Category Archives: Genomics and Personalized Medicine Act

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Precision Medicine - Obama’s Health Care Legacy

As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed into law early in the President’s administration on March 23rd, 2010) is a significant achievement in … Continue reading this entry

Personalized Medicine: Insights Into Current Legal Issues

Guest Post by:  Nate Beaver, Esq.; Gary Koch, Esq.; Antoinette Konski, Esq.; and Judy Waltz, Esq., Foley & Lardner, LLP. In his January 20, 2015 State of the Union address, President Obama brought to the nation’s attention the promise of personalized medicine when he announced the Precision Medicine Initiative (the “PMI”). In announcing this initiative during … Continue reading this entry

USPTO Issues Guidance for Examining Process Patents

On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as … Continue reading this entry

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone that will move the industry in ways that are yet to be realized, or even envisioned – a DNA sequencing super computer (HiSeqX) … Continue reading this entry

The Genomics and Personalized Medicine Act: A Look Ahead

Institutional barriers (e.g., limitations on product reimbursement, unclear regulatory requirements and occasional government redundancies) have been faulted for relatively slow progress toward wide spread implementation of personalized medicine. In an effort to improve access to and appropriate utilization of valid, reliable genetic tests and to secure the promise of personalized medicine for all Americans, then-Sen. … Continue reading this entry

CDC Issues Requests for Comments to Assess and Implement Public Health Genomics

The Centers for Disease Control and Prevention (“CDC”), located within the federal Department of Health and Human Services (“HHS”) is seeking public comments, data or other information to assess the current research, policy and practice environment in public health genomics. The information is solicited to assist the Office of Public Health Genomics (“OPHG”) of the … Continue reading this entry

Gene Patenting Debate Slips Into Patent Reform Bill

On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform.  Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value … Continue reading this entry

Personalized Medicine - Promise, Regulation and Challenges

Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual.  Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease.  In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the … Continue reading this entry