Janssen’s suit against Celltrion in the District of Massachusetts (C.A. No. 1:15-cv-10698) is one of the few currently pending litigations related to biosimilars and the BPCIA. To date, the litigation has focused on three primary issues: (1) infringement and validity of the patents-in-suit, (2) Celltrion’s Notice of Commercial Marketing and the associated timing of Celltrion’s product launch; and (3) amendments to the protective order that would allow Janssen to use confidential information obtained from Celltrion to pursue other litigation. Recent developments in these three areas, discussed below, are being closely followed given that Celltrion’s biosimilar, approved in April 2016, is only the second aBLA to be approved under the BPCIA.

BACKGROUND

Celltrion submitted aBLA No. 125544 seeking to market a biosimilar of Janssen’s Remicade® called Remsima®.  After its biosimilar application was accepted for review by the FDA, the parties engaged in the “patent dance” provisions of the BPCIA, the completeness of which Janssen disputes.  In particular, Celltrion produced its application, including manufacturing information, within the statutory 20-day window. Janssen served its patent list, and then Celltrion provided a detailed statement in response and skipped the rest of the dance by summarily agreeing that all of the patents identified by Janssen would be the subject of the first wave of litigation. Celltrion thus avoided about 5 months of further negotiation.

On March 6, 2015, Janssen sued Celltrion under 35 USC 271(e)(2)(c) for infringement of six patents and to enforce dispute resolution procedure portions of BPCIA.  In particular, Janssen faults Celltrion for (1) failing to provide Janssen within 20 days of when the aBLA was accepted for review “other such information describing the manufacturing process” in addition to the copy of the aBLA, and (2) failing to participate in good faith negotiations, which forced Janssen to file suit to preserve statutory rights.

INFRINGEMENT AND VALIDITY

In its complaint, Janssen alleged that Celltrion infringed six patents: U.S. Patent Nos. 6,284,471; 7,223,396; 5,807,715; 7,598,083; 6,900,056 and 6,773,600.  Four of these patents have been dismissed by stipulation. Claims related to the ’715 and ’396 patents (expiring Sept. 15, 2015 and June 29, 2016, respectively) were dismissed with stipulated agreements that Celltrion would not sell its biosimilar in the United States until the patents expire. (D.I. 83; D.I. 138.)  Claims related to the ’056 and ’600 patents were dismissed with stipulated agreements based on manufacturing documents produced to Janssen. (D.I. 83; D.I. 89.)  Thus, only the ’471 and ’083 patents remain at issue in the case.

The ’471 patent is directed to a composition of a specific antibody.  The asserted claims of the ’471 patent have been rejected during reexamation for obviousness-type double patenting.  Janssen moved to stay litigation on the ’471 patent pending appeal of the reexamination decision.  (D.I. 8.)  The Court denied that stay on May 23, 2016.  (D.I. 157.)

In February 2016, Celltrion moved for summary judgment of invalidity of the ’471 patent for obviousness-type double patenting based on three patents.  (D.I. 127-129.)  This included a so-called Gilead argument about a patent that issued after the ’471 patent, but expired before the ’471 patent.  See Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014). Per the Court’s recent scheduling order, Janssen has until June 17, 2016 to address the Gilead arguments.

On June 3, 2016, Celltrion moved for summary judgment of invalidity of the ’471 patent for obviousness-type double patenting based on two of those previously identified patents in light of arguments Janssen made during reexamination.  (D.I. 176-178.)  Celltrion specifically takes on certain procedural arguments that Janssen made during the reexamination (e.g., that the “two-way” test for obviousness-type double patenting should apply instead of the “one way” test and that the ’471 patent should be considered a divisional, not a continuation-in-part).  Janssen’s response is due July 1.

With regard to the ’083 patent, which expires in 2027, Janssen alleges that Celltrion’s cell culture media infringes the ’083 patent under the doctrine of equivalents.  Trial is currently scheduled for February 2017.  (D.I. 124.)  As discussed below, this is more than 180 days after the date the FDA approved Celltrion’s biosimilar and more than 180 days after Celltrion’s second Notice of Commercial Marketing.  However, following FDA approval of Celltrion’s biosimilar on April 5, 2016, Janssen wrote a letter brief to the Court (D.I. 140) seeking an expedited trial on the merits of this patent infringement allegation, and ultimately seeking a permanent injunction.  The Court held a hearing on May 19, 2016, and thereafter approved a schedule for briefing on an expedited trial.  (D.I. 171.)  On May 31, 2016, Janssen filed a motion for expedited trial on the ’083 patent and to set a discovery schedule, if necessary, for remaining issues on the ’471 patent.  (D.I. 166).   Celltrion’s response is due June 21.

NOTICE OF COMMERCIAL MARKETING

Celltrion gave Janssen Notice of Commercial Marketing long before its biosimilar was approved in April 2016.  Although the Federal Circuit in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1358 (Fed. Cir. 2015), said that Notice of Commercial Marketing was effective only after FDA approval, it is an open question whether that ruling applies to situations in which the parties participate in the “patent dance” (since the parties in Sandoz had not).  This very question should be addressed any day by the Federal Circuit in Amgen Inc. v. Apotex Inc., appeal docketed, No. 16-1308 (Fed. Cir. Dec. 11, 2015).  In April 2015, Janssen filed a motion for a preliminary injunction (PI) based on the argument that the BPCIA prohibits Celltrion from commercially marketing its biosimilar in the United States until 180 days after it is licensed.  In February 2016, the Court denied Janssen’s PI without prejudice in light of the impending decision in Amgen v. Apotex.  In the meantime, Janssen takes the position that Celltrion’s first notice is ineffective under the BPCIA because (1) notice is effective only after FDA approval no matter whether the parties participate in the “patent dance” and (2) in any case, since Celltrion did not participate in all of the “patent dance” provisions, this situation falls squarely within Sandoz.  Celltrion responds that it is not required to provide Notice of Commercial Marketing because it has engaged in the patent dance.

After the FDA approved Celltrion’s biosimilar on April 5, 2016, Celltrion gave a second Notice of Commercial Marketing conditional on the first Notice of Commercial Marketing being ineffective.  October 2, 2016 is 180 days after that second notice.

Janssen has indicated that it will file a renewed motion for a PI after the Federal Circuit issues its opinion in Amgen v. Apotex.  A recent scheduling order (D.I. 171, signed May 31, 2016) sets out an expedited briefing schedule for any such briefing: the parties must confer 2 days after the Amgen v. Apotex opinion, simultaneous briefs must be filed 10 days after the opinion, and simultaneous replies are due 7 days after opening briefs.

A few days ago (on June 6), the parties entered a stipulation that Celltrion will wait to sell its product in the United States until September 15, 2016, unless:

(a) the parties reach an agreement that the Amgen v. Apotex opinion moots the proposed renewed PI;

(b) the Court denies Janssen’s renewed PI; or

(c) Celltrion obtains a Court order authorizing an earlier launch date.

(D.I. 180.)

In a recent order, the Court has set a hearing on claim construction and any motion for preliminary injunction for August 16, 2016.  (D.I. 157.)

AMENDMENTS TO THE PROTECTIVE ORDER

Janssen had also sought to amend the protective order so that it could use confidential information learned from Celltrion to file a new (non-BPCIA) case against Celltrion and its third-party cell culture media supplier (HyClone Labs).  This case would allege infringement of the ’083 patent.  The court granted Janssen’s motion to amend the protective order on May 23, 2016 (D.I. 157), and the amendment was entered on May 31, 2016 (D.I. 169).  This is an interesting turn of events because Janssen will be allowed to use confidential information obtained pursuant to the BPCIA to pursue other litigation.  As Celltrion has noted in its briefing, such a ruling potentially “could erode the incentive for biosimilar applicants to produce their confidential information—a production the Federal Circuit has now held is not mandated by the statute.”  (D.I. 111, at 4 (citing Sandoz).)

We will continue to monitor this case as it develops and provide updates.