Drug & Device News

WHO Official Predicts Dire Future for Antibiotic Effectiveness

Speaking to a group of infectious disease experts in Copenhagen, the World Health Organization's (WHO) director general, Margaret Chan, warned that worldwide resistance to antibiotics is rising, to the point that common illnesses and injuries may once again become lethal. While it has long been known that bacteria, like other living things, develop resistance over time to those substances that threaten their survival, it is becoming more apparent that the popularity of antibiotics has accelerated this process in bacteria that infect humans. Pharmaceutical companies push antibiotics on the public and medical professionals, seeing them as money-makers. Patients demand them. Doctors are known to prescribe them even when unsure if a bacterial infection is present, “Just to be safe.” Patients often fail to take the full course of antibiotic treatment, leaving drug-resistant bacteria in their systems. And livestock treated with antibiotics are consumed by humans, who then ingest pathogens that have developed drug resistance when they eat a pork chop or hamburger. In a WHO release announcing the publication of a new book on the subject, “The Evolving Threat of Antimicrobial Resistance ' Options for Action,” Dr. Cho stated, “In terms of new replacement antibiotics, the pipeline is virtually dry. But much can be done. This includes prescribing antibiotics appropriately and only when needed, following treatment correctly, restricting the use of antibiotics in food production to therapeutic purposes and tackling the problem of substandard and counterfeit medicines.” See www.who.int/mediacentre/news/notes/2012/amr_20120308/en/index.html

India Says Bayer Must License Nexavar

An Indian government agency has ordered a European pharmaceuticals manufacturer to license a local firm to produce one of its patented drug products. Finding the price Bayer charges for the cancer drug Nexavar too high for many Indian citizens to afford, the country's patent authorities determined that the German manufacturer must issue a license permitting Indian drug company Natco Pharma to produce a cheaper generic version for sale to Indian patients. This is the first time India has ordered a compulsory manufacturing license for a patented drug, and it is doubtful this will be the last, since India is not a strong protector of international intellectual property rights. The country did not grant drug patents until 2005, and it has legislation on its books permitting the issuance of a compulsory license if a patented invention has enjoyed commercial exclusivity for at least three years, has not been made available in sufficient quantity to Indian citizens and is too expensive for them to afford. In the case of Nexavar, the drug had been patented by Bayer in India since 2008, yet not nearly enough doses had been sent to India since that time to cover the needs of its liver and kidney cancer patients. In addition, Bayer was charging more than $5000 for a month's-worth of the drug; the same amount of Natco Pharma's generic version will cost about $175. A Natco Pharma release announcing the license stated, “Natco welcomes this order and opines that this opens up a new avenue of availability of [life-saving] drugs at an affordable price to the suffering masses in India.”

Supreme Court Shocks Industry, Finds Process
Patents Invalid

The U.S. Supreme Court has invalidated two patents on a diagnostic test used to determine patient-specific treatments of autoimmune diseases. In doing so, it rocked the biotechnology industry, where large sums are being spent to develop methods to treat patients more effectively by individualizing their drug regimens. The dispute arose after Mayo Collaborative Services, which had previously purchased from Prometheus Laboratories diagnostic tests to determine how thiopurine drugs are metabolized in the body at different doses, announced that it planned to sell its own version of the test. Prometheus claimed infringement of its process patents. A federal district court granted summary judgment to Mayo, finding that the processes claimed by the patents were based on natural laws, rendering them not patentable. That decision was reversed on appeal. The Supreme Court explained that a process based on the use of a natural law must contain other elements or a combination of elements that turn it into an “inventive concept.” Otherwise, patents of this type would make exclusive the natural law itself, thus stifling invention. The Court concluded that the process claims at issue in Mayo Collaborative Services v. Prometheus Laboratories did not meet these conditions. “In particular,” wrote Justice Stephen Breyer on behalf of the Court, “the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”

The following week, on March 26, the Supreme Court sent a case dealing with similar, but not identical, questions back to the Court of Appeals. That case involves patents held by Myriad Genetics concerning genes related to the development of breast and ovarian cancers.

WHO Official Predicts Dire Future for Antibiotic Effectiveness

Speaking to a group of infectious disease experts in Copenhagen, the World Health Organization's (WHO) director general, Margaret Chan, warned that worldwide resistance to antibiotics is rising, to the point that common illnesses and injuries may once again become lethal. While it has long been known that bacteria, like other living things, develop resistance over time to those substances that threaten their survival, it is becoming more apparent that the popularity of antibiotics has accelerated this process in bacteria that infect humans. Pharmaceutical companies push antibiotics on the public and medical professionals, seeing them as money-makers. Patients demand them. Doctors are known to prescribe them even when unsure if a bacterial infection is present, “Just to be safe.” Patients often fail to take the full course of antibiotic treatment, leaving drug-resistant bacteria in their systems. And livestock treated with antibiotics are consumed by humans, who then ingest pathogens that have developed drug resistance when they eat a pork chop or hamburger. In a WHO release announcing the publication of a new book on the subject, “The Evolving Threat of Antimicrobial Resistance ' Options for Action,” Dr. Cho stated, “In terms of new replacement antibiotics, the pipeline is virtually dry. But much can be done. This includes prescribing antibiotics appropriately and only when needed, following treatment correctly, restricting the use of antibiotics in food production to therapeutic purposes and tackling the problem of substandard and counterfeit medicines.” See www.who.int/mediacentre/news/notes/2012/amr_20120308/en/index.html

India Says Bayer Must License Nexavar

An Indian government agency has ordered a European pharmaceuticals manufacturer to license a local firm to produce one of its patented drug products. Finding the price Bayer charges for the cancer drug Nexavar too high for many Indian citizens to afford, the country's patent authorities determined that the German manufacturer must issue a license permitting Indian drug company Natco Pharma to produce a cheaper generic version for sale to Indian patients. This is the first time India has ordered a compulsory manufacturing license for a patented drug, and it is doubtful this will be the last, since India is not a strong protector of international intellectual property rights. The country did not grant drug patents until 2005, and it has legislation on its books permitting the issuance of a compulsory license if a patented invention has enjoyed commercial exclusivity for at least three years, has not been made available in sufficient quantity to Indian citizens and is too expensive for them to afford. In the case of Nexavar, the drug had been patented by Bayer in India since 2008, yet not nearly enough doses had been sent to India since that time to cover the needs of its liver and kidney cancer patients. In addition, Bayer was charging more than $5000 for a month's-worth of the drug; the same amount of Natco Pharma's generic version will cost about $175. A Natco Pharma release announcing the license stated, “Natco welcomes this order and opines that this opens up a new avenue of availability of [life-saving] drugs at an affordable price to the suffering masses in India.”

Supreme Court Shocks Industry, Finds Process
Patents Invalid

The U.S. Supreme Court has invalidated two patents on a diagnostic test used to determine patient-specific treatments of autoimmune diseases. In doing so, it rocked the biotechnology industry, where large sums are being spent to develop methods to treat patients more effectively by individualizing their drug regimens. The dispute arose after Mayo Collaborative Services, which had previously purchased from Prometheus Laboratories diagnostic tests to determine how thiopurine drugs are metabolized in the body at different doses, announced that it planned to sell its own version of the test. Prometheus claimed infringement of its process patents. A federal district court granted summary judgment to Mayo, finding that the processes claimed by the patents were based on natural laws, rendering them not patentable. That decision was reversed on appeal. The Supreme Court explained that a process based on the use of a natural law must contain other elements or a combination of elements that turn it into an “inventive concept.” Otherwise, patents of this type would make exclusive the natural law itself, thus stifling invention. The Court concluded that the process claims at issue in Mayo Collaborative Services v. Prometheus Laboratories did not meet these conditions. “In particular,” wrote Justice Stephen Breyer on behalf of the Court, “the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”

The following week, on March 26, the Supreme Court sent a case dealing with similar, but not identical, questions back to the Court of Appeals. That case involves patents held by Myriad Genetics concerning genes related to the development of breast and ovarian cancers.