Start-Up Company IP Resources
It has been a pleasure working with Chris Molineaux, President of Pennsylvania Bio. His incredible staff (including Greg Byrnes, Cindy Murray and Linda Brueckman) and I have worked together to provide resources
to start-up companies so that technologies that might otherwise "wilt
on the vine" instead become seeds of commercially viable enterprises.
Part of this strategy is to provide targeted information resources to
innovators so that they can more effectively research legal, business
and scientific issues when forming a company.
I provided the links below during a presentation at the Pennsylvania Bio Knowledge Fair so that the audiences (start-up
companies and individual entrepreneurs) could directly view information that experienced lawyers
and investors, among others, consider when creating or evaluating an
intellectual property strategy. Many of the following resources are
overlooked by entrepreneurs in starting their businesses, and utilizing
the information in legal and business models is something that is often
lost in classrooms and in books. However, the value of these resources
in providing competitive intelligence, regulatory insight and market
clarity should be recognized as start-up companies adapt to and evolve
with market conditions. It is understood that the listing below is far
from complete and the information obtained from these resources should
be put in the context of broader legal and business strategies.
IP Strategy Informed by the Commercialization Process
Legal Strategy in Context:
Overview of legal issues associated
with biotechnology, pharmaceutical and medical device innovation, the
path to market, and post-market considerations:
Life Sciences Regulatory and Compliance (Small Molecules,
Biologics, Medical Devices)
- MedTechInsight.com Business information and intelligence on new trends, technologies, and
companies in the medical device, diagnostics, and biotech marketplace
- U.S.
Food & Drug Administration
- Drug
Approvals and Databases
- Orange
Book Approved drug products with therapeutic equivalence evaluations
- U.S.
FDA Paragraph IV Patent Certifications Listing of drugs for which
an ANDA has been submitted, and for which a legal opinion stating
that the underlying drug patent is invalid or does not cover the branded
product has been submitted
- CMS
- Centers for Medicare and Medicaid Services Information about reimbursement
in the public payer system
- CMS
Reimbursement Database Database of reimbursed drugs and medical
devices
- U.S.
FDA Medical Device Databases
- U.S.
FDA 510(K) Premarket Notifications Database of notifications of
intent to introduce medical devices in commerce
- U.S.
FDA PMA Premarket Approval Datebase of FDA-approved medical devices
- U.S.
Department of Agriculture Information about regulation and compliance
related to agriculture biotechnology products
- U.S.
Environmental Protection Agency Information about regulation and
compliance with environmental standards (e.g., Clean Water Act,
Clean Air Act, etc.)
- EMEA
- European Medicines Agengy European drug approval agency
- EPARs
for authorized medicinal products for human use
|
|
Technology Agreements
- "Material Agreements" search tools for agreements
disclosed by publicly traded companies to the SEC. Agreements between
your competitors and potential licensees related to your innovation
can be searched:
- TechAgreements.com
- OneCLE.com
- Entire agreements from above:
- SECInfo.com
|
|
back to top
