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2016 has been a year of IP changes and these changes have had an effect upon biotechnology as well as trade secrets.

Patents: Will the U.S. Supreme Court Grant Cert. In Ariosa v. Sequenom?

Ariosa was one of the most important Federal Circuit decisions in the field of biotechnology in 2015. The patent in dispute claims a prenatal method for detecting the baby’s DNA from the mother’s blood, utilizing paternally inherited genetic sequences from cell-free fetal DNA (cffDNA) circulating in pregnant women’s plasma, thereby providing a way to determine genetic abnormalities in a fetus without amniocentesis.

The court applied the Mayo test and determined that the claims were not patent eligible under Section 101, because they were directed to a natural phenomenon and that the recited steps for detecting such cffDNA were well-understood, routine activities. The decision starkly illustrates the severity of the Mayo test. Ariosa has requested that the decision be reviewed by the Supreme Court. The Supreme Court’s response is still awaited. Absent Supreme Court review, Ariosa’s interpretation of Mayo, which many feel is overbroad, will stand as a further obstacle to patent protection in the field of diagnostics. In a further development the USPTO issued some further Guidance in May 2016 in which the patent eligibility of diagnostic methods was considered where it was suggested that in the appropriate case, a claim simply setting out the physical steps taken prior to drawing a diagnostic conclusion might, if novel and non-obvious, meet the requirements set out by the Supreme Court.

Personalized Medicine, Drug Discovery, Target Discovery and Validation, Leads and Safety

Given the enormous expense in identifying, developing and obtaining regulatory approval for medical treatments, scientists, doctors and industry continually look for ways to streamline this process. One of the new techniques is Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR).

Many of the elements involved in the CRISPR method are not naturally occurring so when seeking to patent new advances related to this technology, rejections under 35 USC 101 (“Section 101”) can be avoided by claiming methods, systems and kits, proteins, artificial DNA and RNA sequences, plasmids and the like.

Defend Trade Secrets Act

President Obama signed the Defend Trade Secrets Act on May 11, 2016 and it came into effect mmediately. The Act for the first time creates a federal cause of action to enable those whose trade secrets have been misappropriated to bring a civil action in the federal courts seeking compensation and an njunction to prevent further misuse of the stolen secrets.

The new law applies to both technical and business information. Together with the changes in patent law made by the America Invents Act which, by virtue of its creation of a Prior Commercial Use Defense reduced the risk that a subsequent patent to another could require one to stop using a method that had previously been used in secret, it significantly raises the importance of trade secret law in the United States.

For additional information, see the article in our Education Center

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