Litigators in the life sciences field are no doubt familiar with the so-called “artificial” act of infringement established by 35 U.S.C. § 271(e)(2)(A)-(B): namely, that a party can be sued for patent infringement by merely filing an Abbreviated New Drug Application (“ANDA”) for a generic drug or a Biologics License
Alleged Theft of Drug Pricing Trade Secrets Could Cost Both Victim and Thief
Life Sciences is an area ripe for trade secrets misappropriation litigation. In recent news, Merz Pharmaceuticals, LLC filed a lawsuit under the North Carolina Uniform Trade Secrets Act alleging that its former director of federal accounts, Andrew Thomas, stole trade secrets relating to Merz’s flagship botulinum toxin drug Xeomin®. Those secrets purportedly included drug pricing strategies, marketing plans, market share data, and potential customer lists, all of which were intended to grow Xeomin®’s presence in the government market sector — a key therapeutic sector for Merz’s drug, which is primarily known for its aesthetic effects.
Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”
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.
Preparing for Europe’s Unified Patent Court
After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand scrutiny under the new patent court.
Update on Artificial Intelligence as a Patent Inventor
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.
When (Patent) Success Isn’t Obvious
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.
Arbitration Clause Not Binding on the United States Patent Office
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.
“About-Face” Representations to FDA Will Be Used Against You
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.
Update on Artificial Intelligence: Court Rules that AI Cannot Qualify As “Inventor”
Striking a blow to patent applicants seeking to assert inventorship by artificial intelligence (“AI”) systems, the U.S. District Court for the Eastern District of Virginia ruled on September 3, 2021 that an AI machine cannot qualify as an “inventor” under the Patent Act. The fight is now expected to move to the Federal Circuit on appeal.
Prior Art Showing An Invention To Be “At Least Possible” Found Sufficient To Invalidate Surgical Device Patent
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.”