High court throws out human gene patents

The Supreme Court on Monday threw out a lower court ruling allowing human genes to be patented, a topic of enormous interest to cancer researchers, patients and drug makers.

The court overturned patents belonging to Myriad Genetics Inc. of Salt Lake City on two genes linked to increased risk of breast and ovarian cancer.

Myriad's BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.

The American Civil Liberties Union has been arguing that genes couldn't be patented, a position taken by a district court judge but overturned on appeal.

The justices' decision sends the case back down for a continuation of the battle between the scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward.

In 2010, a federal judge ruled that genes cannot be patented. U.S. District Judge Robert Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body nor the information it encodes.

But last year, a divided panel of the federal appeals court in Washington that handles patent cases reversed Sweet's ruling. The appeals court said genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body.

The Supreme Court threw out that decision, and sent the case back to the lower courts for rehearing. The high court said it sent the case back for rehearing because of its decision in another case last week saying that the laws of nature are unpatentable.

In that case, the court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn's disease.

"The question before us is whether the claims do significantly more than simply describe these natural relations," said Justice Stephen Breyer, who wrote the opinion in the Prometheus Laboratories case. "To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural law? We believe the answer to this question is no."

The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.

Testing for mutations in the so-called BRCA genes has been around for just over a decade. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer.

Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of eastern European Jewish descent.

Myriad Genetics Inc. sells the only BRCA gene test.

The case is Association for Molecular Pathology v. Myriad Genetics, 11-725.

View the Original article

Columbia University sues Illumina over DNA patents

Reuters – 1 hr 16 mins ago (Reuters) - Illumina Inc, a gene-mapping company facing a $5.7 billion hostile takeover bid by Swiss drugmaker Roche Holding AG, was sued by Columbia University on Monday for allegedly infringing five patents related to DNA sequencing.

According to the complaint filed in the U.S. District Court in Wilmington, Delaware, Illumina commercialized its so-called next-generation sequencing (NGS) products despite knowing about the patents, obtained between 2009 and 2012 and assigned to Columbia.

The university said its patents cover NGS technologies that allow rapid and precise DNA sequencing, which are particularly important in using individuals' genomic DNA sequence information as a basis for providing health care.

Illumina makes products that decode a person's entire genome. Spokesman Matt Benson had no immediate comment.

Each patent has several inventors, including Columbia chemical engineering professor Jingyue Ju, according to the complaint. The university is seeking royalties, triple damages and other remedies.

"Columbia is proud of the outstanding research efforts of its faculty and will defend its patented technology," university spokesman Robert Hornsby said.

The university filed its complaint hours after Roche extended its $5.7 billion cash takeover bid for Illumina. The bid values the San Diego-based company at $44.50 per share, but Illumina considers the offer "grossly inadequate.

Acquiring the company would give Basel, Switzerland-based Roche a leading position in gene sequencing, which could help better identify patients who might benefit from using particular drugs.

Illumina in 2011 posted profit of $86.6 million on revenue of $1.06 billion.

In its annual report, the company projected that expansion in the sequencing market and its product portfolio would drive demand for its technology over the next several years.

Analysts expect Roche to raise its takeover bid, and shares of Illumina have traded above $44.50 since the original bid became public on January 25.

In afternoon trading, Illumina shares were down 31 cents at $50.15 on the Nasdaq.

The case is Trustees of Columbia University in the City of New York v. Illumina Inc, U.S. District Court, District of Delaware, No. 12-00376.

(Reporting By Jonathan Stempel in New York; Additional reporting by Caroline Copley in Zurich; editing by John Wallace and Gerald E. McCormick)

View the Original article