Gas Pedal Case May Limit Abusive Rx Patents

The European Patent Office on Tuesday voided a patent on AstraZeneca’s Nexium, the best-selling acid indigestion pill. This is good news for European consumers, since the drug is nothing more than the mirror image molecule of Prilosec, which went off patent a few years ago.

While the EPO's reasoning won’t be released until early next year, observers say the decision hinged on the drug’s lack of originality, known as “obviousness” in the patent trade. A similar case was recently argued before the U.S. Supreme Court. Patent lawyer Robert Goozner explains why KSR vs. Teleflex, which involved an adjustable gas pedal, could wind up benefiting U.S. drug consumers:

The dispute over U.S. Patent 6,237,565 held by Teleflex involved an adjustable gas pedal that combined two elements, an electronic throttle control with an adjustable pedal system. Both inventions were well-known to automotive engineers.

Since most patents are modifications or combinations of previous inventions, the first question facing the patent examiners was whether the new invention was novel or obvious. If the latter, it can’t be patented.

The current test for determining obviousness is the teaching-suggestion-motivation or TSM test. Under TSM, if one of the known “prior art” patents or publications explicitly teaches, suggests or motivates someone to modify a known technology or combine with other known technology to produce a new invention, then that new invention can't be patented. However, the patent examiner must point out a specific passage in the published patent that actually does the teaching, suggesting or motivating, i.e., the logical road map to produce the obvious and therefore unpatentable invention. The result? The test can almost never be met and trivial inventions like painting a face on the side of a bag wind up getting patent protection (In re Dembiczak).

This low standard of patentability has been exploited by the pharmaceutical industry to reap enormous profits. When a patent for a drug is about to expire, many pharmaceutical firms frequently get another bite at the exclusivity apple by obtaining a patent for a minor variation of the compound coming off patent, an enantiomer (a compound having the same formula and structure, but with mirror image symmetry), for instance, or a prodrug (a compound that produces a known drug when metabolized by the human body). Nexium is the enantiomer of Prilosec.

During oral arguments in November, conservatives on the Supreme Court bench oozed contempt for the TSM test. “It is misleading to say that the whole world is embraced within these three nouns, teaching, suggestion, or motivation, and then you define teaching, suggestion, or motivation to mean anything that renders it nonobvious. This is gobbledygook," Justice Scalia said.

When Teleflex’s counsel Tom Goldstein retorted by noting that “every single major patent bar association in the country has filed [Amicus Briefs] on our side,” Chief Justice Roberts snapped: “That just indicates that this is profitable for the patent bar.” Justice Scalia piled on. “It produces more patents, which is what the patent bar gets paid for, to acquire patents, not to get patent applications denied but to get them granted. And the more you narrow the obviousness standard to these three imponderable nouns, the more likely it is that the patent will be granted,” he said.

The Supreme Court appears eager to raise the obviousness bar for obtaining a patent. If it closes this patent loophole, it could eventually lead to lower prices at the pharmacy. – Robert Goozner

Posted by gooznews at December 20, 2006 05:48 PM