Wednesday, December 22, 2004
Kansas, Idaho, Rhode Island, and Michigan are just four out of thirty-four states that have recently obtained settlements from Bristol Meyer Squib and Danville Pharmacal for violating the antitrust act in preventing the entry of generic alternatives to Buspar, an anti-anxiety drug. In addition to a cash payment, the drug companies agree not to list in the FDA Orange Book Buspar or other patented drugs that may delay the entry of generics onto the market.
The International Herald Tribune reports this morning that the European Court of First Instance has rejected Microsofot's argument that EC's order to change its business practices woud cause irreparable harm to the company (particularly its patents, copyrights, and trade secrets) and to its operations in Europe. This ruling sets the stage for a likely settlement.
Tuesday, December 21, 2004
Good discussion at the Becker-Posner blog on pharmaceutical patents and reimportation. Two points worth delving into some more:
(1) Reimportation policies will result in lower quantity and higher prices in the long run as patented pharmaceutical manufacturers in the US can control the flow of imports by simply reducing the quantity exported into Canada and other source nations. But gray markets are a workable solution where the imports are manufactured in a third nation (such as India in the South Africa situation). In such a situation, the patent owner loses the ability to control the flow of imports through its manufacturing decisions, but still retains some incentive to supply to the countries that are receiving the gray market drugs so as not to give up the market to the importer. I do not think that this limitation on the patent owner's rights to import constitute a takings, and in fact would be consistent with competition policies, particularly the competition objectives of intellectual property law. (Yes there are some; IP law is not only about property rights). Of course this is all assuming adequate safety and efficacy. Politics and social attitudes limit this type of gray market policy, as tried in South Africa, from being adopted in the US.
(2) On trademarks and patents: Fellow bloggers are correct in separating trademark policy from patent policy in general, but there is one area where they do overlap and this is in the area of trade dress and patents protecting design. In the Traffix Devices case from 2001, the Supreme Court stated that trade dress protection under trademark cannot extend to useful features of a product that were previously protected under an expired patent. This decision might have some application to pharmaceuticals if a drug manufacturer attempts to extend the life of a patent through trademark law. The problem is that the useful features protected by patent, such as chemical composition, may not be the basis for the trademark claim. But if color, shape, smell, or taste (all elements of trade dress potentially) can be shown to be connected to the useful elements that were patented, then trademark protection would be limited.
On December 11, the Canadian government proposed amendements to its Patented Medicines (Notice of Compliance) Regulation and its Food and Drug Regulations. The first is similar to the US' Hatch-Waxman Act; the second to the US' FDA regulations.
The amendments to the Patented Medicines Regulation make it easier to bring generic drugs to market by limiting when patent infringement claims can be brought by potential generic drug manufacturers. Under current law, the generic drug maker has the burden to challenge the patent or wait for the patent to expire. Under the proposed amendments, only patents that have claims for the medicines or its use and patents that have application filing dates before the generic submission can be listed in Canada's equivalent of the Orange Book. For more details, follow this link.
The proposed amendments to its Food and Drug Regulations provide protection against unfair commercial use of undisclosed test data or other materials submitted for approval. The amendments are designed to bring Canada in compliance with obligations under NAFTA and TRIPS regarding new chemical entities. For more details, follow this link.