Greenblum & Bernstein, P.L.C.
BIOTECHNOLOGY And BIOSIMILARS
PRACTICE GROUP NEWSLETTER
Recent News in Intellectual Property
In This Issue
· Supreme Court Hears Section 101 Patent Eligibility Case
Jill M. Browning
On December 7, 2011, the Supreme Court heard oral argument in Mayo Collaborative Services v. Prometheus Laboratories regarding whether certain subject matter is eligible to be protected by a patent. At issue in this case is whether a discovery relating to the correlation between blood test results and a patient’s health can be patented. At issue are method of treatment claims, that include a method of optimizing treatment of a disorder that includes administering a drug, determining the level of that drug in the subject; and, depending on that level, increasing or decreasing the drug dosage.
This case is important to the medical community because it will impact the patent eligibility of certain method of treatment claims. Further, it should provide additional insight into how broadly Section 101 of the Patent Act will be construed.
The Justices’ questions and comments during the argument reveal that the Court is struggling with where to draw the line between a law of nature or an abstract idea, which are not eligible for patent protection, and the application of a law of nature, which may be eligible for patent protection.
So far, the consensus is that this is a close case with no clear winner. We will report the decision, which is expected by summer, 2012.
· Biogen Idec and Samsung have announced a joint venture to develop a biosimilar of Rituxan. Rituxan is a blockbuster treatment developed by Biogen and Genentech to treat certain types of cancer and arthritis;
· Fujufilm Corporation announced a 50-50 joint venture with Kyowa Hakko Kirin (both of Japan) with the goal of starting a clinical trial for its first biosimilar candidate by 2013;
· Amgen announced that the U.S. Patent and Trademark Office granted a new patent (US Patent No. 8,063,182) that covers its drug Enbrel and may keep competitors off the market until 2028. Merck BioVentures and Hanwha Chemical made a deal earlier this year to develop a biosimilar of Enbrel.
· Ranbaxy received final FDA approval for its generic version of Lipitor (cholesterol-reducing atorvastatin). Lipitor reportedly had U.S. sales of $10.8 billion in 2010.
The NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property. The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC. For more information, contact Jill M. Browning at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191. Copyright 2011 GREENBLUM & BERNSTEIN, P.L.C.