In
This Issue
· CAFC
Concludes Isolated DNA is Patentable
· Supreme Court’s Active Summer
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Genes
Can Be Patented
The CAFC overturned the lower district court
ruling and held that DNA isolated from the body is eligible for patent
protection. Association for Molecular Pathology v. United States Patent
& Trademark Office, (Fed. Cir. July 29, 2011)(the
“Myriad” case). The issue in
this case was whether “isolated and
purified DNA” is patent-eligible subject matter or whether it fell into the
“product of nature” category which is considered not eligible for patent
protection.
The U.S.
Patent & Trademark Office’s policy on this issue was to permit a patent
for isolated and purified DNA molecules (as well as isolated oligos, DNA
fragments, cDNA, etc.) that have the same sequence as a naturally occurring
gene. Had this case gone the other
way, hundreds of patents issued by the USPTO would have been at risk of
invalidation under 35 U.S.C. §101.
The
Federal Circuit’s opinion does not provide much guidance, for the patent bar,
however, given that each of the three judges on the panel wrote a separate
opinion. At least two of the judges seem
to agree that, given the patent bar’s expectation that DNA should be patent
eligible, the Courts should not exclude DNA inventions as patent-eligible
subject matter. Rather, for this
wholesale change to occur, an act of Congress would be preferable.
There were
comments made by the Judges (in dicta), implying that the isolated DNA, to be
patent-eligible, should be analyzed to determine whether the claimed composition
has some potential for significant utility. For example, isolated oligos have a potential for significant utility
because they can be used as probes.
In any
event, it is likely that this case will be further appealed, either to the
Supreme Court or to a full en banc panel of the CAFC.
U.S.
Supreme Court’s Patent Rulings
The past
summer saw many Supreme Court rulings which affect patent law. Following is a brief synopsis of the
patent-related Supreme Court cases:
 Bayh-Dole
Act Does Not Automatically Vest Ownership Rights In Universities. The U.S. Supreme Court held that the
Bayh-Dole Act does not automatically give title to federal contractors (such
as Universities) merely because the projects are federally funded. Board
of Trustees of the Leland Stanford Junior University v. Roche Molecular
Systems, Inc. et al., (June 6, 2011). Be careful in drafting employee assignment
of invention agreements – the issue in this case turned on the language used
in the Stanford/inventor agreement. The agreement did not include “automatic” assignment language
regarding inventions, but rather, was merely an “agreement” to assign
inventions at some point in the future.
The
Court affirmed that invalidity of a patent must be proved by clear and
convincing evidence in Microsoft
Corporation v. i4i Limited Partnership et al., (Case No. 10-290)(June 9,
2011). The question before the Supreme
Court was whether the party asserting invalidity requires the defense to be
proved by “clear and convincing” evidence or the lesser “preponderance of the
evidence” standard. The long-time
employed standard of “clear and convincing” won the day.
Liability
for inducing patent infringement requires the accused infringer to have actual knowledge that the induced acts
constitute patent infringement, making it more difficult for patentees to
establish infringement against companies who do not themselves infringe a
patent. Global-Tech Appliances Inc. v. SEB, S.A. (Case No. 10-6)(May 31, 2011). Under the new standard announced by the Court, entities who have no
actual knowledge of a patent when accused of infringement, and who are not
“willfully blind” to the patent’s existence, should have no liability for
inducing infringement.
If there
are questions about the cases recited herein, please feel free to contact us
for further discussion. |
