Single Letter Wrong in Medical Patent on Heart Surgury Solution Spells Disaster
Osmolarity vs. Osmolality - What a difference a single letter makes!
Can getting a single letter of the alphabet wrong in an issued patent spell disaster when it comes to litigating against infringers? Unless the mistake is seen as being a minor typographical error that can be corrected by filing a certificate of correction, the answer is a resounding yes.
Hats off to Peter Zura of The 271 Patent Blog for his post on Central Admixure Pharmacy Services v. Advanced Cardiac Solutions (06-13-07).
In this case, Central Admixture Pharmacy Services sued Advanced Cardiac Solutions for patent infringment relating to a chemical solution used duriing heart surgery.
A certificate of correction was sought on the patent and was issued by the patent office to replace all instances of the word "osmolarity" with the word "osmolality".
You might be thinking that all the certificate does is change the "R" in osmolaRity with a "L" so that it reads osmolaLity. Well, yes, BUT....
Whether or not the certificate of correction is proper depends upon whether the change is a clerical or typographical nature or if it constitutes new matter or would require re-examination. Although the district court found the certificate of correction proper, the CAFC disagreed and found that the result of the correction was to broaden the claims since the corrected claims using the term osmolaLity cover less concentrated solutions than the original osmolaRity.
Yikes! Needless to say, non-technical proofreaders or computerized spell-check and grammar checking programs (gasp!) are not adequate alternatives to a careful final review of a patent application by someone familiar with the technical vocabulary of the invention.
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In the online edition of Time magazine, an article reports that asthma inhalers containing chlorofluorocarbons (CFCs) will be illegal for production or sale as of December 31st of this year, because of known detriments of CFCs to the environment. Medical patent attorneys and innovators should look for opportunities to create greener inhalers, particularly as current options are inconvenient.
Medication accounts for a great majority of medical patents, though every medication has its side effects. There's no doubt medicine is saving lives and yet there are clear medical patent opportunities to minimize the risks associated with them. The main difficulty, as you in the medical community may be aware, is that medication is designed to handle a specific issue within the body. However, everything within the body is connected and the challenges in treating one area without impacting any other is significant.
According to Claudia Wallis, knee replacements surgeries will increase by 525% by 2030 (
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particular trial is part of a larger collaboration between Merck and Arena to discover patented ways to treat artherosclerosis and other disorders. While a recent investigation of MK-0354 broke down in the preclinical trial phase, Lief remains optimistic about the progress they've made with this new drug.