Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ROBINS' MICRO-K EXTENCAPS DOSAGE PATENT HELD INVALID

Executive Summary

ROBINS' MICRO-K EXTENCAPS DOSAGE PATENT HELD INVALID on grounds of "obviousness," Columbus, Ohio Federal Court Judge James Graham determined on April 18. Graham's ruling invalidates the patent for the extended release/microencapsulation mechanism used in the company's top-selling potassium chloride product. American Home Products' A. H. Robins filed a patent infringement suit against Erbamont subsidiary Adria Labs in October 1989. Robins charged that Adria Labs' K-Lease potassium chloride capsules with myristic acid-treated shell walls infringed the company's patent for a "Controlled-Release Potassium Dosage Form." However, Graham ruled that Robins' patent was invalid because it involved technology "which is taught or obvious in view of prior art." In his decision against Robins, Graham noted that the basic chemical processes involved in the Micro-K dosage form -- the use of microencapsulation techniques and surfactants to control the dispersibility patterns of drug substances -- were "well known in the pharmaceutical art and had been known since the 1960s." Graham wrote that even if the court were to consider the Micro-K patent valid, Robins would still be unable to claim patent infringment because of differences in the two products' chemical formulations and modes of action. "Myristic acid in the shell wall of the Adria microcapsules does not perform the same function in the same way to obtain the same result as the hydrophilic surfactant external to the microcapsules described in the [Micro-K] patent," the decision states. Still pending in the dispute is a 1989 counterclaim filed by Adria parent Erbamont alleging that Robins "brought their suit in a bad faith attempt to exclude competitors from the market." Adria received an ANDA for K-Lease on April 1990 and has been marketing their version of the extended-release potassium chloride since June. If the court's rule in favor of Erbamont on the counterclaim, the company will receive financial damages. Robins has not yet announced whether they intend to appeal Judge Graham's decision.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS019124

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel