Pharmaceutical and medical device startups face a unique set of challenges, including but not limited to, hiring, conducting clinical trials and finding investors. These stumbling blocks necessitate the assembly of a strong legal team early in the process, to better mitigate risks and establish a robust company foundation, as observed by Tucker Ellis attorneys Mollie Benedict and J. Derek Mason in Bloomberg Law.
This need for proactive legal team arises quite early, generally with the development of an invention; a new drug, treatment method, medical device or test instantly triggers the assembling of the legal task force, composed primarily of Intellectual Property (IP), corporate and litigation counsel.
In the pharmaceutical and medical device industry, reliance on IP, especially patents, is paramount to protect proprietary rights and establish an exclusive operational area. Hence, IP counsel often form the earliest backbone of the legal team for pharma-centric startups, guiding the company through IP and brand protection strategies.
One recommendation urges companies to file patent applications early and often to start building a substantial patent portfolio. Taking a jet start, even before a robust corporate structure or business plan is in place, can help the enterprise carve out its own exclusive territory thereby keeping competitors at an arm’s length. This watchdog role extends to looking out for potential infringers of the company’s trademarks and domain names.
With patent protection in progress, startups can then enlist the help of corporate counsel for official company formation, including crafting corporate governance documents and employment agreements. The later stages of company development see the IP counsel performing ‘freedom to operate’ searches and readying formal FTO opinions to ensure that infringement on third-party IP is unlikely.
As the company grows, the protection of new discoveries becomes crucial alongside preparing for potential litigation. Threats to intellectual property, contract disputes with suppliers, employment litigation and product liability litigation from alleged product harm are all sources of possible lawsuits. In this context, enlisting a litigation counsel team can help the company bolster its defense against such claims. Furthermore, engaging interested litigation counsel can also aid in preventative measures and pre-litigation preparation.
The essence of navigating the high-stakes legal landscape of the pharmaceutical and medical device industry lies in melding together a strong legal team comprising of IP, corporate, and litigation counsel. This combination can prove instrumental in mitigating risks and ensuring a formidable presence in a highly competitive market.