Exclusions from patentability

If products under patent are exempted from the RP system, do the negative effects on the R D of the pharmaceutical sector disappear The exclusion of medicines with a current patent may reduce the economic erosion of the rights granted by the patent, and also the disincentive to invest in R D. But negative effects on innovation are not totally eradicated, as (a) RP increases the uncertainty on the expected return on the investment, (b) incentives for innovation will be damaged due to the fact that the R D process is a joint production process, since the overall return is reduced when RP is applied, and (c) the exclusion of patented products has proved to be only partial in some cases (for example, not excluding drags under a process patent). 

When a new indication is approved, only that indication receives three years of additional exclusivity under the Act. However, there is no effective way to prevent a less expensive generic firm from being used for all indications during this three-year exclusivity period, since physicians do not specify an indication when they write a prescription. This will be the case unless the brand firm utilizes an alternative delivery system or formulation that has exclusivity or patent protection. 

At the other end of the spectrum, a number of countries still exclude several inventions - mainly on food and medicines - from patentability. (For a discussion of the underlying ethical and commercial considerations see, for example, Tobias, 1992.) In the last few years many of those countries have abolished these exclusions, others also consider changing their policies. 

Table 9 Statutory Exclusions of Inventions from Patentability...

We do not have data on the number of patents that include the names of computational chemists as discoverers or co-discoverers. Until about ten years ago, a widespread practice at the pharmaceutical companies was to routinely exclude computational chemists from patents. This exclusion stemmed in part from the hegemony of the organic chemists and partly from the legal reasoning... 

Quite apart from patent protections, innovator products are granted eight years of data protection and ten years of market exclusivity (see above), plus a further year of market exclusivity if a major new indication is registered. This means that a generic medicinal product can be placed on the market only 10 (or 11) years after the original authorization, although experimental activities to prepare the dossier, in particular to conduct bioequivalence studies, can start two or three years earlier. 

Each country may take steps to prevent abuses resulting from the exclusive rights arising from patents, for example, failure to use the invention, but the patent may be revoked only if compulsory licensing is not a sufficient remedy. 

From a commercial standpoint. The Orange Book is significant in two ways (1) it identifies generic competitors (if any) for branded products in the United States, and (2) it provides market exclusivity and patent expiration data associated with new drug approvals. Both of these factors are important in assessing company and product vulnerability. 

Article 52(3) is important when considering what is excluded from patentability, since it explicitly states that the exclusion relates only to the extent to which a European patent application... relates to such subject matter or activities as such. Thus under certain circumstances other principles will apply if the subject matter or activities listed in Article 52(2) are associated with a technical use. For example, the discovery of X-rays as such is not patentable, but the use of X-rays in a process could be protected by means of a patent. A number of EPO decisions follow the general principles of the European Patent Convention in that invention are excluded from patentability only to the extent that application relates to the excluded subject matter of Article 52(2) as such. There is no problem in patenting an invention which includes technical and nontechnical features. 

There is little agreement in the literature about the dates when various adhesives and sealants were first developed or used in a specific application. This is due to simultaneous developments in many parts of the world and the fact that references in the literature are almost exclusively from the more developed countries. Table 1 show Belmonte s [6, p. 4] viewpoint on the times of adhesive developments, up to the year of publication of his work. In the accompanying text he notes that The developments are tabulated according to their first public disclosure, whether by patent or citation in technical literature. ... 

Polyvinyl halide n. A term sometimes used (almost exclusively in patents) for polymers and co-polymers of vinyl chloride. Aside from polyvinyl fluoride, which is more similar structurally to polyethylene, and brominated butyl rubber, which has enjoyed some use in the automobile-tire industry, no polymers containing the other halogens (bromine, iodine, and astatine) exist in commerce. 

Government and University Research. As an industry, plastics engineering has traditionally been driven by the large profits that result from patented processes and materials. As natural offshoots of organic chemistry, however, polymer science and plastics engineering have developed into major fields of study at the academic level. Research into new and improved polymerization reactions and methods has been conducted at many major universities and colleges, and some institutions specialize exclusively in polymer research. 

---