Case Filed: Mar 27, 2014
Case Closed: Jul 28, 2014
Court: Delaware District Court
Judge: Richard G. Andrews
Case Summary:
Mallinckrodt, a global specialty
pharmaceuticals along with Canada-based, Nuvo Research filed a patent
infringement complaint against Amneal, a US-based manufacturer of generic
pharmaceuticals, concerning its filing of an abbreviated new drug application
(ANDA) with the United States Food and Drug Administration (FDA) seeking
approval to market generic version of Mallinckrodt’s pharmaceutical product
Pennsaid®, prior to the expiration of three US patents, which cover the use of
Pennsaid®. The case has been closed as the plaintiff filed a voluntary dismissal,
which was granted by the court.
Patents-in-Suit:
The patents involved in the suit
were: US8217078 entitled ‘Treatment of pain with topical diclofenac’ and US8546450
and US8618164 entitled ‘Treatment of pain with topical diclofenac compounds’.
The patents were issued by USPTO on Jul 10, 2012, Oct 01, 2013 and Dec 31, 2013,
respectively. The patents are scheduled to expire[i]
in Jul 10, 2029. Paladin Labs is the current assignee[ii]
of the ‘078, ‘450 and ‘164 patents (source: MaxVal’s Assignment
Database). The claims of the patents-in-suit cover the method of treating a
patient with an oral NSAID and Pennsaid®.
Pennsaid®:
The drug was first developed in
Canada by Nuvo as a treatment for the signs and symptoms of osteoarthritis,
particularly the knee. Pennsaid® contains the active ingredient diclofenac, a
non-steroidal anti-inflammatory drug (NSAID) that is formulated with dimethyl
sulfoxide (DMSO).
NDA Holder:
Mallinckrodt licensed Nuvo’s
Pennsaid® patents and sought approval from the FDA to market in US.
Mallinckrodt is the current holder[iii]
of the FDA approved new drug application (NDA) no. 020947 for diclofenac sodium
topical solution 1.5%, under the trade name Pennsaid®, in Nov 2009 (source: Patent Marker).
As in Complaint:
Mallinckrodt alleged that Amneal
infringed the patents-in-suit by submitting the Amneal ANDA, by which Amneal
seeks approval from the FDA to engage in the commercial manufacture, use, offer
to sell, sale, or importation of the Amneal Product prior to the expiration of
the ‘078, ‘450 and ‘164 patents.
The complaint further stated that
approval of the Amneal ANDA is substantially likely to result in the commercial
manufacture of a drug product that is marketed and sold for use in a method
claimed in the patents-in-suit.
Mallinckrodt wanted the judge to
declare the case an exceptional and award them attorneys’ fees in light of
Amneal’s conduct.
Other Cases:
Mallinckrodt have filed nearly a
dozen cases and in 2013, it entered into an agreement with Amneal to distribute
generic version of Suboxone®, a prescription medication indicated for the
maintenance treatment of opioid dependence.
See 1:14-cv-00389
for more details. To get alerts
on cases filed/closed, subscribe to our Litigation Alerts.
Max-Insight enables you to access all of our patent tools
such as Patent Term Estimator, Patent Family Tree, Has This Patent Been
Litigated, etc. in one location. Max-Insight is available in 4
different subscriptions: Free, Bronze, Silver and Gold with
varying usage levels. To learn more about Max-Insight, click here.
[i]
Expected expiration date. Patent Term Estimator
is a free web-based tool that automatically calculates patent terms and
expiration dates for U.S. utility patents.
[ii]
MaxVal offers Patent Assignment Alert service
where subscribers receive email alerts when assignments relating to target
applications, patents or entities of interest are recorded.
[iii]
Patent Marker provides an online environment where patentees can virtually mark
products and search products for patent-related information.
Keep sharing this sort of info with us.
ReplyDeleteçevrim şartsız bonus veren siteler
In the past it was to a mind blowing degree troublesome for the understudies to go to different nations to get http://www.pediatricfellowship.com/pediatrics-personal-statement-services/pediatric-surgery-fellowship-personal-statement/ and quality getting ready. In this cutting edge world it has wound up being fundamental for the understudies to advancement to different parts of the world to get pushed guidance.
ReplyDelete