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

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

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

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

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad range. Others have estimated the average cost at approximately $2.5 to $3 billion, with costs increasing annually at a post-inflation rate of approximately 8.5%.

Continue Reading “Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Allele v. Pfizer – The Basics. On April 23, 2021, Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement complaint filed by Allele Biotechnology and Pharmaceuticals, Inc. (“Allele”) in the Southern District of California. The patent at the center of the case is U.S. Pat. No. 10,221,221 (“the ’221 Patent”) which covers Allele’s mNeonGreen, a monomeric yellow-green fluorescent protein notable for its intense brightness. On May 4, 2021, the court denied the motion to dismiss, leaning heavily of the Federal Circuit’s 2008 decision Proveris Science Corp. v. Innovasystems, Inc. As this case continues to develop it could help shed light on an unsettled issue – are “research tools” categorically excluded from the 35 U.S.C. § 271(e)(1) Safe Harbor?

Continue Reading A Guiding Light for the Research Safe Harbor and “Research Tools”?

As we mentioned in the early days of the pandemic, COVID-19 has been accompanied by a rise in cyberattacks worldwide. At the same time, the global response to the pandemic has accelerated interest in the collection, analysis, and sharing of data – specifically, patient data – to address urgent issues, such as population management in hospitals, diagnoses and detection of medical conditions, and vaccine development, all through the use of artificial intelligence (AI) and machine learning. Typically, AIML churns through huge amounts of real world data to deliver useful results. This collection and use of that data, however, gives rise to legal and practical challenges. Numerous and increasingly strict regulations protect the personal information needed to feed AI solutions. The response has been to anonymize patient health data in time consuming and expensive processes (HIPAA alone requires the removal of 18 types of identifying information). But anonymization is not foolproof and, after stripping data of personally identifiable information, the remaining data may be of limited utility. This is where synthetic data comes in.

Continue Reading Synthetic Data Gets Real

On May 5, 2021, the Biden Administration announced its support for waiving intellectual property protections for COVID-19 vaccines.  Understandably, the news made headlines and stirred passionate reactions from the medical community and IP holders alike. But actually bringing about that waiver will be a complicated process, and one that depends on many countries and parties besides the United States.

Continue Reading IP Waiver for COVID-19 Vaccines: What the United States’ Support Means in Practice

In an opinion issued on March 3, 2021, the Supreme Court of Delaware, one of the top commercial courts in the country, overturned a jury verdict that Glaxo Group Limited and Human Genome Sciences, Inc. (collectively, “GSK”) breached the implied covenant of good faith and fair dealing when GSK disclaimed all the claims of a lupus treatment patent it had licensed from Biogen thereby extinguishing its obligation to pay ongoing royalties on sales of its lupus treatment drug. The court’s reasoning and the outcome raise important considerations for life sciences practitioners in the transactional, litigation, and patent disciplines.

Continue Reading Delaware High Court Allows Licensee To Stop Royalty Payments By Disclaiming Patent Claims