Despite massive investments in research and development, pharmaceutical companies can never be certain which compounds will reach the market. For every successful compound, countless resources are spent on research, trials, regulatory processes and other, unsuccessful compounds. This means that when a new drug is brought to market, strong patent protections are critical to recouping these expenses and ensuring return on investment. With a strong patent litigation team in place, it is possible to both protect market share and extend a product’s life span by effectively defending against patent infringements.
An IP lawyer is no stronger than his team
A carefully and meticulously drafted patent is, of course, a prerequisite for any successful innovation. This is true even for patent rights of less commercial value which, if infringed, can often be profitably settled out of court through licensing or other agreements. But when a valuable pharmaceutical patent is infringed, the patent holder needs to rapidly mobilise the most skillful team available to enforce and defend it. This demands an IP lawyer with a highly successful track record and specific expertise in pharmaceutical patent litigation. Equally important, however, is the litigation support team with whom he or she chooses to collaborate.
To successfully enforce patent rights, the team must be familiar with the technical and legal aspects of the case and be capable of discussing them with the lawyer on an even level. For defence of life science patents, an ideal litigation support team would include:
- A top-level patent attorney with extensive litigation experience as well as knowledge of local practice and IP case law.
- One or more patent attorneys with substantial technical expertise in the specific chemistry and biotechnology involved in the case.
- A European Patent Attorney (EPA) with significant and current knowledge of European IP case law and practice.
- An experienced translator of technical and legal documentation and court exhibits.
A patent proprietor may also choose to use the same team to assist IP lawyers on parallel cases in other jurisdictions. By eliminating the learning curve needed for new patent attorneys to understand the same complex legal and technical details of the patent for each case, significant savings can be achieved.
Injunctions require swift action
In markets such as Scandinavia, where generic substitution rules apply, the appearance of one or more generic products may lead to an almost complete loss of market share for the original product within just a few months, or even weeks. In other countries the process of market loss may occur more slowly, but often with equally devastating results. In such cases, receiving a preliminary injunction may be crucial to the original product’s survival. And since the original producer will lose revenue every day that an infringing competitor is allowed to market its product, the sooner an injunction can be obtained, the better.
This makes it critical for a patent proprietor to be able to mobilise an experienced team of patent attorneys and translators to work quickly with the IP lawyer in charge of the case. When faced with an injunction, both the patent proprietor and the potential infringer need to respond as quickly as possible. In these situations valuable time can be saved by choosing an experienced litigation support team with substantial experience in the enforcement of life science patents in collaboration with leading IP lawyers.
Early preparation and communication pay off
In some cases a single litigation case can take up to ten years to carry out, including early case preparation and court proceedings, before a final court decision has been reached. Since the litigation support team will assist the IP lawyer throughout this process, assembling the right team from the very beginning is a clear advantage in terms of both cost and quality. When it comes to successful patent enforcement, communication is also critical. There must be a mutual understanding between the patent proprietor and the entire team of the importance of the case, the litigation strategy and the ongoing costs of enforcement. All of these must be continuously monitored, communicated and executed according to a well-defined plan.
If properly prepared and involved early in the process, an experienced and creative litigation support team will prove its value long before the day when a patent must be defended in court. Having defended a number of previous cases, they will be able to clearly distinguish between vulnerable, possibly unenforceable patents and those that are clear and well supported with suitable fallback positions.
Finding the best experts
In Scandinavia, the number of life science patent litigation cases per year is relatively small. As a rule, most of them are also technically complex. In order to increase the chances of a positive outcome, the science involved in such cases must therefore be presented to the court in an easily understandable and educational manner. Thus, at a very early stage in the process, highly educated experts must be identified to explain the scientific facts of the case as simply as possible in a declaration and by witness testimony in court. A well-connected litigation support team will be able to identify the best experts for the purpose. In some cases it may also be necessary to bring in an independent patent attorney who is able to provide neutral declarations in support of the case, both as regards the infringement as such and the validity of the patent(s) in suit.