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Message from Peter Dolan on Plavix® (clopidogrel bisulfate)
The following is a letter from CEO Peter Dolan delivered to all employees of Bristol-Myers Squibb on August 8, 2006.
Dear Colleague:
There have been further developments in the Plavix patent matter that I would like to share with you. Apotex has launched “at risk” a generic version of Plavix in the U.S. We continue to believe this launch clearly infringes the original and valid composition of matter patent on Plavix held by our partner, sanofi-aventis. We, together with sanofi-aventis, are evaluating a number of legal and commercial options available to us to address this situation, as part of a vigorous defense of our intellectual property.
This launch is called “at risk” because it is occurring before the expiration of the patent on Plavix, and as such potentially subjects Apotex to pay damages should the court ultimately find that our patent is indeed valid and infringed.
At this point, it is too early to determine what effect this action by Apotex could have on the Plavix business. You should know, however, that we have contingency plans in place to mitigate the impact to Bristol-Myers Squibb of the at-risk launch in a range of plausible scenarios.
We have discussed this situation and other matters pertaining to the Plavix patent issue in greater detail in our quarterly Form 10-Q report to the U.S. Securities and Exchange Commission, which was filed earlier today. In addition, both sanofi-aventis and Apotex have issued press releases today. As a result, you may see additional media coverage of this issue, including speculation about what it means for our company as well as for patients.
While we are working hard to minimize the impact of this action on the company, we are concerned as well about the negative implications it will have for patients. Bristol-Myers Squibb and sanofi-aventis have a long-term R&D plan for Plavix that cannot be sustained if we no longer have exclusivity for this product.
In fact, since 1997, more than 100,000 patients have participated in clinical trials involving Plavix that were developed and funded by Bristol-Myers Squibb and sanofi-aventis. These studies have gone a long way in helping physicians understand the value of this important medicine in extending and enhancing the lives of millions of patients with cardiovascular disease.
It is critical for people everywhere to understand that intellectual property protection is essential for companies like ours to continue to develop innovative medicines to treat serious diseases. Actions that weaken patent protection and allow early generic entries into the marketplace result in a negative environment for R&D in general -- and ultimately hurt patients. We intend to continue forcefully making this point to policy makers, the media, and other opinion leaders who are concerned about the future of innovative treatments for serious diseases.
While Plavix is a significant product for our company and for patients -- and one clearly worth fighting to protect, as we are doing -- it is important to remember that we have a number of key growth products that make up a promising portfolio for our future, as well as an outstanding pipeline. It is essential that we stay focused on maximizing the many significant growth opportunities before us -- including those in our vibrant Health Care businesses -- as we continue to execute our strategy and transform our company.
I personally will continue to update you on this matter as we move forward with our plans to defend our Plavix-related intellectual property and business.
Peter
Article Date: 08/08/2006
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