Napp Pharmaceutical Holdings Ltd v Dr Reddy’s Laboratories (UK) Ltd and Sandoz Ltd [2016] EWHC 1517 (Pat)
This was a patent infringement action brought against two generic manufacturers seeking to launch buprenorphine pain relief dermal patches. Napp claimed that the generic products fell within the claims of two of their patents for such patches. The patents’ claims specified the percentage ranges of particular materials (active and excipients). The defendants said that their products fell outside the claimed ranges or that, if they did not, the claims were insufficiently precise. The issues included whether the percentages required were those used as ingredients in the manufacturing process or those measured in the final product and whether the numerical ranges should be interpreted as covering amounts outside the identified limits. There was also a dispute about how to determine infringement using statistical analysis of the results of sample testing (assaying being destructive).
The action was expedited and came to trial in early June, little more than 4 months after the claim was issued. After a three day trial with both technical and statistical evidence, Arnold J held that neither defendant’s product infringed the claims.
Napp has been given limited permission to appeal and the parties are seeking expedition of the appeal.
Michael Silverleaf QC and Benet Brandreth appeared for Dr Reddy’s and Anna Edwards-Stuart represented Sandoz