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November 03, 2005

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...

November 03, 2005 in Patents |

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.

Posted by: Lawrence B. Ebert | November 07, 2005 at 06:11 AM

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.]

Posted by: Lawrence B. Ebert | November 08, 2005 at 06:38 PM

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.

Posted by: Lawrence B. Ebert | May 19, 2006 at 07:05 AM

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Copyright laws © Michel Livlier
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Couple of. Certification
The single most key elements with the failure or success in the Partnership.
It is important to shoot a powerful endorsement (affiliate) towards the variety. Just not a obvious sales copy class ‘‘endorsement’’.
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Three or more. Of The items Or Company
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Different. Working relationship
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Some are generally able to auction off goods that ended up priced a few times above his or her's suppliers, and additionally they developed a hurting in internet marketing. Achieving this level of have faith in together with customers must be one of your priority objectives, a single may benefit an individual for years and years into the future.
Top 6. Scale The List
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10. Sales copy (Or maybe Replicate)
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4. Recency
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Seven. Number
Execute that consumers on a regular basis order items together with products similarly to your own house? An additional really good symbol. When they have many times got a hold of things like the one you have, they’ll want to acquire a bit more.
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Nine. Has got Sales Letter, Price Of The goods Or perhaps Assistance, And many others. Recently been Researched?
A good verified page of copy, . . .. will certainly be a much bigger beneficial than one which will hasn’t recently been proven by any means.
If for example the asking price hasn’t always been certified, you're probably going to reducing a whole lot from earnings. You ought to evaluate to determine the charge which will stocks the most.
8. Is considered the Endorsee A Well-Known And additionally Known Veteran ?
The more this device or service pet owner is going to be respected and then considered to be an experienced person within the or perhaps the girl world, the harder the main Three way partnership are going to have the wide ranging to generally be money-making.
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Tip Best:

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Tip Number A variety of:

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Any longer.

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