Physiology/Medicine Nobels Awarded for Discoveries of “Natural Products”

In re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that clones including Dolly the sheep were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different” structure requirement for patent eligibility that the PTO had proposed abandoning in December 2004:

“[According to Chakrabarty], discoveries that possess ‘markedly different characteristics from any found in nature,’ are eligible for patent protection. In contrast, any existing organism or new discovered plant found in the wild is not patentable.”

In Ariosa, Judges Renya, Linn and Wallach turned a method of isolation of cffDNA into a “natural product”:

“The method therefore begins and ends with a natural phenomenon. Thus the claims are directed to matter that is naturally occurring….Because the claims at issue are directed to naturally occurring  phenomena, …the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”

Earlier this week the Nobel prize in Medicine was awarded to three elderly scientists who made discoveries about natural products that saved or improved the lives of millions of people. A Chinese researcher, Youyou Tu,  searching for possible malaria treatments found a reference to extracting a drug from sweet wormwood in a sort of “Merck Manual” written in 640 A.D. The resulting purified drug, Aftemisinin, and its derivatives are still used to treat malaria.

The other two researchers, William C. Campbell, then at Merck, and Satoshi Omura also discovered a new class of drugs, the avermectins, that they extracted from a cultered sample of soil Omura randomly collected from a golf course. These bioactive compounds were modified to yield anti-parasitics such as ivermectin, that is effective against Elephantitis and  River Blindness, conditions that had rendered parts of Africa uninhabitable.

News reports indicate that the Chinese government was willing to support the search for antimalarials to support military operations in southeast Asia. But would Merck have poured millions of dollars into developing drugs to treat such rare diseases with no chance of recovering their costs? (Merck received US patent no. 4310519 on antiparasitic compounds obtained by fermenting the microorganism the Omura found.)

Intellectual property law setting forth the metes and bounds of the patent-eligibility of natural products is at a tipping point, with at least four Judges willing to create a “judicial exception” to patent-eligibility for products of nature, even if they are identified, then purified and isolated to the point where they exhibit practical utility.  It is one thing to say that a mineral found in the earth, or a plant discovered in the jungle should not be patent eligible, but the limits of the “judicial activism” in this area just have to stop.

Maybe the ACLU can step in to support patenting for once – remember Chris Hansen’s answer to Justice Alito’s question during oral argument about whether or not a drug present in tiny amounts in a tree should be patentable, so that a patient would not have to eat the entire tree to be treated? Mr. Hansen agreed that the purified drug should be patent-eligible and all but cited In re Bergy. I think the Myriad decision was an insult to chemical patent law, but we should fill in our pro-IP roundtable any way we can.

 Chemical & Engineering News article

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