Which arguments will Sandoz make at the Enbrel® patent trial?

Zachary Silbersher

The parties recently filed a report that appears to identify what the trial will focus on, but it was filed under seal.  On April 18, the Court issued an order that pushed the trial in this case from June back to September 2018.  At the same time, the Court ordered the parties to file a report by May 15 that identified how the parties have agreed to streamline the trial.  Specifically, the Court ordered the report to set forth any “agreements reached by the parties to streamline the issues for trial and/or any outstanding issues requiring resolution by the Court.”  (Immunex v. Sandoz, 16-cv-118)(D.N.J. Dkt. 444).  On May 15, the parties filed what appears to be that report.  (See Dkt. 486-487).  Yet, the report has been filed under seal.  And therefore, for now, it is not available to the public.

Understandably, patent litigations typically delve into proprietary and confidential information that one or more of the parties wish to seal from the public.  This information typically involves sales and financial information or proprietary technology that is not otherwise publicly available.  The basis for sealing information is that, among other reasons, it can cause embarrassment or competitive harm.  Yet, in this case, it is unclear why so much has been sealed.

For instance, if the parties have reached agreement on the issues to be tried, why is that information sealed?  Arguments related to infringement of a patent will often implicate proprietary technological information, which may warrant sealing.  But, arguments for invalidity does not always do so.  Why?  Because invalidity arguments are generally based upon public information.  An obviousness argument typically must rely upon prior art references that were most likely public because if they were not public, then in most cases, they cannot constitute prior art.  (This is one reason why IPR petitions are rarely, if ever, sealed.)

Here, as we have previously discussed, we have identified at least three arguments that Sandoz is likely to make at trial, at least with respect to the entanercept protein patents (‘182 and ‘522 patents.)   First, the patents are invalid as obvious in view of prior art.  Second, the patents are invalid for lack of written description, for failing to adequately disclose a fusion protein comprising a soluble fragment of the 75 kDa TNFR and the hinge-CH2-CH3 region of a human IgG.  (Coherus Biosciences previously hinted at this argument in its IPR petitions.)  Third, the patents are invalid for obviousness-type double-patenting. 

The fact that Sandoz intends to make any of these arguments should not, in theory, be sealed from public view.  With respect to obviousness, Coherus has already petitioned the PTAB that the ‘182 and ‘522 patents are invalid as obvious.  Further, Amgen has publicly disclosed the expert report from at least one of its experts that appears to rebut Sandoz’s obviousness argument.  (See Dkt. 478, May 9, 2018).  Understandably, if Amgen is arguing in response to Sandoz’s obviousness argument that Enbrel®’s commercial and/or clinical success is a secondary consideration of non-obviousness, then Amgen’s financial or clinical information backing up the purported success of the drug would be information that is typically sealed.  Yet, the fact that Amgen is arguing commercial success—or even clinical success—is not typically viewed as confidential information. 

The same holds for the other arguments.  The fact that Sandoz is arguing that the patents lack written description is really an argument that must be made within the four corners of the patents themselves—which are already, obviously, public documents.  Finally, with respect to double-patenting, Sandoz has already publicly-disclosed to the Court that it is pursuing such a defense.  (See Dkt. 184, May 25, 2017).  Indeed, the Court issued an order related to discovery on this very issue.  (See Dkt. 194, June 7, 2017).  Admittedly, as we previously discussed, the double-patenting defense may implicate ownership issues of the patents that might arguably be deemed confidential information.  But that is very different from sealing the fact that Sandoz is making the argument.

There are mechanisms for third-parties and investors to challenge the sealing of documents filed within a federal district court action.  Investors mindful of better handicapping this case and Sandoz’s biosimilar entry date should investigate them.