NEWS AstraZeneca files lawsuit over bipolar drug
Pharmaceutical company AstraZeneca has filed a patent infringement lawsuit against drug maker Pharmadax aſter it applied to market a generic version of a schizophrenia and bipolar disorder treatment.
AstraZeneca said the US subsidiary of Taiwan- based Pharmadax would infringe its patent for the Seroquel XR (quetiapine fumarate) drug if it were to market a generic version.
According to the complaint, Pharmadax informed AstraZeneca in September that it had submitted an ANDA to the US FDA to seek approval to manufacture, use and sell extended- release quetiapine fumarate tablets as generic versions of AstraZeneca’s Seroquel.
In the lawsuit, filed at the US District Court for the Central District of California, AstraZeneca said the ANDA would infringe the process of preparing and using its drug, the claims of which are covered by its US patent number 5,948,437.
Te patent, called “pharmaceutical compositions using thiazepine”, was issued on September 7, 1999 and does not expire until 2017.
A US court has rejected attempts by two companies to market generic versions of a birth control pill owned by pharmaceutical company Actavis.
Te US Court of Appeals for the Federal Circuit upheld a lower court decision on October 23.
Baltimore-based Lupin Pharmaceuticals and New Jersey-based Amneal Pharmaceuticals had filed ANDAs, seeking permission to produce generic versions of Actavis’s Lo Loestrin Fe, a prescription pill used to prevent pregnancy.
Dublin-based Actavis sued the companies, claiming its US patent number 7,704,984, called “extended oestrogen dosing contraceptive regimen”, would be infringed by the applications.
In January this year, the US District Court for the District of New Jersey sided with Actavis but the decision was appealed against.
Te federal circuit upheld the district court’s decision, meaning Lupin and Amneal will be prevented from launching generic versions of the drug until aſter the patent expires, in February 2029.
AstraZeneca claimed the commercial manufacture, use, sale or offer for sale within the US, or the importation into the US, will infringe one or more claims of the ’437 patent.
According to the complaint, filed on October 23, AstraZeneca is demanding that the date of the approval of Pharmadax’s ANDA be no earlier than the patent’s expiry date.
AstraZeneca is also seeking a judgment that the patent remains valid and has been infringed by the ANDA application, alongside attorney’s fees.
plunge on patent expiries
Pharmaceutical company Eli Lilly has said its profits fell by more than 50% in the most recent quarter, citing patent expirations and generic competition as contributing factors.
On October 23 the US drug maker said that it earned $501 million in profit in the third quarter of 2014, compared with $1.2 billion a year earlier, a fall of 58%.
Its overall sales revenue fell 16% to $4.88 billion.
According to the firm, the loss of exclusive patents on important medicines including depression treatment drug Cymbalta (duloxetine) was among the biggest factors.
Sales of Cymbalta, the patent for which
expired in December last year, fell 73% to $368 million.
Its osteoporosis treatment drug Evista (raloxifene) began facing generic competition in March this year
following its patent expiring, and sales fell by 65%.
In a statement, company chair John Lechleiter said: “While Lilly’s third-quarter financial results continue to reflect the impact of recent patent expirations, our clinical pipeline is now producing strong momentum to drive future growth.”
Lechleiter added: “In the past quarter alone, three new medicines were approved by the US FDA and several others had positive data readouts.
“We are focused on successfully launching this new wave of innovative medicines while sustaining a steady flow of promising assets in our pipeline.”
Te FDA approved two new drugs to treat type 2 diabetes—Jardiance (empagliflozin) and Trulicity (dulaglutide)—and granted tentative approval for a generic form of Sanofi’s Lantus (insulin glargine).
www.lifesciencesipreview.com Life Sciences Intellectual Property Review Volume 2, Issue 1 9
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