- Court Provides Method for Assessing Quantum of Teva's Section 8 Damages
- April 28, 2017 | Authors: Jillian Brenner; Adrian J. Howard; Beverley Moore; Chantal Saunders
- Law Firm: Borden Ladner Gervais LLP - Ottawa Office
In this case, the parties had asked the Court for specific rulings and guidance in calculating Teva's section 8 damages. The parties were in agreement that Teva is entitled to recover its losses or damages, but disagreed about many important aspects of how those losses should be determined.
On the issue of the relevant period for damages, both parties agreed that the end date of the liability period was February 14, 2013, the day the underlying applications were discontinued. Despite Teva's submissions for an earlier start date, the Court concluded that the patent hold date in August 2010 was the appropriate start date. The Court found that Ratiopharm (Teva took over Ratiopharm) had taken no steps in the real world to expedite the patent hold letter or even to inquire into its status, or to expedite its product monograph.
In determining Teva's share of the generic market, the Court concluded that there would have been no real impediments in the but-for world for Teva to launch Ratiopharm pregabalin on or about the patent hold date. The Court also found that there would have been no other generics who could have supplied the market at that time.
The Court considered the competitive landscape in the but-for world from third party generics, authorized generics, and Pfizer's own generic GenMed. However, there was insufficient evidence that third party generics could and would have entered the pregabalin market during the liability period, or that some other generic would have entered into an authorized generic agreement. The Court also found that Pfizer failed to establish that it would have launched its GenMed product, or that it would have been an effective competitor even if it had launched.
The Court then considered the other relevant factors, including formulary listing, pricing, trade-spend and other miscellaneous accounting and cost issues.