Senator Schumer interferes in the free market, forces Roche to license Tamiflu® to generic drug makers
On October 16, 2005, United States Senator Charles Schumer (D-NY) issued a statement decrying Roche Pharmaceutical's refusal to license the anti-viral Tamiflu® for generic production and demanding "suspension of Tamiflu patent so vaccine can be mass-produced, dramatically increasing supply," (and demonstrating a fundamental ignorance of the fact that Tamiflu is an anti-viral medication, not a vaccine.)
Today, October 21, 2005, Senator Schumer issued a press release entitled "Schumer, Graham, announce that Roche agrees to increase supply of avian flu drug, will meet 4 drug companies starting immediately," which said, in part:
"U.S. Senators Chuck Schumer and Lindsey Graham today announced that Roche Pharmaceuticals was committed to meeting with four generic drug companies starting immediately to redouble their efforts to vastly increase supply of their Avian flu treatment by licensing production to more drug companies. Schumer has repeatedly called for Roche, the maker of Tamiflu, to immediately license the Avian Flu treatment to other drug companies in order to dramatically increase production. Schumer and Graham announced this deal after meeting with George Abercrombie, CEO of Roche Pharmaceuticals N.A.
"Schumer stated, “Roche has graciously stepped up to the plate, and has essentially agreed to share its technology and the rights to manufacture this drug with other companies who are willing to help out.”
Who, in fact, owns Tamiflu® and has the right to license it for generic production?
Implicit in Senator Schumer's statement is a belief that "the rights to manufacture this drug" belong to Roche.
Not according to an action taken by Gilead Sciences of Foster City, California, inventors of oseltamivir (brand name "Tamiflu®") on June 23, 2005, when it notified Roche of its termination of its 1996 patent licensing agreement with the larger company.
For the details of this "reversion of rights" action by Gilead Sciences, go to the Etopia Media
Tamiflu® World article entitled
"Gilead Sciences, Inc., inventor of Tamiflu®, is seeking to terminate its 1996 agreement with Roche, which would result in the rights to Tamiflu held by Roche reverting to Gilead."
To see that the patents on oseltamivir (brand name: Tamiflu®), whoever owns them, don't expire until 2016/2017, click
here and scroll down to the entries regarding "oseltamivir."
Indian web site article questions ownership of Tamiflu® patents
The question of "Who owns Tamiflu®?" is also addressed in an article published today on the Indian-based
Sify Finance web site entitled
"Avian flu drug: Who owns the patent?", which says:
"
Mumbai: As the world watches how Roche supplies its anti-flu medicine Tamiflu to countries faced with the bird-flu problem, a patent twist threatens to add to the existing controversy around the drug and its availability.
"Gilead Sciences, the developer of Tamiflu, is believed to have terminated its agreement with Roche, which has the exclusive marketing right on the drug. And generic manufacturers like
Cipla, looking to make similar versions of Tamiflu, are now taking a close look at the intricacies of who indeed holds the patent on the drug."
Cipla Ltd. and Roche Pharmaceuticals
four generic drug makers and a fifth, not mentioned by Senator Schumer
The four companies with which Senator Schumer wants Roche to cooperate for the rapid mass provisioning of national anti-viral stockpiles are:
Teva Pharmaceuticals,
Barr Laboratories,
Mylan Laboratories, and
Ranbaxy Laboratories.
Ranbaxy Laboratories, one of the four companies included in the Schumer announcement about potential generic licensees, is based in India, as is Cipla, Ltd., which has already announced its capability and intention to produce generic oseltamivir outside of any licensing agreement with anyone.
Ranbaxy sues Barr and Teva
Of possible interest as well is the October 13, 2005, press release from Ranbaxy Laboratories entitled
"Ranbaxy files suit against Barr Laboratories and Teva Pharmaceuticals," which states:
"Ranbaxy Laboratories Limited and Ranbaxy Pharmaceuticals Inc. announced today that, along with Agvar Chemicals Inc., they have filed a joint complaint against Barr Laboratories, Inc. and Teva Pharmaceuticals, USA Inc. for damages and equitable relief for breach of contract, fraud and tortious interference associated with the supply of Active Pharmaceutical Ingredients (API) regarding the commercialization of fexofenadine hydrochloride (the active ingredient in
Allegra®) tablets in the U.S. healthcare market.
"Commenting on the complaint, Jay Deshmukh, Vice President of Global Intellectual Property for Ranbaxy Laboratories Limited, said, “We operated in good faith over a period of five years lending technical expertise to Barr in the development of the fexofenadine hydrochloride tablets, and investing heavily in facilities to meet the demands of Barr, only to be surprised by an undisclosed relationship between Barr and Teva. We believe this is a breach of our agreement with Barr and accordingly are now seeking all appropriate relief from a state court in New Jersey."
Sanofi-aventis sues Barr and Teva
Incidentally, as reported in a September 12, 2005, press release from "sanofi-aventis in the United States," the patent holders for Allegra®, entitled
"Sanofi-aventis Group enters agreement with Prasco Laboratories to market generic versions of ALLEGRA® (fexofenadine HCl):
"This announcement [by Sanofi-aventis of "a distribution and supply agreement with Prasco Laboratories to launch an authorized generic fexofenadine hydrochloride tablet in the United States] follows a September 6, 2005 statement by Barr Pharmaceuticals and Teva Pharmaceuticals that they would be collaborating to launch a generic version of Allegra 30 mg, 60 mg and 180 mg.
"Sanofi-aventis continues to believe that the generic products of Barr Pharmaceuticals and Teva Pharmaceuticals infringes its intellectual property rights, which are currently the subject of ongoing litigation with these two companies. Sanofi-aventis will continue to vigorously defend its rights."
asking the United States Patent Office "Who owns Tamiflu®?
In order to clarify the issue of "Who owns Tamiflu®?," Etopia Media
Tamiflu® World today contacted an official at the United States Patent and Trademark Office and asked for that organization's view on the question. The USPTO spokesperson promised an answer by Monday, October 24, 2005.
irony in the shadow of a possible global avian influenza pandemic
Ironically, Gilead's termination of its licensing agreement with Roche is based on what it alleges were inadequate efforts by the larger company to properly promote the Tamiflu® anti-viral product.
In light of the looming threat of a global avian influenza ("bird flu") pandemic, and long waiting periods for delivery as nations queue up for their share of Tamiflu® for stockpiling for use against this threat, which conditions have precipitated the actions announced today by New York State's Senator Schumer, the question of Roche's good faith in previously manufacturing and promoting oseltamivir on a license from Gilead may have receded into the background, but not so the action of Gilead in terminating its agreement with Roche under the terms of that agreement and seeking to take back for itself the right to manufacture what is now arguably the world's most-sought-after medication, or indeed, substance of any kind.
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