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

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.

Continue Reading “Advancing Education on Biosimilars”: Game Changer or More of the Same?

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.


Continue Reading When Is Less Really More for a Patent Licensee?

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.

Continue Reading Induced Infringement of Method of Treatment Claims: Looking to the Label and Beyond

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?

Continue Reading The Impact of the Ensuring Innovation Act on NCE Exclusivity

When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.

But how does the FDA reach that conclusion? A newly filed case may shed some light on the Agency’s decision-making process.


Continue Reading Generic Competition for Withdrawn Drug Products

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).)

Continue Reading CAFC Tightens Enablement Standard for Functional Claiming of Antibodies

Recent Precedential Decisions Applying Fintiv

When a company is sued for patent infringement, often one early strategic consideration is whether to counterattack the patent’s validity at the Patent Trial and Appeal Board (PTAB) in a parallel post-grant proceeding such as inter partes review (IPR) or post-grant review (PGR). Although the PTAB has recently conformed certain practices more closely to litigation—notably, its claim construction and indefiniteness standards—it remains a valuable venue for patent challengers seeking a relatively speedy, predictable, and cost-effective process.


Continue Reading I’ve Been Sued for Patent Infringement… Is an IPR Worthwhile?