A Lack of Essential Testing Method Parameter in Patent Claims Led to Indefiniteness, but Inequitable Conduct Is Hard to Prove – Lessons from Sun v. Lupin

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). Sun Pharma v. Lupin, 2021 WL 4473411 (Sept. 30, 2021). However, the court did not find inequitable conduct by clear and convincing evidence, despite the inventor’s “hubris” and incorrect understanding […]

Inequitable Conduct Defense During Patent Litigation
in a 505(b)(2) NDA Context

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 drug application (NDA) without breaking the bank. A 505(b)(2) NDA may rely heavily on data from an already-marketed drug product and information in published literature to demonstrate the safety and […]

IPR Estoppel – A Truly Double-Edged Sword

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 defendants. However, the risk/reward calculus has changed over the years since the IPR originated. In particular, the estoppel effects of an IPR decision are now a much more important consideration […]

Tools to Combat Frivolous Hatch-Waxman Cases

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.  Such a challenge generates subject matter jurisdiction for patent infringement suits.  When the brand company timely sues, FDA approval of the patent challengers’ applications is automatically stayed for 30 months […]

Opinions of Counsel & Freedom to Operate: Are They Relevant Again?

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 the FTO opinion for due diligence, merger & acquisition, and for other deal-making needs. For many companies, a question exists: “If we launch this product into the marketplace, will we […]

2021 Post-COVID Trends in Patent Litigation

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 patent litigation will persist. Therefore, we can examine some post-COVID trends.  In-Person Court Hearings and Trials Over the last year, we got used to conducting all hearings and even trials […]

Patent and FDA Strategies for Psychedelics, Psilocybin, and Cannabinoids

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 properties. And how can investigators protect that R&D investment? We look at some strategies relating to psilocybin (the prime compound in magic mushrooms) and cannabidiol (CBD) found in pot to […]

The Practice of Patent Law in the Age of Artificial Intelligence (AI)

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 law undergoing exciting changes due to the rise of AI, particularly using AI in litigation document review and then on AI in patentability.  Technology (AI) Assisted Document Review We discussed […]

Gig Economy Coming to the Legal Profession

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, have a safe, happy, and prosperous new year. We thank you, as always, for the faith, trust, and confidence you have in us.  The Boutique Law Firm vs. Large Law […]

Beware of Sleeping Dogs – Unasserted Orange Book Patents Can Still Bite

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 differences in patent filing dates, patent term adjustments, and patent term extension.  For a single product, there might be patents covering the active pharmaceutical ingredient (including different claims to impurities, […]