In the liability phase of a pharmaceutical patent infringement lawsuit, the branded drug manufacturer may offer evidence of commercial success that flows from the patent to support a finding of non-obviousness.
In the liability phase of a pharmaceutical patent infringement lawsuit, the branded drug manufacturer may offer evidence of commercial success that flows from the patent to support a finding of non-obviousness. Working with economics experts, Cornerstone Research has used economic analysis to answer the following questions on behalf of branded drug manufacturers in a number of cases: Is the drug a commercial success? If so, does the commercial success flow from the claimed invention of the patent or is it due instead to other factors such as marketing?
Some of the key indicators of commercial success that we have analyzed include substantial growth in sales and market share for a drug, premium pricing over competitors, rapid international diffusion, and widespread prescription drug plan formulary placement.
Once commercial success is established, we have used economic analysis to assess whether the success flows from the claimed invention, i.e., whether there is a nexus between the patent and the commercial success. We have also evaluated whether the pharmaceutical company’s marketing for the drug at issue is “excessive” and undermines a conclusion of a nexus.
With regard to establishing the nexus between the claimed invention and the commercial success, we have analyzed the responsiveness of sales to new information about drug benefits (such as new clinical trial results or FDA indication approvals) or patented formulation improvements (such as extended release formulations) and the inclusion of a drug on most major managed care drug formularies based on therapeutic considerations.
In our analyses of the role of marketing, we have compared the branded company’s marketing efforts to appropriate industry benchmarks, while accounting for factors that drive marketing intensity such as the stage in a drug’s life cycle, order of entry into a therapeutic category, and the arrival of new information about product quality.