated cDNA, polypeptide,
and antibody natural products. If Myriad requires
more than "isolation" for other natural products, where
will it draw the line? For example, would a protein require a
non-natural sequence for patent eligibility, or would chemical
modification of a natural structure be sufficient?
While Myriad's full impact is still being determined,
and the public debate on limiting patents continues, it is already
clear that Myriad has fundamentally changed biotechnology
patenting. Given the current political climate, further
developments will probably come from the USPTO, and from
courts' application of Myriad, rather than new
legislation. Nutter will continue to keep you updated as the USPTO
guidance and case law regarding Myriad develop.
This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.