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Roche prevails on two IPR challenges to Herceptin patents—does it matter?

Zachary Silbersher

We previously wrote about Roche’s encroaching biosimilars for Ritxuan®, Herceptin®, and Avastin®.  This week, Roche prevailed on two IPRs covering patents for Herceptin®, but lost a third IPR covering another patent for the same drug. What does this mean? 

Herceptin® faces five potential biosimilars, including from Celltrion, Pfizer ($PFE), Amgen ($AMGN), Samsung Bioepis and Mylan ($MYL).  These companies have filed several IPR challenges to Roche’s patents covering Herceptin.  Yet, on October 3, 2018, Roche prevailed on two of those challenges, but lost on a third.   

Roche prevailed on upholding the patentability of two patents, U.S. Patent Nos. 6,627,196 and 7,371,379.  The patents cover common dosages for treating cancer with Herceptin®’s anti-ErbB2 antibody.  This is good news for Roche.  Biosimilars must often copy the dosage of the innovator drug.  Specifically, the BPCIA states that “an application for licensure of a biologics product . . . shall include information demonstrating that . . . the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product.” (42 U.S.C. § 262(k)(2)(A)(i)(IV)). 

This means that when an innovator has patents covering the biologic’s dosage, those patents can be a high hurdle to biosimilar entry unless they are invalidated.  In other words, the patents can be hard to design around.  Clearly, the biosimilars for Herceptin® are concerned about likely infringing these ‘196 and ‘379 patents.  In addition to Celltrion, who just lost its IPR challenges, both Pfizer and Samsung also have pending IPRs against the same patents.  In theory, these pending IPRs could still invalidate the patents.

Yet, in this case, this win for Roche is unlikely to be too material.  That is primarily because the ‘196 and ‘379 patents expire in less than a year.  Our calculation is that both patents expire in August 2019.  Yet, it is unlikely that any of the pending biosimilars are likely to launch long before that. 

For one thing, most of the pending biosimilars do not yet have FDA approval.  Samsung’s aBLA is still pending.  Celltrion’s aBLA was rejected in April 2018, and re-filed in June.  Pfizer’s aBLA was also rejected in April 2018.  Amgen’s aBLA was rejected in June 2018.  The only one who has FDA approval is Mylan, and in March 2017, Mylan reached a licensing deal that likely locked in an entry date regardless of the fate of Roche’s patents covering Herceptin®.

More importantly, Samsung, Celltrion, Pfizer and Amgen are currently embroiled in patent litigations with Roche.  The cases were filed in late 2017 or early 2018, respectively.  Yet, they are all pending before the same judge in Delaware, who has put them on the same schedule for discovery.  A critical upcoming catalyst is the Markman hearing in all four cases, which is currently scheduled for March 2019.  This hearing is likely to flesh out the strengths and weaknesses of Roche’s overall patent cases against the Herceptin® biosimilars. 

In other words, the pending litigations are unlikely to wrap up before the end of 2019, and more than likely to continue well past expiration of the ‘196 and ‘379 patent.  In addition, the ‘196 and ‘379 patents are hardly the only patents asserted by Roche in those litigations.  Roche has asserted between 20 and 40 patents against each of the respective biosimilars.  Many of those patents also face multiple pending IPRs.

One of the most important patents is U.S. Patent No. 6,407,213.  This patent covers the Herceptin® protein, and is a critical obstacle to any biosimilar entry.  The biosimilars filed ten separate IPR petitions against this single patent (which might be a record, or something close to the record, for the number of IPRs filed against a single patent.)  At least four of these IPRs are scheduled to receive a Final Written Decision by the end of 2018.   

Yet, the ‘213 patent will expire in June 18, 2019.  It remains to be seen whether, once the biosimilars start receiving FDA approval, they will launch at risk, and whether the outcomes of these IPRs against the ‘213 patent will be a catalyst.

Meanwhile, Roche lost an IPR challenge to a third patent, U.S. Patent No. 7,892,549, which covers a method of treating breast cancer with the Herceptin® protein and chemo.  Yet, this patent also seems unlikely to move the current needle on entry dates for the biosimilars.  That is because the ‘549 patent appears to have expired in December 2017.  

The ‘549 patent has a priority date in 1997, and was granted close to five years of patent term extension.  But it was also terminally disclaimed over U.S. Patent No. 7,846,441, which appears to have a priority date in December 2017.  Thus, even if the biosimilars had not prevailed on invalidating this patent, it would have unlikely stood as a material obstacle to entry, especially given the lack of FDA approval to date (except for Mylan.)

There remain several more IPR challenges to other patents that Roche is asserting to protect its Herceptin® estate from biosimilar competition.  Our review of IPRs against approximately 10 Herceptin® patents shows that, many of these IPRs are unlikely to be too material to determining entry dates for the biosimilars.  Many of the patents expire in 2018 or by 2019 at the latest. 

 Given that the pending BPCIA patent litigations are likely to still remain pending throughout 2019, that raises a number of questions:  Will the biosimilars launch at risk?  In this case, there may be more incentive to do so given the sheer number of potential biosimilars.  Being first to the biosimilar market may be critical.  Indeed, if many of the key patents covering Herceptin® will expire in 2019, then an at-risk launch may not, in fact, be that risky. 

Yet, that raises another question:  when did Mylan agree to launch?  That launch may encourage others to launch at risk.  We will address these questions, and others around potential launches of the Herceptin® biosimilars in future posts.