Cinacalcet – USA

On Sep 18, 2019, Delaware court judge rejected Sun Pharma’s contention that its settlement with Amgen entitles Sun to launch its generic version.

Amgen sued Sun in Sep. 2016 for filing ANDA to market generic version of Sensipar®. The Parties settled & entered into Settlement Agreement on Oct. 24, 2017. On Aug. 24, 2018, Court entered a judgment of non-infringement in favor of Piramal, Amneal and Watson (Teva). On Dec 27, 2018, FDA approved Watson / Teva’s ANDA & on Dec. 28, Teva launched generic product in US market. Shortly thereafter, on Jan 2, 2019, Amgen and Teva reached a settlement agreement whereby Teva acknowledged that its generic product infringed the US 9,375,405 patent and agreed that it would immediately cease sales of this product. Also, on Jan 2, 2019, in order to comply with its notification duties outlined in section 5.3 of the Agreement, Amgen notified Sun of Teva’s launch and of their subsequent settlement.

Main dispute in this case was related to the part of Agreement which relates to Amgen’s obligations if other manufacturers of generic Cinacalcet entered the market at risk. Sun argued that it is entitled to a license under Section 5 of the Agreement. Specifically, Section 5.2(b) states that the “Entry Date” could be the earlier of “the Launch of a Generic Cinacalcet Product by a Third Party, Amgen, or an Amgen Affiliate, except as provided under Section 5.5.” Section 5.5 outlines Amgen’s obligations if a Third Party engages in an “At-Risk Launch.  According to it, Amgen need to enter into an agreement with each such Third Party selling such Generic Cinacalcet Product requiring each such Third Party to cease and desist from selling such Generic Cinacalcet Product form the market within 30 days of such agreement, then Amgen will not seek a temporary restraining order or preliminary injunction against Sun.

Sun urges that, based on Amgen’s deficient response to Teva’s market entry, it is entitled to a license to sell its generic Cinacalcet. Sun’s argument rests primarily on its claim that despite Teva’s launch and downstream sales, Amgen did not contract with each downstream distributor to effectuate a cease and desist regarding the selling of the Teva product. Per Sun’s reading of the Agreement, such authorized downstream sales trigger application of section 5.2 of the Agreement, thus granting Sun a license to enter the market.

Court however, disagreed & said that Amgen complied with Section 5.5(a)(ii) as it did in fact enter into a cease and desist agreement with Teva five days after Teva entered the market. Sun reads this language differently, urging that it obligates Amgen to effectuate “any further sale of such Generic Cinacalcet Product” by both Teva and all Third-Party distributors. In short, relying on language that simply does not exist, Sun insists that Amgen must have “policed the market,” – that is, policed both Teva and Third-Party distributors. Court disagreed with Sun’s interpretation for several reasons.

First and foremost, Amgen’s cease and desist obligations under the Agreement refers to Third Parties who engaged in at risk launch. It is undisputed that distributors and resalers did not engage in at-risk launch – only Teva did. Thus, reading the agreement as a whole, Court concluded that a “Third Party” does not include distributors. The Agreement is absolutely silent that this obligation also includes distributor resales and downstream purchasers.

Second, there simply is no language in the Agreement to support Sun’s contention that Amgen agreed to remove all generic products from the market, or that Amgen had a duty to police the entire market after such a launch. Reading section 5.5 as a whole, “each such Third Party” can only refer to Teva because only the generic manufacturer has the ability to be the first to sell the specific generic Cinacalcet product in the United States. And Teva was the only third party to have “Launched” a generic Cinacalcet.

Therefore, under this construction, Sun is not granted a license to market its Generic Cinacalcet Product at this time.