The complaint
The case is Wearne Digital Pte Ltd v. Pfizer Inc., No. 1:26-cv-08691 (S.D.N.Y.). Its single count pleads direct infringement under 35 U.S.C. 271(a) of at least claim 9 of the '067 patent, titled Platform and System for Use in Therapeutic Procedures, which issued September 27, 2022. The complaint says the patent issued from a continuation in a family that traces to an Australian application filed February 15, 2018 by David Wearne. It pleads no induced, contributory, or willful infringement.
Claim 9
Claim 9 recites a method for managing the use of portable therapeutic platforms for a therapeutic procedure. It requires providing a plurality of therapeutic procedural packs, each comprising a therapeutically effective item required to conduct the therapeutic procedure and an electronic communications device having a unique identification code for receiving and transmitting information about the environment surrounding and including each pack. That information is transferred between each pack's electronic communications device and a computer system including a processor that processes it in real time, and an automated control response is initiated. The processed information must enable control over manufacture of the packs and their deployment to different geographic segments, and the computer system must be configured to initiate the automated control response by modifying a step in a therapeutic procedural pack manufacturing process so that the packs include determined therapeutically effective items.
The accused method
The complaint defines the accused method as Pfizer's system for distributing vaccines, pharmaceuticals, or other therapeutic products that require cold chain or ultra-cold chain, which it says includes cold chain or ultra-cold chain shipping containers, GPS-enabled data loggers and temperature monitoring devices, and a connected computer system for monitoring and controlling manufacturing and distribution. It names domestic cold chain distribution of products such as antibody-drug conjugates, monoclonal and polyclonal antibodies, and recombinant proteins, and ultra-cold chain distribution of mRNA COVID-19 vaccines such as COMIRNATY.
Venue and relief
For venue, the complaint relies on Pfizer's global headquarters in New York City and its Pearl River, New York site, which it describes as the primary research and development center housing work on Pfizer's collaboration with BioNTech, and alleges that Pfizer distributed the vaccine to medical providers in the district using the accused products. The prayer asks for a permanent injunction or, alternatively, a reasonable ongoing royalty for adjudicated infringement after judgment; damages of no less than a reasonable royalty under 35 U.S.C. 284, with interest; accountings and supplemental damages; and an exceptional-case finding with fees under 35 U.S.C. 285. The complaint says any requested injunction "should be tailored to proven infringement and to account for continuity of access to vaccines and other therapeutics."
What to watch next
Watch for Pfizer's answer or any motion to dismiss, and for any petition for inter partes review of the '067 patent. The case can end at any time by license, settlement, or dismissal.