How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for?

By way of background, a sponsor can obtain orphan drug exclusivity when the FDA approves an application for a drug that has first been designated under 21 U.S.C. § 360bb of the Orphan Drug Act (ODA) for a “rare disease or condition.”  Id. § 360cc(a).  Except in any of three statutorily prescribed circumstances (§§ 360cc(b), (c)), the FDA cannot approve another application for the “same drug” for “the same disease or condition” for seven years after the first approval.

Continue Reading In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit on the federal or state level. The EU’s passage of the General Data Protection Regulation (GDPR), intended to protect personal data, is a prime example. Several years after GDPR enactment, California adopted a privacy rights statute of its own, the California Consumer Privacy Act (CCPA). Other states have since passed comprehensive consumer privacy laws, with similar proposals under consideration in many state legislatures. This progression should serve as a reminder for those in the United States to keep a watchful eye on European regulatory activity as a potential harbinger of things to come in the U.S.

Continue Reading U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation.  After all, communications with regulatory bodies are often performed by non-attorneys who may not appreciate the consequences of their statements in future litigation. And while in ideal circumstances the patentee’s attorneys will ensure accurate and consistent communications and try to put potentially inconsistent statements in context, it is not always possible to do so once the genie is out of the bottle. Belcher Pharmaceuticals, LLC v. Hospira, Inc., exemplifies the dire consequences that can result from inconsistent communications with regulators—particularly if a defendant can point to a single source for those communications.    Continue Reading “About-Face” Representations to FDA Will Be Used Against You

Striking a blow to patent applicants seeking to assert inventorship by artificial intelligence (“AI”) systems, the U.S. District Court for the Eastern District of Virginia ruled on September 3, 2021 that an AI machine cannot qualify as an “inventor” under the Patent Act.  The fight is now expected to move to the Federal Circuit on appeal.

Continue Reading Update on Artificial Intelligence: Court Rules that AI Cannot Qualify As “Inventor”

The situation is familiar: an employee leaves one company to go work for another, or perhaps to found her own start-up.  She may be working on the same problems that she faced at her former workplace, and in the same technological space.

The employee’s work at her new company results in the issuance of a patent, and the new company takes the lead in the marketplace.  Based on the work done by the employee at the former employer, however, the former employer may believe that it has ownership rights in the new patent.

What rights might the former employer have?  A recent Federal Circuit decision, Bio-Rad v ITC – CAFC, sheds some light on how courts may resolve this kind of dispute—and how thorny the issues may be.  Key takeaways are summarized here.

Read the full post on Proskauer’s Minding Your Business blog.

On August 23rd, the Federal Circuit upheld in part and reversed in part a decision from the Patent Trial and Appeal Board’s (PTAB or Board) concerning Ethicon’s patent on a robotic surgical tool, holding that the Board’s finding of no motivation to combine is not supported by substantial evidence. In doing so, the court determined the PTAB “went too far” in its holding of non-obviousness by requiring Intuitive to specifically identify a preexisting surgical device performing as many functions as required by the Ethicon patent; it was enough that the prior art established such a device was “at least possible.” Continue Reading Prior Art Showing An Invention To Be “At Least Possible” Found Sufficient To Invalidate Surgical Device Patent

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding but sought to clarify its reasoning. GlaxoSmithKline v. Teva. Specifically, the majority stated that a generic manufacturer’s touting of AB equivalence to a brand drug is generally not evidence of intent to induce infringement—but in the specific facts of this case it did support inducement, because the Court found ample evidence tying claim limitations to statements in Teva’s label even though the patented method was omitted as a distinct indication. The Court also found that Teva’s advertising statements regarding treating “heart failure” evidenced intent to induce physicians to prescribe the drug to treat CHF. Continue Reading GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

The question whether an artificial intelligence (“AI”) system can be named as an inventor in a patent application has obvious implications for the life science community, where AI’s presence is now well established and growing. For example, AI is currently used to predict biological targets of prospective drug molecules, identify candidates for drug design, decode genetic material of viruses in the context of vaccine development, determine three-dimensional structures of proteins, including their folding form, and many more potential therapeutic applications.

Continue Reading Artificial Intelligence as the Inventor of Life Sciences Patents?

Over the last seven years there has been commotion in Obviousness-type Double Patenting (“ODP”) practice. One of the latest cases to spur a considerable amount of interest is Mitsubishi Tanabe Corp. v. Sandoz, Inc., which is currently on appeal to the Federal Circuit (“CAFC”). While a detailed review of this case is not the intent of this post, as a fair number of practitioners have provided insightful coverage, an historical overview is helpful for framing the decision and issues that need clarification from the CAFC.

Continue Reading Why Obviousness-type Double Patent Analysis Isn’t Obvious

On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy Roosevelt’s trust-busting and Franklin Roosevelt’s “supercharged antitrust enforcement”. Asserting that a “fair, open, and competitive marketplace has long been the cornerstone of the American economy,” the Executive Order sets forth 72 initiatives across over a dozen federal agencies.

Continue Reading President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector