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Ophthalmic, Parenteral, & Otic Drug Development: Does FDA’s Draft Guidance Provide A Vehicle To Avoid Patent Problems?
In April 2022, FDA released a proposed draft guidance (FDA Dock.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 The Draft Guidance suggests that FDA may entertain proposed ANDA formulations that differ in the pH adjuster in the ANDA formulation as compared to the Reference Listed Drug […]
Understanding Means-Plus-Function Claims in Patent Law
We previously wrote about product-by-process claims in patent law describing them as an atypical patent claim. See our article here: https://ipfdalaw.com/understanding-product-by-process-claims-in-patent-law/. Another atypical claim is a so-called “means plus function” claim. The M+F claim has a statutory root under 35 U.S.C. Sec. 112(f) (previously under 35 U.S.C. Sec. 112, sixth paragraph). The statute states that: […]
Standards of Review in Patent Appeals to the Federal Circuit Court of Appeals
Introduction By statute, the Court of Appeals for the Federal Circuit has appellate jurisdiction over appeals from the administrative boards of the Patent & Trademark Office (appeals from the Patent Board and the Trademark Board) and the various district courts. The Federal Circuit also has appellate jurisdiction over other subjects such as the Court of […]
The Role of Prior Art in Patent Law – Old and Admitted Prior Art
Despite the promulgation of the American Invents Act (AIA) in 2012, the concept of prior art has basically stayed the same. Section 102 embodies two different concepts. First, the concept of novelty embodies that there are things other people do to destroy the novelty of the patent applicant’s claimed invention. These include publishing the subject […]
The 505(b)(2) Application and the ANDA – Similarities and Differences
FDA’s 505(b)(2) Application The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is […]
Understanding Product-By-Process Claims in Patent Law
Typical patent claims are to products or processes but not both. But product-by-process claims exist and have existed for decades. Plainly, the typical product-by-process claim is designed to claim a product when made by a particular process. It is a hybrid type of claim. But questions arise of how product-by-process claims are interpreted when considering […]
