Patent Nonsense On Avian Flu

Boston: Alec van Gelder has written a thoughtful piece arguing against governments breaking Roche's Tamiflu patent in case of an outbreak of Avian Flu. The most pertinent arguments are that the raw ingredients are hard to come by (it would involve increasing production of a particular herb) and that the production process is difficult (although I doubt that means that other companies would need Roche to teach them how to make it). These are good points, although I'm not sure how true they are...
Lawrence B Ebert at IPBiz disagrees that the chinese herb (which he identifies as Star Anise) is needed in the production of Tamiflu, nor that Indian companies wouldn't be able to produce the drug. He also claims that "Tamiflu was developed by Gilead, who owns the patent", and draws emphasis to the last paragraph of Alec's column, which states that the most important role of government is to uphold private property rights...there are many people who would argue that the role of government is to benefit its entire populace, not just the rich...

Comments

[Lawrence B. Ebert]

To followup on a few points:

There is no doubt that the the patent on
Oseltamivir phosphate (known as TAMIFLU)[US 5,763,483] was granted to Gilead and is currently owned by Gilead (but exclusively licensed to Roche Holdings). There is currently a dispute between Gilead and Roche on whether Roche has complied with the terms of the license.

Of ways to synthesize, note the following text from a later US patent:

Oseltamivir phosphate (Ro64-0796, GS4104) is a prodrug of oseltamivir carboxylate (Ro64-0802, GS4071), a potent and selective inhibitor of the neuraminidase glycoprotein essential for replication of influenza A and B viruses. Oseltamivir (Tamiflu.RTM.) is available from Roche Pharma.TM. AG (Switzerland). Alternatively, oseltamivir can be prepared according to the methods described in U.S. Pat. No. 5,763,483 to Bischofberger et al and U.S. Pat. No. 5,866,601 to Lew et al.

One notes that Taiwan already claims to be able to make some form of oseltamivir, and I suspect pharma companies in India can make oseltamivir also.

I discuss further issues with the natural product in star anise at IPBiz.blogspot.

My major concern with van Gelder's piece was that he got so many facts wrong.

Of the point about the role of government in this, note that we already have a US statute (created during World War I) to deal with the government using patented inventions. I discussed this most recently in THE IMPACT OF WORLD WAR I ON PRESENT DAY PATENT ISSUES (Intellectual Property Today, Feb. 2005). If the government uses something from a patented invention, the government does have to pay for it. The question becomes "how much." In the case of Bayer's CIPRO, the question of "how much" was resolved without invoking the statute.

There are other examples of government intervention. The government forced the creation of a "patent pool" of aviation patents during World War I, which adversely affected the interests of the Wright Brothers. The government forced Marconi out of the American radio business. The government adjusted the patent rights of AT&T/Bell Labs.

[Lawrence B. Ebert]

On the need to use star anise as a source of shikimic acid for the synthesis of Tamiflu, please note that Roche licensed the Frost patent from Michigan State University and made a substantial amount (tons) of shikimic acid using this pathway in the fiscal year ending June 2005. Alec van Gelder's suggestion that the production of star anise is a bottleneck is simply wrong. Professor Frost himself is already gearing up to make shikimic acid.

While the production process for Tamiflu involves some difficult steps (e.g., the azide step), nothing here is that remarkable.

The policy question is a different matter, but van Gelder's factual assertions are without merit.

[More is available on IPBiz.]

[Lawrence B. Ebert]

As a followup to the earlier discussion about the manufacture of TAMIFLU, note that Professor Elias J. Corey came up with a synthesis of TAMIFLU that avoids the use of shikimic acid entirely. See
http://ipbiz.blogspot.com/2006/05/new-routes-to-make-tamiflu.html

In discussing the NEW synthetic route, Chemical & Engineering News acknowledged of the PAST that "Roche has been obtaining the shikimic acid starting material via extraction from Chinese star anise fruit AND fermentation processes." Van Gelder's assertion that the star anise was the ONLY source of shikimic acid was wrong at the time it was made. Corey was quoted: "I think the Tamiflu supply problem is solved," although one notes that Roche claims it will produce 400 million flu treatments annually by the end of 2006 (without the use of Corey's synthesis).

Of a separate, later development, note that the Supreme Court in eBay v. MercExchange ruled that the traditional 4-factor test is the correct rule for deciding whether to grant a permanent injunction against a patent infringer. One of the factors involves balancing the public interest. Without passing judgment on the validity of Van Gelder's arguments on patent policy, one notes that the US Supreme Court is going in a direction other than that indicated by Van Gelder.

[pomn]

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[Cassandra]

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