Discover the key reasons why 80% of life sciences startups fail to secure their intellectual property. Learn essential strategies to avoid common pitfalls and safeguard your innovations.
Securing ‘Intellectual Property (IP)’ is necessary for the survival and prosperity of startups, especially in the competitive domain of life sciences, where rapid progress is being made. However, a shocking 80% of life sciences startup companies fail to properly protect their innovations. The results of such a mistake can be dire, loss in revenue, loss in competitive edge and most likely the shutting down of the startup itself. This article looks at what is causing this to happen so much, and provides you with a few tips on how you might be able to avoid falling into one of these traps in the future.
No complete IP plan
Inadequate Planning
One aspect of IP often overlooked by many technology and other startups is an appropriate 1st-generation patent strategy to support product development and market entry. This can lead to fractured IP protection which can open core-values of their innovation to piracy.
Absence of Expert Guidance
Pharma consulting firm in Boston and biotech consulting firm in Boston can be engaged to get the required knowledge to tread the IP landscape. Unfortunately, most startups do not engage early on with specialized legal counsel to customize solid IP protection.
Weak patent protection: The 14-year market exclusivity is insufficient.
Narrow Patent Claims
Many startups file patents with very narrow claims making it easy for competitors to work around. The broader the patent claim, the greater protection it offers and the harder it is for other people to use similar technologies.
Delayed Patent Filing
When it comes to patent process, timing is the key. Delays can mean missed opportunities, particularly if a competitor files a similar patent before you. Timeliness of patent applications should always be important to startups, especially those in the life sciences.
Inadequate IP Due Diligence
Overlooking Existing Patents
If you fail to properly carry out an intellectual property due diligence, it often can result into inadvertently falling foul of existing patents which can cause expensive legal battles and possible financial distress for a startup.
Overlooking its Freedom-to-Operate (FTO) Analysis
An extensive FTO analysis will also be important to consider when creating a new product, so that this does not infringe on existing patents. This is a critical step that many start-ups do not pay attention to, potentially exposing to significant legal risks.
Poorly Managed Trade Secrets
Useless Nondisclosure Agreements
Though trade secrets can have great value, they need to be protected. Judges and Juries decide who was first to invent through patents. Trade Secret Owners must rely on nondisclosure and confidentiality agreements. In many cases, especially with startups whose in house attorneys are not as influential and company documents are often generic or weak.
Lack of Internal Controls
Trade secrets must be protected by internal policies and controls. For example, mandatory training for employees and proper IT security are part of this concept. The startup should take the following steps to avoid both accidental and intentional leaks.
Undervaluing Regulatory Hurdles
Getting Through Regulatory Pathways
The life sciences sector operates in an inherently complex and rapidly changing regulatory environment. They need to know the regulatory requirements relating to their innovation so they are not slowed down by unseen risks that can cause legal issues later.
Engaging Regulatory Experts
Hiring a life science consulting firm in Boston could give you crucial details about what it takes to navigate regulatory pathways. These companies will assist startups to become compliant and facilitate the approval.
Poor IP Portfolio Management
Overlooking Portfolio Reviews
Regularly reviewing the IP portfolio helps to identify holes and vulnerabilities in protection, and opportunities to enhance it. Startups often overlook this and are left with bad or insufficient IP protection.
Not Aligning IP To Business Goals
A proper IP strategy should match the goals of a startup. So, the IP portfolio provides a competitive edge and lets you achieve long-term goals.
Limited Financial Resources
Budget Constraints
With start-ups typically working with restrictions on funding, IP protection often gets under-invested. However, a price of IP litigation or loss of competitive edge is much higher than what you would spend on strong IP protection in the first place.
Seeking External Funding
Lastly, seeking capital from investors that recognize the value of IP protection can supply the needed financial backing. This next step you will need to take in order to win investors over when seeking funding is your IP strategy.
Ignoring international IP protection
Overlooking global markets
A startup is the best example as it always keeps eye on its home markets to get the fast track entry but less attention and importance is given to International IP protection. Yet, in a life sciences sector that is global by its nature, long-term success can only be guaranteed if you have a strategy for protecting your innovation internationally.
How Different Regions Have Performed?
This is really important, as each country have their laws and rules regarding IP rights. It is important for startups to appreciate these differences and adapt their IP strategy accordingly.
Conclusion
Contact BioBoston Consulting or visit our website to find out how we can help your organization.
