Of the 14 PGR cases that began hearing, 9 were final decisions... All claims subject to trial are ‘unpatentable’
Following patents 324, 320, and 313, variant patents were also blocked... Steps to virtually eliminate Halozyme’s patent burden
Alteogen (196170) has taken steps to virtually free itself from Halozyme's patent burden surrounding subcutaneous injection (SC) formulation technology. As the U.S. Patent and Trial Board (PTAB) ruled two additional Halozyme patents unpatentable, the Patent Invalidation Trial (PGR) filed by Merck (MSD) recorded the same result in all nine cases with final decisions.
There are a total of 14 PGRs raised by MSD and for which hearings have begun. Among these, in the nine cases that reached the final decision first, the patentability of the claims subject to trial was denied without one exception. MSD is commercializing Keytruda SC, which uses Alteogen's ALT-B4, and is in the process of filing a patent infringement lawsuit with Halozyme in the United States.
Final decision: 7 cases → 9 cases… Modified patent number 313 is also blocked
In the previous seven cases where final decisions were made, the PTAB denied all patentability of the claims subject to trial. With the addition of these two cases, the number of cases for which a final decision has been made increases to 9.
These two cases have something in common: a patent that includes a modification of amino acid position 313 among Halozyme's modified PH20 technology. In the previous case, patents containing variations at positions 324 and 320 were judged unpatentable, and this time, the same result was obtained in two patents containing variations at 313.
Merck has raised the issue that the scope of the PH20 variant that these two patents seek to protect is excessively broader than the scope supported by actual experiments and patent specifications. In these two cases, the PTAB also ruled that the remaining claims subject to trial were unpatentable.
9 consecutive patents denied... Keytruda SC clears a significant portion of the Halozyme patent barrier
MSD is commercializing Keytruda subcutaneous injection formulation using Alteogen's ALT-B4. Halozyme is in the process of a separate patent infringement lawsuit against MSD in a federal court in New Jersey, and the patents subject to this PGR are also related to that lawsuit.
PTAB decisions are limited to the claims reviewed in each PGR, and follow-up proceedings are possible. This does not mean that all of Halozyme’s PH20-related patents have been invalidated.
Of the 14 PGR cases for which trials have begun to date, final decisions have been made in 9 cases, and the patentability of the claims subject to trial has been denied in all of them. The PTAB's final ruling on the remaining five cases also remains. Separately, the three IPR cases filed by Merck began trial last month and are in progress.
※ This article referred to data introduced in the Naver blog ‘J’s Value Investment Story’, and related raw materials such as the U.S. Patent and Trial Board (PTAB) ruling and U.S. Patent and Trademark Office (USPTO) data were separately checked.
