Greenblum & Bernstein, P.L.C.
BIOTECHNOLOGY And BIOSIMILARS
PRACTICE GROUP NEWSLETTER
Recent News in Intellectual Property
July - August 2011
In This Issue
· CAFC Concludes Isolated DNA is Patentable
· Supreme Court’s Active Summer
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.
The NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property. The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC. For more information, contact Jill M. Browning at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191. Copyright 2011 GREENBLUM & BERNSTEIN, P.L.C.