Biological patent

A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions,[1] and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.[1]

Biological patents in different jurisdictions

Australia

In February 2013, Judge Justice John Nicholas ruled in the Federal Court of Australia in favour of a Myriad Genetics patent on the BRCA1 gene.[2] This was a landmark ruling, affirming the validity of patents on naturally occurring DNA sequences. However, the U.S. Supreme Court came to the opposite conclusion only a few months later. The Australian ruling has been appealed to the Full Bench of the Federal Court; submissions in the case include consideration of the U.S. Supreme Court ruling.[3][4] This decision was decided in 2014, affirming Nicholas J's decision in favor of Myriad, confirming that isolated genetic material (genes) are valid subjects of patents.[5] As of June 2015 the case was pending hearing in the High Court of Australia.[6] In October 2015 the Australian high court ruled that naturally occurring genes cannot be patented.[7]

Europe

European Union directive 98/44/EC (the Biotech Directive) reconciled the legislation of biological patents among certain countries under the jurisdiction of the European Patent Organisation.[1] It allows for the patenting of natural biological products, including gene sequences, as long as they are "isolated from [their] natural environment or produced by means of a technical process."[1]

The European Patent Office has ruled that European patents cannot be granted for processes that involve the destruction of human embryos.[8]

Japan

Under the umbrella of biotechnology, applications for patents on biological inventions are examined according to general guidelines for patents. In response to requests for additional clarity, the Japan Patent Office (JPO) set forth specific guidelines for biology-related inventions. Over the years, the JPO has continued to amend these guidelines to clarify their application to new technologies. These amendments have broadened the scope of patents within the biotechnology industry. The Japanese Patent Act requires that patented inventions be “industrially applicable”, i.e. they must have market or commercial potential. The JPO explicitly lists “medical activities” among inventions that fall outside the scope of industrially applicable inventions, meaning that methods of surgery, therapy, and the diagnosis of human diseases cannot be patented.[9]

United States

In the United States, up until 2013 natural biological substances themselves could have been patented (apart from any associated process or usage) if they were sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents include those on adrenaline,[10] insulin,[11] vitamin B12,[12] and various genes.[13] A landmark ruling by the U.S. Supreme Court in June 2013 declared naturally occurring DNA sequences ineligible for patents.[14]

Ethics

The patenting of genes is a controversial issue in terms of bioethics. Some believe it is unethical to patent genetic material because it treats life as a commodity, or that it undermines the dignity of people and animals by allowing ownership of genes.[15] Some say that living materials occur naturally, and therefore cannot be patented.[16] The American Medical Association's stance is that gene patents inhibit access to genetic testing for patients and hinder research on genetic disease.[17]

While some feel that a patent on living material is unethical, others believe that not allowing patents on biotechnological inventions would also be unethical. Supporters of this idea suggest that patents allow the public, as well as policy makers, to hold the owner of the patent(s) accountable. They favor biological patents because they require disclosure of information to the public.[18] Agreements such as the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) require members of the World Trade Organization (WTO) to have intellectual property protection laws in place for most biological innovation, making it unlikely that many countries will prohibit patents on genes altogether.[16] Some say that patenting genes only commodifies life if a patent applies to an entire human being, arguing that patents on single body parts do not violate human dignity.[19]

Another area of controversy in genetic patenting is how gene samples are obtained. Prior consent is required to collect genetic samples, and collection of samples from people requires consent at the national and community levels as well as the individual level. Conflicts have resulted when consent is not obtained at all three levels. The question of benefit sharing also arises when obtaining genetic samples, specifically the potential responsibility of the collector to share any benefits or profits of the discoveries with the population or person from whom the sample came.[16]

The last major ethical issue involving gene patents is how the patents are used post-issuance. A major concern is that the use of patented materials and processes will be very expensive or even prohibited to some degree by conditions the patent owner sets.[20] Limiting access like this would directly impact agricultural institutes and university researchers, among others. Some fear that holders of biotechnology patents would exploit their rights in order to make larger profits, at the potential expense of farmers, healthcare patients, and other users of patented technologies.

The ethics of using patents to increase profits are also debated. A typical argument in favor of biotech patents is that they enable companies to earn money that the companies in turn invest in further research. Without these patents, some worry that companies would no longer have the resources or motives to perform competitive, viable biotech research.[16]

See also

References

  1. ^ a b c d Sharples, Andrew (2011-03-23). "Gene Patents in Europe Relatively Stable Despite Uncertainty in the U.S." Genetic Engineering and Biotechnology News. Retrieved 2013-06-13.
  2. ^ Corderoy, Amy (February 15, 2013). "Landmark patent ruling over breast cancer gene BRCA1". Sydney Morning Herald. Retrieved June 14, 2013.
  3. ^ Corderoy, Amy (March 4, 2013). "BRCA1 gene patent ruling to be appealed". Sydney Morning Herald. Retrieved June 14, 2013.
  4. ^ Corderoy, Amy (June 14, 2013). "Companies can't patent genes, US court rules". Sydney Morning Herald. Retrieved June 14, 2013.
  5. ^ "Full Federal Court Upholds Gene Patents: D'Arcy v Myriad Genetics Inc [2014] FCAFC 115".
  6. ^ "D'Arcy v. Myriad Genetics Inc & Anor".
  7. ^ "Genes can't be patented, rules Australia's High Court". www.newscientist.com. 7 October 2015. Retrieved 27 September 2018.
  8. ^ Decision G2/06 of 25 November 2008, WARF/Stem Cells (OJ EPO 2009, 306). See also Decision T 2221/10 of 4 February 2014, Culturing stem cells/TECHNION.
  9. ^ iPS Cell Technology Spurs Biological Patenting in Japan (PDF), World Intellectual Property Review, May 2013, archived from the original (PDF) on 2013-12-30, retrieved 2013-08-06
  10. ^ Crouch D (23 May 2012). "Guest Post: Myriad Misunderstanding of Parke-Davis v. Mulford". Patentlyo. Retrieved 26 Mar 2017.
  11. ^ "Why People with Diabetes Can't Buy Generic Insulin". Johns Hopkins Medicine. 18 Mar 2015. Retrieved 26 Mar 2017.
  12. ^ Zuhn D (9 Jun 2009). "Gene Patenting Debate Continues". PatentDocs: Biotech & Pharma Patent Law & News Blog. Retrieved 26 Mar 2017.
  13. ^ Cook-Deegan R, Heaney C (22 Sep 2010). "Patents in Genomics and Human Genetics". Annu Rev Genom Hum Genet. 11: 383–425. doi:10.1146/annurev-genom-082509-141811. PMC 2935940. PMID 20590431.
  14. ^ Association for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) [1] Archived 2013-06-13 at the Wayback Machine
  15. ^ Dresser R. 1988. Ethical and Legal Issues in Patenting New Animal Life. Jurimetrics 28:399-435
  16. ^ a b c d Marchant GE. 2007. Genomics, Ethics, and Intellectual Property. Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. Ch 1.5:29-38
  17. ^ "Gene Patenting".
  18. ^ Caulfield TA, Gold ER. 2000. Genetic Testing. Ethical Concerns, and the Role of Patent Law. Clinical Genetics 57:370-75
  19. ^ Resnik, DB (2001). "DNA Patents and Human dignity". The Journal of Law, Medicine & Ethics. 29 (1): 152–165.
  20. ^ Andrews, LB (2000). "Genes and Patent Policy: Rethinking IP Rights". Nature Reviews Genetics. 3: 803–8. doi:10.1038/nrg909.

External links

  • Relevant legal provisions of the European Patent Convention:
    • Article 53(a) EPC: "Exceptions to patentability" (formerly Article 53a EPC 1973)
    • Rule 28 EPC: "Exceptions to patentability" (formerly Rule 23c EPC 1973), barring the patentability of, notably, "processes for cloning human beings" (Rule 28(a) EPC); "processes for modifying the germ line genetic identity of human beings" (Rule 28(b) EPC); and "uses of human embryos for industrial or commercial purposes" (Rule 28(c) EPC)
Amarillo hops

Amarillo is a popular brand name of the VGXP01 hops owned by Virgil Gamache Farms Inc. The VGXP01 c.v., was discovered by Virgil Gamache Farms Inc. in one of their hop yards in Washington State and propagated and introduced by them as Amarillo brand. Unlike most varieties of hops, which may be acquired and propagated by the purchase of rhizomes, Amarillo brand hops are privately grown or sourced by Virgil Gamache Farms; also the organization holds a trademark on the name "Amarillo" for hops. There is a biological patent on the plant.

Association for Molecular Pathology v. Myriad Genetics, Inc.

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a case challenging the validity of gene patents in the United States, specifically challenging certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences. Prior to the case, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. Diagnostic claims were already under question through the In re Bilski and Mayo v. Prometheus cases. Drug screening claims were not seriously questioned prior to this case.

The case was originally heard in Southern District Court of New York. Proponents of the validity of these patents argued that recognizing such patents would encourage investment in biotechnology and promote innovation in genetic research by not keeping technology shrouded in secrecy. Opponents argued that these patents would stifle innovation by preventing others from conducting cancer research, would limit options for cancer patients in seeking genetic testing, and that the patents are not valid because they relate to genetic information that is not inventive, but is rather produced by nature. The District Court ruled that none of the challenged claims were patent eligible.

Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The Federal Circuit reversed the district court in part and affirmed in part, ruling that isolated DNA that does not exist alone in nature can be patented and that the drug screening claims were valid but that Myriad's diagnostic claims were unpatentable. On appeal, the Supreme Court vacated and remanded the case for the Federal Circuit to reconsider the issues in light of Prometheus. On remand, the Federal Circuit held that Prometheus did not affect the outcome of the case, so the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari. The Supreme Court granted certiorari and unanimously invalidated Myriad's claims to isolated genes. The Supreme Court held that merely isolating genes that are found in nature does not make them patentable.

Bioethics

Bioethics is the study of the ethical issues emerging from advances in biology and medicine. It is also moral discernment as it relates to medical policy and practice. Bioethics are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy. It includes the study of values ("the ethics of the ordinary") relating to primary care and other branches of medicine. Ethics also relates to many other sciences outside the realm of biological sciences.

Biological patents in the United States

As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.Until recently, natural biological substances themselves could be patented (apart from any associated process or usage) in the United States if they were sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents on isolated products of nature include adrenaline, insulin, vitamin B12, and gene patents. However, the US Supreme Court ruled in 2013 that mere isolation by itself is not sufficient for something to be deemed inventive subject matter.

Bioprospecting

Bioprospecting is the process of discovery and commercialization of new products based on biological resources. Despite indigenous knowledge being intuitively helpful, bioprospecting has only recently begun to incorporate such knowledge in focusing screening efforts for bioactive compounds. Between 1981-2010, one third of all small molecule new chemical entities approved by the U.S. Food and Drug Administration (FDA) were either natural products or compounds derived from natural products.

Bioprospecting may involve biopiracy, the exploitative appropriation of indigenous forms of knowledge by commercial actors, and also includes the search for previously unknown compounds in organisms that have never been used in traditional medicine before.

Directive on the legal protection of biotechnological inventions

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

is a European Union directive in the field of patent law, made under the internal market

provisions of the Treaty of Rome. It was intended to harmonise the laws of Member States regarding the patentability

of biotechnological inventions, including plant varieties (as legally defined) and human genes.

Implications of U.S. gene patent invalidation on Australia

On 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid. The patents were initially issued on the basis that the genes were isolated and purified to a non-naturally occurring state, however the court found, amongst other things, that the purification was not markedly different from a product of nature and thus was not patentable. The ruling may have implications for holders of other gene patents and the patentability of other naturally occurring substances. It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.

Myriad Genetics' patents for the testing of the breast cancer genes are currently licensed for use in Australia to Genetic Technologies Limited. Genetic Technologies attempted to enforce its rights and stop other laboratories from performing the tests as recently as 2008, but was forced to back down following public protest. The US court decision has prompted further debate about the legitimacy of gene patents in Australia. A Federal Government inquiry into the issue is currently underway and is expected to report in September 2013.

In Re Roslin Institute (Edinburgh)

In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014), is a 2014 decision of the United States Court of Appeals for the Federal Circuit rejecting a patent for a cloned sheep known as "Dolly the Sheep"— the first mammal ever cloned from an adult somatic cell.

International Union for the Protection of New Varieties of Plants

The International Union for the Protection of New Varieties of Plants or UPOV (French: Union internationale pour la protection des obtentions végétales) is an intergovernmental organization with headquarters in Geneva, Switzerland. The current Secretary-General of UPOV is Francis Gurry.UPOV was established by the International Convention for the Protection of New Varieties of Plants. The Convention was adopted in Paris in 1961 and revised in 1972, 1978 and 1991. The objective of the Convention is the protection of new varieties of plants by an intellectual property right. By codifying intellectual property for plant breeders, UPOV aims to encourage the development of new varieties of plants for the benefit of society.

For plant breeders' rights to be granted, the new variety must meet four criteria under the rules established by UPOV:

The new plant must be novel, which means that it must not have been previously marketed in the country where rights are applied for.

The new plant must be distinct from other available varieties.

The plants must display homogeneity.

The trait or traits unique to the new variety must be stable so that the plant remains true to type after repeated cycles of propagation.Protection can be obtained for a new plant variety (legally defined) however it has been obtained, e.g. through conventional breeding techniques or genetic engineering.

John Nicholas (judge)

John Victor Nicholas is an Australian judge. He has been a Judge of the Federal Court of Australia since November 2009. Prior to his appointment, Nicholas practised as a Senior Counsel in Sydney, principally in commercial law.

Medical patent

A medical patent may refer to

a biological patent (see also gene patent)

a chemical or pharmaceutical patent

a patent on a medical device

Oncomouse

The OncoMouse or Harvard mouse is a type of laboratory mouse (Mus musculus) that has been genetically modified using modifications designed by Philip Leder and Timothy A Stewart of Harvard University to carry a specific gene called an activated oncogene (v-Ha-ras under the control of the mouse mammary tumor virus promoter). The activated oncogene significantly increases the mouse's susceptibility to cancer, and thus makes the mouse suitable for cancer research. The rights to the invention were owned by DuPont until recently. The USPTO found that the patent expired in 2005, which means that the Oncomouse is now free for use by other parties (although the name is not, as "OncoMouse" is a registered trademark).

Patent applications on the OncoMouse were filed back in the mid-1980s in numerous countries such as in the United States, in Canada, in Europe through the European Patent Office (EPO) and in Japan.

Outline of intellectual property

The following outline is provided as an overview of and topical guide to intellectual property:

Intellectual property – intangible assets such as musical, literary, and artistic works; discoveries and inventions; and words, phrases, symbols, and designs. Common types of intellectual property rights include copyright, trademarks, patents, industrial design rights, trade dress, and in some jurisdictions trade secrets. They may be sometimes called intellectual rights.

See outline of patents for a topical guide and overview of patents.

Patent (disambiguation)

A patent is a set of rights granted by a government to an inventor.

Patent Lens

The Lens is an online patent search facility and knowledge resource, provided by Cambia, an independent, international non-profit organization dedicated to democratizing innovation. Launched in 2000, the Patent Lens allowed free searching of over 10 million full-text patent documents, including United States patents and applications, Australian patents and applications, European patents and Patent Cooperation Treaty (PCT) applications. The Patent Lens was distinguished as being the only not-for-profit facility of its kind, with international coverage and links to non-patent literature and tutorials.

In 2013 the Patent Lens was officially replaced with Cambia's new site The Lens. The Lens made improvements in the visual presentation of patent analysis and workspace management. It also features a biological facility with a number of advanced tools for searching and analysing sequences found in patents.

Patome

Patome is a database of biological sequence data of issued patents and/or published applications

Plant breeders' rights

Plant breeders' rights (PBR), also known as plant variety rights (PVR), are rights granted to the breeder of a new variety of plant that give the breeder exclusive control over the propagating material (including seed, cuttings, divisions, tissue culture) and harvested material (cut flowers, fruit, foliage) of a new variety for a number of years.

With these rights, the breeder can choose to become the exclusive marketer of the variety, or to license the variety to others. In order to qualify for these exclusive rights, a variety must be new, distinct, uniform and stable. A variety is:

new if it has not been commercialized for more than one year in the country of protection;

distinct if it differs from all other known varieties by one or more important botanical characteristics, such as height, maturity, color, etc.;

uniform if the plant characteristics are consistent from plant to plant within the variety;

stable if the plant characteristics are genetically fixed and therefore remain the same from generation to generation, or after a cycle of reproduction in the case of hybrid varieties.The breeder must also give the variety an acceptable "denomination", which becomes its generic name and must be used by anyone who markets the variety.

Typically, plant variety rights are granted by national offices, after examination. Seed is submitted to the plant variety office, who grow it for one or more seasons, to check that it is distinct, stable, and uniform. If these tests are passed, exclusive rights are granted for a specified period (typically 20/25 years (or 25/30 years, for trees and vines). Annual renewal fees are required to maintain the rights.

Breeders can bring suit to enforce their rights and can recover damages for infringement. Plant breeders' rights contain exemptions from infringement that are not recognized under patent law. Commonly, there is an exemption for farm-saved seed. Farmers may store the production in their own bins for their own use as seed, but this does not necessarily extend to brown-bag sales of seed. Further sales for propagation purposes are not allowed without the written approval of the breeder. There is also a breeders' exemption (research exemption in the 1991 Act) that allows breeders to use protected varieties as sources of initial variation to create new varieties of plants (1978 Act), or for other experimental purposes (1991 Act). There is also a provision for compulsory licensing to assure public access to protected varieties if the national interest requires it and the breeder is unable to meet the demand.

There is tension over the relationship between patent rights and plant breeder's rights. There has been litigation in Australia, the United States, and Canada over the overlap between such rights. Each of these cases was decided on the principle that patents and plant breeders' rights were overlapping and not mutually exclusive. Thus, the exemptions from infringement of plant breeders' rights, such as the saved seed exemption, do not create corresponding exemptions from infringement of the patents covering the same plants. Likewise, acts that infringe the plant breeders' rights, such as exportation of the variety, would not necessarily infringe a patent on the variety, which only allows the patent owner to prohibit making, using or selling the patented invention.

Plant variety (law)

Plant variety is a legal term, following the International Union for the Protection of New Varieties of Plants (UPOV) Convention. Recognition of a cultivated plant (a cultivar) as a "variety" in this particular sense provides its breeder with some legal protection, so-called plant breeders' rights, depending to some extent on the internal legislation of the UPOV signatory countries, such as the Plant Variety Protection Act in the US.

This "variety" (which will differ in status according to national law) should not be confused with the international

taxonomic rank of "variety" (regulated by the International Code of Nomenclature for algae, fungi, and plants), nor with the term "cultivar" (regulated by the International Code of Nomenclature for Cultivated Plants). Some horticulturists use "variety" imprecisely; for example, viticulturists almost always refer to grape cultivars as "grape varieties".

Protection of Plant Varieties and Farmers' Rights Act, 2001

The Protection of Plant Variety and Farmers Right Act, 2001 (PPVFR Act) is an Act of the Parliament of India that was enacted to provide for the establishment of an effective system for protection of plant varieties, the rights of farmers and plant breeders, and to encourage the development and cultivation of new varieties of plants. This act received the assent of the President of India on the 30 October 2001.

The PPV&FR Act, 2001 was enacted to grant intellectual property rights to plant breeders, researchers and farmers who have developed any new or extant plant varieties. The Intellectual Property Right granted under PPV&FR Act, 2001 is a dual right – one is for the variety and the other is for the denomination assigned to it by the breeder. The rights granted under this Act are heritable and assignable and only registration of a plant variety confers the right. Essentially Derived Varieties (EDV) can also be registered under this Act and it may be new or extant. Farmers are entitled to save, use, sow, re-sow, exchange or sell their farm produce including seed of a registered variety in an unbranded manner. Farmers' varieties are eligible for registration and farmers are totally exempted from payment of any fee in any proceedings under this Act. The period of protection for field crops is 15 years and for trees and vines is 18 years and for notified varieties it is 15 years from the date of notification under section 5 of Seeds Act, 1966. Annual fee has to be paid every year for maintaining the registration and renewal fee has to be paid for the extended period of registration. Farmers can claim for compensation if the registered variety fails to provide expected performance under given conditions. The rights granted under this Act are exclusive right to produce, sell, market, distribute, import and export the variety. Civil and criminal remedies are provided for enforcement of breeders' rights and provisions relating to benefit sharing and compulsory licence in case registered variety is not made available to the public at reasonable price are provided. Compensation is also provided for village or rural communities if any registered variety has been developed using any variety in whose evolution such village or local community has contributed significantly. The procedural details and modes of implementing this Act are provided in PPV&FR Rules, 2003. In the present article, we are discussing some of the important legal provisions of this Act along with some of the case studies.

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