Patent production

Apphcation for discovery and product patents must be made early in the process. Appropriate labels ate designed and the product is submitted to the FDA for approval to begin human testing in the form of an Investigational New Dmg Apphcation (INDA). When such approval is granted, the clinical evaluation is developed as follows. 

J. P. Durand, A. S. Baley, P. Gateau, and A. Sugier. Process to reduce the tendency of hydrates to agglomerate in production effluents (meth-ode pour reduire la tendance a 1 agglomeration des hydrates dans des effluents de production). Patent EP 582507,1994. 

A. M. Durr, Jr., J. Huycke, H. L. Jackson, B. J. Hardy, and K. W. Smith. An ester base oil for lubricant compounds and process of making an ester base oil from an organic reaction by-product. Patent EP 606553, 1994. 

F. Montgomery, S. Montgomery, and P. Stephens. Method of controlling porosity of well fluid blocking layers and corresponding acid soluble mineral fiber well facing product. Patent US 5222558, 1993. 

J. T. Sears, R. Muller, and M. A. Reinsel. Inhibition of sulfate-reducing bacteria via nitrite production. Patent WO 9612867, 1996. 

Levin8 prepared a survey for research and development R D heads in which they were asked about the effectiveness of different methods for protecting products and processes patents, industrial secrecy, rapidity in the learning curve and sales efforts. The results showed that product patents were considered to be more effective than process patents, but in general all the other methods were regarded as more effective than the protection provided by patents, in a general survey that was not addressed to any particular sector. 

Forget, L. and Siche, A. (2005). Lamination method and apparatus for manufacturing multilayered products. Patent No. 1537994. 

A product patent claim would recite such and such substance. A related process patent claim would recite a process for making such and such substance by performing steps (a) and (b). A corresponding... 

An examination of two listed product-by-process patents illustrates this latter point. Patent Nos. 6,063,927 (the 927 patent) and 6,172,233 ( 233) both claim paroxetine hydrochloride made according to specified processes. In each case, the patent itself acknowledges that paroxetine hydrochloride was well known at the time the brand-name company applied for the patents. The brand-name company represented to the Patent Office in the patent document that the recited process was new and made the claims patentable. Therefore, if valid, these patents cover only those products (paroxetine hydrochloride) made according to the specified process, just as process patents cover products made according to the specified process. In contrast, product patents, such as listable drug substance and formulation patents, cover a product regardless of the process by which it is made. Thus, product-by-... 

In the USA, purity alone often facilitates patenting of a product of nature (Table 2.3). The PTO recognizes purity as a change in form of the natural material. For example, although vitamin B12 was a known product of nature for many years, it was only available in the form of a crude liver extract, which was of no use therapeutically development of a suitable production (fermentation) and purification protocol allowed production of pure, crystalline vitamin B12 which could be used clinically. On this basis, a product patent was granted in the USA. 

Grabowski, Henry. 2004. Are the Economics of Pharmaceutical RScD Changing Productivity, Patents and PoHtical Pressures. PharmacoEconomics 22(Suppl. 2) 15-24. 

For the successful coinmerciahsation of almost all biocatalysis products, patent protection is essential since without patent protection, and the prospect of a period of enforceable monopoly in which to recoup investment and make a profit, it is unlikely that the substantial investment required for bringing a product process to the market will occur. Frequently, the compare making the invention does not wish to, or is not able to, bring the invention to the market itself. Instead, it enters into an alhance with a partner which is better able to do this. In this case, and especially in the period where it is still uncertain that the product will be useful or commercially successful, patents and patent applications, and the know-how associated with the product or processes, may be the most valuable asset of the company. 

In Part IV, we turn to the issue of patents and pharmaceuticals. Adam Mannan and Alan Story argue that drug access could be improved if product patents were abolished. They argue that even if a process patent is present, competitors can find alternative processes or uses for the chemical compound and create price competition. To further support their argument, the authors explain how the patent system was created not because it had to create conditions for sustainable innovation, but for market protection. They note that, until recently, few countries even recognized pharmaceutical product patents and some countries, such as India, were able to develop a thriving industry as a result of the absence of product patents. 

Abolishing the product patent a step forward for global access to drugs... 

This paper asks why we continue to strengthen an ill-functioning institution. Let us cut back the barriers to access and reassess how medicines, new and old, can be delivered effectively. There are two pharmaceutical patent types the product patent, that is, the chemical itself and process patents, that is, the ways a medicine can be manufactured or administered. The difference between the two is that whilst the process patent only makes market entry more difficult, the product patent is an absolute bar to market entry and product competition. Simply, where there is a product patent the chemical... 

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