Limit certain patents, not patient care

The AMA and other medical organizations have taken a strong stand on how wrongly permitted patents stand in the way of good health care.

Posted April 16, 2012.

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A recent opinion of the U.S. Supreme Court starts out citing an earlier judicial example tying together Albert Einstein, Sir Isaac Newton and the essence of what’s off-limits to be patented. Einstein could not have patented E=mc2, nor could Newton have patented the law of gravity, noted the court, because those discoveries were manifestations of nature upon which no one could make an exclusive claim.

Smaller in scale, but no less a manifestation of nature, are workings and responses of the human body. In a unanimous decision, the justices rightly applied the example from that earlier ruling to a patent case that represented a major threat to patient care.

The high court invalidated two patents licensed by Prometheus Laboratories Inc. for a blood test that determines the appropriate dosage of thiopurine to treat autoimmune diseases. The court agreed with Prometheus critics that the essence of the patents — the correlations between metabolite levels and the likely harm or ineffectiveness of dosing — were observed, natural manifestations of the human body. As such, the patents could not stand.

In practical terms, the high court’s decision is critically important in allowing physicians to practice without fear of running afoul of “a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available & to provide sound medical care.” That depiction of medicine, had Prometheus prevailed, came from a friend-of-the-court brief filed by the Litigation Center of the American Medical Association and the State Medical Societies and other health care associations.

The medical minefield described in the brief starts with the clinical measurement and observation essential to individual patient care. It extends to interactions between physicians and labs, the work of researchers and flow of knowledge upon which medicine is built. In addition to addressing the legal issues of the case, the brief pointed out the fundamental ethical issue that physicians must rely on the most up-to-date findings when treating their patients.

The court’s detailed, 24-page opinion focused more narrowly on applying earlier rulings to the facts of the case, and in doing so thoroughly dismissed the Prometheus patent claims. “The steps in the claimed processes [of the patents] & involve well-understood, routine, conventional activity previously engaged in by researchers in the field,” wrote Associate Justice Stephen G. Breyer for the court. The opinion, though, also noted that upholding the patents could inhibit further discoveries and tie up treatment decisions, thus impeding the ability of physicians to provide care. However, in a closing comment, the court left it up to Congress to balance the conflicting interests raised by medical patents. (If lawmakers are faced with that challenge, they would do well to read the health care associations’ amicus brief in this case as well as AMA policies opposing patents that interfere with patient care.)

The justices were not quite finished with medical patents. Within days of the Prometheus ruling, they sent another case back to an appeals court — one that had upheld two medical patents — for reconsideration. At issue is the validity of patents held by Myriad Genetics on two genes — BRCA1 and BRCA2 — that can be examined to see if a woman is at risk for breast or ovarian cancer. The Assn. for Molecular Pathology and other medical groups in 2009 sued, claiming some women could not confirm their test results elsewhere because Myriad held exclusive rights to use of the genes and related diagnostic testing.

The Litigation Center, along with other groups, filed an amicus brief in the Myriad case along similar lines as the Prometheus matter, arguing that the practice of medicine is hurt by patents on gene sequences, DNA molecules and comparisons of gene sequences. Myriad said the genes it isolated were different from those occurring naturally in the body.

Following the Supreme Court’s decision on its patents, Prometheus countered that companies would shy away from new research and development. Others in the biotech industry voiced concerns that the ruling could scare off patent applications related to genetic tests for personalized medicine.

Neither the high court nor the signers of the health care associations’ amicus brief are anti-patent. This case and others like it revolve around established and well-reasoned boundaries that define what is patentable, and the predictable, serious consequences of not respecting them.

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