BSKB's Hailey R. Bureau, Ph.D., was quoted in an article for Bloomberg Law regarding recent rulings by the US Court of Appeals for the Federal Circuit regarding strict enforcement of certain Patent Act provisions. These rulings regarding Section 112, a written description requirement and an enablement standard, have created a high burden for Applicants in the life science industry to overcome.
Drug makers and biotechnology companies are increasingly becoming more frustrated, as their patents are being struck down due these strict standards. This has lead to the creation of "multiple Supreme Court petitions seeking to bring the country’s primary patent appeals court to heel."
Dr. Bureau was quoted saying "Hopefully the Supreme Court can provide a course correction for the course we’re on now. The court has been on this path for the past decade, but now it seems like the past three very recent decisions came to a head in the past year.”
She goes on to say, “The question not only is how do we, as the applicant, show possession, [but] how do we show we have enough possession? Based on some goalposts that the Federal Circuit has set, that appears to be invisible that no one else can see except for the court.”
For more information and to read the full article, click the link below.