eBay decision has not led to a reduction in patent protections for biotech- these cases are still easy for patentees to win
Aaron Stiefel and Krista Carter in 2016
Senior counsel @ Arnold and Porter; 10 Years Later—Impact of eBay on Patent Injunctions in the Life Sciences; Arnold & Porter firm; https://www.arnoldporter.com/en/perspectives/publications/2016/06/2016_06_21_10_years_later_impact_of_ebay_13037
Where Are We Now? The more things change, the more they stay the same. At least this is true for most life sciences cases in a post-eBay world. While many recent case law developments have tended to limit patentee rights and make enforcement more difficult (e.g., the rising § 101 and §112 definiteness bars and the availability of new post-grant procedures), eBay’s requirement that courts apply the traditional four-factor injunction standard for patent cases has not drastically affected the ability of life sciences companies to obtain injunctions after determinations that their patents were infringed and not invalid. Patentees do, however, have to make more of an effort now than pre-eBay to prove irreparable harm and the inadequacy of monetary damages. For life sciences companies where the value of market exclusivity is paramount, these first two factors should be relatively straight-forward to establish in most cases. However, they may be overcome by the public interest factor, which continues to be the most common barrier to an injunction for life sciences companies. And where market exclusivity is not of paramount value to the patentee (as demonstrated through licensing practices), or where the public interest would objectively be disserved by an injunction, declining to seek a permanent injunction may save valuable time and resources while maintaining credibility with the court and the public. The last decade of patent injunction case law provides some lessons learned. A few key take-aways for life sciences companies seeking to enforce their patent rights include: Consider the injunction case during pre-litigation due diligence to decide whether an injunction would be appropriate based on public interest implications and also whether it is worth the necessary time and resources to mount a fact-intensive injunction case based on the likelihood an injunction would be granted; If the company decides to seek an injunction, start marshaling the evidence early to be able to create a sufficient record to establish that the eBay factors favor an injunction and rebut any anticipated arguments against an injunction; Especially if the infringing product is already on the market, identify prospective harms, such as specific customers the patentee may lose to the competitor, the company’s plans to reduce prices to compete, and the quarter-over-quarter loss of market share that will likely continue if the infringing activity is not enjoined. To prove irreparable harm and inadequacy of monetary damages: Build the story and evidence to show the importance of the right to exclude and market exclusivity to the company’s business model, and the parade of horrible harms that would occur if forced to license valuable patent rights to a competitor or other player in the market; and Explain why existing license agreements, if any, do not mandate a finding that monetary damages would be adequate; for example, because the licenses were not to competitors, were to small, non-threatening market players, or were cross-licenses with other companies (even competitors) where the value of the agreement exceeded the patent rights because they ended lengthy, expensive litigation. To prove an injunction would not disserve the public interest: If possible, seek an injunction prior to the launch of the infringing product to preclude a public interest argument of physician or patient preference for or reliance on the infringing product, and also make the point that any alleged benefit to the public is mere speculation; If the infringing product has already launched, marshal evidence that it does not provide patients with any concrete medical or safety benefits beyond the patented products already on the market; and Where the public interest factor may militate against a complete injunction, be creative in fashioning requested injunctive relief to minimize effect on public interest while preserving as much market exclusivity as practical. In sum, while eBay has not dramatically altered the landscape for patent cases in the life sciences industry, it has created some curves in the road to obtaining permanent injunctions—curves that can best be traversed by understanding the trends in the post-eBay case law and preparing accordingly.