Human genetics and genomics are fundamental scientific fields with significant commercial value. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts and sometimes fails to adapt to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive postdiscovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted patents but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims.
In April 2009, the U.S. The 50,000th U.S. Patent and Trademark Office (USPTO) granted patent that was added to Georgetown University’s DNA Patent Database. Its database includes patents that make claims mentioning terms specific to nucleic acids (e.g., DNA, plasmid, nucleotide, RNA, etc.). The specificity of many terms unique to nucleic acid structures makes it possible to monitor patents that correspond to and arise largely from research in genetics and genomics. The rise of have been accompanied by patents. genomics and genetics since the 1970s, not only due to their countability but also because science and commerce have been deeply intertwined, one chapter in the story of Medical, agricultural, energy, environmental, and other economic applications of modern biotechnology sectors. The first DNA patents were granted in the 1970s, but numbers surged in the midway through the 1990s, when molecular genetic methods began to produce patentable inventions.
A government document that grants the right to exclude others is known as a patent. from using, selling, importing, or offering to sell an invention that is claimed in the patent. That right is enforced by national courts. In essence, a patent grants the right to sue for using, selling, or distributing an invention without authorization. Patent offices grant patents in response to patent applications. There are different procedures. a little, but the criteria for granting patents are generally the same everywhere. An innovation subject matter that can be patentable The U.S. definition is “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”. An invention must also meet three criteria for patentability:
(a) novelty, (b) nonobviousness, which in Europe is referred to as an inventive step, and (c) utility (or in Europe and the majority of other jurisdictions, industrial application). In addition, an invention must be described in a patent. enough detail for a “person with ordinary skill in the art” to make and use it without conducting “undue experiments.” The patent needs to be “enabling” and “written.” description is adequate. Patent examination is the procedure for ensuring that these requirements are met. International consensus about general patent criteria does not, however, necessarily lead to consistent interpretation and implementation across jurisdictions. Genomics is one of the fields in which interpretation of patent criteria yields the most disparate results?
The United States of America grants far more patents based on DNA sequences (111,112), for instance, and generally permits claims that are broader than those of the other patent offices serving large biotechnology markets in Japan and Europe. These patents are also issued significantly faster in the United States compared to Europe, which is in turn a bit faster than Japan.
The Impact of Patents
In the US, the patenting of plant varieties is particularly important because, with appropriate claims The patent allows the owner of the patented variety to prevent other people from breeding with it. purposes. Compared to PVP, this is a significant distinction. Proving that a new variety meets the criteria for patentability is more difficult and more costly than obtaining plant variety protection, where the criteria for protection are lower. Patent protection is also frequently obtained through a broad patent which claims the gene, the vector or carrier for effecting the transformation and so on, which might include a number of potential crops or varieties that incorporate the gene. For practical purposes This may have the same effect as patenting the plant as a whole because patents typically extends to “all material…in which the product is incorporated”.
Market forces will likely steer research efforts, regardless of the patenting incentives. by the private sector to where there is the most substantial potential return. However, in contrast to medicines, there is the potential for companies to become attracted to crops that are widely grown in developing countries. The investment costs are correspondingly lower than for medical research, and the potential markets correspondingly larger. Take, for instance, rice, whose value production in India alone exceeds that of the US maize market, has hitherto been a crop where breeding has been the preserve of the national or international public sector (principally the CGIAR). Since then
the private sector has become increasingly interested in rice research. Monsanto the genomes of two major rice varieties have been sequenced by Syngenta and others. The number The number of rice- related patents issued annually in the United States has increased from less than 100 in 1995 to over 600. in 2000.
So far about 80% of trials of transgenic crops have occurred in developed countries, where three quarters of the world’s GM crops are grown. The breeding strategies of the multinationals have been naturally oriented to the needs of developed world markets, and the commercial sectors of developing nations with middle incomes (for instance, China, Brazil, and Argentina). The development of genetic traits such as herbicide tolerance has been determined principally by the search for commercial advantage, rather than for characteristics useful to poor farmers in developing countries. But companies are introducing GM varieties which, although controversial both in developed and developing countries, are considered by some developing countries to be of potential benefit to them (for example, the Bt gene which confers insect resistance). 28 Bt Cotton or Bt maize is now grown in at least five developing countries, and other countries may be interested, if they can resolve environmental concerns. For instance, India has recently approved the planting of Bt Cotton. Companies have also donated technologies of relevance to developing countries (for example, through royalty free licences), including those related to vitamin A enriched rice (Golden Rice) and cassava. Some companies have published scientific articles based on their genomic research, but have aroused controversy by not depositing the raw data in public databanks. Negotiations about the deposit in public databanks have been complicated by the companies’ desire to limit access to components of data with the greatest potential commercial value.
Thus there is the potential for agricultural technologies developed by the private sector to spill over to the benefit of the commercial sectors in developing countries. But if the Green Revolution which was developed and applied with public sector funding failed to reach effectively poor farmers living in agro-ecologically diverse rainfed environments, it is apparent that biotechnology-related research led by the private sector will be even less likely to do so. For that, more public sector research specifically oriented to such farmers will be required. In 1998, the CGIAR system spent $25 million on such research compared to the $1.26 billion invested by Monsanto.
IMPORTANT PRINCIPLES
There is a certain element of risk associated with all AR procedures. Therefore, it is necessary to determine the AR procedure’s therapeutic and research value in each case.
1. Informed Consent : After duly counseling the couple / oocyte/semen donor, an Written informed consent ought to be obtained from both spouses in addition to the donor, if that’s the case. v They should be explained the various risk factors associated with the procedures in simple language and the words that they can understand. Among these are risks. associated with ovarian hyperstimulation, anaesthestic procedures, and invasive procedures like laparoscopy and ovarian aspiration, among others v They should be explained the possibility of multiple pregnancies, ectopic gestation, increased perinatal and spontaneous abortion rates, premature births, and infant mortality as well as growth and developmental problems, possible side-effects (e.g. of the drug used) and the risks of treatment to the women and the risks associated with multiple pregnancy. They should also be explained that –
- the procedure’s success or failure cannot be predicted, and it is necessary to reduce the number of viable foetuses, in order to ensure the survival of at least two children;
- there may be possible disruption of the patient’s domestic life which the treatment may cause;
- concerning the potential deterioration of gametes or embryos connected storage, and possible pain and discomfort;
- regarding the treatment’s cost to the patient (assuming an appropriate breakdown). proposed and of an alternative treatment, if any (there must be no other “hidden costs”).
- about the importance of informing the clinic of the result of the pregnancy in a pre-paid envelope; and
- about the advantages and disadvantages of continuing treatment after a certain number of attempts. Informed consent should include information regarding use of spare embryos. It should be made clear whether embryos that are not used for transfer could or could not be used for research purposes or implanted in another woman’s womb, also known as “preserved” for later use or destroyed. Investigators should ensure that participants are informed and consent is taken afresh in writing on the above issues at every stage.
Consent may be withdrawn at any time before implantation.
Specific consent must be obtained from couples who have their gametes or embryos frozen, with regard to what should be done with them in case of death, or if one of the parties loses the ability to revoke her or his approval. v Investigators should clarify the ownership of the embryos that they belong to the genetic mother or the laboratory. Abortions should never be encouraged for research purposes. No AR procedure will be done without the consent of the spouse or partner. There is no ethical objection at the moment for IVF or any other related procedure for research or for clinical application. Selection of Donor : The semen bankassumes the responsibility in selection of the suitable donor on following terms :
In order to determine the, the donor should undergo a thorough physical examination. good health of the donors of semen, oocyte or embryo. The donor should be healthy with reasonable expectation of good quality eggs or sperms and preferably with proven fertility record. The physical characteristic and mental make-up of the donor should match as closely as possible to that of the spouse of the recipient, specially with reference to colour of the skin, eyes and hair, height and build, religious and ethnic background, education, and blood type of ABO Blood group of the proposed donor and donee should be tested with respect to Rh compatibility.
No person suffering from any sexually transmitted disease (e.g. syphilis, infectious diseases (such as gonorrhea, chlamydia, herpes, HIV, etc.), C, HIV) or genetically transmissible disease should be used as donor. Sexually Within a week of receiving the seminal, transmitted diseases should be ruled out. fluid.
It is essential that donated semen is cryo-preserved and used only after 6 months because this would allow the center to test the donor again for HIV after six months and eliminate the potential risk of HIV transmission in the ‘window’ period of HIV infection.
Identity of the donor as well as the recipient should be protected from each other. However, the donor’s records must be kept for at least 10 years. years to locate her or him in the event of an emergency, and should be confidential.
Confidentiality of the entire procedure and its outcome is advisable and therefore, It is best not to accept a relative as a donor so that they can avoid being identified and claims of parenthood and inheritance rights.
Any information about clients and donors must be kept confidential. No
information about how couples are treated as part of a treatment agreement may be disclosed to anyone other than the accreditation authority or persons covered by the license, except with the consent of the person(s) to who the information pertains to, or in the event of a patient-related medical emergency, or a court order. This individual or individuals have the right to choose what information passed on and to whom.
The donor’s written consent should be obtained prior to the unrestricted use of sperm. or oocytes for AR, as well as an undertaking from him / her that he / she will not attempt to seek the identity of the recipient. In case the donor is married, the written consent of the spouse should be taken, if possible. It is also desirable to restrict the use of semen from the same donor to a maximum of 10 pregnancies to avoid the possibility of an incestuous relationship occurring at some point in the future among the children. v If the oocyte donor develops any health issues as a result of the procedure as a result of donation, the recipient should bear the subsequent health care costs. regardless of whether they receive oocyte donation, a potential recipient couple as planned or not.
In case of unused surplus/ spare embryos, consent of the concerned couple should be obtained in order to cryopreserve such embryos so that they can be given to those in need.
Conclusion
There are reasons to be concerned about the future. First, academic researchers’ general lack of awareness or concern regarding existing intellectual property is clearly linked to the lack of substantial evidence for a patent thicket or patent blocking issue. That could change dramatically and possibly even abruptly in two circumstances. Realizing that they are not shielded from legal responsibility, institutions may become more concerned about their potential patent infringement liability and take more active measures to educate researchers or even attempt to control their behavior. The latter could be both burdensome on research and largely ineffective because of researchers’ autonomy and their ignorance or at best uncertainty about what intellectual property applies in what circumstances. Alternatively, patent holders, equally aware that universities are not shielded from liability by a research exception, could take more active steps to assert their patents against them. This may not lead to more patent suits against universities—indeed, established companies are usually reluctant to pursue litigation against research universities—but it could involve more demands for licensing fees, grant-back rights, and other terms that are burdensome to research. Certainly, some holders of gene-based diagnostic patents are currently active in asserting their intellectual property rights. Even if neither of these scenarios materializes, researchers and institutions that unknowingly and with impunity infringe on others’ intellectual property could later encounter difficulties in commercializing their inventions.
Author: Khadija Fatma, Research scholar, Faculty of Law, Aligarh Muslim University, Aligarh
Juris Centre 