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LSIPR Newsletter 02:13

India’s Patent Office revokes Sutent cancer drug patent Mumbai, india

India’s Patent Office has revoked pharmaceutical company Sugen and licensee Pfizer’s patent for the cancer drug Sutent (sunitinib), agreeing with Indian drugs maker Cipla that it lacks inventive step. An injunction preventing Cipla from launching a generic version of sunitinib, has also been lifted. Sugen was granted a patent for sunitinib in 2007. Cipla filed a post-grant opposition in 2008, arguing that the invention of the active compound in Sutent would have been obvious to anyone skilled in medicinal chemistry, based on prior art published on previous compounds used in anti-cancer treatments. Cipla also argued that Sugen had failed to disclose information required under Section 8 of India’s Patent Act.

In its counterargument, Sugen attributed Cipla’s lack of inventive step claim to hindsight bias, but the claim was upheld and the patent revoked in September 2012. Sugen appealed against this decision at Delhi’s High Court, and was granted an injunction preventing Cipla from launching its sunitinib. Cipla appealed against the injunction at India’s Supreme Court and in November, the case was referred to the assistant controller of patents. The decision to revoke Pfizer’s patent was published by the controller on February 11. Cipla is now free to produce sunitinib unless Sugen and Pfizer can have it reinstated. A spokesperson for Pfizer said that the company is disappointed with the Indian Patent Office’s decision and plans to appeal against it. “This ruling may further deter innovative companies from engaging in local

partnerships and investing in the healthcare industry in India. “While Pfizer understands the Indian government’s intent to improve affordability and access to medicines, these concerns need to be addressed holistically to ensure both the quality and availability of innovative medicines,” said the spokesperson. Ranjna Dutt, a partner at Remfry & Sagar, said it would be a wise decision to appeal against the Patent Office’s finding, given how important sunitinib is to Sugen. Dutt welcomed the controller’s decision to reject Cipla’s claim of non-disclosure, adding that the controller did not observe the information disclosure requirement under Indian law very strictly, but said: “It was a little surprising that the controller accepted Cipla’s claim that Sugen’s application lacks inventive step—this decision is not well-reasoned.” n

FDA approves generic heroin substitutes washington DC, US

The US Food and Drug Administration (FDA) has approved two generic versions of Reckitt Benckiser’s heroin replacement tablet Suboxone—despite Reckitt’s claims that the product is unsafe. Suboxone (buprenorphine and naloxone) is the most commonly prescribed opiate addiction treatment in the US. In 2012, it had sales of $625 million and accounted for 20 percent of Reckitt’s operating profits. Reckitt obtained the US rights to the product in 2002 but has been battling generic competition since its orphan drug status expired in October 2009. In September 2012, the company announced it was withdrawing Suboxone tablets from sale over concerns that they could be accidentally taken by children and filed a petition urging practitioners to switch to its follow-up product, Suboxone Film. Suboxone Film retains its patent until 2022 and dispenses one dose at a time through a strip of film placed under the tongue. The company also asked the FDA to deny any applications for generic versions of Suboxone without unit-dose packaging. The FDA rejected this petition. In a letter dated February 22, it said there is no evidence

to suggest banning products that don’t use unit doses would reduce accidental poisoning. The FDA also said that regulatory controls already in place for Suboxone are adequate.

Amneal confirmed that its generic could be available at pharmacies by early March. In a recent statement, Activis said it intends to begin shipping the product immediately.

“While Reckitt has declared its intention to withdraw Suboxone tablets from sale in the future, our understanding is that this product continues to be shipped and sold … Reckitt’s own actions undermine…its claims with respect to the severity of this safety issue,” the letter added.

Reckitt Benckiser said in a statement that it is disappointed with the FDA’s decision but will not be reintroducing Suboxone tablets. Share prices of the company fell by more than 4 percent following its announcement.

The approved generic versions of Suboxone will be sold by New Jersey pharmaceutical companies Amneal and Activis. In a statement released on February 25, Chirag Patel, president and co-chairman of Amneal, said: “The FDA’s decision to approve the first generic equivalents to Suboxone tablets will ensure that millions of patients in the US ... now have access to a high quality, low cost generic version.” Chintu Patel, CEO of Amneal, added: “We appreciate the FDA’s thorough assessment of Reckitt’s Citizen’s Petition and applaud their recent decision to deny it in its entirety. The FDA determined that Reckitt’s petition did not raise valid scientific or regulatory issues associated with the product, which Amneal contended in its comments on the petition. Physicians should have no concerns in writing prescriptions for the generic tablet form of the product.”

Life Sciences IP Review

Adam Samansky, partner at Edwards Wildman Palmer LLP in Boston, said: “Innovator pharmaceutical companies are continually trying to bring new products to market that address unmet needs and drive value for the company’s shareholders. “In today’s litigious climate, and even where a new product presents a clear clinical benefit, generic competitors…routinely accuse innovators of anticompetitive behaviour when the innovator then seeks to withdraw an old product. “In this case however, while the FDA specifically noted that the Commentergenerics’ allegation of an alleged intent by RB to ‘delay approval of generic versions of its products’ under 505(q)(1)(E) was not a basis for the agency’s denial of RB’s Petition, [it] referred allegations of anticompetitive business practices to the Federal Trade Commission,” he added. n

LSIPR Newsletter - February  

Life Sciences Intellectual Property Review newsletter for February 2013.