10 NEWS IN BRIEF


Supreme Court rejects Teva’s request to stay Copaxone ruling


The US Supreme Court has rejected Teva’s request to stay an appeals court ruling that allows generic drug makers to enter the market with their own versions of multiple sclerosis drug Copaxone (glatiramer acetate) before its patents expire.


The Chief Justice of the US said that Teva had demonstrated “a fair prospect of success on the merits” in its appeals against the US Court of Appeals for the Federal Circuit’s decision, but denied Teva’s application citing the company’s potential to recover patent infringement damages.


The appeals court invalidated one of the patents covering Copaxone, 5,800,808, which is due to expire on September 1, 2015.


LSIPR Newsletter 04:14 Lilly beats back challenge to Alimta patent INDIANA, US


Te US District Court for the Southern District of Indiana has upheld a patent covering Eli Lilly’s second biggest drug Alimta (pemetrexed disodium), aſter a challenge by Teva’s US pharmaceutical arm.


Judge Tanya Walton Pratt found on March 31 that Teva failed to show by “clear and convincing evidence” that Lilly’s 7,772,209 patent is invalid for obviousness, obviousness- type double patenting, inadequate description or lack of enablement.


Lilly launched the case aſter a group of companies, including Teva, filed ANDAs with the US FDA for approval to make and sell pemetrexed disodium products covered under the ‘209 patent.


Te patent describes a method of administering chemotherapy drug pemetrexed with folic acid and vitamin B12 to reduce the incidence of toxicity. It is due to expire on May 24, 2022, while the compound patent will expire on January 24, 2017; both including paediatric exclusivity.


No to Teva


EMA and Australian regulator collaborate on orphan drugs


The European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration have agreed to share the full assessment reports “related to marketing authorisations of orphan medicines”.


If the same marketing authorisation application is received in parallel by the regulators, they will be able to use scientific exchange to start evaluation of the medicine.


However, the regulators will reach their own conclusions about whether the medicine is suitable to be authorised in their respective markets.


EMA said in a statement: “Global collaboration on orphan medicines and rare diseases is particularly important in view of the small number of patients worldwide and the need for the limited number of studies performed to benefit patients regardless of where they live.”


Alimta is used in the treatment of nonsquamous cell non-small cell lung cancer. In 2013 it generated $2.7 billion in revenues.


Alimta patent valid


Michael Harrington, senior vice president and general counsel for Lilly, said: “We are pleased with the district court’s ruling on Alimta’s vitamin dosage regimen patent and are confident that the patent is valid and enforceable.


“Te significant scientific research that Lilly performed in support of the vitamin dosage regimen patent deserves IP protection. We continue to emphasise that protection of IP rights is extremely important to the biopharmaceutical industry and the patients we serve.”


Teva did not immediately respond to a request for comment. n


Purdue sues Teva to block OxyContin challenge


NEW YORK, US


OxyContin (oxycodone hydrochloride) maker Purdue Pharma has filed suit against Teva to stop the generic drug maker trying to litigate claims to a patent for which it had filed a Paragraph III certification.


Teva filed an ANDA in 2011 seeking approval from the US FDA to make and sell a generic version of Purdue’s blockbuster painkiller OxyContin.


Its Paragraph III certification indicated that it would start marketing its generic oxycodone hydrochloride extended release tablets only aſter Purdue’s patents covering the product expire.


Te case, which was brought at the US District Court for the Southern District of New York on April 3, relates to US


OxyContin generic sought


patent 6,488,963, which covers a method of formulating pharmaceutical products.


In the complaint, Purdue argued that Teva could have pursued, but did not pursue, the patent claims in its prior litigation with Purdue, which have now concluded. n


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