Eli Lilly and Co. has again started legal action against Mayne Pharma (USA) Inc. for the infringement of two patents related to gemcitabine, filing a new complaint on Thursday after the case was administratively closed in November.
As per the complaint filed by Eli Lilly, Mayne has violated patent law by seeking FDA approval to manufacture, use and sell a “Gemcitabine Hydrochloride for Injection” pharmaceutical product. The manufacture, use, and sale of the product after FDA approval would further infringe two of Eli Lilly's patents, the company claims.
“While we don't discuss the details of any active litigation, we will vigorously assert our rights to continue to help reduce the overall costs of health care through the introduction of high quality, less costly generic products,” said Jason Hodges, spokesman for Hospira.
Patents in Issue:
US 4,808,614 and US 5,464,926.
Eli Lilly alleges Mayne's proposed products infringe a patent issued in 1989 for “Difluoro Antivirals and Intermediate Therfor,” which expires in May 2010, followed by a six-month period of market exclusivity from the FDA. The other patent encompasses the method of treating tumors in mammals with the relevant drug, and expires in November 2012, followed by six months of market exclusivity.
“Mayne's actions create a reasonable apprehension of irreparable harm and loss resulting from its threatened imminent actions,” Eli Lilly said in the complaint.
Gemzar has been a top seller for Eli Lilly, with 2005 sales of $1.3 billion. The company has shown that it is ready to fight for its rights to market Gemzar.
Eli Lilly filed a complaint against Mayne Pharma (USA) Inc. for infringing the same two patents in October 2006, but the case was administratively closed in November 2007.
In February 2006, it sued Teva Pharmaceutical Industries Ltd. and a subsidiary, Sicor Pharmaceuticals Inc., to prevent them from selling generic versions of Gemzar. Eli Lilly learned in January of that year that California-based Sicor had filed ANDAs with the FDA to market doses of gemcitabine before Eli Lilly’s patents expire.
7 comments:
Interesting stuff. 2 questions:
1) What kind of a delay will this put on marketing generic gemcitabine in the USA? If this is a goal of Sun Pharma.
2) Any guesses on what the potential pricing of generic gemcitabine will be in the USA?
Thanks,
John
Answer 1: This will not affect the marketing of generic Gemcitabine by Sun. Sun has already filed a suit for declaratory judgement in Michigan Eastern District Court. The patent in litigation is US5464826. Sun has filed a complaint that there is a case of controversy between Elililly and Sun w.r.t this patent and the claims of this patent are invalid in view of prior art. Anyways Sun is going to market its product in Nov. 2010, so there are possible chances that the outcome of this case will be with us.
As per my opinion, Sun will always like to settle the litigation with the innovator (Eli lilly).
Answer 2: Sorry! I dont have any Idea about the pricing details.
How can you say "Sun is going to market its product in Nov. 2010". Is this your etimate or "well informed" guess?
This is well informed guess because the product patent is going to expire in Nov. 2010 and innovator has not sued Sun for '826 patent, though Sun has filed a suit for declaratory judgement in Michigan district court, asserting that there is a case of controversy and the patent is invalid.
So, either the innovator will give covenant not to sue Sun later for this patent or will go for litigation. The out come of this litigation will alos be important for the marketing of this product as Sun would like to play safe.
Do you think that Hospira's strategy claiming their rights to help decrease overall cost of health care through high quality generic could succeed at time of ongoing discussion about rising costs of health care in the US? I guess, they could get some political support in pre-election time.
Isn't Sun already marketing gemcitabine in India and other markets? What is the patent situation there?
Sun is not marketing gemcitabine in India. I dont have any clue of other markets.
I have do look for patent situation and will get back to you as soon as possible.
Post a Comment