NEWS Children’s hospital seeks landmark ruling on gene patents
A Canadian children’s hospital has launched a lawsuit focusing on whether genes should be patentable, the first of its kind in the country.
Te lawsuit, initiated by the Children’s Hospital of Eastern Ontario (CHEO), will question five patents related to testing for heart disorder long QT syndrome (LQTS) and will claim they should not have been issued.
Te five patents targeted are held by the University of Utah Research Foundation, Genzyme Genetics and Yale University.
LQTS is a heart rhythm disorder that can cause fast, chaotic heartbeats and trigger fainting spells, seizures or sudden death.
Doctors can diagnose LQTS with a blood test and electrocardiogram. If treated, patients can live a healthy life.
Currently, rights to the test are exclusively controlled by the three US organisations.
CHEO said it was set to become one of Ontario’s testing centres for the syndrome but that it had received a cease-and-desist order from the patent holders.
Te hospital said that if patients are tested for LQTS, their lab samples are sent to the US for analysis. CHEO claimed this takes more time and that the cost is double what it would be in Canada.
In a statement, CHEO said its physicians and scientists believe that the patenting of human DNA “interferes with their ability” to provide high-quality care and make full use of genomic technologies.
Te lawsuit was filed at the Federal Court of Canada on November 3, the hospital said.
“CHEO is far more comfortable delivering on patient care in the exam or operating room than in the court room, but this question is too important to be leſt unchallenged,” said Gail Graham, CHEO’s chief of genetics.
Biotechnology company Amgen has filed a lawsuit against Sanofi and Regeneron Pharmaceuticals accusing the pair of infringing three patents.
In the lawsuit, filed at the US District Court for the District of Delaware on October 28, Amgen has accused the companies of infringing its patents by creating an antibody that blocks the protein PCSK9, helping disorders as a result.
to
Te lawsuit seeks to prevent the manufacture, use and sale of Sanofi and Regeneron’s alirocumab, a drug they are producing together, on the grounds that is too similar to Amgen’s own evolocumab.
According to the Fierce Biotech news website, the lawsuit is the latest development in an “increasingly contentious” race between the companies, all of which are attempting to be the market leader for new cholesterol-lowering drugs.
Amgen asked the US FDA in August to approve evolocumab, aiming for a 2015 launch.
treat cholesterol-related
According to the complaint, earlier this summer Sanofi and Regeneron, which have partnered together, paid the FDA $67.5 million for a special priority review voucher to cut the review time from ten months to six months for their alirocumab drug.
In a statement announcing the lawsuit, Amgen
said it was seeking an injunction to “prevent the infringing manufacture, use and sale” of alirocumab.
“Amgen will be substantially and irreparably harmed if defendants are not enjoined from infringing the patent[s],” it said in the complaint.
“Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on August 28, 2014,” it added.
Sanofi and Regeneron did not respond to a request for comment.
“Genetics is poised to make major advances that will allow us to more rapidly provide life-saving diagnoses and treatments; continued patenting of DNA will stop us from fully realising that potential.”
Te University of Utah, Yale University and Genzyme Genetics did not immediately respond to requests for comment.
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Life Sciences Intellectual Property Review Volume 2, Issue 1
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