U.S. Court of Appeals for the Federal Circuit

June 2011 Patent Group Lunch

June 28, 2011

Topics covered in this month’s patent prosecution presentation include the Supreme Court’s ruling in the Microsoft v. i4i case upholding the clear and convincing standard.  Case law dealing with “analogous art” for mechanical cases is also addressed.  Finally, recent case law from the U.S. Court of Appeals for the Federal Circuit (CAFC) dealing with inequitable conduct and Bayh-Dole Act is presented.  Click here to download a copy of the presentation.


April 2011 Patent Prosecution Lunch

May 2, 2011

Topics covered in this month’s patent prosecution presentation include recent case law from the U.S. Court of Appeals for the Federal Circuit (CAFC) dealing with reissue applications and dependent claims.  A brief overview of the arguments being presented in the Microsoft v. i4i case is also reviewed.  Oral arguments in this case were recently heard by the United States Supreme Court.  Case law developments dealing with written description for mechanical cases is also addressed.  Finally, an overview on the breakdown of patent applications filed in Europe in 2010 is presented.  Click here  to download a copy of the presentation.


Federal Circuit Hears Oral Arguments in the Myriad Gene Patent Case

April 22, 2011

On April 4, 2011, the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology, et al. v. USPTO, Myriad Genetics, et al.  This case involves the controversial topic of whether human genes qualify as patentable subject matter.

Myriad Genetics currently holds patents covering the BRCA1 and BRCA2 genes (both wild-type and mutant forms), along with methods for their use e.g., recognizing certain mutations that may identify an individual as being more susceptible to developing cancer.  For example, certain mutations in these genes have been linked to a variety of cancers, including hereditary breast and ovarian cancers.  Myriad currently markets diagnostic tests that are protected by the patents in dispute.  The ACLU and others have challenged these patents on the grounds that genes are products of nature, and are therefore not patentable subject matter.  They also argue that these patents have blocked further research that could result in cheaper, alternative diagnostics and treatments for cancer.

On the other side, Myriad argues that these genetic products are “isolated and purified” and thus are different than their forms as they exist in nature.  Myriad also argues what many biotechnology and pharmaceutical companies have been arguing for years, namely, that patent protection is needed to protect companies that invest considerable time and money developing these medical products.

At the district court level last year, New York federal district court Judge Robert Sweet ruled against Myriad’s patents, holding that they merely covered isolated DNA from nature and thus did not qualify as patentable subject matter under 35 U.S.C. §101.  A copy of this opinion can be found here.

The outcome of this case will have a dramatic impact on the biotechnology industry, an industry comprised of companies that rarely turn a profit early on in their existence, but rather, value themselves on the strength of their patent portfolio.  Indeed, venture capitalists rely heavily on the strength of a start-up company’s patent portfolio when deciding whether or not to invest in that company.  These investments, particularly for start-up companies, are necessary to continue the company’s growth.  We will continue to update the status of this case is it progresses.