Patentability

Are isolated human genes and the comparison of their sequences patentable? In Association for Molecular Pathology v United States Patent and Trademark Office,  1:09-cv-04515-RWS (S.D.N.Y. March 29, 2010), the United States District Court for the Southern District of New York held that fifteen claims contained in seven patents relating to certain human genes (Breast Cancer Susceptibility Genes 1 and 2) were invalid because the claims covered products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.  The patent claims at issues were directed to (1) isolated DNA containing all or portions of the gene sequences for Breast Cancer Susceptibility Genes 1 and 2 and (2) methods for "comparing" or "analyzing" those gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer.  The plaintiffs included persons with breast cancer who had received inconclusive diagnostic results from the laboratory that held the patents at issue; because of the laboratory’s exclusive right to isolate Breast Cancer Susceptibility Genes 1 and 2 and to compare or analyze those gene sequences, plaintiffs could not obtain diagnostic services or second opinions from any other laboratory.  The district court, relying on “long recognized principles of molecular biology and genetics,” recoginzed that “DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature.”  The court concluded that “DNA's existence in an "isolated" form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to "isolated DNA" containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101. Similarly, because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under § 101.”

Patent Marking

In Forest Group, Inc. v Bon Tool Company (Fed. Cir., December 28, 2009), the Federal Circuit (which hears all appeals on patent issues decided by the federal trial courts), interpreted the false marking provision of the U.S. patent law to require a fine “per article” that is falsely marked, rather than one fine for each “decision” to mark articles that are not covered by the referenced patent.  In Forest, a seller of spring-loaded parallelogram stilts of the type commonly used in construction had marked its own products with the patent number for the patent it believed applied to those products.  The seller, who owned the patent at issue, brought an infringement claim based on that patent and the district court ultimately construed the patent in a manner that did not cover the seller’s own product.  After the district court’s determination that the product sold by the seller was not covered by its own patent, the seller placed an order with its manufacturer for additional stilts marked with the patent number.  The district court imposed a single fine on the seller for falsely marking each of the stilts in that order.  The Federal Circuit reversed, holding that the statute required imposition of the fine for each article falsely marked.  The seller argued “that interpreting the fine of § 292 to apply on a per article basis would encourage “a new cottage industry” of false marking litigation by plaintiffs who have not suffered any direct harm.”  The court agreed, but noted that this “is what the clear language of the statute allows.” 

D.   Copyright