Patents enabling" requirement

Suggested Best Practices for Chemists Enablement requires that the patent teach how to make and use the invention. To address the "how to make" requirement of enablement ... 

Apart from the essentials of novelty, unobviousness, and utility discussed above, further challenges require special attention when seeking patent protection. The invention should be described in such a manner as to comply with both the written-description and the enablement requirement. These requirements are contained in 35 U.S.C. 112, which states that the specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. .. . Similar regulations exist in other patent laws, as exemplified by Articles 83 and 84 EPC. 

We discussed in Chapter 6 that a patent that lacks utility will receive rejections under both 101, the utility requirement, and 112 [1, the enablement requirement. 

The enablement requirement is difficult to understand and apply because it requires that we not only understand what the patent application actually teaches, but we also need to ascertain how that knowledge in combination with what is already known in the art would be applied by one of ordinary skill in the art to determine if the practice of the claimed invention requires undue experimentation. To further compound the challenge, there is very little enablement federal case law in the chemical and pharmaceutical arts to light our way. 

A strategy of using different types of claims and claims of the same type but different in scope can be applied to robotics [2] used in making peptides and nucleotide sequences, libraries created on the surface of phage [9], diagnostics [10] which use combinatorial libraries or to virtually any invention in the field of molecular diversity - limitations on the type and scope of the claim being dictated by the prior art (under 35 USC 102 and 103 the claim cannot cover that which was previously known or claim subject matter deemed to be obvious in view of that which was previously known) existing at the time of the invention and the extent of disclosure included in the patent application. (A patent application must fully describe and disclose the invention which is claimed. This is referred to as an enablement requirement under 35 USC 112.)... 

Thus, in the year 1950, an inventor named Tolkmith (IS) presented a patent application claiming a certain methane phosphonic chloride. The only utility stated for the compound was that it was of value as an intermediate for the preparation of more complex phosphorus derivatives and as a constituent of a parasiticide. The Patent Office Board of Appeals in its decision, held that the applicant s showing of utility did not comply with Section 112 of the patent statutes requiring that the manner and process of making and using the invention be described in such exact terms as to enable one skilled in the art to make and use the same. The board went on to say ... 

In reporting something new, such as a method for making a compound, a procedm-e for an analysis, or a process for making a physical measurement, the author s description should be adequate to enable one interested, if he so desires, to repeat the work. In the case of U.S. patents, one requirement of patentability is to have the description sufficiently explicit and detailed that one skilled in the art can make or use the object patented. Famous legal cases have involved this point. 

One must take into account that the United States generally has a more stringent enablement requirement than that of many other countries. Thus, in the DNA sequencing example above, a partial sequence may be sufficient in other parts of the world. In such countries, a patent application having only a partial sequence and an earlier filing date may have priority over a second patent application filed by another party where the second application is based on a U.S. application, the filing of which was delayed because the full sequence was not yet complete (6). 

Issuance of a patent obviates the legal necessity for keeping the information contained in the patent application secret. The Patent Act requires the patentee to make the knowledge behind the invention publicly available. Under 112 of the Act, a patent applicant must include in the patent application a written description of the patent that is clear, concise, full and exact enough to enable someone skilled in the most relevant art to make and use the invention without undue experimentation. The patent application must also set forth the best mode for carrying out the invention that the inventor contemplates at... 

The printed pubHshed document which represents the patent rights granted by the Federal Government can be a complex Hterary work. There are specific and rigid legal requirements for the description, disclosure, and definiteness which support these affirmative rights and enable enforcement of those rights by the inventor or owner of the patent. The basis for this fiiU and complete disclosure of the invention in the patent is clearly articulated in the U.S. Constitution. 

An additional statutory requirement is that of disclosure. A patent must provide the pubHc with a disclosure which is enabling, definite, and shows the best mode for practicing the claimed invention. 

Teaching how to make and use an invention, also known as enablement, is a requirement for obtaining a patent. Establishing an invention s usefulness, also known as utility, is a separate requirement for patentability. An application can meet the utility requirement but still fail to demonstrate enablement. During the trial phase, the district court conducted a two-pronged analysis of the application and concluded that the application lacked both utility and enablement. However, on appeal, the Federal Circuit focused only on the utility requirement. 

The need to deposit viable cultures of microorganisms to meet the legal requirement of providing a sufficient or enabling disclosure of the invention represents a substantial business risk of giving competitors a head start in their R D if no worthwhile patent protection is obtained ultimately. In other technical areas only information describing the invention is disclosed, and not actual physical materials that either embody the invention or that are very closely related to the invention. 

To ensure the widest access to drugs, the proposal requires open licensing of all relevant patents, thus enabling generic competition from the outset. The innovating firm, however, retains an interest in the product for some years, since its reward is based on the number of units sold. This provides incentives for promotion of the drug as well as oversight of quality control. 

While TRIPS does not require countries to grant patents on new uses of existing medicines, the U.S.-Morocco, U.S.-Australia, and U.S.-Bahrain FTAs do, enabling companies to extend patent terms on existing products, thereby "evergreening" their monopolies (MSF 2004), and indefinitely keeping generic competitors out of the market. 

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