IRVINE, Calif., Sept. 10, 2014 /PRNewswire/ -- Newly issued guidance by the Supreme Court has the potential to reshape the landscape of biologic drug and product commercialization, says Kyle J. Heppenstall, Managing Director of CompassX Consulting, a consultancy that focuses on architecting and executing strategies for Health executives.
"Two recent Supreme Court decisions have emboldened the U.S. Patent and Trademark Office (USPTO) to announce that thousands of patents, if reviewed today, would never have been approved," said Heppenstall, who consults with some of the world's largest Life Science organizations.
The two cases and their decision years are:
- 2013 Association for Molecular Pathology v. Myriad Genetics Inc., argued that human genes cannot be patented because they occur naturally.
- 2012 Mayo Collaborative Services v. Prometheus Laboratories, invalidated a blood measuring patent because it used a "law of nature."
What is the Trend?
"Although I agree with both Supreme Court rulings, it is the interpretation of these rulings that is a growing concern to industry and research groups. That concern has already begun to be realized, and the rejections are starting to pile up," said Heppenstall, who issued the company's latest FREE research guide, "The Healthcare Executive's 4 Step Guide to Massive Results," To obtain a copy, visit http://www.compassx.com/freetools.
A new study, released by Bloomberg news and a patent law firm, noted that in 1,000 recent patent applications for natural products or laws of nature, the USPTO rejected 40%.
"The reason for the rejections? The USPTO, in almost 60% of those cases, cited the two Supreme Court rulings (Myriad, Mayo)," he said.
Hans Sauer, the Deputy General Counsel for IP at the Biotechnology Industry Organization (BIO), stated the rejection rate would have been less than 10% five years ago. Sauer also wrote directly to the USPTO, "BIO members believe that the USPTO has gone beyond interpretation of recent Supreme Court decisions, and has engaged in unwarranted extrapolation and expansion of law, in ways not prompted by the Myriad decision."
A Growing Concern
"The Affordable Care Act (ACA) has recently introduced a path to expedited regulatory approvals for biosimilars (e.g. generics). Now, the USPTO has started a trend toward what appears to be a more difficult environment for obtaining new patents to protect biologic discoveries," he said. "With biologics now claiming seven of the top-ten revenue-producing drugs in 2013, the importance of patent issuance and protection could not be more significant to biotech innovation."
For information, go to www.compassx.com/
About Kyle J. Heppenstall
Kyle Heppenstall is the Managing Director of CompassX Consulting, a Healthcare, Pharma and Life Sciences focused consultancy. CompassX, a management consulting firm, architects and executes foremost strategies for Health executives. Kyle has been featured in publications such as: American Medical Association News, CNBC, Bloomberg News, Investors Business Daily and Corporate Compliance Insights.
SOURCE Kyle Heppenstall