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Patent Disputes & Contract Litigation

Brattle’s intellectual property experts have an in-depth familiarity with all of the analyses and types of testimony required in patent cases involving biologics, pharmaceuticals, and medical devices. We have extensive experience quantifying economic damages in both lost profits and reasonable royalty cases. In addition, we frequently provide expert analysis on the extent of the commercial success achieved by a drug, as well as the nexus between the at-issue patent and that commercial success. In numerous cases, we have been involved determining whether a patent owner requires injunctive relief to prevent irreparable harm. 

Brattle has also assessed damages in numerous breach of contract cases for life sciences companies. To calculate damages in these cases, our experts have rigorously analyzed all aspects of the world “but for” the alleged breach, including quantitative and qualitative analyses of the underlying regulatory environment, the extent of competition among arguably similar therapies, ex ante expectations of future sales and profitability, historical pricing and sales trends, and customary interpretation of specific contractual terms.

Engagements
REPRESENTATIVE ENGAGEMENTS

Below is a list of representative engagements for our Patent Disputes & Contract Litigation practice.

Co-marketing agreement dispute

On behalf of a medical device company that had developed an innovative treatment for a common urological condition, Brattle quantified the damages resulting from failure of the company’s marketing partner to live up to the terms of its marketing and distribution agreement. This failure, which occurred during a point in time when several competing therapies were entering the market, allowed competitors to become established during what would otherwise have been the device company’s primary opportunity to win market share. Our team developed an econometric model of the adoption of new therapies by physicians and their subsequent supplier loyalty to their original suppliers to estimate the device company’s lost sales.

Commercial success analysis

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 drugs’ 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.

Consultation and market analysis

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 the first company to bring an innovative medical device of this nature to market could expect to enjoy.

Damages analysis in the pharmaceutical industry

Brattle experts have calculated lost profits and/or reasonable royalties in a number of disputes involving biologic drugs and conventional pharmaceuticals (including over-the-counter (OTC) drugs.) In these engagements, we have provided economic assessments of the but-for world, in which the alleged patent infringement did not take place.  In constructing this but-for world, we have paid particular attention to the impact of patents on launch timing, the availability of non-infringing alternatives, and the extent to which infringement may have made the drug more attractive relative to competing therapies.  We have also evaluated the extent to which the branded drugs’ 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.

Injunctions and at-risk entry

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.

Premature termination claim

For a major pharmaceutical company, Brattle provided expert testimony before an arbitration panel on the damages that the company suffered as a result of the termination of a co-marketing agreement for a prescription hormonal replacement therapy. The client’s co-marketing partner terminated the agreement just as the product reached a breakeven point, and well before the agreement was due to expire. Our expert quantified the profits that the pharmaceutical company would have earned had the agreement run its expected course, as well as the profits the company could have expected to earn on its existing portfolio of products had it never entered into the agreement. In response to Brattle’s testimony, the arbitration panel awarded the pharmaceutical company approximately $60 million in damages.

Promotional efforts dispute

Brattle was engaged by a large pharmaceutical manufacturer to evaluate whether the manufacturer had met its contractual obligations for promoting a product that it had licensed from a smaller drug company. We presented evidence concerning the probability that a drug in development would eventually be approved by the FDA and evaluated the plaintiff’s damage estimates.

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