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GENE PATENTS CHALLENGED ON GROUNDS OF PUBLIC POLICY

Patenting living organisms has been permitted since the Supreme Court’s decision in Diamond v. Chakrabarty in 1980. Whether this precedent will apply to gene patents remains to be seen. To date, the most controversial dispute in this arena involves gene patents related to breast and ovarian cancer.
 
In May, the ACLU and others filed suit against Myriad Genetics, Inc., The University of Utah Research Foundation, and the United States Patent & Trademark Office challenging the validity of various patents for the two human genes BRCA1 and BRCA2. The complaint lists patients and researchers who have been restricted or prevented access to these genes for disease diagnosis, research, or other clinical applications. The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., filed in the United States District Court for the Southern District of New York, alleges certain claims of eight patents exclusively licensed to Myriad Genetics are (1) invalid under Article I, Section 8 of the U.S. Constitution and 35 U.S.C. § 101 for patenting “products of nature, laws of nature and/or natural phenomena,” and (2) unconstitutional under the First and Fourteenth Amendments of the U.S. Constitution for being “patents on abstract ideas or basic human knowledge and/or thought.”  Given the many issues raised by this case and the effect it could have on gene patenting, we will be following this case closely. (Click here to follow the progress of the case).

WILL BILKSI AFFECT YOUR BIOTECH PATENT?

The recent Federal Circuit decision in In re Bilski last October has begun to cause some concern in the biotech sector. As we have reported in previous blog entries, Bilski created a new test for method claims in patents, requiring a claimed process to be tied to a machine or apparatus, or to transform an article into a different state or thing (see blogs “In re Bilski: What Constitutes a Statutory ‘Process’ Under §101?” posted 11/5/08, “Supreme Court To Review Method Patent Case” posted 6/2/09, and “More on Bilski and Business Method Patents” posted 6/3/09). Even though the technology in Bilski was not scientific in nature, some are concerned that the precedent set by this case could have ramifications for the biotech sector since many issued biotech patents and pending biotech patent applications, such as, but not limited to, certain processes for genetic testing, do not rely on a machine or transformation.   As we await the U.S. Supreme Court hearing in October, we hope that the potential application of Bilski to the biotech sector will be addressed by the Bench.

LAWYERS AVOID $755,000 SANCTION IN PATENT INFRINGEMENT ACTION BROUGHT AGAINST CITRIX

In Orenshteyn v. Citrix Systems, Inc., the Federal Circuit reversed in part a ruling from the U.S. District Court for the Southern District of Florida, which entered summary judgment of non-infringement in a patent infringement action brought by the inventor of  U.S. Patent 5,889,942and U.S. Patent 6,393,569, both entitled “Secured System for Accessing Application Services from a Remote Station.”  The appellate court also reversed a sanction of $755,633.17, imposed against the Plaintiff inventor, and two of his attorneys.  

While the Federal Circuit found that the “case was not litigated well by [Plaintiff] and his counsel,” it did find that there was a triable issue with regard to at least one of the asserted claims of the patents-in-suit, and reversed the summary judgment as to that claim, but affirmed the summary judgment as to all other asserted claims.  Accordingly, the case was remanded to the district court for trial on the remaining asserted claim, and the defendant’s non-infringement and invalidity defenses.  

Based on the reversal, as well as the fact that the Defendant’s Rule 11 motion for sanctions was served after entry of summary judgment, thereby depriving Plaintiff and his attorneys of the 21-day safe harbor, the appellate court found that an award of Rule 11 sanctions was an abuse of discretion.  However, because an issue remained as to whether the Plaintiff’s attorneys should have corrected the Plaintiff’s testimony regarding pre-filing investigation conversations, the appellate court left open for the district court’s determination whether sanctions were appropriate for vexatious litigation, but cautioned that any award should be limited to the “costs, expenses, and fees attributable to the multiplication of the proceedings that resulted,” which it predicted would be “a fraction of the total litigation cost”.