Although the prospects for such a decision appear much lesslikely after the court's oral argument, another case the court has decided thisterm raises questions on the continued viability of provisions that permit abranded drug company from forbidding re-importation of drugs sold abroad (oftenat deeply discounted prices). This case,
Kirtsaengv. John Wiley, involved the purchase of textbooks in Thailand that werereimported and sold at a discount (compared with U.S. prices) and a profit(compared with Thai prices) by Mr. Kirtsaeng, a Thai student in graduate schoolin the United States. The court, basing its decision on its interpretation ofspecific provisions of copyright law and the impact of the common-law,"first-sale" doctrine, held that Wiley did not have the right to restrictresale of the textbooks after they had been the subject of an authorized sale.This case is not dispositive for patent rights (the court has declined theopportunity to rule on international patent exhaustion), but as a policymatter, the decision does raise some issues for international drug sales. Underthe rationale in
Kirtsaeng, it seemspossible that a purchaser of branded drugs made under the authorization of aninnovator drug company abroad (or purchased from a U.S. manufacturer in anauthorized sale for resale in a developing country) could reimport the drugmuch like Kirtsaeng did his textbooks, with the same or even greateropportunity for profit. The consequences of such an outcome are moresignificant, however, insofar as they might impede or reduce the availabilityof low-priced U.S. drugs in such developing countries.
In another aspect of the
Kirtsaengcase, agreements on the sale of the textbooks—that they were intendedsolely for use outside of the United States—did not restrict reimportation,suggesting for the court that preventing restrictions on sale of goods protectedby intellectual property rights after a first sale is more important than anysuch negative consequences of the rule on,
interalia, providing affordable drugs abroad. This result at best could fuelefforts, such as the decision in the
Gleevaccase against
Novartis in India in mid-April, to restrict intellectual propertyrights of U.S. drug companies in developing countries, and at worst, willimpair incentives for American companies to provide such low-cost drugs inthese countries.
Kevin Noonan is a partnerwith the law firm McDonnell Boehnen Hulbert & Berghoff LLP and representsbiotechnology and pharmaceutical companies on a myriad of issues. A formermolecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.