Case Briefing

Arrow appealed, objecting to the physician's testimony on the grounds that he had no expertise in fluid mechanics and his opinion had no scientific basis, as required by Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, (1993). The appellate court, however, found that the physician's opinion testimony was admissible because the witness was not required to be an expert in any other field than the one in which he was unquestionably qualified: the field of medicine. As an emergency-room physician with 16 years of experience working with various catheters, the physician was adequately qualified to testify under Arkansas law, according to the court. Here, the court stated that the witness' experience sufficed to qualify him as an expert, and the fact that the physician's 'testimony was not based on flow rates, viscosity, friction, or other scientific properties of blood flowing through a 1.6-mm opening' was merely a matter for the jury to consider in determining the weight to be accorded his testimony.

Patent Term Extension Denied for Combination Drug

Because the U.S. Patent and Trademark Office properly applied 35 U.S.C. ' 156, which authorizes term extensions for patents covering a limited class of drugs, the U.S. District Court for the Eastern District of Virginia, Alexandria Division, granted defendants' motion for summary judgment, upholding the PTO's decision denying the extension of plaintiff's combination drug patent. The Arnold Partnership v. Rogan, Civ. Act. No. 02-858-A, 2003 U.S. Dist. LEXIS 2839 (2/20/03).

Plaintiff is the owner of a patent for a combination of ibuprofin and 'hydrocodone or a pharmaceutically acceptable acid addition salt.' The commercial embodiment of this is Vicoprofen, the first commercial composition drug approved by the FDA that contained this combination, but both hydrocodone bitartrate and ibuprofen had previously been marketed as separate drugs.

Plaintiff's patent was set to expire Dec. 18, 2004. On Nov. 20, 1997, plaintiff filed with the PTO for a patent term extension under ' 156. The PTO denied the application, finding that it failed to satisfy the 'first commercial marketing' requirement of ' 156 because both hydrocodone bitartrate and ibuprofen had previously been approved by the FDA for commercial marketing and use. This decision followed PTO precedent established in 1989 that allows patent extensions under ' 156 for combination drugs only if the patent covering the drug claims at least one active ingredient that had not previously been approved for commercial marketing or use.

The district court here looked to the plain meaning of the act's terms and of its legislative history to find that the PTO's interpretation was correct and that plaintiff was not entitled to a patent extension under ' 156.

Physician's Testimony Allowed over Objections

In a wrongful death action, the Court of Appeals of Arkansas, Division One, upheld a jury's award of compensatory damages and $4 million in punitive damages against Arrow International, the manufacturer of a device that facilitates insertion of a catheter into a patient's body, despite Arrow's objections concerning the qualifications of plaintiff's physician witness. Arrow International Inc. v. Sparks, CA 02-75, 2003 Ark. App. LEXIS 107 (2/12/03).

Plaintiff, the administratrix of decedent's estate, sued the doctor, the hospital and Arrow for her father's wrongful death. After settling with the doctor and hospital, the case proceeded to trial, where the jury awarded $700,000 in compensatory damages (25% apportioned to Arrow, making it liable for $125,000) and punitive damages. After hearing testimony from plaintiff's physician witness that decedent's excessive bleeding could not have occurred in the manner asserted by Arrow, the jury found that Arrow's percutaneous sheath introducer, which has two parts, was inherently dangerous and that the separation of the two parts caused decedent to bleed to death.

Arrow appealed, objecting to the physician's testimony on the grounds that he had no expertise in fluid mechanics and his opinion had no scientific basis, as required by Daubert v. Merrell Dow Pharmaceuticals , 509 U.S. 579, (1993). The appellate court, however, found that the physician's opinion testimony was admissible because the witness was not required to be an expert in any other field than the one in which he was unquestionably qualified: the field of medicine. As an emergency-room physician with 16 years of experience working with various catheters, the physician was adequately qualified to testify under Arkansas law, according to the court. Here, the court stated that the witness' experience sufficed to qualify him as an expert, and the fact that the physician's 'testimony was not based on flow rates, viscosity, friction, or other scientific properties of blood flowing through a 1.6-mm opening' was merely a matter for the jury to consider in determining the weight to be accorded his testimony.

Patent Term Extension Denied for Combination Drug

Because the U.S. Patent and Trademark Office properly applied 35 U.S.C. ' 156, which authorizes term extensions for patents covering a limited class of drugs, the U.S. District Court for the Eastern District of Virginia, Alexandria Division, granted defendants' motion for summary judgment, upholding the PTO's decision denying the extension of plaintiff's combination drug patent. The Arnold Partnership v. Rogan, Civ. Act. No. 02-858-A, 2003 U.S. Dist. LEXIS 2839 (2/20/03).

Plaintiff is the owner of a patent for a combination of ibuprofin and 'hydrocodone or a pharmaceutically acceptable acid addition salt.' The commercial embodiment of this is Vicoprofen, the first commercial composition drug approved by the FDA that contained this combination, but both hydrocodone bitartrate and ibuprofen had previously been marketed as separate drugs.

Plaintiff's patent was set to expire Dec. 18, 2004. On Nov. 20, 1997, plaintiff filed with the PTO for a patent term extension under ' 156. The PTO denied the application, finding that it failed to satisfy the 'first commercial marketing' requirement of ' 156 because both hydrocodone bitartrate and ibuprofen had previously been approved by the FDA for commercial marketing and use. This decision followed PTO precedent established in 1989 that allows patent extensions under ' 156 for combination drugs only if the patent covering the drug claims at least one active ingredient that had not previously been approved for commercial marketing or use.

The district court here looked to the plain meaning of the act's terms and of its legislative history to find that the PTO's interpretation was correct and that plaintiff was not entitled to a patent extension under ' 156.