In biotechnology you cannot get very far without solid IP. For a startup company, having a solid IP strategy is an essential requirement to maximizing value. Muna Abu-Shaar, PhD, Founder of Biospark Intellectual Property Law, presented core elements to protecting IP during Biotech Startup Day in Boston. Here is what we learned:
- Avoid prior art or making any non-confidential disclosures. This means you need to file early and often.
- Provide sufficient written claims in a patent. This means developing the data to support the claims—this is a point of emphasis.
- Show that the claimed invention is distinct from natural products. This means developing specific data that highlights the “marked differences” between your invention and natural products.
- If you are a platform company, consider trade secrets as part of the IP strategy—why spell out how you do something if you don’t have to?
- If you think you are blocked from pursuing an idea due to preexisting IP, be aware of the “safe harbor” provision that exempts infringement activities relating to development of data for submission to the FDA.
- Know your freedom to operate (FTO), which will require you to know competitive IP landscape and patents on other molecules under development.
- It is prudent to lock up your IP before speaking to other companies to avoid the stealing of unprotected ideas.
“Protecting your IP” was part of Biotech Startup Day, a one-day dedicated program specifically designed for early stage projects and young companies to get on the radar of the global life science community. Biotech Startup Day is held during BioPharm America™ 2016, Boston’s exclusive life science partnering event.
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