[A2k] Fwd: [Ban-GEF] Federal Circuit's Decision Sounds the Death Knell for Gene Patents

[Roberto Verzola]

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Subject: [Ban-GEF] Federal Circuit's Decision Sounds the Death
Knell for Gene Patents
Date: Saturday 16 May 2009
From: Robt Mann <robtm@xtra.co.nz>
To: Recipient List Suppressed:

*United States: Federal Circuit Limits Patentability Of Genetic
Sequences*
12 May 2009

*Article by William L. Warren*

/Originally published April 13, 2009/

On April 3, 2009, the U.S. Court of Appeals for the Federal
Circuit
issued /In re Kubin/ (Fed. Cir., No. 2008-1184), perhaps the most
significant patent law decision affecting the genetic engineering
industry in over a decade. At issue is the patentability of
isolated
genetic sequences, in this case encoding a previously identified,
but
unsequenced, protein.

(SEPARATE REFERENCE FOLLOWS)

      In Re  Kubin: Federal Circuit's Decision Sounds the Death
Knell for
      Gene Patents

Blog Photo_Josh Sarnoff
<http://blogs.kentlaw.edu/.a/6a00e553911187883301156f63a619970c-pi>
*GUEST BLOGGER Joshua D. Sarnoff*

The U.S. Court of Appeals for the Federal Circuit ("Federal
Circuit")
has decided an important case regarding the application of the
obviousness requirement to gene patents.  In re  Kubin,
No.2008-1184
(Fed. Cir. Apr. 3, 2009)
<http://blogs.kentlaw.edu/files/inrekubin.pdf>.  That case upheld
the
rejection by the U.S. Patent and Trademark Office (USPTO) of
typical
claims to gene sequences as unpatentable because they were
obvious.

The recent U.S. Supreme Court case KSR International, Inc. v.
Teleflex Corp., "calls into serious question the validity of many
of
the genetic sequence and other natural products or phenomena
claims
issued by the PTO."  This is because the Federal Circuit and the
USPTO for decades had been applying a much more limited test of
obviousness than was authorized by the law and binding
precedents.
The Federal Circuit consequently allowed patents on purported
inventions that would have been rejected previously.  In Kubin,
though, the Federal Circuit recognized that KSR
had "unambiguously
discredited" the Federal Circuit's earlier holdings that had
rejected
an "obvious to try" approach to finding gene patents obvious.
See,
e.g., In re Deuel, 51 F.3d 1552, 1559 (Fed. Cir. 1995).  Given
the
correct approach, the Federal Circuit held the claims invalid;
there
was sufficient motivation for skilled persons to isolate the cDNA
sequences, given prior art knowledge of the importance of the
protein
and a reasonable expectation of success in doing so given that
the
methods of DNA isolation were conventional.  The Federal Circuit,
referring to Supreme Court language in KSR, said, "Therefore, the
claimed invention is 'the product not of innovation but of
ordinary
skill and common sense.'"  Similar motivations should exist for
isolating the sequences claimed by many issued patents, and the
reasoning of Kubin (known methods, a reason to apply them, and
expected success makes the result obvious) also should extend to
other reasons for isolating genetic sequences than a known
important
protein.  Thus, many if not most issued gene patents are likely
invalid for obviousness.

Joshua D. Sarnoff is a Professor of the Practice of Law at
Washington
College of Law, American University, where he supervises law
students
in the practice of intellectual property law.  He is a registered
patent attorney, teaches patent law, and has been involved in a
wide
range of intellectual property legal and policy disputes.

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[ US Federal circuit limits p.pdf of type application/pdf deleted ]