In a decision that demonstrates pharma patent woes around the world, Indian drugmakers Natco Pharma and Alembic Pharmaceuticals won permission to export their copies of two on-patent Bayer blockbusters, to help other copycat drugmakers develop their own versions.
Delhi’s High Court permitted Natco to export its generic version of Bayer's Nexavar to a Chinese company and Alembic to export knockoff Xarelto to Brazil and the Middle East, according to Bloomberg. The branded drugs brought in more than $4 billion for Germany’s Bayer last year.
In making their argument, the Indian drugmakers said prohibiting such exports would essentially grant Bayer longer exclusivity periods. Copycat drugmakers would have to play catch-up when finally get their hands on the drugs' active ingredients, they contended. The exports are for research purposes rather than sales.
On Nexavar, the decision adds insult to injury for Bayer as the cancer med is the only pharmaceutical product to subject to a compulsory license in India.
Also this week, an Indian court ruled against Cipla’s move to market its generic version of Novartis’ Onbrez, according to Bloomberg Quint. Novartis, which has partnered with Lupin on the respiratory med in India, had protested Cipla’s 2014 generic launch.
The rulings come as multiple parties urge the U.S. Trade Representative (USTR) to reprimand particular IP offenders around the world. The agency is in the process of drafting its Special 301 report, which flags countries with patent regimes it considers questionable. For its part, the pharma industry is pressing U.S. officials to focus on its patent-law and enforcement worries in more than a dozen countries, India included.
Pushing back against those designations are the nonprofits Knowledge Ecology International (KEI) and Médecins Sans Frontières (MSF), which filed comments of their own with the USTR. The groups focused on expanding access to drugs, rather than boosting patent protections. Among other points, they're targeting high-level drug pricing and R&D systems they see as poised for a change.
“Instead of unilateral trade pressure to create stronger monopoly protectionism for pharmaceutical companies, the U.S. government should seek to establish improved incentives and norms to fix the world’s broken research and development system,” MSF wrote.
“The reliance on high medicine prices, backed by exclusivities and monopolies, is a flawed paradigm for funding innovation,” the group continued.
Arguing for a system that doesn't link R&D costs to drug prices, KEI is asking the Trump Administration to consider its ideas “with an open mind.” The group says the current drug development model shouldn’t be considered “sacred” because it’s both “insanely expensive” and “based upon policy-induced and logically unnecessary rationing of access.”