In April 2022, FDA released a proposed draft guidance (FDA Dock.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
Upadhye Tang LLP was founded a few years ago to focus on our core competencies: IP and FDA law. We know the life sciences business
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.
A lawsuit that goes to the bitter end will result in a winner and a loser. And with the win in hand, the winner then
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
Since its creation by the America Invents Act of 2011, Inter Partes Review (or IPR) has been a valuable tool for current or future patent
Generic pharmaceutical companies and §505(b)(2) NDA filers routinely use Paragraph IV certifications to challenge the patents a brand company listed on the FDA’s Orange Book.
An Opinion of Counsel or Freedom To Operate (FTO) opinion though not legally required often, is a good business practice. First, a company may seek
Though we don’t know when, someday life will return to normal. And we may redefine what the new normal is. But we do know that
Magic mushrooms and pot. Yes, currently people use them for illicit reasons. But the compounds in them are now being investigated for typical pharmaceutical therapeutic
The rise of “artificial intelligence” has changed the world. Patent law and litigation are no exception. This article explores several areas in the practice of
This year-end newsletter will discuss the benefits of technology in the boutique law firm. But first we say Happy Holidays and may you, the reader,
A blockbuster pharmaceutical product is often protected by layers of patents, grouped in different patent families and often having different expiration dates due to the
The U.S. Court of Appeals for the Federal Circuit (CAFC) has exclusive jurisdiction over patent law appeals. That means that it is the sole appeals
