New Dimensions of Patent Law: A Global Perspective

A man with an invention on which he has spent his life, but has no means to get it developed for the good of humanity - or even patented for himself- must feel the pinch of poverty very acutely.”  - JamesPayn (English novelist)

A Patent is an exclusive right granted to a person who has invented a new and useful article or an improvement of an existing article or a new process of making an article. During the term of the patent the owner of the patent i.e. the patentee can prevent any other person from using the patent invented and is entitled to retain this property in such a manner as the real owner of any other movable property does, but after the very expiry of the duration of the patent, any interested person can use the said invention.      

A Patent is a legal monopoly, which is granted for a limited time by a country to the owner of an invention. Merely to have a patent does not give the owner the rights to use or exploit the patented invention. That right may still be affected by other laws such as health and safety regulation or the food and drugs regulation or even by other patents. The patent, in the eyes of the law, is a property right and it can be given away, inherited, sold, licensed and can even be abandoned. As it is conferred by the government, which in certain cases even after grant or even if it has been, in the meantime, sold or licensed, can revoke it.

Patent law is a specific area of law that encompasses the legal regulation, jurisprudence, and enforcement of specific intellectual property rights known as patent rights. A patent is a government issued right granted to individuals or groups that protects their original inventions from being made, used, or sold by others without their permission for a set period of time. While patents can be legally obtained without the use of an attorney, an attorney who specializes in patent law can help ensure that their client’s patent is enforceable by law. Because patent law pertains to intellectual property, which is like any other property in that it can be legally sold, exchanged, traded, or abandoned, the finer points of patent law are frequently amended as technology changes. This is another reason why an attorney specializing in patent law is of significant use to those seeking a patent.

It means a grant of some privilege, property or authority made by the Government or the Sovereign of the country to one or more individuals. The instrument by which such grant is made is known as ‘Patent’.

It conveys to the inventor substantive right and secures to him the valuable monetary right which he can enforce for his own advantage either by using it himself or by conveying the privileges to others. He receives something tangible, something which has present existing value which protects him from some competition and is the source of gain and profit. A patentable invention must be new, useful and non-obvious. Invention must be disclosed fully, the full disclosure of the patent is mandatory. If an inventor fails to disclose the invention full, the patent will not be granted. The grant of a patent confers the exclusive right of use on the patentee for commercial gain but the act recognizes that the Central Government may use any invention even without the payment of royalty to the inventor. Only the true and the first inventor of the invention or his assignee or his legal representative can apply.

 A patent is necessary to encourage research and development it induces an inventor to disclose his invention, stimulates capital investment, affects economy, encourages technological development, encourages establishment of new industries. If the inventor does not get the patent rights over his invention and introduce his product or process based on his invention in the market, anybody can copy his invention and exploits it commercially. To debar others from using, selling or working out his invention, the inventor must go for getting a patent.

New dimensions of patent law:

Patenting biotechnological products:

Biotechnology is the injection of scientific knowledge into the manufacturing processes by which marketable goods are made out of biological phenomena. It involves the study of method by which living resources (plant, animal, microbial), can be tailored to generate industrial processes and move specimens for use in agriculture, forestry, horticulture, medicine, health and environment. Biotechnology has been defined as, “The application of scientific and engineering principles to the processing of materials by biological agents to produce goods and services”.  

It comprises cell culture, fermentation technology, industrial microbiology, genetic engineering and so on.

Biotechnology is the ‘engineering’ of genetic materials towards practical ends, such as medical and veterinary advances, modified crops and improved animal breeds. Applications for patenting were filed for human and animal DNA sequences, or for new gene therapies and medicines or for both.

Patents are viewed as vital to protecting the commercial interests and intellectual property rights in biotechnology. Patents are limited rights based on a claim that a new technological invention has been created and fully communicated to the public. Patents can cover new products, processes that creates these new products, new processes for producing existing products and new processes generally. While patenting of a biotechnological invention it is important that it meets the 3 criteria’s laid down by the TRIPs to meet patentability, namely which are new or novel, involves an inventive step or not obvious and capable of industrial application.

It has been estimated that thousands of patent applications were made in respect of micro organisms, plants and for human and animals DNA sequences.

In essence, the India Patents Act gives only very limited protection to research-based pharmaceutical companies. Patenting of human material in the form of gene sequences is considered to be wrong as it amounts to commercialization of life. Failure of the basic patent principles to cater to the needs of genetic inventions has given rise to ambiguities for companies concerned with bio-technology.

Patenting of genes:

Our Genes define us, as a species as well as individuals, and hence for human genes there are strong oppositions both on the religious and secular front. A gene patent is a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims. Gene patents are a part of the broader category of biological patents.

Patents are being granted to genes despite there being many arguments for keeping the genes in the public domain. A patent cannot be granted on a gene as it naturally occurs. Isolation of the gene is required for it to be patentable. The patent offices have treated genes as a new chemical compound and have granted “composition of matter” patents. Thus a patent granted on an isolated and purified DNA composition confers the right to exclude others from any method of using that DNA composition for up to 20 years from the date of filing. However Human Beings are not patentable as human multi-cellular living organisms are not a patentable subject matter under section 101.

Gene patents may claim the isolated natural sequences of genes, the use of a natural sequence for purposes such as diagnostic testing, or a natural sequence that has been altered by adding a promoter or other changes to make it more useful. The courts have upheld claims on altered sequences, but courts and lawyers' opinions have been mixed on upholding the use of natural sequences and particularly the sequence itself. Patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism.

Patenting of Micro-organisms and Cells:

The first successful directed insertion of recombinant DNA into a host micro-organism took place in 1973, and since then scientists realized the huge potential involved in directing cellular machinery to develop new and improved products and processes. Many of these products were micro-organisms or cells. Hence with the development of the recombinant DNA technology, the potential of patenting the living organism resulting from the technology arose. The sciences of molecular biology, genetics, biophysics, cell biology and immunology have for the last few years made startling advancement and opened up vast possibility for the development of new and novel technologies. The grant of patent for engineered micro-organism meant grant of product status to that micro-organism, which revolutionised the field of biological research.

Patenting Of Pharmaceuticals:

The pharmaceutical industry is one of three technology-based industries in which the patent virtually equals the product. While only a small - and declining - number of new chemical entities are approved annually, thousands of patents are applied for to protect variants of existing products, processes of manufacture or, where admitted, second indications of known pharmaceutical products. Since patents confer exclusive rights regarding the production, sale and use of the patented subject matter, they can be used to restrain competition and set prices higher than those that would have existed if competitive products were available. This is the very purpose of the patent system, which is generally justified as necessary to encourage investments to develop new products and processes. Concentration of manufacturing takes place in pharmaceuticals industry as well as in the other branches of industry and it is characterized by the joining of firms. However, there are several specific features in patenting pharmaceutical products. Enforcement of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) made it compulsory to establish in all World Trade Organization (WTO) Members patent protection on pharmaceutical products and their manufacturing methods as well as patent protection of drugs. WTO Doha Declaration is an essential stage in patent protection of pharmaceutical products establishing the legal basis and compulsory licensing system. In 2005, the European Commission completed the Regulation of the European Parliament and the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems.

Patenting Biological Materials:

A biological patent is a patent relating to an invention or discovery in biology. It can be a composition of matter, a method for obtaining or using one or more thereof, or a product combining such things. Even when a natural biological substance itself is patented (apart from any associated process or usage), this has been permitted in the United States as long as they are sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents on isolated products of nature include adrenaline, insulin and vitamin B_12. New plants and seeds are also patentable. Isolated and manipulated cells - even human cells - can also be patented. There has been much patenting of genetically modified organisms. This includes bacteria, viruses, seeds, plants, and even non-human animals. For example, a genetically modified mouse, dubbed the Oncomouse (type of laboratory mouse that has been genetically modified using modifications to carry a specific gene called an activated oncogene), that is useful for studying cancer, was patented by Harvard University.

Patenting of plants:

Plant patents encompass newly found plant varieties as well as cultivated spores, mutants, hybrids and newly found seedlings on the proviso that they reproduce asexually. Asexual reproduction is defined as any reproductive process that does not involve the union of individuals or germ cells. It is the propagation of a plant to multiply the plant without the use of genetic seeds. Modes of asexual reproduction in plants include grafting, bulbs, apomictic seeds, rhizomes and tissue culture. Specifically excluded from protection under the Plant Patent Act are tuber-propagated plants and plants found in an uncultivated state. In some countries (including the United States, Australia and Europe) plants can be covered by patent claims provided that the patent applications are able to meet all of the necessary standards and requirements that exist in that country for patentability. Under the Trade-Related Aspects of Intellectual Property Agreement which binds World Trade Organization members, member countries that choose not to provide such mechanisms for plants under their national patent system must provide an alternative way in which an entity may claim that it has a legal right to intellectual property, to the partial exclusion of the rights of others, in plants and plant products.

Patenting of Animals:

The USPTO issued its first patent for an animal in 1988, for the 'Oncomouse,' a mouse genetically-manipulated to develop cancers mimicking human diseases. In awarding the Oncomouse patent to Harvard University, the U.S. became the first country in the world to issue a patent for an animal, which later that year was labeled as "Product of the Year" by a popular financial magazine. However, public concern was so strong that legislation for a moratorium on animal patents was considered by Congress in 1987 and 1989, and an unsuccessful legal challenge was filed by an animal protection organization. Since then, the Oncomouse has been patented in both Europe and Japan. Since the USPTO's announcement in 1987 that animals are "patentable subject matter," over 660 patents have been granted on animals. Animals cannot be patented in Canada.

Patenting of Cosmetic processes:

It has been observed under Australian Law, that cosmetic processes and methods for improving or changing the appearance of the human body or of parts of it are not of a like kind with medical, prophylactic or therapeutic processes or methods, and can therefore be the subject matter of a patentable invention. Thus it was held that a process for improving the strength and elasticity of keratinous material, especially human hair and fingernails, is a proper subject matter of a patent.

Patent in Computer Programmes:

Software has traditionally been protected under copyright law since code fits quite easily into the description of a literary work. Thus, Software is protected as works of literature under the Berne Convention, and any software written is automatically covered by copyright. This allows the creator to prevent another entity from copying the program and there is generally no need to register code in order for it to be copyrighted. While Software Patenting has recently emerged, Patents give their owners the right to prevent others from using a claimed invention, even if it was independently developed and there was no copying involved. Further, it should be noted that patents cover the underlying methodologies embodied in a given piece of software. On the other copyright prevents the direct copying of software, but do not prevent other authors from writing their own embodiments of the underlying methodologies.

It is possible to patent programs for computers which, when run on a computer produce a "technical effect or includes hardware". However, if a program does not produce a technical effect when run on a computer it is unlikely to be patentable. A technical effect is generally an improvement in technology and needs to be in an area of technology, which is patentable. For instance, an improved program for translating between Japanese and English is not patentable because linguistics is a mental process, not a technical field. On the other hand, a program, which speeds up image enhancement, may be patentable because it produces a technical improvement in a technical area.

Some countries, such as the USA, which may be a large potential market for your software, have a more liberal approach to software patenting and often grant patents for software, which would be excluded in India and other countries.

Right of Publicity:

The right of publicity has developed to protect the commercial interest of celebrities in their identities. The theory of the right is that a celebrity’s identity can be valuable in the promotion of products and the celebrity has an interest that may be protected from the unauthorised commercial exploitation of that identity. The famous have an exclusive legal right during life to control and profit from the commercial use of the name and personality. The law protects the celebrity’s sole right to exploit this value whether the celebrity has achieved her fame out of rare ability, dumb luck, or a combination. The exploitation of images of celebrities has become a big business. Celebrities have therefore attempted to capture the economic benefit associated with this market for them. The right of publicity generally forbids the unauthorised use of the name or likeness of another individual for commercial purposes without that person’s consent. Thus one cannot sell dolls that look like a celebrity without his permission.

Trade Secret:

A trade secret is a formula, practice, process, design, instrument, pattern, or compilation of information which is not generally known or reasonably ascertainable, by which a business can obtain an economic advantage over competitors or customers. One popular misconception held by many is that trade secret protection is incompatible with patent protection. It is typically said that if you apply for a patent you can no longer maintain a trade secret on the invention, but this is an oversimplification. It is true that in order to obtain a patent you must disclose your invention so that others will be able to both make and use the invention, and, to obtain a patent in the United States, if you have any preferences you must likewise disclose your preferences. What is typically not appreciated though is that the critical time for satisfying this disclosure requirement is at the time the application is filed. In many if not most situations, improvements will be made to an invention even after filing of the patent application, and additional information will be learned. None of this additional information must be disclosed and can instead be kept as a secret. Virtually all patent licenses include clauses that require the inventor to disclose any trade secrets they have. Frequently it is this information not disclosed in the patent that is the most commercially viable. Thus, if you are attempting to sell or license your patent rights you want to make sure that you take steps to continue to maintain your trade secrets as secrets, otherwise they will be lost. Accordingly, before disclosing any secrets not already protected by an issued patent you should use a non-disclosure agreement. Compared to patents, the advantages of trade secrets are that a trade secret is not limited in time (it "continues indefinitely as long as the secret is not revealed to the public", whereas a patent is only in force for a specified time, after which others may freely copy the invention), a trade secret does not imply any registration costs, has an immediate effect, does not require compliance with any formalities, and does not imply any disclosure of the invention to the public. The disadvantages of trade secrets include that "others may be able to legally discover the secret and be thereafter entitled to use it", "others may obtain patent protection for legally discovered secrets", and a trade secret is more difficult to enforce than a patent.