Medical Device and FDA Representation
We help medical device clients with end-to-end legal solutions. We help with navigating the Safe Harbor Act provisions under the so-called Bolar exemption (35 U.S.C. 271(e)), and representing medical devices in typical patent infringement actions. Because of this background, we also assist companies in moving device applications along through to clearance of 510(k) applications. We are particularly sensitive to statements made in regulatory filings that might implicate future patent infringement. For example, the 510(k) premarket notification and clearance procedures require identification of the predicate device against which the “substantial equivalence” is measured. Applicants must carefully craft statements in the 510(k) dossier to ensure that patent law doctrine of equivalents is not implicated.
We have experience in the following technology areas: stents, drug-eluting devices, neurological/spinal implants, cardiac rhythm management devices, angioplasty devices, catheters and guide wire devices, dental implants, tissue remodeling and ablation devices, pumps, imaging devices, cardiac valves, catheters, implantable joint replacements and implants, orthopedic devices, and robotic surgery devices.
Our clients span the spectrum of clients from individuals (physicians, “garage inventors”), small start-ups, VC/angel investors, university incubator spin-offs, and large medical device companies.
- Prosecution strategy, claim constructions issues, avoiding statements during prosecution that may limit future enforcement because of claim construction, literal infringement, and the Doctrine of Equivalents
- Freedom to operate and due diligence by providing advice on IP and FDA issues; providing legal opinions to support due diligence; risk mitigation
- Litigation involving patent infringement, safe harbor application, joint inventorship allegations, and contractual issues
For Branded Companies seeking NDA or 505(b)(2) approvals, please see our in-depth practice description HERE.
For Generic Companies seeking ANDA or 505(b)(2) approvals, please see our in-depth practice description HERE.
To learn more about our FDA & GMP practice, please see our in-depth practice description HERE.
To learn more about our Patent Litigation expertise, please see our in-depth practice description HERE.
To learn more about our Commercial Litigation expertise, please see our in-depth practice description HERE.