Background

The Ranbaxy vs. Apotex case involved a dispute over a patent related to a process for making amorphous cefuroxime axetil, a broad-spectrum antibiotic. The case study highlights the importance of checking for patent rights before launching a product.

Plaintiff- Appellee: Ranbaxy Laboratories Limited (Indian multinational pharmaceutical company), an innovator & generic drug manufacturing company in India.

Ranbaxy used the same process for manufacturing of  cefuroxime axetil as claimed in the Apotex patent, but with acetic acid as a polar solvent, that was surrendered by Apotex during patent examination/ prosecution.

Defendant- Appellant: Apotex (Canadian pharmaceutical corporation), is the largest producer of generic drugs in Canada.

• US5847118: Patent owned for process for preparing amorphous cefuroxime axetil, claiming highly polar organic solvent (sulfoxides, amides and formic acid).
• Apotex asserted its patent under the Doctrine of Equivalents (DOE), admitting that there was no literal infringement by Ranbaxy by use of acetic acid.

Court proceedings

The district court found that prosecution history estoppel precluded Apotex’s reliance on the DOE because:

(1) Apotex had submitted a narrowing amendment for reasons related to patentability, and

(2) Apotex had surrendered solvents of the same polarity as acetone, namely, acetic acid.

The Federal Circuit Court of Appeals affirmed the New Jersey District Court’s denial of a preliminary injunction sought by Apotex against Ranbaxy to prevent them from using one of Apotex’s patented methods.

Decision

• The Federal Circuit found that Apotex could not rebut the presumption of surrender of equivalents on the grounds that the equivalent would have been unforeseeable at the time of the amendment, finding specifically that acetic acid was readily known to be equivalent to formic acid at the time the amendment was made.
• The Supreme Court instructed that Federal Courts could presume that patentees abandon the right to protection under the doctrine of equivalents with respect to any elements that are contained in an amendment, but that patentees could rebut this presumption and claim equivalent protection in such cases if they can prove that the equivalent could not reasonably have been foreseen at the time of drafting the amendment.

Summary

The case study highlights the importance of conducting FTO analysis before a product launch. It illustrates how IP protection could be an important mechanism to gain competitive-edge in market, stop infringement losses and also promote innovation and commercialization of novel product for benefit of the society.

At PATHtoIP®, we ensure that every client receives exceptional results and  insights through high-quality Intellectual Property research. As an experienced firm, we are dedicated to providing IP protection and delivering results capable of reaching your goals.