An Inconvenient Truth about Canadian Patent Law.

The Skilled Addressee in Pharmaceutical Patents

The readers of pharmaceutical patents are not technicians, hobbyists, or simple baccalaureates.  The addressee is not a person with sophisticated manual dexterity and a recollection of all relevant patent disclosures but without a whit of creativity, as the patent law assumes; but a team of information specialists, lawyers, medicinal chemists, doctors, organic chemists; in fact, a team comprising whatever skills are needed in order to properly understand the content of any document that pertains to a medicinal agent.  In particular, the medicinal chemists and organic synthetic chemists, who mostly have interests in pharmaceutical patents, are inventors themselves with well established creativity.

The patent system provides a 20 year monopoly in exchange for a public disclosure of truly breakthrough discoveries of new classes of medicines and with this I have no quibble.

  

However, at the same time it gives 20 years exclusivity for many mundane workman activities which do bring into existence for the first time new subject matter but this information follows inevitably from conventional scientific developments.  Examples of these activities are the discovery of the various polymorphic forms, hydrates, and solvates of a new drug substance and its pharmaceutically acceptable salts. 

Another example of an undeserved patent monopoly is the formulation of such new pharmaceutical salt into a dosage form that has acceptable dissolution in stomach acid that it can serve as an immediate release tablet candidate. Another undeserved patent subject is the formulation of a pharmaceutically acceptable salt into a standard delayed-release or enteric form.  Both these are almost always activities which can be worked out by routine investigations following pre-planned protocols.  There are some particularly difficult instances when a creative solution is required to solve a formulation problem and a patent would be warranted but the putative inventor should be called upon to show to the patent examiner evidence that the standard procedures would not produce the required result and the successful assignee of a granted formulation should be required to forfeit any patents for the formulations that are claimed to be inadequate.

The Common General Knowledge

The law has accepted today that the skilled addressee is actually a team as assembled by a pharmaceutical company.  The natural of the common general knowledge which is allowed to be combined with some prior art in order to assess obviousness has not kept up with the concept of the addressee as a team of inventors with advanced degrees who have access to computer driven scientific literature searching machines. The concept of the common general knowledge is still valid. What is intended is that this common general knowledge is information that is already memorized and available to the reasoning process in the head of one member of the team  That is to say, for example, that knowledge of a particular chemical reaction that is known to PhD organic chemists would be considered part of the common general knowledge.  Thus the common general knowledge would be a function of the graduate curriculum for the specialist who eventually obtains a PhD in the discipline.

The existence of a published protocol for solving the standard problem: making polymorphs, making pharmaceutical salts, formulating a n immediate release tablet, making a delayed release tablet, making an extended release tablet should vitiate claims of creativity in performing these activities.