Inequitable Conduct Defense During Patent Litigation<br>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 […]

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 […]

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, […]

Inherent Anticipation – How Certain Is Certainty?

In pharmaceutical cases, infringement defendants will argue that an asserted patent claim is anticipated or obvious. Often it is difficult to prove a patent claim obvious.Seemingly trivial and mundane modifications of the prior art could turn out to be “unexpected.”Motivations to modify the prior art could be hard to prove in a counterfactual back-in-time analysis.Who […]

Rule 12(c) Motions for Judgment Pleadings

A Fast, Cheap and Good Way to Win a Patent Case, and Pre-Litigation Considerations regarding a Rule 12(c) Motion Patent cases are costly. As a defendant, other than surrendering and take a (bad) deal to settle the case early on, is there a way to really cut down on the cost of the litigation?Better yet, is there […]