Your most effective IP strategy begins early during product development.
The state of the art in IP strategy changes and evolves – as recent court decisions and the new patent law and new FDA biologics regulations demonstrate. And strategic considerations are different for small molecules, biologics, devices and diagnostics. So, if you wait to plan your IP strategy until you see what comes out of the lab, then you’ve missed the most crucial opportunity to build asset value and secure the partnerships that will drive ultimate success. I’ve designed successful IP strategies for the pipeline products of major pharmaceutical companies, small biotech and medical device start-ups, not-for-profit research institutes and both Federal and university technology transfer programs.
Patent protection on compositions of matter isn’t enough — you need a portfolio of IP and regulatory assets that build value and facilitate business transactions.
Accomplishing this requires a facile understanding of the competitive landscape and of your freedom to operate. It also requires early design and planned spending for R&D and clinical trials in order to optimize the ultimate mix of available patent and regulatory exclusivities. While patent attorneys are essential members of the IP strategy team, they typically aren’t cross-trained to understand the details of all of the relevant business considerations. I’ve had extensive experience in business development, negotiations, patent law and managing the NIH’s world-class technology transfer office.
You need to build exceptional IP value and investor confidence.
You want to spend the right amount of money to secure the right IP to someday close a deal or secure investor funding – but you don’t want to file applications in every country in the world and you’d like to know what big biopharma and major investors actually will care about when they conduct due diligence on your IP portfolio. I design intellectual property portfolios at an early stage to align my clients’ R&D plans and budgets with an optimal patent and regulatory exclusivity position for their products. And I manage patent portfolios and have extensive experience negotiating collaboration agreements and other technology transactions involving IP. So I know how to build IP value that matters.
You want to conduct due diligence on another company or prepare your own enterprise for someone else’s due diligence study.
I conduct due diligence studies, both for investors and M&A evaluations – also for corporate boards and management who want to identify and resolve problems in advance or who want to take steps to enhance IP value before a deal is negotiated.