Supreme Court Hears
Patent Eligibility Case
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.
NEWS
· 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. |
