Molecular Biotechnology: Principles and Applications - Glick B., Pasternak J. 2002

Regulation of Molecular Biotechnology Research and Patenting of Biotechnological Inventions
Patenting of Biotechnological Inventions
General Issues in the Patenting of Inventions

For a product or process to be patentable, it must meet four fundamental requirements.

1. Any invention for which practical applicability has been demonstrated must be novel. In this context, "novelty" means that the invention has not been patented anywhere else, does not belong to already existing products or processes, and has not been disclosed in any publications prior to the filing date of the patent application. This applies to all countries except the United States; in the US, an inventor is entitled to file a patent application no later than one year after information regarding the relevant invention has been published.

2. A patent cannot be granted for something that was simply unknown previously; the invention must involve an inventive step, meaning it must not be obvious to a person skilled in the art (the Patent Office makes the final determination as to whether an invention satisfies the "inventive step" patentability requirement).

3. The invention must be "useful," regardless of whether it relates to a process, device, substance, microorganism, or multicellular Organism.

4. A patent application must contain a specification of the invention that discloses it in sufficient detail to enable practice by those skilled in the art.

Inventions and discoveries that are excluded from patentability include scientific theories, mathematical Methods, aesthetic theories, and therapeutic Methods for the Treatment of humans and animals¹⁾. Furthermore, under a foundational principle of patent law, a patent cannot be granted for "products of nature." This is because society has no interest in granting anyone monopoly rights over things that exist naturally and belong to everyone. However, companies and individuals frequently circumvent this limitation by filing a patent application for a process of purifying a product, thereby avoiding the direct question of what is actually being protected by the patent: the natural product itself or the organism used to obtain it.

There is no simple and rapid system for granting patents. An application must be prepared by a professional, typically a patent attorney, and drafted in compliance with specific regulations. An application filed in the US must include the title of the invention; an Abstract providing a concise Summary of the invention; a section called "Background of the Invention," which describes the state of the art in the relevant technical field in as much detail as possible; a section termed "Summary of the Invention," which discloses the principal Features of the invention; drawings and diagrams to facilitate understanding of the subject matter; a section containing data substantiating the enablement of the invention; and, finally, the claims, which define The Scope of the invention and help clarify how the invention can be put into practice. The patent application is submitted to the United States Patent and Trademark Office (PTO), where it undergoes examination for novelty, non-obviousness, utility, and enablement—in other words, compliance with the requirements for patentability.

If the examiner concludes that the invention meets the patentability requirements, a decision is made to grant the patent.

¹⁾ In the Russian Federation, all of these categories are considered patentable. — Trans. note.

However, obtaining a patent does not automatically mean that the patented product can be freely manufactured and sold. Before entering the market, the product must be certified in accordance with statutory requirements. For example, if a patent was granted for a genetically modified microorganism, that invention must satisfy all criteria developed for testing products derived from Recombinant DNA technology: the manufacturer must submit safety data regarding the cultivation method of the microorganism, its dissemination, and its release into the environment. Enforcement of patent rights is the responsibility of the patent holder; this means that legal action can be initiated against any party infringing the patent. Such disputes are resolved in courts rather than at the Patent Office. Similarly, if a third party (an individual, industrial company, firm, Organization, etc.) considers the issuance of a patent to be unjustified or unlawful, it has the right to file a lawsuit in court.

If the examiner rejects a patent application, the applicant may appeal to the Patent Trial and Appeal Board, and in the event of an adverse decision, challenge it through the judicial system. For some applicants, patenting is a bitter experience of dashed expectations. There are numerous well-known patent litigations where the stakes are so high that legal proceedings drag on for years, funded entirely by the opposing parties. Thomas Edison, who held over a thousand patents by the end of his life, once remarked that "every patent is an invitation to a lawsuit."

Among the primary categories of patents are product patents and process patents. Products include homogeneous substances, compositions, and various devices, whereas processes encompass METHODS FOR PRODUCING products, acts and steps, and methods of using products (Table 23.1). The Patenting of Biotechnological Inventions builds upon the historical experience of patenting innovations in agriculture, food Processing, microbiology, Pharmaceuticals, and medical industries. One such example is Louis Pasteur's patent for a beer production process via Fermentation. Today, the majority of patent Applications in biotechnology pertain to patent-eligible subject matter and are granted without any major issues. Less straightforward was the case of the first patent issued for a genetically modified microorganism. The application was filed by A. Chakrabarty, then working for General Electric, and the innovation consisted of introducing several Plasmids into a bacterial Cell, each carrying genes responsible for one of the hydrocarbon degradation pathways. The resulting microorganism was capable of degrading multiple components of crude oil and held great promise for oil spill bioremediation. Nevertheless, the patent application was rejected by the PTO on the grounds that microorganisms are products of nature and are therefore not patentable. However, in a landmark 1980 decision, the US Supreme Court ruled that Chakrabarty's Bacteria could indeed be patented under existing law, since "a man-made micro-organism is patentable subject matter... as a manufacture or composition of matter."

Class="center">Table 23.1. Main categories of patents in recombinant DNA technology

The principal debate surrounding the patenting of the aforementioned genetically modified microorganism centered on the method of its production. Previously, induced mutagenesis followed by Selection aimed at obtaining organisms with novel traits had already been recognized as a patentable invention. However, Introduction/32.html">Genetic Engineering was viewed as a Procedure that "tampered with nature itself," prompting the objection that an inventor had no right to profit from manipulating "products of nature." This line of reasoning failed to gain traction, and in the US starting from 1980 (and subsequently in other countries as well), it became established by law that living organisms—regardless of the method used to obtain them—are patent-eligible. To grant a patent on them, they must undergo examination to determine compliance with criteria such as "novelty," "inventive step" ("non-obviousness"), and "utility."