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Patentes do Gene disparadas para baixo na corte

por Brendon Nafziger, DOTmed News Associate Editor | April 02, 2010

Myriad announced they intended to appeal the verdict shortly after it was delivered.

"While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation," the company's president Peter Meldrum said in a statement on Tuesday.

DNA exceptionalism

Patents cannot be filed for products "found in nature." Thus, courts have held that genes found naturally in the body are not subject to patent. However, the U.S. patent office does protect genes tinkered with by scientists or discovered and then isolated from the body and used for testing, as these generally undergo some sort of modification.

Myriad, in its suit, claims that by isolating and purifying the gene they alter it substantially, as for example, they cut out the junk DNA filler that makes up the bulk of most genes.

"Preparations of isolated and purified DNA molecules, which alone can be put to use in these ways, are patentable because they are fundamentally different from anything that occurs in nature," Jim Greenwood, the president and CEO of the Biotechnology Industry Organization (BIO), an industry trade group that filed an amicus brief for Myriad, said in a statement.

But while Judge Sweet granted that there might be some differences between a gene found in the body and the same one "purified" and extracted in a test tube, what is important about genes is not so much the structure of the individual genes, but rather the information encoded inside, making DNA "distinct in its essential characteristics from any other chemical found in nature," he wrote in his decision.

And by isolating the DNA, Myriad was not changing the "information" in a significant enough way to merit a patent.

The Court also determined the method for diagnosis using the so-called breast cancer genes was not patentable, as it was based on an "abstract mental process."

This ruling is based on the In re: Bilski decision reached by a federal court last year. In it, the court ruled that business method patents based on abstract processes were invalid unless embodied in a specific machine or unless they materially transformed a substance, as with a chemical formula, according to legal experts DOTmed news spoke with.

But the Bilski decision itself is up for review by the Supreme Court, which heard the case last year. A decision from the Court is expected any day now, but legal experts don't think, however this case is decided, it will greatly affect the current ruling.