Comments from an issue of ASBMB Today
An essential debate, December 2012
The 20th century began with biochemists arguing whether enzymes’ catalytic actions had first-order or zero-order kinetics. The confusion was resolved by Michaelis and Menten recognizing how a saturable active site creates both behaviors depending on the supply of substrate in relation to the half-saturation concentration (Km). The response to substrate availability of a saturable process is predictably unchanged by substrate supplies several-fold above the apparent Km of the process. To see a linear response to supply, the supply should be provided near (or below) the Km value. This idea likely applies to the low responsiveness of tissue accumulation of arachidonate when its dietary omega-6 linoleate precursor is eaten at levels above 1 percent of food energy. [Lands, Prog. Lipid Res. 47, 77 – 106 (2008).]
Protecting biomedical inventions through patents,
An issue with filing for a patent on your invention is that (1) the (U.S. Patent and Trademark Office) is incredibly incompetent and (2) your patent disclosure is published within 18 months of submission, long before it is examined and any , if at all, claims are allowed. This means that you reveal all the details of your invention with no assurance that you will ever obtain patent coverage. I have personally experienced the situation where two patents on which I was a co-inventor were again issued by the USPTO three years later to another set of “inventors,” leaving us in a situation that to maintain our claims would have required millions of dollars of litigation to retain our rights. In many cases, maintaining the invention as trade secrets may be a superior solution to maintaining your exclusivity and with no expiration date.
Larry, you have brought up a good point. Under certain circumstances, it makes sense to keep an invention, a process of manufacture, for example, as a trade secret. Although a trade secret does not expire, third parties are not prevented from using it if it is discovered (for example, by reverse engineering). On the other hand, an applicant can file a nonpublication request when filing a patent application so that the disclosure of the application only becomes public when a patent issues. All of these and the issues discussed in the article highlight the importance of initial strategic planning before filing a patent application.
In the December 2012 issue of ASBMB Today, the cover story on the controversy over the omega-6 dietary recommendation has an error. For a potential clinical trial that analyzes the health outcomes from a range of linoleic acid amounts in the diet, the essential fatty acid has to be dropped to less than 5 percent of calorie intake, not 1 percent as stated in the story.