Eli Lilly and Company LLY announced that it has received a favorable ruling in a lawsuit against generic drugmaker Teva Pharmaceutical Industries Limited TEVA related to the infringement of a vitamin regimen patent for its cancer drug Alimta by the U.S. Court of Appeals for the Federal Circuit. Shares of Lilly gained 2.5% on Thursday following the news.
In fact, Lilly’s share price have risen 4.9% so far this year, better than the increase 0.6% witnessed by the Zacks-classified Large-Cap Pharma industry.
The Court of Appeals confirmed a lower court’s 2015 decision on the validity of Alimta’s vitamin regimen patent. In 2015, the U.S. District Court for the Southern District of Indiana ruled that Teva’s wholly owned subsidiary, Teva Parenteral Medicines, Inc.’s proposed generic version of Alimta would infringe the branded drug’s vitamin regimen patent. We note that earlier in Mar 2014, the same court had upheld the validity of the vitamin regimen patent.
While the compound patent covering Alimta in the U.S. is set to expire later this month, the vitamin regimen patents will remain valid up to May 2022 if Alimta’s patent is ultimately upheld through all the remaining challenges. The compound patent has already expired in major European countries and Japan in Dec 2015.
A number of generic manufacturers are seeking approvals in various countries to market generic forms of Alimta prior to the expiration of its vitamin regimen patents.
In Feb 2016, the UK High Court ruled that a generic version of Alimta proposed by Allergan plc AGN will not infringe the vitamin regimen patent in the UK, France, Italy and Spain, given that it is diluted only with dextrose solution. The court said that it will allow either party to request it to revisit its decision in case there is a material change of circumstances at any point within Jun 2021. Lilly said that it plans to seek permission to appeal the decision of non-infringement to the court. A hearing is scheduled for this April.
Meanwhile, Neptune Generics and Sandoz, the generic arm of Novartis AG NVS, submitted petitions to the U.S. Patent and Trademark Office (USPTO) seeking inter partes review (IPR) of Alimta’s vitamin regimen patent. The USPTO granted the petition in Jun 2016. A final written decision on the merits would be issued by the USPTO by mid 2017.
In the third quarter of 2016, Alimta generated sales of $570.4 million, down 9% year over year, reflecting lower demand in the U.S. due to competitive pressure mainly from immuno-oncology agents. While U.S. sales declined 7%, ex-U.S. sales dipped 1% due to loss of exclusivity in several countries. We note that Alimta is one of the top revenue grossers at Lilly and a longer commercial life for Alimta would provide top-line support as several products in Lilly’s portfolio are already facing patent expiration.
Products like Zyprexa, Cymbalta, Evista and Gemzar are all facing declining sales due to generic competition. In 2017, Lilly is expected to lose patent protection for key drugs like Strattera, Cialis, and Effient in the U.S.
Lilly has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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