NEWS Eli Lilly patent expiries cause revenue to fall
Pharmaceutical company Eli Lilly has reported that
its US revenue in 2014 dipped by 29%
compared to the previous year, laying the blame on key patents, including those for Cymbalta (duloxetine hydrochloride) and Evista (raloxifene hydrochloride), expiring. In its full-year results, published on January 30,
the Indianapolis-based company also reported that
its total worldwide revenue fell from
$23.1 billion in 2013 to $19.6 billion last year, representing a 15% fall. Eli Lilly lost US patent exclusivity covering
its anti-depressant drug Cymbalta in December 2013. In 2014, the drug’s global revenue fell by 68%
year-on-year—from just over $5 billion to $1.6 billion. However, there was a 6% increase in sales of Cymbalta outside the US in the same time period. Meanwhile, global revenues for the company’s
osteoporosis drug Evista fell from $1 billion in 2013 to $419 million a year later, representing a 60% drop. Te main US patent covering Evista expired in March 2014.
Eli Lilly 2014 results
AstraZeneca has sued Glenmark Pharmaceuticals for allegedly infringing four patents protecting its breast cancer drug Faslodex (fulvestrant). Te pharmaceutical company filed the case
at the US District Court for the District of New Jersey on January 26. Te case follows Glenmark’s filing of an ANDA at the US FDA to make and sell a generic version
of Faslodex in a 250mg/5ml strength before four patents protecting the drug expire. AstraZeneca’s Faslodex patents are due to
expire in 2021. Faslodex is an oestrogen receptor antagonist used
to treat hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following anti-oestrogen therapy.
Worldwide revenue in the fourth quarter of 2014 decreased by 12%, compared with the same period in 2013. While its revenue has taken a hit in the last year,
the company said it expects its 2015 sales figures to range from $19.5 billion to $20 billion. It is hoped that
the January acquisition of Novartis Animal
Health will add “significant value”, the company said. John Lechleiter, chief executive of Eli Lilly, said:
“While Lilly’s fourth-quarter 2014 results continue to reflect the impact of patent expirations, we are moving to a period of growth led by diabetes, oncology and animal health.” He added: “Despite the loss of
significant
revenue for Cymbalta and Evista following the expiration of our US patents, we saw strong performance from many other products. At the same time, we made excellent progress with our innovation-based strategy, and we continue to advance our pipeline.” In February Pfizer also reported a drop in sales,
which it blamed on the expiration of patents protecting arthritis medicines Enbrel (etanercept) and Celebrex (celecoxib).
AstraZeneca sues Glenmark to defend breast cancer drug In a letter to AstraZeneca notifying the company
of its ANDA filing, Glenmark claimed that the four patents are invalid, unenforceable and would not be infringed by the generic product. AstraZeneca has asked for a judgment that
the four patents are valid and enforceable, that Glenmark’s submission of its ANDA was an act of infringement, and that Glenmark’s proposed generic product would infringe its patents. Te Anglo-Swedish company has also asked
for an order that any FDA approval of Glenmark’s ANDA will not be provided until aſter the four patents expire, as well as a permanent injunction stopping Glenmark from making or selling its proposed product before the patents expire. Last June, AstraZeneca sued Sandoz, and
then in September it took action against Illinois- based Sagent Pharmaceuticals, to protect the same patents. Both cases were filed in the New Jersey district court. Both companies had filed ANDAs before
AstraZeneca took action. Te lawsuits have not yet been resolved. A spokesperson for AstraZeneca told LSIPR:
“AstraZeneca contends that generic fulvestrant injection products and their use will infringe the claims of AstraZeneca’s patents. We have full confidence in and are vigorously defending and enforcing our intellectual property protecting Faslodex.” Glenmark did not respond to a request for
comment. 8 Life Sciences Intellectual Property Review Volume 2, Issue 2
www.lifesciencesipreview.com
SEBASTIAN KAULITZKI /
SHUTTERSTOCK.COM
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