NEWS OF THE W EEK
INTELLECTUAL PROPERTY: Major drug companies try to protect their products
L
ANDMARK DRUG patent protection cases involv-
ing Bayer, Roche, and Novartis are advancing in India this month. Together, they will help determine how friendly the country is to Western pharmaceutical makers. On Sept. 3, Bayer filed an appeal with the Intellectual Property Appellate Board in Chennai over a compulsory license order entitling the Indian firm Natco Pharma to produce a generic version of the Bayer kidney and liver cancer drug Nexavar. Issued in the spring, the license let Natco onto the market by paying Bayer a modest 6% royalty on sales of the generic drug. The order marks the first time that a foreign branded drug has been subject to compulsory licensing in India. On Sept. 7, Roche lost a case in the High Court of Delhi, where it had argued that the Indian drug producer Cipla was infringing on its patents by selling a generic version of the lung cancer drug Tarceva. In a 275-page ruling, the court sided with Cipla’s contention that Tarceva is based on a different polymorph of the active ingredient erlotinib than the one Roche patented in India. Roche had attempted to patent the different polymorph, but India rejected it as too similar to the patented one. “We are strongly considering an appeal,” Roche says. “Many of the cheap generic drugs today used in India were once patent-protected and are only available to society because companies such as Roche were willing to take a risk by investing in new innovative drugs.” Meanwhile, on Sept. 11, Novartis began contesting in
India’s Supreme Court key features of the pharmaceutical patent regime that the country instituted in 2005. The Novartis challenge follows India’s repeated refusal to grant patent protection to the cancer drug Gleevec on the grounds that it is nothing more than a new crystal form of an older compound. Gleevec enjoys patent protection in most major markets around the world. “Novartis challenged the decision not to grant a patent to our life-saving medicine Gleevec because we strongly believe safeguarding incentives for innovation through the granting of patents leads to better medicines for patients,” the company says. Although each case involves its own complex scientific and legal circumstances, drugmakers and patient activists are watching the disputes for the tone they collectively will set about intellectual property protection in India. Some observers see India as a model for the developing world. Legal and medical scholars Peter Roderick and Allyson M. Pollock, at Queen Mary, University of London, argue that India’s system of intellectual property protection “should help rather than hinder” access to drugs in India. “The Bayer and Novartis cases are seeking to undermine public health considerations aimed at improving access and therapeutic advantage,” they write (Lancet, DOI: 10.1016/S01406736(12)61513-X).—JEAN-FRANÇOIS TREMBLAY RAVEENDRAN /AF P/GET T Y IM AGES/N EWSCO M
BIG PHARMA FIGHTS DRUG RULINGS IN INDIA
Protesters in New Delhi in July demand that the Novartis drug Gleevec not get patent protection.
GENOMICS Genome institute refocuses extramural research to advance clinical applications The National Institutes of Health’s National Human Genome Research Institute (NHGRI) is restructuring its extramural research program and making other organizational changes to accelerate the application of genomics to medicine. The reorganization, announced on Sept. 10, splits NHGRI’s extramural research unit into four new divisions. The Division of Genome Sciences will fund basic genomics research, technology development, and large-scale sequencing efforts; the Division of Genomic Medicine will focus on applying genomics to medicine
and clinical care; the Division of Genomics & Society will oversee an expanded effort to understand the ethical, legal, and social implications of genomics; and the Division of Extramural Operations will manage grant administration and reviews. “This reorganization reflects the expanding scope of genomics research, as described in NHGRI’s new strategic vision published in Nature last year,” NHGRI Director Eric D. Green says. “The mission of the institute has dramatically evolved from the singular focus on the Human Genome Project, for which
WWW.CEN-ONLIN E .ORG
9
S E PTE M BE R 17, 20 1 2
NHGRI was created, to pursuing an exciting and broad set of opportunities for using genomics to advance medical science and improve human health.” As part of the reorganization, two additional divisions—the Division of Policy, Communications & Education and the Division of Management—will be created from programs currently housed under the institute director’s office. The institute’s Division of Intramural Research will not undergo any changes. The reorganization will become effective on Oct. 1.—BRITT ERICKSON
