We previously wrote about Genentech’s U.S. Patent No. 6,407,213 (“the ’213 patent”) to Carter, first in October 2017, and more recently in March 2018. At the time of our last update, the ’213 patent had been at issue in six district court litigations, and had been the subject of ten filed IPR petitions, variously by Mylan Pharmaceuticals, Inc., Celltrion, Inc., Pfizer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., and Samsung Bioepis Co., Ltd.
At that time, the two IPR proceedings brought by Mylan settled prior to institution; at least some grounds in the petitions by Celltrion, Pfizer, and Samsung Bioepis had been instituted; and the Boehringer Ingelheim petitions were pending.
Since then, there have been major developments not only in the litigations, but also with institutions, rehearings, and final written decisions in the IPRs. They are addressed below. One point that sticks out is that many of the actions appear to have settled, or otherwise been dismissed.
Beginning with actions that have terminated, soon after our previous article was published, the Boehringer Ingelheim petitions IPR2017-02031 and IPR017-02032 were both instituted on less than all grounds on March 29, 2018. However, in a request for rehearing based on the SAS Institute Supreme Court decision (which we covered in a post on our PTAB blog), both petitions were instituted as to all grounds in May 2018. Later filed requests for rehearing by Genentech were denied on the issue posed by SAS Institute. In the latest action, however, Boehringer Ingelheim requested adverse judgment as to both petitions, and both motions were granted on July 31, 2018.
Following the much earlier Mylan settlement (dismissed in March 2017), the Boehringer Ingelheim IPRs are the first sign that Genentech has begun attempting settlement with (at least some of) the various parties challenging its ’213 patent.
In May 2018, the case Celltrion v. Genentech, No. 4:18-cv-00274 (N.D. Cal.) was dismissed. The judge found that Celltrion’s declaratory judgment action failed to state a claim for relief, as Celltrion did not complete its obligations under the patent dance, and as such was not properly able to file a declaratory judgment action. Celltrion since appealed this decision to the Federal Circuit in July, and then voluntarily moved to dismiss the appeal in November. The dismissal was granted on November 30, 2018.
Next, in Genentech v. Pfizer, No. 1:17-cv-01672 (D.Del.), a stipulated dismissal due to settlement was entered on December 4, 2018.
As for actions which have reached determinations regarding the ’213 patent, Final Written Decisions were entered to both IPR2017-01374 by Celltrion and IPR2017-01488 by Pfizer on November 29, 2018. In each of these IPRs, 18 challenged claims were determined to be unpatentable, while 11 challenged claims survived. Of the surviving claims, 8 of the claims appear to have survived, at least in part, based on the defeat of two primary references (contained in all instituted grounds) as prior art by demonstration of support for the claims in the ’213 patent’s priority document, and by Genentech’s evidence of prior invention.
As for ongoing actions, in July, hearings were held as to both Celltrion petitions, IPR2017-01373 and IPR2017-01374, as well as both Pfizer petitions, IPR2017-01488 and IPR2017-01489 (and, by extension, the joined Samsung Bioepis petitions). As of this writing, Celltrion IPR2017-01373 and Pfizer IPR2017-01489 are both pending.
Of the pending litigation, many are currently around a similar stage. In Genentech v. Celltrion, No. 1:18-cv-00095 (D. Del.), a motion stipulating dismissal of certain of the patents alleged in the complaint was entered on October 17, 2018. Dismissal did not include the ’213 patent. The case as a whole remains ongoing, and is currently in the midst of discovery and claim construction.
Genentech v. Celltrion, No. 1:18-cv-01025 (D. Del.) was filed July 11, 2018. The parties have stipulated as to consolidation with the above action on December 3, 2018, but as of this writing, the stipulation does not appear to have been entered.
In Genentech v. Amgen, No. 1:17-cv-01407 (D.Del.) a claim based around Amgen first providing one date for its notice of commercial marketing, and then providing an earlier date was dismissed on April 17, 2018. The matter was consolidated with another Genentech v. Amgen case, No. 1:17-cv-01471, in October, and the consolidated cases are currently in the discovery process.
An additional case against Amgen, Genentech v. Amgen, No. 1:18-cv-00924 (D. Del.), was filed on June 21, 2018. A similar dismissal of certain of the patent infringement claims was made July 19, 2018. Otherwise, the case is ongoing, and is in the midst of discovery and claim construction.
The last litigation to be filed to date, Genentech v. Samsung Bioepis, No. 1:18-cv-01373 (D. Del), was filed on September 4, 2018. Discovery appears to have just begun following entry of scheduling orders, discovery orders, and protective orders in November 2018.
In sum, several IPRs and litigations are ongoing with the Carter ’213 patent at issue, but several cases have been dismissed or have apparently settled since our last update. Importantly, 18 claims of the ’213 patent have been found unpatentable by IPR proceedings brought by Celltrion and by Pfizer, and it will be interesting to see how this might impact the ongoing litigations.