Request By:
John Godfrey
Assistant General Counsel
Health and Administrative Laws
and Counsel, Kentucky Drug
Formulary Council
Department for Human Resources
275 East Main Street
Frankfort, Kentucky 40621
Opinion
Opinion By: Robert F. Stephens, Attorney General; Nancy S. Marksberry, Assistant Attorney General
This is in response to your request for an opinion regarding the consideration of the patent status of certain drugs by the Kentucky Drug Formulary Counsel. The question arises as a result of a petition by Pfizer, Inc., to remove doxycycline drug products from the Kentucky Drug Formulary. You ask whether the Council should:
1. Assume that the Pfizer patent is valid and repeal 902 KAR 1:045 relating to doxycycline? or;
2. Continue the regulation in effect, pending the outcome of litigation involving patent infringement claims? or;
3. Ignore the patent status of drugs in determining "therapeutic equivalency" pursuant to KRS 217.819?
It is the opinion of this Office that the Kentucky Drug Formulary Council may ignore the patent status of drugs in determining "therapeutic equivalency" pursuant to KRS 217.819.
KRS 217.819(1) provides:
The Council shall prepare a formulary of drugs and pharmaceuticals with their generic or chemical names, if any, that are determined by the council to be therapeutically equivalent to specified brand name drugs and pharmaceuticals.
The Kentucky Drug Formulary Council is charged with the determination of therapeutically equivalent drugs. The patent status of those drugs and pharmaceuticals is an entirely separate issue with which the Council need not concern itself. The adjudication of the validity or invalidity of patents rests solely within the jurisdiction of the federal courts, not state agencies.
We see no conflict with the Kentucky Drug Formulary Act and the federal patent laws. Pharmacists are required to fill prescriptions in accordance with KRS 217.822, which provides, in part:
When a pharmacist receives a prescription for a brand name drug for which one (1) or more equivalent drugs are listed in the formulary prepared by the drug formulary council, he shall select the lowest priced therapeutically equivalent drug listed by the drug formulary council which he has in stock, unless otherwise instructed by the purchaser or his physician. . . .
Pharmacists must substitute those therapeutically equivalent drugs listed in the formulary, as required by the use of the mandatory "shall." KRS 446.010(29). At first blush, this appears to require pharmacists to either substitute generic drugs for patented brand name drugs or violate state law. However, pharmacists are required to substitute only those therapeutically equivalent drugs listed in the formulary which they have in stock. The Kentucky Drug Formulary Act does not require pharmacists to sell a therapeutically equivalent drug in violation of a patent, since they need not stock infringing drugs or pharmaceuticals. Pharmaceutical
Society of New York, Inc. v. Lefkowitz, F.2d (2d Cir. 1978).
In summary, the Kentucky Drug Formulary Council need not consider the patent status of drugs when determining therapeutic equivalency for purposes of listing generic drugs in the Kentucky Drug Formulary.