In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to Carter. The ’213 patent, “Method for making humanized antibodies,” which Genentech has stated in SEC filings covers technology used in developing the breast cancer drug Herceptin® (trastuzumab), has since been asserted or is otherwise at issue in six  district court litigations.  In addition, some of the pending IPRs have also been instituted for review.

To briefly summarize the IPRs, Samsung Bioepis was the most recent party to file petitions against the ’213 patent, filing two IPRs in September. These petitions moved for joinder with two earlier-filed and pending Pfizer petitions.  In total, ten petitions have been filed, with two by Mylan settled prior to institution, and with two each by Celltrion and Boehringer Ingelheim.

Both Celltrion IPRs were instituted on December 1, 2017. All challenged claims were instituted as to at least one ground in each of the IPRs, with one IPR being instituted as to seven obviousness combinations and the other as to six obviousness combinations and two anticipation references.

The two Pfizer IPRs were also instituted on December 1, 2017. Due to a protective order entered in the case, the decisions instituting the reviews were not released at the time of the institution. Joint statements were later filed in both IPRs stating that neither Institution Decision was requested to remain sealed. In IPR2017-01488, the sealed decision was published on January 11, 2018. All claims challenged were instituted as to at least one ground, and ten originally filed grounds (two anticipation grounds and eight of obviousness) were instituted. The corresponding Samsung Bioepis petition was instituted and the motion for joinder was granted on February 22, 2018.

As to Pfizer’s IPR2017-01489, despite the joint statement that the parties did not request the institution decision to remain sealed, the decision does not appear to have been published, and as such the reasoning of the Board is not available for analysis. However, the corresponding Samsung Bioepis petition was instituted and the motion for joinder was granted on February 22, 2018. This decision, while not reflecting the reasoning of the Board, reflects that at least one ground was instituted as to all claims challenged in the petition, and that all seven asserted grounds (all obviousness grounds) were instituted.

The two Boehringer Ingelheim petitions remain pending.

The ’213 patent has now been asserted or challenged in six complaints, with the first lawsuit filed on October 6, 2017. The first three complaints were between Genentech and Amgen, with Amgen’s proposed biosimilar to Avastin® (bevacizumab) being at issue. The status of those cases has recently been covered here.

The other three lawsuits in which the ’213 patent has been asserted or challenged are related to proposed biosimilars to Herceptin®. The first of these lawsuits began with Genentech alleging infringement of some 40 patents by Pfizer related to its efforts in seeking approval of a Herceptin® biosimilar.

Pfizer provided a copy of its Biologics License Application (“BLA”) on September 5, 2017, following FDA’s acceptance of the BLA for review. Genentech responded with a letter alleging that Pfizer has not provided sufficient manufacturing information, to which Pfizer responded by pointing out the sections in its BLA containing information related to Genentech’s requests, and also providing some additional documents.

Genentech maintained to Pfizer that the provided manufacturing information was insufficient, and provided its initial list of patents to Pfizer on November 3, 2017. On November 17, 2017, Pfizer provided Genentech with its notice of commercial marketing. On the same day, Genentech filed suit. In its complaint, Genentech stated that Pfizer had not provided its detailed statement regarding the non-infringement and invalidity of the patents in Genentech’s list.

In its answer filed on January 10, 2018, Pfizer noted that it provided its detailed statement on January 2, 2018. In its counterclaims, Pfizer further alleged that it had complied with the requirements of the Biologics Price Competition and Innovation Act (“BPCIA”), while Genentech’s filing of a suit before Pfizer’s detailed statement was due was premature and therefore a violation of the BPCIA.

Specifically regarding the ’213 patent, in addition to allegations that the ’213 patent was invalid and not infringed, Pfizer alleged in greater detail that the ’213 patent was unenforceable due to the misrepresentation of a prior art reference made to the Examiner during prosecution in order to overcome a rejection based on that prior art reference.

The suit is pending, with the most recent action being a Joint Status report filed on February 12, 2018.

The other two Herceptin®-related suits involve Celltrion and Teva’s efforts towards a Herceptin® biosimilar, the first of which involves Celltrion and Teva filing as co-plaintiffs for declaratory judgment of non-infringement, invaldity, and unenforceability of 38 patents, including the ’213 patent, on January 11, 2018. We have previously reported on this suit. Since our previous report, an amended complaint was filed on February 8, 2018, with a stipulation filed the same day extending the time to answer to March 1, 2018.

A motion to dismiss appears to have been filed on February 28 (a motion to file under seal was filed the same day as the motion, while the unredacted motion was inadvertently publically accessible and has since been removed). In a redacted version of the motion attached to Genentech’s motion to file under seal, Genentech alleges that the BPCIA preserves Genentech’s right to sue first as the innovator, and that Celltrion and Teva’s declaratory judgment action is barred.  Responses are due March 14, 2018, and a motion hearing is set for April 4, 2018.

On January 12, 2018, Genentech responded with its own suit for infringement of 40 patents against Celltrion and Teva. A stipulation in this case has extended the time to answer to April 16, 2018. A response from Celltrion and Teva has yet to be filed.