The Catholic University of America

 

Welcome to the Research and Patents section of our webpage.

 

Dec. 2013 letter to HRSA Grantees on Pilot Program for Enhancement of Employee Whistleblower Protection
The latest whistleblower statutes went into effect July 1, 2013 per the National Defense Authorization Act for FY 2013. The statute at 41 USC 4712 applies to all employees working for contractors, grantees, sucontractors and subgrantees of federal grants and contracts.The requirement to comply with and inform all employees of the Pilot Program is in effect for all grants, contracts, subgrants and subcontracts issued beginning July 1, 2013 through Jan. 1, 2017.

Draft NIH Genomic Data Sharing Policy 9-27-13, updated with input Nov. 7, 2013.

This draft policy applies to all NIH funded research that involves large scale human and non human genomic data producted by array-based or high-throughput genomic techniques. Once finalized, compliance will be a condition of an NIH Award. Informed consent guidelines will need to be updated. For background read "The Immortal Life of Henrietta Laks".

Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al, June 13, 2012, Case No. 12-398.
This unanimous decision of the U.S. Supreme Court held Myriad's patent applications  for the BRCA1 and BRCA2 genes were simply details of an iterative process for finding the location of gene sequences, but extensive effort alone is not enough to satisfy the demands of 35 USC 101 which holds an exception for laws of nature, natural phenomena, and abstract ideas, and thus these sequences of genes were not patentable. The patents granted would have given Myriad the exclusive right to isolate an individual's BRCA1 and BRCA2 genes, and Myriad had sent cease and desist letters to other medical establishments offering testing for the genes, which are associated with an increased risk of ovarian and breast cancer. The Court did allow the  BRCA cDNA (synthetically created DNA)  to be patent eligible as it is not a product of nature. The Court noted there were no method claims before the Court, as the process used to isolate the DNA was well understood by geneticists at the time the patents applications were submitted.  See Academic Scientists Hail Supreme Court's Rejection of Gene Patents, in the Chronicle June 13, 2013 article. The immediate end result is to break the monopoly and lower the cost of testing for the genes. The long term end result is broader, with most isolated gene patents being invalidated. See also the July 15, 2013 Washington Post blog by Timothy Lee titled " Why are universities trying to limit access to breast cancer tests?" for a summary of the role universities have played in the patenting of genes controversy.

Changes To Implement the First Inventor To File Provisions of the Leahy-Smith America Invents Act, Final Rule, 78 Fed. Reg. 11023, Feb. 14, 2103
The rule revises the rules of practice in title 37 of the Code of Federal Regulations to implement, and to address the examination issues raised by, section 3 of the Leahy-Smith America Invents Act (AIA), which, inter alia, converted the U.S. patent system from a “first to invent” to a “first inventor to file” system. These changes in section 3 of the AIA are effective on March 16, 2013.


Examination Guidelines for Implementing the First Inventor To File Provisions of the Leahy-Smith America Invents Act,
78 Fed. Reg. 11059, Feb. 14, 2103
The USPTO is providing the examination guidelines to assist in the implementation of the “first inventor to file” provisions of the Leahy-Smith America Invents Act (AIA), and to clarify certain aspects of the law in response to public comment. The guidelines will be effective as of March 16, 2013.

Feb. 22, 2013 Office of Science and Technology Policy memo directing each Federal Agency with over $100 million in annual conduct of research to develop a plan to support increased public access to the results of this research.