Brattle’s intellectual property experts have an in-depth familiarity with all of the analyses and types of testimony that are required in patent cases in the pharmaceutical and medical device industries. In particular, we have extensive experience quantifying economic damages in both lost profits and reasonable royalty cases. We also regularly provide testimony on commercial success, an issue that commonly arises when drug-related patents are subject to an invalidity challenge. In addition, we frequently provide expert analysis for clients involved in injunction cases, where the goal is to determine if the competitive harm arising from patent infringement can be addressed through a damages award or whether the patent owner requires injunctive relief to prevent irreparable harm.
For numerous cases in which generic drug manufacturers alleged that the patents on a branded drug were invalid due to obviousness, Brattle has prepared expert reports analyzing the commercial success achieved by drugs covered by the patents at issue. These reports explained economic criteria for commercial success, empirically evaluated drugs’ success with respect to those criteria, and assessed evidence regarding the strength of the nexus between the drug’s patented properties and its sales. Our analyses have involved composition, formulation, and method of use patents. Our work has involved treatments for a wide array of conditions, including various types of cancer, hormone deficiency, acne, GERD, and IBS.
Brattle experts have extensive experience in estimating damages for patent infringement matters in the medical device industry. For example, in a recent complex case, the plaintiff —who had asserted three patents against the defendant— was, in turn, accused of infringing one of the defendant’s patents. Brattle’s expert analyzed the manner in which these devices were used, the related products used with them in surgery, and the nature of competition offered by alternative surgical approaches. Our expert also examined the client’s manufacturing facilities and production systems, its transfer pricing policies, and the effects these had on the lost profits of the subsidiary that owned the patents in suit. At trial our expert testified regarding both lost profits and reasonable royalty damages. The jury awarded Brattle’s client over $100 million in damages.
Brattle Group experts have calculated lost profits and/or reasonable royalties in a number of disputes involving prescription and over the counter (OTC) drugs. In these engagements, we have provided economic assessments of customers’ branded and generic alternatives to the drug at issue. We have also evaluated the extent to which the branded drug’s sales can be attributed to its manufacturer’s marketing assets and other intangibles in order to assess the plaintiffs likely sales in the “but for” world. Drugs analyzed include those used to treat asthma and other respiratory conditions, HIV/AIDS, GERD, and bacterial infections.
Brattle economists have worked on a number of cases in which branded drugs have been faced with patent challenges by generic companies under the Hatch-Waxman Act. In many of these cases, the generic company has sought to enter the market “at risk”—i.e., prior to resolution of the patent suit—and the branded drug company has responded with a request for a preliminary injunction. In these injunction cases, we have been asked to evaluate whether the branded drug company would suffer irreparable harm due to “at risk” generic entry. We have addressed this question by analyzing the likely impact of such entry on the branded drug company’s sales, research incentives, marketing efforts, employment, and manufacturing facilities. We have also investigated the impact of such entry on the branded drug’s formulary status and the goodwill of its customers.
In a patent infringement lawsuit involving artificial heart valves, Brattle provided consultation and market analysis. The technology in question enabled replacement of damaged heart valves via transluminal catheter, eliminating the need for invasive open heart surgery. Brattle work addressed the relationship between thoracic surgeons and interventional cardiologists in the commercialization of this technology, identified a series of medical innovations that share important characteristics with it, and discussed some of the specific advantages that is the first company to bring an innovative medical device of this nature to market could expect to enjoy.