GENERIC MEDICINE SUPPLIER REQUESTS SECRETARY TOMMY THOMPSON TO TAKE ACTION TO LOWER PRICE OF TWO BLOCKBUSTER DRUGS
EMBARGOED UNTIL 9:30AM THURSDAY JANUARY 29, 2004
Essential Inventions, Inc., announces that it will request
Secretary of Health and Human Services Tommy Thompson to use
authority under Bayh-Dole Act to license generic production of
two blockbuster drugs funded by federal government; abusive pricing cited as grounds.
PRESS CONFERENCE: 9:30-11:00am, Thursday January 29, 2004
Washington Press Club
SPEAKERS: James Love, President of Essential Inventions, Inc./ Director
Consumer Project on Technology (CPTech)
Sean Flynn, Senior Attorney, CPTech
(202-387-8030, cell: 202-294-5749; Sean.Flynn@CPTech.org
Others by phone
ADD’L CONTACT: Joy Spencer, Joy.Spencer@CPTech.org; 202-387-8030; cell: 703-727-6761
On Thursday January 29, 2004, Essential Inventions, Inc., will file two complaints with Secretary of Health and Human Services Tommy Thompson alleging abusive pricing of government funded medicines by two of the largest pharmaceutical companies in the world.
One complaint will state that Abbott Laboratories has endangered public health and failed to make a government-supported invention available to the public on reasonable terms when it recently increased five-fold the price of the best selling AIDS medicine, Norvir.
A second complaint will state that Pfizer Corp. has failed to make a government-supported invention available to the public on reasonable terms by charging U.S. consumers between two and five times as much as Canadians and Europeans for the best-selling glaucoma treatment, Xalatan.
Each of the two medicines was discovered in the performance of federal research grants, awarded by the National Institutes of Health. The Bayh-Dole Act, passed in 1980, gives the Secretary the authority to “march-in” on each patent and license other producers to supply U.S. consumers where necessary to alleviate health needs or because the patent holder has failed to make the invention available on reasonable terms.
To allay concerns about negative impacts on research and development for new medicines, each complaint will request that Secretary Thompson require that generic producers under the licenses contribute to special funds for new medicine development.
ESSENTIAL INVENTIONS, INC.
Essential Inventions, Inc. is a non-profit corporation organized under the laws of the District of Columbia in January 2004. The Corporation’s Articles state that it was organized to “promote the creation and distribution of essential inventions and other works that support public health, nutrition, learning, and access to information and cultural life.”
Essential Inventions, Inc., has suppliers that are ready to manufacture generic versions of Xalatan and Norvir at highly reduced prices to U.S. consumers.
The Bayh-Dole Act (passed in 1980) permits inventors to retain ownership of inventions supported by federal grants, subject to “march-in” rights that can be used to license anyone to use the patent without consent of the patent holder.
The government’s march-in rights may be used if the invention is not made “available to the public on reasonable terms” or if “action is necessary to alleviate health or safety needs.”
The government has apparently never used its march-in rights for a medicine. Essential Inventions, Inc. will argue that these cases do provide grounds for use of the government’s march-in rights.
Latanoprost (sold by Pfizer under the trademark Xalatan) was discovered by a scientist at Columbia University working under a grant from the National Eye Institute.
Latanopost is the highest selling glaucoma treatment, with sales over $1 billion in 2003.
Xalatan is sold in the U.S. (CVS price) for $60 for a 4-6 week supply (active ingredient: 1% of sales price). The U.S. price is generally 2-5 times higher than in Canada or Europe, despite U.S. taxpayers having funded its invention.
Extensive information about the development of Latanoprost is provided in an April 23, 2000 article in the New York Times written by Jeff Gerth and Sheryl Gay Stolberg, titled "Drug Companies Profit From Research Supported by Taxpayers." http://www.nytimes.com/library/national/science/health/042300hth-drugs.html
Ritonavir (sold by Abbott under the trademark Norvir) is a protease inhibitor used to treat HIV/AIDS. Its most common use is as a “booster” to increase the efficacy of other protease inhibitors.
Ritonavir was invented with a grant to Abbott from the National Institute on Allergies and Infectious Diseases.
Abbott made over $1 billion in ritonavir sales in the first 5 years on the market.
In December 2003, Abbott increased the price of ritonavir five-fold. A full treatment dose will now cost over $45,000 /year and a 200mg booster will cost nearly $8,000 /year (which must be combined with three or more other HIV drugs).
Abbott anticompetitively insulated its own ritonavir boosted product, Kaletra, from the price increase. Kaletra is now the cheapest ritonavir-boosted protease inhibitor on the market.