As U.S. rep eyes global IP, India lets local pharmas export copies of on-patent Bayer blockbusters

India flag
India's Natco and Alembic have been granted permission to export two Bayer blockbusters to foreign companies seeking to develop copycats.

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.


Veeva 2020 Unified Clinical Operations Survey

We believe you have the knowledge and expertise to make this year's Veeva 2020 Clinical Operations Report even more robust and insightful than the last. Please take a moment to share your opinion in this 10-minute survey. All qualified respondents will be entered to win a $500 Amazon gift card.

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.

RELATED: Bayer fails last-ditch attempt to block India's cheap Nexavar copies

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.

RELATED: As Trump talks 'America First' on trade, pharma presses its global patent rights

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.”

Suggested Articles

Only months after a game-changing new approval for Vascepa, Amarin has lost a key fight over its patents—and now it's scrambling to respond.

Move over, Roche. There’s a new small cell lung cancer therapy on the scene, and it belongs to AstraZeneca.

Fujifilm says it is prepared to ramp up production of Avigan for any country that wants to try it as a potential treatment for COVID-19.