In Univ. of Strathclyde v. Clear-Vu Lighting LLC, the Federal Circuit grappled with the issue of whether claims directed to methods and systems for inactivating bacteria using blue light were obvious in view of a prior art combination that taught the claimed elements but lacked an indication of success. Ultimately, the Federal Circuit found that the patent’s success where the prior art failed – inactivation of the bacteria without a photosensitizer did not support a finding of obviousness.
Continue Reading When (Patent) Success Isn’t Obvious

The Federal Circuit’s recent ruling in MaxPower Semiconductor Inc. et al v. Rohm Semiconductor USA, LLC highlights the interplay between the liberal federal policy favoring arbitration agreements and the Patent Trial and Appeal Board’s (“PTAB”) authority as an agency tribunal having a broad role to protect the public interest in ensuring the quality of patents.

Challenging the validity of a patent through the inter partes review (IPR) process at the PTAB is a conventional alternative to litigating invalidity in federal court. MaxPower addressed the question of whether the PTAB will defer to an agreement to arbitrate that did not expressly preclude the parties from proceeding before the PTAB.
Continue Reading Arbitration Clause Not Binding on the United States Patent Office

Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”. Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997) Findings of infringement under DOE, particularly in biotechnology related cases, have often been considered an exception rather than the rule. One such exception is the recent Federal Circuit nonprecedential decision in Jennewein Biotechnologie GmbH v. International Trade Commission, September 17, 2020, Chen, R. (Glycosyn LLC, the patent owner, joined as an Intervenor). The Federal Circuit affirmed an exclusion order from the International Trade Commission (ITC) relying on an application of DOE to find infringement supported by substantial evidence.
Continue Reading A Reminder of Doctrine of Equivalents in Biotechnology: Jennewein Biotechnologie GmbH v. International Trade Commission

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

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?

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.

Continue Reading Federal Circuit Invalidates Device Patent As Directed to an Abstract Idea

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