APPENDIX 4 FURTHER MATERIALS SUBMITTED BY BARR LABORATORIES Barr Laboratories, Inc. 265 Livingston St, Northvale, NJ 07647 Telephone (201) 767-1900 CERTIFIED MAIL I am the President of Barr Laboratories, Inc., a "generic" drug manufacturer, with annual sales of approximately 60 million dollars. It has just come to my attention that you are supporting an amendment to the above referenced legislation that would give Warner-Lambert's Lopid a 5 year patent term extension. I understand that you are considering this proposed amendment because: Warner-Lambert was required to perform additional Warner-Lambert, by receiving FDA approval for and was therefore "entitled" to some relief. Barr Laboratories, Inc. vehemently opposes this proposed amendment as well as any amendment that would nullify any of the provisions of the Act. The Act, as you know, created a delicate balance between the rights of "innovator" companies such as Warner-Lambert, "generic" companies such as Barr, and the consumers right to safe, effective and reasonably priced drugs. The proposed amendment flies directly against both the letter and the spirit of that Act. The result of the proposed amendment, if enacted, would be to keep the costs of this life saving drug at a premium during the pendency of Lopid's exclusivity. I believe that Lopid now has annual U.S. retail sales at pharmacy acquisition cost in excess of $40,000,000 and that its sales are growing at the rate of 35% per year. Therefore, even assuming that sales do not increase during the period of "exclusivity", and the product is currently being sold at "only" a 25% premium over what a generic competitor product would be (this is a conservative percentage, it is usually more), the effect of the legislation would cost the consumer over $10,000,000 per year for the period of the exclusivity. Savings of this magnitude are the very reason for the enactment of the Act. I see no reason to create an exemption for Lopid. Warner-Lambert has and will continue to reap the profits from their epidemiological studies and their patent for two more years. Even after this time, history shows that innovators' products, such as Lopid, continue to be the industry leader, in both volume and certainly profits, even after generic competition begins. Furthermore, Barr, prior to this time, has had no knowledge of this proposed amendment and had already begun the extensive research and developmental work necessary to submit and gain FDA approval of an Abbreviated New Drug Application for the product. Our work has been aimed at gaining approval prior to the July 4, 1989 patent expiration date (the approval would, of course, not be effective until after July 4, 1989). It is totally inequitable to allow Warner-Lambert to circumvent the Act, especially since Barr and probably other generic competitors have already spent considerable time and money in reliance upon the Act. Curiously, I must note, that had the product been approved by the FDA on January 1, 1982 (in lieu of December 21, 1981) with Lopid receiving the 10 year protection provided for in the Act, such protection would expire on January 1, 1992. However, you are now supporting an amendment that would give them exclusivity to July 4, 1994. Therefore, Warner-Lambert is gaining over 21⁄2 years of exclusivity (January 1, 1992 through July 4, 1994) due to their "misfortune" of obtaining an early FDA approval. I hope that you will not support this amendment and use your considerable influence to delete this amendment from the proposed legislation. Sincerely, BARR LABORATORIES INC. Cohen President EAC:1d h Barr Laboratories, Inc. 265 Livingston St, Northvale, NJ 07647 Telephone (201) 767-1900 October 26, 1987 The Honorable Robert W. Kastenmeier, Chairman Courts, Civil Liberties and the Administration of Justice Subcommittee 2137 Rayburn House Office Building Washington, D.C. 20515 Re: Subcommittee Hearing October 8, 1987 Lopid Patent Term Extension & Fairness Act of 1987 Dear Mr. Kastenmeier: I sincerely regret having to forego the opportunity to appear before your subcommittee. The day before my appearance, I was advised about new legislation being introduced by Senator Byrd that would have the sole purpose of giving Maxzide Tablets 7 years of marketing exclusivity in addition to the 3 year marketing exclusivity that was to expire on October 22, 1987. On October 7, 1987, at approximately 3 P.M., I was advised that this bill had a good chance of quick passage unless Congressional opposition could be mustered immediately. I was asked to quickly mobilize the full support of our New Jersey Senate and Congressional delegation. It was imperative that I concentrate all my efforts to obtain such support. I immediately called your Subcommittee and informed them of my decision. Our marketing potential for a tablet bioequivalent to Maxzide is in the immediate future. We had just settled costly patent infringement litigation with the NDA holder and had already received a bioequivalence approval and expect a full ANDA approval shortly. In fact, we had begun "gearing-up" for marketing and expect multi-million dollar yearly sales immediately upon marketing. If we lose this issue with Mylan, it will cost Barr over $50 million and I would be forced to consider significant loss of personnel. I fervently hope that you can understand my position in this matter. Your efforts and commitment on these and related issues are greatly admired and appreciated. |