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
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
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
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
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
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
In April 2022, FDA released a proposed draft guidance (FDA Dock.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
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
Introduction By statute, the Court of Appeals for the Federal Circuit has appellate jurisdiction over appeals from the administrative boards of the Patent & Trademark
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
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
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
Back in August, the Federal Circuit’s GSK v. Teva opinion landed with quite a splash in the Hatch-Waxman world. In that case, Teva’s carvedilol “skinny
In patent litigation, most attorneys focus on the patent document itself. After all, the patent is being asserted in the litigation so it makes sense.
In a recent District of New Jersey decision, Chief Judge Wolfson found a patent indefinite, obvious, and not infringed (due to a failure of proof).
The § 505(b)(2) regulatory pathway gives a smaller pharmaceutical company, a start-up company even, the opportunity to submit and obtain FDA approval of a new