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Biology of Genomes ELSI Panel Discusses Gene Patenting Court Cases

COLD SPRING HARBOR, NY (GenomeWeb) – At an ethical, legal, and social implications (ELSI) panel at the Biology of Genomes meeting here yesterday afternoon, legal experts discussed the current climate surrounding gene patenting and the key court cases leading up to it.

The session, moderated by the National Human Genome Research Institute's Lawrence Brody, largely focused on three related cases that have been heard in the US Supreme Court over the past few years, starting with the 2010 Bilski v. Kappos case, which involved the validity of patenting an invention centered on a business model algorithm.

The panel also discussed the Mayo Collaborative Services v. Prometheus Laboratories case — a 2012 suit that centered on a set of blood-based metabolites for determining drug dose profiles that was ultimately deemed unpatentable — and the recent Association for Molecular Pathology v. Myriad Genetics case, in which the Supreme Court ruled that products of nature are ineligible for patenting.

As part of that discussion, panelists Arti Rai from Duke University and patent attorney Claire Laporte of Boston law firm Foley Hoag took a look at section 101, the US patent law at the heart of such suits, which allows for patenting of new and useful processes, machines, manufacturing processes, or compositions of matter.

Rai, co-director of the Duke Law Center for Innovation Policy, noted that there had been longstanding "common law exceptions" made for products of nature, laws of nature, and abstract ideas.

Even so, she explained that counter-veiling cases have cropped up over the years — for instance, findings of a 1948 suit ruled new bacteria combinations ineligible for patenting. On the other hand, genetically modified bacteria programmed to break down crude oil was deemed "markedly different" from natural bugs in the 1980 case of Diamond v. Chakrabarty.

For her part, Laporte described the nuts and bolts of patent applications and the information they're required to specify, including a detailed description of the innovation at hand and the scope of the legal monopoly associated with the patent.

Rai noted that early gene patents, which began gathering steam in the early 1980s, tended to cover complementary DNAs with therapeutic applications. In more recent history, though, such patents started including genes and smaller stretches of sequence with potential diagnostic applications — a shift that eventually triggered cases such as AMP v. Myriad.

There is still uncertainty in the wake of that case, according to Rai, despite the Supreme Court's ruling against natural product patenting. For instance, it remains to be seen how current patent rulings will affect the thousands of natural sequence patents still in force.

Laporte, too, explained that the full fallout of that ruling has yet to play out, since full-length genes with intronic sequences, bacterial genomes, regulatory DNAs, and the like can likely no longer be patented.

In addition, the panelists noted that patents related to biological correlations, personalized medicine, stem cells, antibodies, protein products, small molecules from nature, and more may come under further scrutiny in the future.

Nevertheless, Laporte noted that legal distinctions associated with the patent system do not necessarily address moral and ethical concerns that could stem from certain patents, such as ownership and personhood issues, informed consent, and privacy concerns.

She also cautioned that hostility against the patent system as a whole may have the unintended consequence of discouraging patenting and increasing companies' use of trade secret strategies that keep more and more innovations under wraps.