We provide custom and creative advice to our clients to help them leverage design-around opportunities while developing and executing regulatory strategies to bring their life-saving products to market and keep them there.
We draw on the experience of our dedicated team in a range of technologies, including combination drug-device products and surgical instruments.
The firm has handled or is handling a number of major patent matters concerning a wide variety of medical devices, including auto-injectors, pre-filled syringes, surgical instruments, stents, suturing devices, immunoassays, inhalers, applicators, and over-the-counter hCG devices.
In addition to providing patent evaluation and litigation services, we routinely advise our clients on device-specific regulatory approval requirements, based on our vast experience with approval requirements of combination drug/biologic-device products, including FDA’s sameness standard and human factor studies. We also counsel clients on patent listing considerations related to device patents in FDA’s Orange Book.
Our representative drug delivery device expertise includes:
- Spiriva® (tiotropium) (dry powder inhaler)
- ProAir® (albuterol) (dose counter/actuator)
- Axiron® (testosterone) (applicator)
- Perclose® (vascular closure device)
- MIVS® (surgical eye instrument)
- Glucose monitoring devices
- Biometric sensors
- Various immunoassays (pregnancy/ovulation)
Medical Devices HighlightsView All
RMMS Secures Invalidity And Non-Infringement Victories on Patents Related To Axiron® (Testosterone) Transdermal SolutionAugust 22, 2016 Read More
More and more leaders in the life sciences industry are turning to RMMS for successful IP outcomes.
Here’s what they have to say.
Patent litigation specialist boutique Rakoczy Molino Mazzochi Siwik LLP has a stellar reputation for its work in the life sciences sphere.Legal 500
The RMMS team always keeps its client's end goal in mind and secures the best outcome for them.Chambers USA
Rakoczy Molino Mazzochi Siwik LLP has a highly-regarded Chicago-based life sciences practice. The team is known for its deep litigation experience assisting clients with patent validity, Hatch-Waxman, and IP infringement disputes. The team is further able to support clients on commercial matters including patent licensing and collaboration agreements.Chambers USA
Boutique firm much admired for its artful representation of generic pharmaceutical manufacturers in complex ANDA litigation. Other areas of strength include freedom-to-operate searches and licensing and collaboration agreements. Increasing bench strength sees it offer wider expertise beyond its traditional generics client base, bolstering its handling of brand mandates.Chambers USA
What's your biggest IP challenge?
The life sciences team at RMMS is ready to help.