Recent Developments in Medical Device Patent and FDA Law
Patent litigation in the medical device area continues. Along with pharmaceutical patent litigation, medical device patent litigation continues to provide important rulings and case law precedent. Because of the large-scale investment needed to bring medical devices to the market, device sponsors need certainty about the law and its application to ensure a return on the […]
Patent Infringement Damages and Injunctions – The Basics
Patents, as one part of intellectual property protection, provide a valuable property right and play an important role in economic development, a reward for innovations, add to the technological knowledgebase, and increase the general welfare. Patentees obtain patents for defensive purposes (file applications for publication and issuance to create prior art against others); commercial purposes […]
Why Patent? Ways to Monetize Patents
Patents, as one part of intellectual property protection, provides a valuable tool for protecting ideas, R&D, and business growth. It is a political policy decision of how patents are obtained, maintained, enforced, etc. Different countries have different views on patent policy. For many, though, patents are a driving force for economic development. And for other […]
How a Generic Drug Can Become A Branded Drug: A Case Study – Is Par’s Varenicline Trying?
Typically, brand and generic drugs stay nicely in their own lanes. The consuming public generally knows when the drug taken is branded or generic. But are there times when a generic drug may become a branded drug, whether unintentionally or intentionally? And when we say a branded drug in this context, we do not mean […]
Enablement of a Patent Specification – Supreme Court Rules That Full Really Means That … Full.
In a previous article published, we discussed the role of written description and how written description should be contextualized within the meaning of the Section 112(a) of the patent laws. [Click HERE:] There we wrote that the Supreme Court has steadfastly refused to take any case about whether Section 112(a) requires a “full” written description […]
Life Sciences Hot Issues from 2022 and Upcoming 2023 Ones
Introduction Life sciences patent and FDA law had its fair share of events in 2022. We highlight several interesting areas in 2022 and then profile some upcoming issues in 2023. Some of the issues are related to drug policy, some about FDA’s operations, and some about patents. Supreme Court Updates The US Supreme Court was […]
Ice Hockey Referee and Patent Litigator – What On Earth Do These Have In Common?
Introduction The closest comparator for the ice hockey referee is the federal trial court judge. I am not a judge but I thought this would be a fun little article about what being an ice hockey referee and a patent litigator might have in common. I am a USA Hockey Level 3 ice hockey referee […]
Five (5) & Ten (10) Year Data Exclusivity for New Drugs – When To File Generic Drug Applications
Brand pharma companies invest valuable resources, time, and money in moving drugs from development to FDA approval. The new drug approval may also enjoy some type of FDA exclusivity. Typically, FDA exclusivity falls into two types: (1) data exclusivity; and (2) approval/market exclusivity, both of which are known in the industry but not defined expressly […]
Billion Dollar Verdicts Wiped Out Due to Patent Law’s Written Description
Imagine your billion dollar win wiped out later. You’d be mad. You’d wonder how that happened. You’d ask if you did anything wrong to deserve that wipe out. You’d ask if you could have done something different. Patent law’s “written description” invalidity has wiped out wins by ruling the patent was indeed invalid. Naturally each […]
Ophthalmic, Parenteral, & Otic Drug Development: Does FDA’s Draft Guidance Provide A Vehicle To Avoid Patent Problems?
In April 2022, FDA released a proposed draft guidance (FDA Dock. No. 2022-D-0108) involving pH adjusters in drug development relating to ophthalmic, parenteral, or otic drug products. The Draft Guidance suggests that FDA may entertain proposed ANDA formulations that differ in the pH adjuster in the ANDA formulation as compared to the Reference Listed Drug […]
