Can Teva’s patents block Lilly’s anti-CGRP Emgality from the market?

Zachary Silbersher

The anti-CGRP market is heating up.  Amgen’s ($AMGN) Aimovig® received FDA approval in May 2018, and Teva’s ($TEVA) Ajovy® received approval in September.  Hot on their heels, Eli Lilly’s ($LLY) Emgality® just received FDA approval at the end of September.  The drugs will all be sold for essentially the same price of $6900 / year.  Given the tight competition, can Teva use its patents to kick anyone off the market?

Both Teva and Lilly filed respective aBLA’s for their anti-CGRP antibodies with the FDA in October 2017.  Teva’s anti-CGRP antibody is fremanezumab, and Lilly’s is galcanezumab. 

Shortly after that, Teva sued Lilly.  On October 2017 and February 2018, Teva commenced two lawsuits against Lilly in the district court in Massachusetts.  The lawsuits claimed that Lilly’s proposed anti-CGRP biologic would infringe nine Teva patents, including patents covering an anti-CGRP antagonist antibody (U.S. Patent Nos. 8,597,649; 9,266,951; 9,340,614; 9,346,881; 9,890,210; 9,890,211) as well as patents covering a method treating headache using an anti-CGRP antibody (U.S. Patent Nos.  8,586,045; 9,884,907 and 9,884,908).

On September 27, 2018, the district court dismissed both of Teva’s lawsuits.  The court held that it lacked jurisdiction to hear the case because Lilly’s aBLA with the FDA had yet to be approved, and it remained too speculative and uncertain when and if it would be approved.  Coincidentally, on the same day, the FDA approved Lilly’s galcanezumab antibody.  On the same day, Teva immediately re-filed its patent lawsuit, asserting the same nine patents.  Teva is seeking not only damages, but an injunction that kicks Lilly’s Emgality® from the market.  Given that the court dismissed the prior case on technical, jurisdictional grounds, rather than on the merits, the case is likely to proceed at this time.

Meanwhile, Lilly has pre-emptively attacked all nine of Teva’s patents.  Lilly has filed nine petitions for inter partes review with the PTAB, challenging the validity of each of the patents asserted in the litigation by Teva.

On August 8, 2018, Lilly filed IPR petitions challenging the ‘649 patent, the ‘951 patent, the ‘614 patent, the ‘881 patent, the ‘210 patent, and the ‘211 patent.  Teva’s initial responses are due in November and December 2018, depending on the specific petition, and the PTAB should decide whether or not to institute the individual petitions during February and March 2019.  On September 28, 2018, Lilly filed an IPR petition challenging the ‘045 patent, and on October 1, 2018, Lilly filed IPR petitions against the ‘907 patent and the ‘901 patent.  Teva’s responses to these latter IPRs will not likely be due until January 2019, with institution to be decided most likely in April 2019.

It will be interesting to watch for Lilly’s next move.  We anticipate that Lilly may file a motion to stay the district court litigation.  If so, then Lilly’s gambit has, thus far, worked.  By challenging the originally-filed district court actions on jurisdictional grounds, Lilly was able to essentially delay those cases for close to a year, all the while buying itself time.  Meanwhile, Lilly prepared and filed IPRs against all of the asserted patents.  That means, the district court litigation is still in its infancy, even though Teva tried to commence the cases close to a year ago. 

When deciding whether to stay a litigation in light of a parallel, pending IPR, courts typically consider whether the district court case is in its infancy versus closer to trial.  Lilly’s galcanezumab now has FDA approval, and thus, Teva can finally pursue its patent-infringement action in district court.  But Teva’s case has just started, and is very far from trial.  That likely weighs in favor of staying the case.  Some courts have been unwilling to stay litigations until the IPRs are actually instituted by the PTAB.  In this case, however, it will likely be close to six months before Lilly tees up the motions to stay and they are fully-briefed and ripe for the court’s decision. 

Whether Lilly moves to stay the case may depend upon how strong it believes its non-infringement defenses to be.  Here, however, the preliminary signs suggest Lilly thinks its best way out of this case is by arguing the patents are invalid, rather than by arguing that it does not infringe. 

Many of Teva’s patents cover its anti-CGRP antibody.  But the patents are reminiscent of antibody patents asserted between competitors in other cases, such as for PCSK9-inhibitors, anti-CD38 antibodies and entanercept. The patents are very broad.  They cover the protein not necessarily by what it is (the amino-acid sequence), but by what it does (the amino-acid residues to which the antibody binds on the antigen.)  Likewise, the defendants in these cases have frequently stipulated to infringement shortly before trial.  We see that as a possibility in this case based upon how the patented claims are drafted, but it remains too early to tell.

Either way, Lilly has already gone all-in trying to invalidate Teva’s patents by pre-emptively attacking their validity at the PTAB.  Importantly, the anti-CGRP migraine market is not a two-competitor market, but likely to be a four-horse race.  (Alder’s eptinezumab does not yet have approval.)  The reason that matters is because Lilly may have been wary of invalidating Teva’s patents if it believed it could circumvent them through non-infringement.  That’s because, invalidating the patents will provide not only Lilly with freedom-to-operate around Teva’s patents, but also the other two competitors in the market. 

Here, however, Lilly may know that its best bet to circumvent the patents is through invalidity, given the breadth of the patents.  Alternatively, Lilly may have surmised that there is not much windfall to its competitors even if the patents are invalidated.  Alder ($ALDR) has already taken a license to Teva’s patents.  (That license also obliged Alder to withdraw a pending opposition to a related European patent.)  And Teva does not yet appear to have sued Amgen, even though Amgen received approval a while ago.

Thus, the next few catalysts in this space include watching for whether Lilly moves to stay the district court case, and reviewing the strength of Lilly’s responses to the IPRs later this year.