Case Briefing

Drug Manufacturer Settles

Bristol-Myers Squibb Co. has settled federal charges that it blocked the sale of cheaper generic versions of three of its drugs, allegedly costing cancer patients and others hundreds of millions of dollars. The Federal Trade Commission said the company tried to limit competition for two of its anti-cancer drugs, Taxol' and Platinol', and the anti-anxiety drug BuSpar'.

Under terms of the settlement, Bristol will pay $93 million for damages claimed by states and individual consumers, and an additional $7 million if other states agree to participate in the settlement, according to Connecticut Attorney General Richard Blumenthal. New York-based Bristol said in a statement that it agreed to the settlement “to achieve a resolution of these matters which will allow it to continue its focus on discovering and developing quality medicines.”

Bayer Not Liable, Says First Baycol Jury

On March 18, a Texas jury found Bayer Corp. not liable in a case brought by an 82-year-old man who claimed his legs were severely weakened by the use of Bayer's cholesterol-lowering drug, Baycol'. Haltom v. Bayer AG, Tex. Dist. Ct., Nueces Cty., No. 02-60165-2 (3/18/03).

At trial, plaintiff's lawyers had produced documents and e-mails obtained from Bayer that tended to show the company failed to warn physicians of possible side effects of the drug. Bayer has acknowledged that Baycol can cause rhabdomvolysis, a disease that destroys muscle cells and can in extreme cases lead to kidney failure. Bayer asserted at trial that it had indeed warned physicians of the risks.

The Texas jury, which deliberated for 2 1/2 days, delivered the first verdict of an approximate 8000 cases brought concerning Baycol. About 450 of those claims have already been settled.

Pharmaceutical Patent Invalidated

The U.S. District Court for the Western District of New York granted defendant G.D. Searle's motion for summary judgment on the grounds that the patent was invalid because it: 1) failed to meet the written description requirement of 35 U.S.C. ' 112 P. 1, and 2) failed to meet the enablement requirement of 35 U.S.C. ' 112. University of Rochester v. G.D. Searle & Co., Inc., 2003 U.S. Dist. LEXIS 3030 (3/5/03).

Plaintiff, University of Rochester, was granted U.S. Patent 6,048,850, which covers a pharmaceutical 'method for selectively inhibiting PGHS-2 activity in a human host' whereby 'the activity of PGHS-1 is not inhibited.' PGHS-1 and PGHS-2 are enzymes that are required to produce hormones called prostaglandins. PGHS-1 prostaglandins protect the stomach lining, while PGHS-2 prostaglandins cause pain and inflammation. A compound that selectively inhibits PGHS-2 production without affecting PGHS-1 production is beneficial for relieving pain without causing stomach irritation. The '850 patent describes an assay to determine whether a compound will selectively inhibit PGHS-2, and then describes the above method of treating disease with this compound. The court hinges its patent invalidation decision on the fact that the patent does not specify which compound(s) is (are) to be used to carry out the method of the patent.

Patents are presumed valid under 35 U.S.C. ' 282. Clear and convincing evidence that the patent is invalid is required to rebut the presumption of validity. In this case, the court found clear and convincing evidence that the patent is invalid neither the written-description nor the enablement requirements were satisfied.

The court determined that, as a matter of fact, the '850 patent did not satisfy the written requirement because it did not specify a necessary element of the invention. Specifically, the patent did not claim a compound that could be used in the method of treating a disease. The only way to determine the compound is through trial and error; therefore, the invention was incomplete.

The court also found that as a matter of law, the enablement requirement was not satisfied by the current patent because, as specified, it would require one skilled in the art to undertake undue experimentation in order to carry out the method of the patent. 'To be enabling, the specification of the patent must teach one skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.” The court held that since this patent essentially calls for trial and error to find the correct compound, the enablement requirement is not satisfied.

Drug Manufacturer Settles

Bristol-Myers Squibb Co. has settled federal charges that it blocked the sale of cheaper generic versions of three of its drugs, allegedly costing cancer patients and others hundreds of millions of dollars. The Federal Trade Commission said the company tried to limit competition for two of its anti-cancer drugs, Taxol' and Platinol', and the anti-anxiety drug BuSpar'.

Under terms of the settlement, Bristol will pay $93 million for damages claimed by states and individual consumers, and an additional $7 million if other states agree to participate in the settlement, according to Connecticut Attorney General Richard Blumenthal. New York-based Bristol said in a statement that it agreed to the settlement “to achieve a resolution of these matters which will allow it to continue its focus on discovering and developing quality medicines.”

Bayer Not Liable, Says First Baycol Jury

On March 18, a Texas jury found Bayer Corp. not liable in a case brought by an 82-year-old man who claimed his legs were severely weakened by the use of Bayer's cholesterol-lowering drug, Baycol'. Haltom v. Bayer AG, Tex. Dist. Ct., Nueces Cty., No. 02-60165-2 (3/18/03).

At trial, plaintiff's lawyers had produced documents and e-mails obtained from Bayer that tended to show the company failed to warn physicians of possible side effects of the drug. Bayer has acknowledged that Baycol can cause rhabdomvolysis, a disease that destroys muscle cells and can in extreme cases lead to kidney failure. Bayer asserted at trial that it had indeed warned physicians of the risks.

The Texas jury, which deliberated for 2 1/2 days, delivered the first verdict of an approximate 8000 cases brought concerning Baycol. About 450 of those claims have already been settled.

Pharmaceutical Patent Invalidated

The U.S. District Court for the Western District of New York granted defendant G.D. Searle's motion for summary judgment on the grounds that the patent was invalid because it: 1) failed to meet the written description requirement of 35 U.S.C. ' 112 P. 1, and 2) failed to meet the enablement requirement of 35 U.S.C. ' 112. University of Rochester v. G.D. Searle & Co., Inc., 2003 U.S. Dist. LEXIS 3030 (3/5/03).

Plaintiff, University of Rochester, was granted U.S. Patent 6,048,850, which covers a pharmaceutical 'method for selectively inhibiting PGHS-2 activity in a human host' whereby 'the activity of PGHS-1 is not inhibited.' PGHS-1 and PGHS-2 are enzymes that are required to produce hormones called prostaglandins. PGHS-1 prostaglandins protect the stomach lining, while PGHS-2 prostaglandins cause pain and inflammation. A compound that selectively inhibits PGHS-2 production without affecting PGHS-1 production is beneficial for relieving pain without causing stomach irritation. The '850 patent describes an assay to determine whether a compound will selectively inhibit PGHS-2, and then describes the above method of treating disease with this compound. The court hinges its patent invalidation decision on the fact that the patent does not specify which compound(s) is (are) to be used to carry out the method of the patent.

Patents are presumed valid under 35 U.S.C. ' 282. Clear and convincing evidence that the patent is invalid is required to rebut the presumption of validity. In this case, the court found clear and convincing evidence that the patent is invalid neither the written-description nor the enablement requirements were satisfied.

The court determined that, as a matter of fact, the '850 patent did not satisfy the written requirement because it did not specify a necessary element of the invention. Specifically, the patent did not claim a compound that could be used in the method of treating a disease. The only way to determine the compound is through trial and error; therefore, the invention was incomplete.

The court also found that as a matter of law, the enablement requirement was not satisfied by the current patent because, as specified, it would require one skilled in the art to undertake undue experimentation in order to carry out the method of the patent. 'To be enabling, the specification of the patent must teach one skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.” The court held that since this patent essentially calls for trial and error to find the correct compound, the enablement requirement is not satisfied.