Letter from Essential Inventions to Mark Rohrbaugh, Director of the NIH's Office of Technology Transfer

March 10, 2004

Dr. Mark Rohrbaugh
Director of the Office of Technology Transfer
Office of Intramural Research
NIH
6011 Executive Blv.
Suite 325
Rockville, MD 20852

RE: Petition to use authority under Bayh-Dole Act to promote access to ritonavir, supported by National Institute of Allergy and Infectious Diseases contract No. Al27220

Dear Dr. Rohrbaugh:

We write to provide additional information related to the petition to use the government’s March-In rights under the Bayh-Dole Act for Norvir (ritonavir), and to request a meeting to discuss the petitions to use the government’s March-In rights for both Norvir (ritonavir) and Xalatan (latanoprost).

Since filing the initial petition on January 29, 2004, we have been informed by Abbott Laboratories that the 400% price increase on Norvir, announced the day before Christmas Eve 2003, will only be implemented in the U.S. This means that U.S. consumers will be paying five times the price that European and Canadian consumers pay for a U.S. government funded invention. We believe that this fact supports our contention that Norvir is not being made “available to the public on reasonable terms” 35 U.S.C. § 201(f).

We have also been informed by scientists in the competitive research and drug development sector that Abbott’s price increase is having a chilling effect on the research and development pipeline for Hepatitis C medicines. We are informed that this is because the next class of Hepatitis C medications may utilize treatment methodologies similar to that of protease inhibitors, requiring ritonavir to achieve maximum effectiveness. The effect of Abbott’s unreasonable price increase for ritonavir will dissuade other companies from research and development in this new field, harming the research and development for Hepatitis C and possibly other diseases.

We request a meeting with you and your staff so that we can discuss this and other topics. We also request that a formal hearing be scheduled on any issues of fact that are relevant to the determination in this matter, as called for in the implementing regulations, 37 C.F.R. § 401.6.

Thank you for your consideration.

Sincerely,

James Love
President
Essential Inventions, Inc.

Sean Flynn
Counsel
Essential Inventions, Inc.

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