Nearly seven years after the landmark Supreme Court decision in Alice Corp. v. CLS Bank Int’l, subject matter eligibility for patent claims under 35 U.S.C § 101 remains a moving target. In Alice, the Court found claims for a computerized escrow arrangement ineligible for patenting because they were directed to the abstract idea of “intermediated settlement” and did not recite an inventive concept that could impart eligibility under Section 101. While the Alice case focused on a software invention, a few recent lower court decisions suggest that, in certain circumstances, medical device patents may not be immune from similar patent eligibility challenges.
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%.
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?
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.
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.
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.
The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act of 2021. Formerly S.164, it was introduced in the Senate in February 2021 and sped through the House to enactment on April 23, less than three months later.
In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed
The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result, pharmaceutical companies need to consider freedom to operate issues long before they receive FDA approval or market their new product. These considerations might lead a company to take a license, seek to invalidate a competitor’s patent, or some combination of the two. The Patent Trial and Appeal Board (“PTAB”) is a popular venue for challenging patent validity and in 2020, Bio/Pharma and Chemical Patents accounted for 12% of petitions filed at the PTAB.
Reference product sponsors often obtain patents claiming methods of using a known drug to treat a condition or disease. Because generic and biosimilar developers typically do not treat patients, and thus do not directly infringe the claims, plaintiffs must sue under a theory of induced infringement—i.e., that the generic or biosimilar developer recommended, encouraged, or promoted a patented use for the drug. Demonstrating induced infringement most often involves the label of the defendant’s product, but increasingly may involve non-label evidence such as the defendant’s press releases, brochures, product catalogs, advertisements, and statements to the FDA, doctors, and investors. This non-label evidence is likely to be especially significant in the biologic context.
The Ensuring Innovation Act recently became law after passing in the Senate with unanimous, bipartisan support. According to one Senator, the intent of the legislation was to “close loopholes to prevent awarding market exclusivity to products that do not present true innovation and unduly delay cheaper generic from entering the market.” Is this much ado about nothing, or much to be concerned about?