Monday, March 25, 2013

Patenting and Protecting Plants in the United States

The United States is considered to be safe haven for the breeders and cultivators for the protection of the plants. USA is proud of being a provider for protection under both systems such Plant Patent System and Plant Variety Protection. Plant Patent Law is nurtured among small minority of countries in which the United States is the most notable among them. The United States has to be appreciated for their management of their Intellectual Property as it has inculcated a policy which promotes a situation where anything made by hand of man under the sun are eligible for patenting.

Development of new varieties by traditional breeding is carried out by the two forms of protection through out the world. As the protection devices are primarily intended for the public welfare and the only the second priority goes to the inventor or author, as Congress envisaged, there is a little bit confusion arising as the public, in the case the farmers, are being affected their choice in the market. These developments occurred mainly due to some international conventions and with the advent of the Agreement on Trade Related Aspects of Intellectual Property (TRIPS) in the world trading system of the former GATT and the new World Trade Organization. Hence the focus of the brief discussion circles around the types of protection extended in the United States, the recent conventions and agreements like TRIPS and how it has effectively made an impact over the protection of plants in the United States and the aftermath consequences.

Solid base for the protection

Going back to the evolution of US patent, people of those time back in 1790 had generated an idea about the concept of patent and how it was put into use. There was an activating momentum in the field of plant commercialization with the backing of inspiring cultivation and with the planters transforming into the businessmen bent on introducing new plants reproducing them through cutting, grafting using other asexual methods which enable them sell them and make profits. When these breeders and cultivators using this opportunity made the patent office understanding their problems which resulted in Plant Patent Act of 1930. The breeders of trees (fruits-citrus and nuts), shrubs (azalea, viburnum etc.) and ornaments (such as blueberry, grape, raspberry and strawberry) were the main beneficiaries of the Act of 1930.

Before the Act it was believed that even the artificial bred plants were produced of nature for the purpose of patent law were not subjects to patent protection. There was an exclusion of sexually produced plants as it was believed that seed reproduction would not make a way for new varieties of plants under the Act of 1930. The interesting thing to be in this Act was the plant patent law was not incorporated in the general patent law. While enacting the Plant Patent Act of 1930, the intention of Congress was to extend to plant breeder the relief he deserves and the economic reality behind providing the protection getting materialized. And later on realizing the large input of time, money and effort of the breeder or cultivator in the development of a new plant variety, either by 'traditional 'breeding methods or by 'modern' molecular modification. With the entry of corporations in the field of breeding, it has become an inevitable from the marketing perspective of the economy to provide an adequate protection to them to come up with their technology in expediting the process by using winter breeding sites and genetic manipulation which might enable them to produce new varieties faster but at an unaffordable cost. The economic aspects are well considered and hence to recover the cost of research and development, the breeders are vested with exclusive marketing rights of the new variety. Thus the different types of protection such as plant patents, plant breeders rights (plant variety protection) and now utility patents are there which makes the plant protection enriched in the country comparatively.

US Plant Patents

At present the patent law of the United States is no more a separate statute and it is incorporated in the general patent law. Under this law the Title being 35, Chapter 15, Section 161 states:

"Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefore..."

Patents to plants which shall be stable and asexually reproducible and it shall not be any potato or other edible tuber reproducible plant.

Asexual Reproduction: The purpose of the asexual reproduction is to establish the stability of the plant. It is the process of propagating of a plant to multiply without the aid of genetic seeds.Some of the methods if asexual reproduction is rooting cuttings, division, layering, tissue culture etc.

Some 5000 plant patents have been granted (about 0.2% of all US patents) and the variety "roses" itself accounted for a major chunk. The demand for patent protection came in the first instance from the rose breeders as well fruit breeders.

The important matter to be taken into account while the scope of the plant is considered in this statute, a US court specifically decided in 1940 that bacteria cannot be covered by means of plant patents. Although bacteria may be broadly classified within the plant kingdom and reproduce asexually the court held that the term must be given its ordinary meaning in the common language of the people. But the fungi are included.

The Patent and Trade Mark Office is responsible for administration of plant patents. The application procedure is almost the same as other patent application except only a single claim is allowed. Specimen plants are not routinely required and a drawing, colored if necessary will be sufficient. The claim must be novel with distinguishing character of the new plant to be stated in more relative and less precise quantitative terms than in patent claims for other articles of other kinds. i.e seeking patent protection precisely over specific issue for eg: in case a plant is developed on the basis of a genetic mould and invented to be cure for some fatal deceases the protection must be sought on that précised particular reason and not in general.

The propagation of plants by special methods which are classified as general methods of manufacture as distinct from techniques directed producing an individual new variety is open to protection under the ordinary law of process patents. In general other plant cell culture methods which are operated for the purpose of producing secondary metabolites such as perfumes and flavors rather than the plants themselves involve the same patentability consideration as process invention of the usual kind. The same also can be said in relation to genetic manipulation of plants for this and related purpose, a strategy which falls clearly under the heading of microbiological process invention. The types of claim obtainable and useful to inventors in this connection will be touched upon when some of the special difficulties of patenting this kind of technology.

All the elements of patentability along with elements of patentability along with the concept of enabling disclosures are also required for getting protection for plant. The plant patent is aimed at the plant itself rather than distributed among flowers, fruits, seeds or other products.

US Plant Variety Rights

Some breeders/companies estimate that it takes ten to fifteen years to develop a new variety. In order to expedite the process companies use winter breeding sites and genetic manipulation. Although these applications may produce new varieties faster, they also incur heavy costs. To recoup the cost of research and development, the breeder may be awarded with some exclusive marketing rights for the new variety. This is one of economic aspects behind giving the protection either in the form of patent or other kind of protection. In the case of protection of plant this right is known as plant breeders' right-PBR (plant variety protection or PVP).

Plant Variety Protection Act of 1970 is applicable only to plants propagated by seed. It provides protection for the breeder of any novel variety of sexually reproduced plant (other than bacteria, fungi or first generation hybrids) who has so reproduced the variety or his successor in interest, shall be entitled to plant variety protection. With the 1994 amendments, Congress strengthened PVPA protection by eliminating the sale provision from the crop exemption, extending the protection period from eighteen to twenty years, and providing for infringement suits against makers of "essentially derived" varieties. Congress made this provision to curb the practices of copying protected varieties .It has to be analyzed that the variety subject to be copied derives from the initial variety (FN).

In the case of protection of plant variety rights, the application are dealt in a different manner. The Plant Variety Protection Office (PVPO) is responsible for administration of PVP Act being originated within Agricultural marketing device of the Department of Agriculture and they are authorized in issue of Certificate of Protection and not the USPTO. The procedure is little bit lengthy and complex

The process of application, examination and issuance of certificate

All the US citizens and residents and US Companies are eligible to apply for PVP. The plant varieties, for eligibility, shall be new, uniform, stable and distinct from all other varieties. The information in large has to furnished by the applicant to the PVPO. The application forms must carry certain information with regard to identification of ownership and the variety, its name, contact information along with family ascertainment such as botanical clarification (family, genus and species) in case a sale or disposal of the seed is carried out the report must be provided by applicant when and where variety was released to dispel the doubts whether the variety is new. The application must be aforesaid items with fees seed sample and exhibits showing the distinctiveness of the plant variety.
The distinctness is checked after searching is carried out in the concerned appropriate databases. Commissioner verifies the findings of the examiner writes to the applicant to make the payment of the fees to issue the certificate and it is issued accordingly.

Utility Patents for Plants

The process of application and examination for obtaining utility patent is same as that of plant patent system. Newly developed plant breeds are patentable subject matter, under general utility patent statute (notwithstanding additional protections potentially available under Plant patent Act and plant Variety Protection Act). To obtain utility patent protection, plant breeder must show that plant it has developed is new, useful and non-obvious, and must provide written description of plant and deposit of seed that is publicly accessible.

The reasons for excluding the bacteria may be the same reason justified during the enactment of 1930 patent law while exclusion of fungi is unknown where hybrids are excluded they have their own built in protection for their developer since he can control the in-bred or particular stocks and hybrid cannot be reproduced from the hybrid seeds. In the case of newly accepted varieties of hybrid and in-bred corn after the introduction of TRIPS suggestion, have become the patentable subject matter a Supreme Court laid down in J.E.M AG Supply. Inc v Pioneer Hi-bred International Inc (2002)even for obtaining Utility Patents.

This case presents the question whether utility patents may be issued for plants under 35 U.S.C. section 101 or whether the Plant Variety Protection Act or the Plant Patent Act. The U.S. Supreme Court held that utility patents may be issued for newly developed sexually reproduced plant and plant seeds (FN). The Court denied the petitioner's contention that the exclusive means of protecting sexually reproduced plant and plant seeds are found in the Plant Patent Act of 1930(PPA) and the Plant variety Protection Act (PVPA). It was held by the Supreme Court that newly developed breeds fall within the subject matter of section 101 and neither the PPA nor the PVPA limits the scope of section 101's coverage against the petitioner's (J.E.M.AG Supply Inc)arguments that awarding utility patents for plants upset the scheme contemplated by Congress. Court is well aware of the broad language of the section 101 (the decision of Chakrabarthy case) concluding the living things are patentable under this section. Responding to the petitioners arguments is that the district courts' (FN) and Federal Circuits'(FN) decision went against the Congress intent, Court held that there is no specific language in the PPA demonstrating that Congress intended these statutes to be "exclusive means of granting intellectual property protection to plants"(FN). With regard to the PVPA, it was explained that because it was harder to qualify for a utility patent than for a Plant Variety Protection(PVP)Certificate, it only made sense that utility patents would confer a greater scope for protection and it was also noted that PVPA also did not include "any statement that plant variety certificates were to be at the exclusive means of protecting sexually reproducing plants" and that Congress when passed the PVPA, the PTO had already released a number of plant utility patents.

Trade Secret Protection

Trade secret protection is outside the federal statutes and is derived from state tort law. The basic commercial morality is emphasized by this mode of protection thus preventing misappropriation of somebody's valuable commercial trade secret. The indefinite period of protection, unlike other patent protections and plant variety protection, is the most fascinating one for the plant breeders. But the main element of trade secret like keeping 'secret' incurs continuous strain, costly expenditures for taking precaution to maintain the 'secret' which is subjected to 'no more secret' with some act of reverse engineering of the invention from the part of the competitor or somebody else. Hence this sort of protection invites large amount of uncertainty and risks.

In Pioneer Hi-Bred Int'l Inc. v Holden Foundation Seeds and the "Genetic Message from the Cornfields of lowa", there is a case involves misappropriating the genetic material in two of its hybrid parent corn seed lines and it was claimed by the Pioneer that those were their highly successful parent lines and the Holden used them to develop copies that were only slightly different. In considering the case the District Court said that this is a clear cut case of trade secret violation and the defendant is liable. On appeal, Eight Circuit affirmed the decision of the district court and it has made the plant breeders eligible to sue others for misappropriation of the 'secret' genetic messages of varieties they create.

As the Eight Circuit has noted that owner of the trade secret could not possess the absolute right over the property in the trade secret which might prevent the world from using that secret. While patent protection grants the patentee the right to exclude others from making, using, or selling his invention, trade secret law merely aims to protect against the misappropriation of a reasonably protected commercial secret. As the purpose of trade secret is limited to maintaining commercial morality and encouraging innovation, greater protection can not be expected from trade secret which is inevitable for protection of a plant.

Purchase Contracts

Another means of achieving intellectual property protection is through contract. Seed companies have also used language in purchase contracts to gain better protection than the PVPA can offer. It is a contract between the purchaser/farmer and a supplier seed company where the purchaser acknowledges and agrees that the production from the supplier will be used only for feed or processing and will not be used or sold for seed, breeding or any variety improvement purposes. Further there will be an undertaking that it would be a violation of this agreement to allow the subsequent production of the seed (sold) to be used to create a seed variety or seed product from said production which may be used for seed purposes by others other than the supplier company.

Under this agreement the supplier can maximum purse breach of contract remedies if the contract is violated as aforesaid this protection under contract confer a stronger protection than PVPA and arguably better than that of utility patents too.

Label Notices

Label Notices provide another means of protection .

TRIPS Agreement for Plant Protection

Article 27(3)(b) states that members must provide patent or sui generis protection or a combination of the two. Article 27 is merely a restatement of existing intellectual property practice. Protection, whether in the form of patents or plant variety rights which accord with the International Convention for the Protection of New Varieties of Plants (UPOV) - the commonly accepted alternative to patent protection - has been available for genetic material for many years. Article 27(3) seems to be a mandating protection, which should take or the extent to which TRIPS can control the scope of the right. In addition to the flexibility contained within the provisions relating specifically to patent law..

Article 27(3) is seen as providing two possible approaches by which member states are left with the option of choosing either of the two in accordance with the UPOV line is already being accepted by the US

Until the landmark decision on In re Hibberd by a US Court in 1985 , agreements like TRIPS did not have significant relevance to farmer's rights. Article 27(3) provides the important clause for the protection has become a cause for the concern so long as exemption provided to the farmers and breeders to use varieties protected under the Plant Varieties Protection Act have ceased to be active under the Utility Patents Act (TRIPS)

UPOV line of protection

The most common sui generis protection for plant varieties is provided and well defined by UPOV. It was recognized that the plant breeding industry was becoming economically very important. In order to ensure that the economic, as wellas, agricultural, potential of this new industry was realized it was felt that plant material should be protected by some form of intellectual property right.
In US with the introduction of a protection of asexually reproducing plants took a turn in PVP Act of 1970 for protection for sexually reproducing plants to become available and with the introduction of TRIPS Agreement it has become possible to obtain even the utility patent over the plant material.

Under UPOV 1978 farmers local varieties remain as 'open access' because they rarely meet requirements of 'uniformity' and 'stability'. UPOV 1978 has a universal provision entitled 'farmers exemption', which allows any who buys a seeds of protected variety to save seeds from resulting crops for subsequent replanting without having to pay additional royalties to the original plant breeder.
This had offended the Corporations and they have tried lobbying various governments to curb this practice of 'farmers exemption' along with 'researchers exemption' provided under UPOV-1978. The corporations' intentions were carried out by the UPOV-1991 when it was revised. The revision in 1991 has reduced the 'farmers' exemption' into an optional one instead of mandatory (Art.15.2). It is left to the discretion of the Governments of each member state whether to provide this exemption to farmers or not. The plant breeder's facility or exemption like marketing essentially derived varieties without the permission of the original plant breeder is limited which is a direct stimulant for reshaping the monopoly.The revised UPOV-91 has empowered the member states to grant utility patents for sexually reproduced plants which was not allowed in the previous UPOV-78.

Conclusion

The protection for the plant breeders and cultivators definitely gives more incentives to useful inventions and technological upheaval. But as constitution has empowered the Congress to carry out the mission, while giving protection to the inventors or breeders for their utilization of skills, knowledge , money, effort and other contributions towards some inventions, the primary concern shall be with the public interest. But with the implementation of world trade agreements like TRIPS and UPOV, this type of attitude is taking a U turn from the policy, enacted by the framers of the Constitution and the sacred intent of the Congress.

It would be appropriate to think that farmers or other breeders shall go for some traditional way of cultivation, but it is a question whether they go for the primitive style of farming with a revival. It is technological era. The new type of cultivation evokes the requirement of the newly found seeds and methods with which the farmers and breeders can produce good quality products at the minimum cost.
In case it is expensive, and not attracting customers it would be ideal for the farmers to confine to the traditional farming. But the scenario is changing. They have to dance to the tunes of changing phases. Hence the precautions have to be taken to save this agricultural sect from getting alienated from the society due to the excesses of some Corporations or big individual or group breeders.

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