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Who Makes Tamiflu?

by Contributing Writer

Overview

Governments, the World Health Organization and the Swiss drug manufacturer Roche are all under great pressure to ensure adequate supplies of the antiviral drug Tamiflu (chemical name: oseltamivir) in the event of a deadly pandemic flu outbreak. Concerns have been fueled by the Asian outbreaks of highly pathogenic avian flu since 2003 and the emergence of a novel influenza of swine origin (imprecisely referred to as swine flu) in 2009. While governments, international organizations and corporations stockpile hundreds of millions of antiviral therapy courses, Roche, which possesses exclusive global rights to the manufacture of Tamiflu, has expanded its manufacturing capacity to 400 million courses annually, which, when added to current stockpiles, Roche says should be adequate in a global emergency. This represents a 10-fold production increase from 2004.
Tamiflu Intellectual Property

All new drugs have patent protection for a specified number of years. Gilead Sciences owns the Tamiflu patent, which is protected until 2016. Roche acquired the worldwide rights to develop and market the drug from Gilead in 1996. Roche and Gilead have extended sublicenses to generic drug manufacturers as one approach to emergency Tamiflu production. These sublicensees cannot use the Tamiflu name, and Roche does not ensure the quality of the products. Roche says it maintains agreements with more than 19 contract manufacturing partners in 10 countries to perform particular functions in the manufacturing process. The company has also granted permission for a few governments particularly hard hit by avian-flu outbreaks to partially or completely manufacture the drug (Indonesia, the Philippines, Thailand and Vietnam).

Tamiflu Patent Challenge

The World Trade Organization's agreements on trade-related intellectual property rights are country-specific, and patent challenges are often complex legal battles with uncertain impact outside the country in question. Tamiflu is not patent-protected in a number of emerging countries and is involved in patent litigation in India with generic drug manufacturer Cipla Ltd. The suit is based on grounds of: lack of inventive step, failure to comply with Section 3(d) of the Indian Patent Act, and failure to sufficiently disclose the invention claimed. After a favorable court ruling in 2009, Cipla announced its readiness to supply 1.5 million doses to any government that wishes to stockpile the drug in response to the swine-flu outbreak.
Exceptions to Patent Exclusivity

Most countries have provisions in their laws that permit their governments to overturn patents in exceptional circumstances. Through compulsory licensing, the World Trade Organization allows member governments to authorize supply from generic drug companies in cases of national health emergencies and pandemic outbreaks. Such systems have been considered or enacted by a number of countries, including England, the European Union, Canada and Taiwan.
Assisted Supplies of Tamiflu to Developing Nations

In 2009, the World Health Organization added the first generic oseltamivir to its list of prequalified drugs to ensure improved access to medicines that meet unified standards of quality, safety and efficacy. Cipla Ltd. may now receive supply orders from WHO member states, UN agencies, and nongovernmental organizations. Roche has donated millions of courses of Tamiflu each year to the WHO and individual governments. Roche has also granted sublicenses to generic drug manufacturers in South Africa, China and India, which all have large populations with great need. Hetero Drugs (India) was issued a sublicense by Gilead to manufacture and export oseltamivir to about 100 developing countries.
Illegal Manufacture of Tamiflu

Many Internet sites sell counterfeit Tamiflu without a prescription in the United States and should be avoided because there are no assurances that they are either safe or even contain any active ingredient.
Conclusion

Governments around the world, international organizations and Roche continue to grapple with striking the fine balance between protecting exclusivity rights and meeting public health concerns. Roche maintains alliances with pharmaceutical partners to ensure that in the event of a severe global flu pandemic, there will be sufficient supplies of Tamiflu that are safe and effective.