Dosage regimen is not patentable: EU Judgement

What is patentable and what is not is always remain unclear by reading the simple lines of legislation and its just a simple words but when we interpret, it always lead to many meanings.

Recently in a decision, in case of Actavis Vs Merck related to a patent of dosage regimen, they held patent invalid as the subject matter is not in the scope of patentability under article 53(c) EPC 2000.

For full judgement please click here (Source: Kluwer patent blog)

Merck arm sues Sun for patent violation for Temodar

The Cancer Research Technology, a group company of Schering Plough Corp and a subsidiary of the US headquartered pharma giant Merck & Co, has alleged that Sun Pharma, by attempting to manufacture a generic version of cancer drug Temodar (Temozolomide), is infringing the patent coverage of the former.

Cancer Research has filed the suit against Sun Pharma in the US district court of New Jersey. The drug, which is one of the world's best selling brain cancer drug has annual sales worth $380 million in the US market alone and clocks global revenue of $1 billion per annum. The patent being challenged is set to expire in 2013.

Sun Pharma is not the first generic manufacturer to have filed an abbreviated new drug application (ANDA) related to the drug and therefore would not be entitled to most sought after 180 days of exclusive marketing opportunity for the drug. The patent related to drug is being litigated in the US courts since 2007.

The US-based Barr Labs was the first generic player to have received a tentative approval from the US Food and Drug Administration to manufacture this brain tumour drug. Later in 2008, Israeli drugmaker Teva acquired Barr. Temodar was developed by Schering-Plough Corp. Merck bought Schering-Plough in early 2009. So the litigation related to the drug is being pursued by Merck and Teva by virtue of their respective acquisitions.

In an important victory for Teva, last January, a federal court ruled that Merck's patent claims related to the concerned drug was ‘unenforceable’. Merck not only appealed against the decision, which is being heard currently in US courts (Federal Circuit), it also reached a settlement with Teva. The Israeli drugmaker, which had the option of launching the generic version of the drug in the US market, decided to hold off the launch post its agreement with Merck.

Teva said in March that it will begin selling its drug only if the court where a decision on the drug is pending, agrees that a patent on the brain cancer drug is unenforceable. In return, Merck agreed to allow Teva to start selling its generic in August 2013 if the patent is upheld. At that time Merck will still have pediatric exclusivity on the brain cancer treatment. (Source: http://www.financialexpress.com/)

Merck Saphris sNDA gets FDA nod

The US Food and Drug Administration (FDA) has approved Merck's two supplemental new drug applications (sNDA's) for Saphris (asenapine) sublingual tablets to expand the product's indications.

Saphris is prescribed for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Saphris, an antipsychotic medication which works by changing the actions of chemicals in the brain, has received approval in the US on 13 August 2009.
Merck Neuroscience Clinical Research vice president David Michelson said that they look forward to discussing those new uses for Saphris with the mental health community.
(Source: http://regulatoryaffairs.pharmaceutical-business-review.com)