In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law of nature. The claim’s recitation of the term “to detect the allele” was insufficient to qualify the claims for eligibility because the clam element “merely asks the user to compare the non-coding sequences … amplified and analyzed with a library of non-coding sequences….” Slip Op. at 17. Continue reading this entry
Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its progress and future direction. The President also announced a series of awards, funded by the National Institutes of Health (“NIH”), to build the infrastructure and data collection tools necessary to support the voluntary research cohort who will share health, familial and genetic information. (For more information on the voluntary research cohort, see my prior post of January 26, 2016).
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Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of January 26, 2016) has rolled out a program to collect health data from one million volunteers to inform and guide future research. Consumers too, outside the confines of the traditional health care system, are collecting and crunching their own data points with the help of smart phone apps that measure the numbers from steps taken in a day to blood glucose levels.
It is not inconceivable that this data will be shared domestically and globally, as informed analytics will drive research and development of new therapeutic interventions and preventive health care. The EU and the US recently reached a tentative agreement relating to the legality of cross-border data transfers. Under EU law, companies have to step through certain hoops to legally be able to transfer personal information, including health information, to the US. Until recently, one of the mechanisms to do this was for the US company to certify under the Safe Harbor agreement between the US and the EU. In October of last year, a high level EU court invalidated the Safe Harbor agreement due to deficient privacy and security protections, rising primarily out of the NSA surveillance revelations.
Technically since that time, companies relying on Safe Harbor have been violating EU law when transferring health information from the EU to the US. On February 2, the EU and the US reached a tentative agreement for a new Safe Harbor framework, now called “Privacy Shield.” For more information on the tentative agreement, see Foley & Lardner’s Legal News Alert: Tentative Agreement on New “Privacy Shield” Framework for Transatlantic Data Flows Reached.
Foley’s Legal News Alert is co-authored by James Kalyvas, Chanley Howell, Aaron Tantleff, Sophie Lignier, Steve Millendorf, and Michael Chung.
Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. It was during his 2015 State of the Union Address that the President stated:
“[T]onight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier. We can do this.”
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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on their unique genetic or clinical profiles. According to an article published by the FDA in the spring of 2015 (FDA Continues to Lead in Precision Medicine), targeted, personalized therapies have been a priority for the agency since the 1990s when Herceptin (trastuzumab) was approved for treating breast cancer patients expressing high levels of the HER-2 biomarker. The FDA article also notes that 30-targeted therapies were approved since 2012 and in 2014 alone, eight of the 41 novel drugs approved by the Agency were targeted, including:
1. Lynparza (olaparib) for the treatment of advanced ovarian cancer.
2. Blincyto (blinatumomab) for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL).
3. Harvoni (ledipasvir and sofosbuvir) to treat patients with chronic hepatitis C infection.
4. Viekira Pak (ombitasvir, paritaprevir, dasabuvir and ritonavir) for the treatment of chronic hepatitis C infection.
5. Cardelga (eliglustat) for the long-term treatment of Gaucher disease type 1.
6. Beleodaq (belinostat) for the treatment of peripheral T-cell lymphoma.
7. Zykadia (ceritinib) to treat patients with non-small cell lung cancer (NSCLC).
8. Vimizim (elosulfase alpha) for the treatment of Mucopolysaccharidosis Type IV (Morquio Syndrome).