In Sawstop Holding LLC v. Vidal the Federal Circuit confirmed what many practitioners suspected— the Patent and Trademark Office will only award a patent term adjustment to offset a delay caused by appellate review of a patent prosecution if the appeal results in allowable claims ready for issuance.
In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s attempt to obtain a patent for an invention created by his AI system called DABUS (“Device for Autonomus Bootstrapping of Unified Sentence). Most recently, we considered Thaler’s appeal of the September 3, 2021 decision out of the Eastern District of Virginia, which ruled that under the Patent Act, an AI machine cannot qualify as an “inventor.” Continuing this series, we now consider the USPTO’s recently filed opposition to Thaler’s appeal.
Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification should be devoted to something that is not supposed to be part of the claim? The answer may be none at all according to a recent Federal Circuit decision, Novartis Pharmaceuticals v. Accord Healthcare Inc. The key, according to the decision, is that the specification should not describe the negative limitation in a manner inconsistent with how it is used in the claim.
In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs (the “GSK decision,” discussed here and here), Judge Richard Andrews in the District of Delaware held that plaintiff Amarin Pharma (“Amarin”) failed to plead facts sufficient to show that Hikma Pharmaceuticals’ (“Hikma”) carved-out product label and/or public marketing statements induced infringement of Amarin’s patents. The holding suggests that carved-out labels (so-called “skinny labels), despite the GSK decision, continue to provide some measure of protection from liability based on induced infringement.
Our previous blog posts, Artificial Intelligence as the Inventor of Life Sciences Patents? and Update on Artificial Intelligence: Court Rules that AI Cannot Qualify As “Inventor,” discuss recent inventorship issues surrounding AI and its implications for life sciences innovations. Continuing our series, we now look at the appeal recently filed by Stephen Thaler (“Thaler”) in his quest to obtain a patent for an invention created by AI in the absence of a traditional human inventor.
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.
The Federal Circuit recently reversed a jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno Therapeutics, Inv. v. Kite Pharma, Inc.. This case further builds on the application of the written description requirement to claims that recite functional limitations, and is instructive to patent prosecutors.
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.
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.
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.