March 2012

March 20, 2012, by Mandour & Associates, APC

Los Angeles – India-based Natco Pharma Ltd has licensed a generic version of Bayer’s cancer drug Nexavar, effectively ending Bayer’s so-called monopoly on the drug. Under the licensing agreement, Natco will be required to pay a six percent royalty fee to Bayer.

This case of compulsory licensing, where the government allows another entity to produce a patented product without consent from the patent owner, came out of necessity for public emergency since Bayer’s patented Nexavar was priced out of reach. The Pittsburgh, Pennsylvania-based subsidiary of the German pharma giant markets Nexavar for about $5,600 per month to the Indian market under a patent that will expire in 2020.

Determining that Bayer was not making the drug available to the public at a ‘reasonably affordable price,” the patent office approved Natco Pharma’s application to manufacture the kidney and liver cancer treatment snorefinib. The drug will reportedly be available to Indian patients for $175 per month.

“We are disappointed about this decision,” stated Bayer spokeswoman Sabina Cusimano, adding, “We will see if we can further defend our intellectual property rights in India.”

The ruling from the patent office will likely upset other Western pharmaceutical companies as well. Over the past several years, Western companies have been pushing for stronger patent protections and rules in response to a $26 billion Indian generics industry they claim is infringing on their intellectual property rights. They also argue that the 2005 Patent Act that allows for the compulsory licensing fails to guarantee investors’ rights. Human rights groups insist that the Indian generics are a vital resource for saving lives in poor and underdeveloped countries, where patients cannot afford to pay the high prices for the Western drugs to treat deadly diseases like cancer, HIV, and malaria.

“This is a victory for Indian patients and for India’s generic manufacturers, which are under attack,” said Natco’s general manager, Madineedi Adinarayana. He added that Bayer’s patent “was not working as a patent in India,” and predicted that “many more such cases will follow.”

The 2005 Patent Act requires that a patent be at least three years old before a generics company can apply for a compulsory license. Regardless of the recent law, many Indian pharmaceutical companies are reluctant to apply for the licenses out of fear it may jeopardize future opportunities to manufacture other drugs for Western companies.

March 12, 2012, by Mandour & Associates, APC

Los Angeles – A group of sixty family farmers, seed businesses, and organic agricultural organizations have joined together in a lawsuit to challenge chemical giant Monsanto Company’s ongoing allegations of patent infringement.

The farmers’ lawsuit was filed after years of Monsanto taking them to court in order to assert its patent rights. In the latest courtroom action for the lawsuit filed last March, the Organic Seed Growers & Trade Association (OSGATA) offered Judge Naomi Buchwald arguments to what they say has been nothing short of a climate of fear created by Monsanto’s long series of patent infringement lawsuits. OSGATA represents as much as twenty-five percent of the nation’s organic farmers and non-organic farmers alike.

OSGATA’s complaint, filed under the Declaratory Judgment Act, would allow for a preemptive judgment that would clear the farmers of any patent infringement before they even grow and harvest their crops. The farmers are reportedly not seeking any monetary damages from Monsanto.

According to the individual farmers and businesses suing Monsanto, the issue is that Monsanto’s transgenic plants, also known as genetically modified organisms or GMO’s, are contaminating their organic crops by introducing the unwanted GMO’s into the soil. Interestingly, Monsanto has often responded to the farmer’s complaints by suing them for patent infringement, even though the farmers were desperate to keep the material out of their crops.

Jim Gerritsen, an organic seed farmer and president of OSGATA, said, “We consider the threat of contamination from GMO crops to be significant, and the reality is that the organic market will not tolerate anything that has GMO content, either by design or contamination.”

Monsanto, who is the largest commercial grower of corn seed in the world, claims that any cross-pollinating from the wind or at distributors’ seed bins is completely unintentional.

The patent attorney representing the farmers is attempting to prove that Monsanto’s GMO seed patents are invalid because they have no social utility. Patent law requires patented inventions to have a social utility and Monsanto’s seed is harmful to society, therefore making the patents invalid.

Patent attorneys for Monsanto have asked the judge to dismiss the lawsuit, citing that it is “hypothetical” and “abstract.” The judge has until the end of March to respond to Monsanto’s request.

March 2, 2012, by Mandour & Associates, APC

Los Angeles – Wind turbine industry giants General Electric (GE) and Mitsubishi Heavy Industries (MHI) were both handed partial victories in the latest round in an on-going patent infringement battle over wind turbine technology.

In GE’s favor, a federal court ruled that the United States International Trade Commission will be required to reconsider its decision that MHI did not infringe on GE’s technology for turbine wind power, a reversal of its January 2010 ruling. In that decision, the Trade Commission said that Mitsubishi’s 2.4 megawatt wind turbines did not infringe any of GE’s turbine patents, thus allowing Mitsubishi to continue importing the turbines into the United States.

The long-running patent infringement battle began in February 2008, when GE filed a complaint with the Trade Commission claiming that the Japan-based Mitsubishi and its American subsidiary had infringed three of its patents related to variable speed wind turbine technology.

The most recent ruling comes as good news to GE, however Mitsubishi did not emerge without victory. The Court of Appeals upheld the previous ruling by the Trade Commission that Mitsubishi had not infringed on a second patent and also said that one of the three patents allegedly infringed had expired and was dropped from the case. Companies must be able to prove that a patented technology is being used in the United States in order to file a patent infringement complaint with the International Trade Commission.

“GE will continue to take necessary steps to protect its significant investment in technological research and development in the United States and around the world,” the company said in an online statement.

General Electric acquired the wind power assets from Enron during its bankruptcy proceedings in 2002. At the time of the acquisition, Enron was the only remaining U.S. manufacturer of large wind turbines, with GE managing to double its Wind Division’s annual sales to $1.2 billion in 2003 by increasing engineering and supplies. In 2009, GE purchased Norwegian turbine company Scanwind and eventually became the second largest wind turbine producer in the world. Vestas Wind Systems A/S, a Danish company, is reportedly the world’s largest manufacturer of wind turbine technology.

No comment was available from Mitsubishi Heavy Industries regarding the ruling.