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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (19385)	3/21/2006 3:38:14 PM
From: Biomaven	Read Replies (2) \| Respond to of 52153

Justices take on question of what can be patented WASHINGTON (AP) — Several Supreme Court justices appeared hesitant to decide a fundamental question Tuesday — what can and cannot be patented? — as the court wrangled over a disputed patent for determining vitamin deficiency. Justices stressed that the broader question had not been asked in the case, which involves the infringement of a 1990 patent on a method of diagnosing B vitamin deficiencies, until the dispute reached the Supreme Court. "It seems imprudent of us to discuss it here if it hasn't been discussed in the Court of Appeals," Justice Anthony M. Kennedy said. Bush administration lawyer Thomas Hungar encouraged the court not to take up the question whether the patent covered a law of nature, a natural phenomenon or an abstract idea. None of those can be patented. If the court does reach to that broader issue, attorneys said it could affect the claims made in literally tens of thousands of older patents on drugs, medical devices, computer software and other inventions. That makes the case a potential blockbuster. The patent at issue in the case describes first how the level of an amino acid called homocysteine can be measured in a patient and, then, how a high level is associated with a deficiency of folic acid or B12. The method is used by laboratory testing companies nationwide, including Laboratory Corp. of America Holdings. In 1998, LabCorp stopped paying some royalties on the patent. The patent's holders, including Metabolite Laboratories Inc. and Competitive Technologies Inc., sued. LabCorp lost, was ordered to pay about $5 million and then lost again on appeal. LabCorp attorney Jonathan Franklin argued that the patent gave its owners a monopoly over a natural phenomenon: High levels of homocysteine suggest deficiencies in two B vitamins. The audience at Tuesday's arguments could infringe the patent by merely thinking about that relationship, Franklin suggested. Metabolite Laboratories countered that the patent covers a practical application of the discovery when used as part of a diagnostic step. Metabolite attorney Miguel Estrada conceded, under questioning by Justice John Paul Stevens, that a doctor could infringe the patent by ordering a homocysteine test with the intent of determining B vitamin levels and then using the test results to infer whether there was indeed a deficiency. Justice Stephen Breyer said allowing doctors, scientists and computer experts to begin patenting every "useful idea" could establish "monopolies beyond belief." Breyer asked if it would make sense to send the case back to the lower courts. "What was made by man here?" Justice Antonin Scalia later asked, calling the invention the discovery of a natural principle. "When there's the presence of one substance in a human being, there is a deficiency of two others." LabCorp originally argued that the patent was overly vague, and that allowed it to use tests, called assays, developed by other companies to measure homocysteine levels. Metabolite Laboratories disagreed and sued. Whether the court would tackle the broader question of the patent's covering a law of nature remained unclear. Estrada cautioned that answering it could "wreak havoc on the patent world." Chief Justice John Roberts recused himself from the case because his former law firm represents LabCorp. The case is Laboratory Corporation of America Holdings v. Metabolite Laboratories Inc., et al., No. 04-607.

To: Biomaven who wrote (19385)	3/21/2006 4:30:17 PM
From: Ian@SI	Read Replies (1) \| Respond to of 52153

Current process strikes me as far from ideal -- far too costly, time consuming and preventing access to life saving treatments. Surely, it can be improved.

To: Biomaven who wrote (19385)	3/21/2006 7:46:43 PM
From: zeta1961	Read Replies (1) \| Respond to of 52153

Peter, why do you think that prohibiting placebo controlled trials is a mistake? Elisabeth

To: Biomaven who wrote (19385)	3/22/2006 12:26:38 AM
From: Jibacoa	Read Replies (1) \| Respond to of 52153

but the prohibition on placebo-controlled trials is a mistake. It's important to note that some treatments might actually make things worse, so it's not clear that a treatment is always better than placebo. Peter, In cases where there is no available "accepted treatment" and where the illness is such that makes the condition "pre-terminal", I don't think there is much to be lost in trying a new treatment that has had already some P1 or PII trials for "safety & toxicity" evaluation and has some scientific logic for its use. If myself or a close relative would have a metastatic Ca., I probably wouldn't be in favor of having one of the presently "accepted treatments" with highly toxic chemicals that severely impact the quality of life and at the most only accomplish a few more weeks of suffering. I do believe that some of those "FDA accepted treatments" actually make things worse in many cases. On the other hand, I would like to be able to try or elect to have a "new experimental or not yet approved treatment" in which there seems to be some possibility of improvement and that decision should be left to me and my Oncologist, if I am able to afford the cost of that treatment. (I am not looking for the Government to pay for it.<g>) Bottom line, I am in favor of S.1956 to be applied in those pre-terminal or otherwise hopeless cases. RAGL Bernard