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Life Sciences
The FTI Intellectual Property group has a deep breadth of experience in intellectual property matters in the Life Sciences industries. Representative intellectual property engagements are described below:
Assisted a defendant, who manufactured laboratory-sterilizing equipment, with a litigation brought by a competitor. The defendant hired a former sales employee of its competitor and the competitor was claiming lost profit, which we evaluated.
Assisted a defendant in a copyright litigation in calculating damages relating to a pharmaceutical data product.
Prepared expert testimony for plaintiffs in patent infringement suit involving a pediatric vaccine. Addressed lost profits, price erosion and reasonable royalty base and rate.
Retained by plaintiffs in patent infringement claim related to materials and methods used in the production of human proteins by recombinant DNA technology. Issues addressed included the determination of reasonable royalty rate and the appropriate royalty base.
Assisted a large nonprofit pharmaceutical research and development organization to determine licensing opportunities for a patent portfolio related to a drug still in the early phases of testing and development. The project included analyzing the patent landscape of existing and potential future competing products, identification of key issues affecting the market value of the portfolio, determination of a reasonable range of compensation to be expected licensing rights to the portfolio and help in contacting and negotiating with potential licensees.
Assisted one of the preeminent
U.S.
biotech companies in the quantification of damages related to assertions that other biotech and pharmaceutical companies were infringing upon their patented drug development technology. Analyses preformed included the calculation of reasonable royalty rates for each of the infringers, and research and evaluation of the forecast market for the potential drug targets. Assessed the probabilities of success that each of the infringers would successfully developed a viable drug target, and considered such issues as time to market and first/second/third to market scenarios and their impact on damages.
Assisted a company and its related consortium of universities in a patent and trade secret dispute related to Amyloid compounds. These compounds are currently in clinical trials to treat Amyloid related diseases such as Alzheimer's and diabetes. This project will involved valuing the patents and patent applications, and the trade secret information, in several different contexts.
Assisted a medical device company developing a reasonable royalty rate for Transmyocardial Revascularization or "heart laser" technology. Because of the limited number of competitors, the finite nature of the market, and the high cost of the equipment, royalty rate considerations included "first to market" advantage and market saturation. This analysis also required an understanding of the pre-market approval process for medical technology.
Assisted a biotech company in the evaluation of the economic substance of certain of its license agreements with a particular licensor. Collected and compiled product and sales information and calculated license fees due to the licensor under several different interpretations of the agreements. The analyses provided counsel the necessary economic scenarios, which facilitated the settlement of claims filed by the licensor.
Retained by the defendant in a patent infringement suit involving the use of a cancer treatment drug with a next generation drug delivery system. Analyzed defendants overall profitability, product line profitability and historical financial projections. Analysis also included a review of the companies marketing and sales information as well as relevant licensing agreement and industry information.
Quantification of lost profits was required in association with alleged infringement of a therapeutic and prophylactic drug developed from genetically modified virus-like particles to be used to destroy or delay the development of the human papilloma virus.
Developed a generic licensing pricing model for a life sciences consortium to be used by future practitioners in the blood plasma industry to determine a reasonable royalty for products and processes not yet invented. Analysis included certain industry figures, government regulatory impacts, comparable product developments, and consumer purchasing habits among other factors.
Assisted a research organization in determining the fair market royalty rate for licensing the rights to a very valuable new technology in the drug industry. Our activities included the research and analysis of various factors that are expected to impact the royalty rate and establishment of a consistent methodology to employ for licensing purposes. Some of the factors we considered include market and industry conditions, advantages and characteristics of the new technology, competitive technologies, public policy issues, and regulatory issues, among other things. The result of our work was a licensing notebook that described and documented the processes and procedures for calculating a royalty.
Directed team in constructing a negotiation strategy and providing real time valuation assistance during negotiations over rights to a drug expected to be a blockbuster for a very well known health care provider and research organization.
Created a pharmaceutical industry model to project the market for a generic drug and the impact of market entry order on sales and pricing in that market. Analysis included substitution rates, pipeline characteristics, market comparables, and number of competitors. Models indicated, among other things, first-mover advantages in various circumstances and a value associated with that advantage.
Prepared, distributed, summarized and analyzed the results of a commissioned survey of world-wide patenting practices amongst 16 major pharmaceutical companies for a variety of different patenting situations.
Conducted an intellectual asset management diagnostic on a biotech company specializing in cancer therapeutics. The objective was to evaluate the company’s infrastructure and determine its effectiveness for managing their intellectual assets. The project revolved around analyzing how the portfolio was managed, the supporting IT systems, incentives and compensation, and knowledge sharing techniques.
For manufacturer of optical equipment / lasers equipment, developed estimate of economic damages arising from alleged infringement of Vertical Cavity Surface Emitting Laser (VCSEL) technology. Analysis focused on definition of relevant markets, customer acceptance and profits margins and the entitlement to various forms of damages. Developed estimate of reasonable royalty damages.
For a medical products manufacturer, provided estimate of economic damages arising from alleged patent infringement of emergency medical extrication collars. Developed estimate of lost profit damages (including examination of manufacturing and marketing capabilities, evaluation of alleged non-infringing alternatives, and derivation of incremental profit margins) based on proportionate market share.
For a diversified healthcare/pharmaceutical company, developed estimate of the type and amount of economic damages resulting from patent infringement of diagnostic and guiding catheters. Analysis focused on incremental costs and profit margins in the
U.S.
and international markets, definition of relevant markets, manufacturing efficiencies, distribution channels and customer acceptance. Also analyzed economic factors relevant to a hypothetical negotiation for purposes of setting a reasonable royalty rate
Conducted a royalty audit on behalf of a biotechnology company that had entered into a joint business arrangement with a major pharmaceutical. The pharmaceutical had the responsibility to calculate and pay royalties based on net profits. The joint business had both
U.S.
and international operations. We reviewed the business operations and royalty calculations in several of the primary locations and identified numerous compliance issues, including improper cost allocations and the inclusion of contractually disallowed costs. The findings resulted in substantial recoveries for the client.
Assisted in the damages analysis and preparation of expert reports in a patent infringement suit involving orthopedic surgical instruments. Areas of involvement included an analysis of the arthroscopy market, competitive market share, and the profitability of the instruments. Applied the
Panduit
factors and
Georgia-Pacific
factors to determine the appropriate lost profits and reasonable royalty damages.
Assisted in the damages analysis and preparation of expert reports in a patent infringement case involving an antibiotic formulation. Analyzed plaintiff’s overall profitability, product line profitability, and sales and distribution contracts. Analysis also included a review of plaintiff’s marketing and sales information as well as relevant licensing agreements and industry information. Applied the Panduit factors and Georgia-Pacific factors to determine the appropriate lost profits and reasonable royalty damages. Also assisted in the deposition of witnesses and critique of opposing expert reports.
Advised Trustee for diabetic test strip manufacturer in pursuit of preferential transfer claims. At issue was corporate solvency when various payments were made. Solvency hinged on the contingent value of patent infringement damages. Issues assessed included lost profits, reasonable royalties, corrective advertising, enhanced damages, attorney's fees and prejudgment interest.
Retained by the plaintiff in a patent infringement matter. Calculated lost profits and determined a reasonable royalty on a white blood cell hematology control technology. Analysis included assessing the market and profitability of hematology instruments, reagents and controls and an analysis of various licensing, technical and business factors to determine an appropriate royalty rate. The dispute involved a manufacturer and processor of human blood controls against a leading hematology instrument manufacturer.
Retained in a patent infringement matter regarding patents covering white blood cell hematology control technology. The dispute involved a manufacturer and processor of human blood controls against a leading hematology instrument manufacturer. Calculated lost profits and determined a reasonable royalty. Analysis included assessing the market and profitability of hematology instruments, reagents and controls.
Engaged by defense counsel involved in a patent infringement dispute related to aortic stents. Provided analysis of lost profits and reasonable royalty.Matter pending.
Engaged by plaintiff’s counsel involved in trademark dispute related to high profile pharmaceuticals. Analysis involved assessment of lost profits, defendant’s profits and corrective advertising.
Prepared analysis of lost profits for plaintiff's counsel representing a medical device company in a patent infringement matter. Infringement related to the sale of spinal implants in both the
U.S.
and abroad.
Engaged by plaintiff's counsel representing a large medical device manufacturer in a patent infringement matter involving knee implants. Analysis included both lost profits and reasonable royalty.
Retained by the Plaintiff in a patent infringement suit involving blade technology. The technology is used in performing refractive surgery for vision correction. The analysis involved the review of each party's sales, cost and profits in the assessment of a reasonable royalty. The case settled before trial.
Assisted the Plaintiff in a patent infringement case involving the use of stent technology for the treatment of Abdominal Aortic Aneurysms. The analysis involved a review of the company’s domestic and international sales, costs and profits information in conjunction with various industry licensing rates.
Assisted the plaintiff in a patent infringement suit involving multi-focal intraocular lenses used in cataract surgery. The analysis involved a detailed review of the defendant’s sales, costs and profit information as well as existing license agreements in the determination of an appropriate royalty.
Retained by the defendant in a patent infringement suit involving the use of a cancer treatment drug with a next generation drug delivery system. Analyzed defendants overall profitability, product line profitability and historical financial projections. Analysis also included a review of the companies marketing and sales information as well as relevant licensing agreement and industry information.
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