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LSIPR Newsletter 12:14 Bayer’s Nexavar appeal rejected by Indian Supreme Court DELHI, INDIA


Bayer has lost an attempt to block a generic version of its cancer drug Nexavar (sorafenib) in India aſter the country’s highest court rejected an appeal from the German pharmaceutical company.


Te Supreme Court of India rejected Bayer’s appeal from the Bombay High Court, which in July backed a 2012 ruling by the Controller General of Patents to grant a compulsory licence to Natco Pharma, an Indian generics company, to market its own version of the drug.


Bayer has since been fighting against the decision, which will enable Natco to sell Nexavar for just $173 (10,900 rupees) a month compared with the $5,500 a month it currently charges.


Te company told LSIPR it was “disappointed” with the decision.


“We are analysing the order and will determine any future course of action aſterwards,” it added.


In a statement on its website on December 12, Natco confirmed the court’s decision but did not offer further comment.


In its order, the Supreme Court said: “In the facts of the present case, we are not inclined to interfere. Te special leave petition is dismissed, keeping all questions of law open.”


Bayer has now lost appeals against the ruling at all


three possible stages: the Intellectual


Property Appellate Board, the High Court, and now the Supreme Court.


Last year, LSIPR spoke to the company’s chief IP counsel Jörg Tomaier, who said increased reliance on compulsory licensing by some countries “undermines the incentives” for innovation.


“India is a case in point. Its policies do not, in fact, provide its poor population better access to medication. For the majority of Indians, even essential, off-patent, medicines remain unaffordable.”


Te case has attracted interest abroad with the US Trade Representative including India on its priority watch list in its Special 301 Report earlier


this year and signalling the pharmaceutical industry as an area of concern.


Te 301 Report is an annual rundown of US trading partners and their efforts to protect IP. n


Drug makers on brink of $65bn patent cliff, says report LONDON, UK


Pharmaceutical companies will suffer an estimated $65 billion drop in sales over the next five years due to the expiry of patents protecting several leading drugs, according to a UK research and consulting firm.


Te expiries, dubbed the ‘patent cliff ’, will hit Japanese drug maker Otsuka, US-based company Eli Lilly, and UK business AstraZeneca the hardest, according to the report by GlobalData.


A significant proportion of losses will come in the central nervous system (CNS) treatment sector, said the report, titled PharmaLeaders: Global Pharmaceutical Market Benchmark Report.


Adam Dion, GlobalData’s analyst covering healthcare industry dynamics, said Otsuka—and its schizophrenia drug Abilify (aripiprazole)—could be the biggest victim of the patent cliff.


Previously, LSIPR reported that some patent protection for the drug, which made 575.7 billion yen ($5 billion) in sales during the last financial year, was set to expire in April next year.


“Abilify’s upcoming US patent expiration in 2015 means the drug will lose a massive $6.2 billion by 2019 as the result of generic


competition, making it the biggest victim of the pharmaceutical industry’s current patent cliff,” said Dion.


In a bid to ease the potential damage, Otsuka agreed a $3.5 billion deal


to buy Avanir Pharmaceuticals to expand its drug portfolio.


Dion added that Eli Lilly and AstraZeneca had seen profits fall in the CNS therapeutics market.


GlobalData pointed to AstraZeneca’s patent loss on bipolar treatment Seroquel (quetiapine fumarate) and the subsequent market entry of generics Teva and Sandoz in 2012, and


decreasing sales of Zyprexa (olanzapine), Eli Lilly’s drug used to treat schizophrenia and bipolar disorder, since 2011.


Jason Rutt, head of patents at law firm


Rouse, said sometimes a big pharmaceutical company has done research & development (R&D) badly and faced an individual patent cliff, but that “this is not what we see here”.


“New drugs tend to treat smaller populations. Tey do so very effectively, but the smaller population size leads to much smaller revenues for the pharma industry. Tis generational change is giving rise to the patent cliff,” Rutt told LSIPR.


He added: “Te patents I write now are likely to be for small biotech companies with an interesting approach to cancer, or a new diagnostic tool, whereas ten years ago I was writing and prosecuting patents for big cardiovascular and CNS indications.


“To manage this, the pharma companies have become marketing companies and experts in running phase III clinical trials, with large amounts of early R&D being done by small companies, which sell on successful projects later to big pharma.”


Otsuka, AstraZeneca and Eli Lilly did not respond to a request for comment. n


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