September 2006
"What sets intellectual property law apart from most other laws or legal principles is its apparent conflict with the well established principles of free trade. Patent law establishes a state granted, limited monopoly to an individual or a company in contrast to many and varied forms of antimonopoly and anti-trust laws all over the world."

There are a few fundamental factors when one considers the "philosophy of intellectual property law" or more particularly for purposes of this article, the "philosophy of patent law". There are, of course, those who claim that there is no such thing as a "philosophy of intellectual property law", whether it relates to patents of not and that it is not worth examining under it under a microscope for things that are plainly not there or not relevant. It is claimed that the philosophy of law, as a broader enquiry already serves the same purpose and that a further dissection is neither needed nor desirable.

Of the many definitions of the word "philosophy", the following one seems the most sensible: "the rational investigation of the truths and principles of being, knowledge, or conduct"Clearly, patent law can happily attract a rational "investigation of truths" and it certainly has "principles of being or knowledge".

Upon a "rational investigation of truths", we can establish that what sets intellectual property law apart from most other laws or legal principles is its apparent conflict with the well established principles of free trade. Patent law establishes a state granted, limited monopoly to an individual or a company in contrast to many and varied forms of antimonopoly and anti-trust laws all over the world. How is it possible then, for these two clearly conflicting legal paradigms to function in harmony and to the benefit of society and the individual?

Value of Inventive Pursuit
The answer lies in the value of inventive pursuit to society and the individual.

Inventive pursuit is of benefit to society in the advancement of science, technology and art it brings about and it benefits the individual in the opportunity for personal gain as a result of expending time and other resources on the inventive pursuit. The latter, of course, being conferred by virtue of the limited monopoly made possible by a patent.

So therefore, the individual (or a group of individuals in a company) as opposed to society in general, may expend time, money and energy in research and development of a product or a process and in return he receives a limited monopoly wherein he can recoup his resources ploughed into the project and make a profit for himself. The monopoly is limited in various ways, most notably in duration. A patent does not endure forever it endures for twenty years, in most jurisdictions.

Thereafter, the principle of free trade resumes for the subject matter of the patent. It is then in the public domain and free to be used and produced by anyone in healthy competition to the original patentee.

In order to balance the scales of this quid pro quo between the welfare of the individual and the welfare of society properly, the individual (the patentee) has to do one more thing in order to qualify for his limited monopoly. He has to "give" the technology to the world after his monopoly expires. He does this by describing the invention fully and completely and in addition, he has to set forth the best method of performing the invention.

Any patent application is accompanied by a document called a patent specification, which includes, inter alia the description of the invention and the disclosure of the best method of performing the invention. The specification also contains the claims but these define the scope of the invention for purposes of determining the "forbidden territory" which is open for access only to the patentee or his licensee, for the duration of the patent.

Thus we can see the logic in sanctioning monopolistic self-gain in favour of the individual, which is to the benefit to society and herein is this "conflict" between seemingly "opposing" legal principles resolved.

Disclosing the Best Method
But so much for the philosophy of these principles. In practice, things are a little more complicated, as they usually are. In particular, the requirement of disclosing the best method of performing the invention has been criticized and debated in many countries around the world recently. The best method requirement was enacted for the first time in 1870 and has always formed a key element in patent drafting. The rationale lies in the philosophical principle that it is in the interest of society that the best method be disclosed clearly and unequivocally and that without this requirement, the quid pro quo balance tips towards the patentee. Then inventors might be tempted to keep their best methods to themselves and disclose inferior methods in the patent specification, to the detriment of society.

Regardless of the above, one of the main objections to the best method requirement is that it is clearly a subjective requirement.

Full disclosure of the invention itself, i.e. the description of the invention can and invariably is an objective requirement but describing the best method of performing the invention can and will always be the best method in the view of the inventor.

It is argued that the best method requirement is far too onerous on the inventor and it is currently proposed to be removed from the United States Patents Reform Act of 2005. It has already been removed form the European Patent Convention (EPC) legislation. In the case of Railroad Dynamics Inc v A Stucki Co, 469 US 871 (1984) it was argued that this requirement is actually a disincentive to innovation, it leads to greater litigation and it encourages inventors to forego patents and secure their rights by way of trade secrets instead. In the United States, the National research Council of the National Academies recommended that the best method requirement be abolished on two grounds, namely that it produces a negative result on a cost benefit analysis and furthermore, that it is an impediment to international harmonization, considering that the EPC has no such requirement. However, TRIPPS does allow member states to incorporate the best method requirement in Article 29.

Enablement
The more objective requirement of full disclosure, or enablement, as it is also known is a little less problematic. The EPC defines "enablement" as "The European patent application must disclose the invention in a manner that is sufficiently clear and complete for it to be carried out by a person skilled in the art."

In the United States case of Genetech Inc v Novo Nordisk 108 F 3d 1361 (Fed Cir 1997) evidence was led that a patent specification lodged in support of a 1979 patent application relating to the protection of a protein of hGH amino acids be struck down. The description contained a vague and generic statement of the possibility of cleavable fusion expression along with the DNA sequence but it did not describe in any detail how to make the hGH amino acid using cleavable fusion expression.

The patentee argued that the description was sufficient to enable a person skilled in the art to be able to provide all the missing information but this rejected by the court. The court held that the specification must supply the novel aspects of the invention in the specification itself.

The standards for validity by American courts for biotechnology enablement are very high. One of the reasons for this is that in the field of biotechnology, inventions often produce surprising results. Therefore, the courts will be loathe to make inferences where there is no direct and unequivocal disclosure. For example, in an invention relating to a electrical circuit, the court will accept that a person skilled in the art will know that an electrical current will run through a copper material as well as an aluminium material, without the inventor specifically stating that in the enabling disclosure. However, with a biotechnological invention, no such indulgence is allowed and nor is it desirable.

Unless it is spelled out in the enabling disclosure, there can be no claim based on the phenomenon.

In an informative article by Aniruddha Sen in an article in Hanse Law review (Vol 2 No1) 2006 entitled "Clear and complete disclosure in Biotechnology patent applications A comparison of the laws in the USA, Europe and India", the author proposes to make a "fundamental distinction" between biotechnology patents used for pharmaceutical/medicinal/ therapeutic purposes and inventions intended to be used for other purposes. The strictness of disclosure, so it is argued, "should be much higher for pharma/medicinal biotechnological inventions..."

The author furthermore proposes that the best method requirement be reinstated but acknowledges that the best method requirement is a subjective requirement and fraught with practical difficulties. Rather perplexingly, the author then continues to recommend that the "best method standard be  made an objective standard" and states furthermore that "Ifa better method of making use of the invention is found, then the burden of proof should be shifted to the inventor to show that he did not know of it". It is respectfully submitted that the author's recommendation does not remove the subjective element from the enquiry (what is a "better method" if that is not also subjective?) and furthermore places a notorious and nearly impossible onus on the inventor, namely proving a negative. (As an example, how can I prove that I was not aware of the presence of someone behind me. I can easily prove that I was aware of his presence, for example by describing what he wore i.e. a testable proposition. But there is no way to test my evidence that I was not aware.)

The writer suggest that a compromise be struck, namely that instead of requiring the "best method" for performing the invention, the requirement merely be "a method of performing the invention". This was the route that the South African Patents Act of 1978 took in Section 32(3). This section provides for the contents of the specification and reads as follows:"A complete specification shall sufficiently describe,

ascertain and, where necessary, illustrate or exemplify the invention and the manner in which it is to be performed in order to enable the invention to be performed by a person skilled in the art of such invention."

By Andre Human

© Al Tamimi & Company 2006