Smith & Nephew, HTC, Hurtigruten, Google, Denison: Intellectual Property [Myriad extracted]
By Victoria Slind-Flor - Jun 21, 2011 4:00 AM PT [Bloomberg]
[...]
Diagnostic Medical Test Patents Draw High Court Scrutiny
The U.S. Supreme Court, accepting a case that will shape the burgeoning business of personalized medicine, agreed to consider what types of diagnostic medical tests can be patented.
The justices agreed yesterday to hear an appeal from the Mayo Clinic, which is challenging a lower court decision backing two patents for determining the dosage of medicines to treat stomach diseases. The ruling cleared the patents’ owner, Prometheus Laboratories Inc., to press an infringement suit against two Mayo units.
Patent protection is important for companies that are focusing on personalized medicine, including Myriad Genetics Inc. (MYGN) and Novartis AG. (NOVN) The field involves determining whether a patient is genetically susceptible to a particular disease or would be especially responsive to certain medicines.
The case will test the scope of the U.S. patent laws. Mayo contends the two Prometheus patents cover natural phenomena, which the Supreme Court previously said can’t be patented. Prometheus says its discoveries involve the application of a law of nature, not the law itself.
“The patents do not claim or preempt any purely natural phenomenon,” Prometheus argued in court papers. The company said in May that it was being acquired by Nestle SA. (NESN)
The two patents cover a method for determining the proper dosage of medicines to maximize effectiveness while limiting toxic side effects. Doctors can use the method to treat inflammatory bowel diseases including Crohn’s disease and ulcerative colitis.
The Mayo Clinic, a not-for-profit medical practice based in Rochester, Minnesota, had licensed the patents prior to 2004, when it created its own test.
The U.S. Court of Appeals for the Federal Circuit, which specializes in patent issues, overturned a trial judge’s conclusion that the patents were invalid.
The Federal Circuit also is considering if Myriad’s diagnostic claims are eligible for patent protection as part of a review of a decision involving patents for tests to determine if a person is more likely to get breast cancer.
The primary part of that case revolves around the issue of whether genetic sequences, isolated from the body, can be patented or if they are something that occurs in nature.
Myriad, Novartis, Laboratory Corp. of America Holdings’s Monogram Biosciences and Genomic Health Inc. (GHDX) all have urged that diagnostic methods be patentable. Monogram and Genomic Health told the Supreme Court in 2009 that they would have difficulty getting funding without patent protection.
The annual market for diagnostic tests and drugs tailored to individuals may reach $42 billion by 2015, according to a 2009 report from PricewaterhouseCoopers LLP.
The case is Mayo Collaborative Services v. Prometheus Laboratories, 10-1150, U.S. Supreme Court (Washington).<snip>
bloomberg.com |
