Biotechnology & Patents

Patent protection for the Biotechnological inventions including biological material and gene sequences is a significant step towards development of the overall biotechnology industry. The benefits of biotechnology have even expanded to include the fields of medicine for treatment of diseases and agriculture for improvising upon the food quality, quantity and safety. The patentability of biological material has always invited contentious debates since primarily the major research work involves isolated biological materials that were existing in nature. This raises the most obvious question for the readers whether certain substances isolated from nature or derived by manipulating the genetic structure of living matter including plants, animals, and microorganisms are “inventions” or “discoveries” since the latter are excluded from patentability.

Broadly, modern biotechnology includes the techniques of recombinant DNA, gene transfer, plant regeneration, cell culture, monoclonal antibodies, and bioprocess engineering. The legal bodies of TRIPS contracting states endeavored to evolve a harmonized system of patent protection for biotechnological inventions wherein “biological material originating from nature or produced by means of a technical process” were considered to be a patent subject matter. However, plant and animal varieties; essentially biological processes for the production of plants or animals, such as crossing or selection, but excluding microbiological processes, and human body and the simple discovery of one of its elements, including the sequence or partial sequence of a gene were categorized as a non patentable subject matter. On the contrary, an element isolated from the human body or produced by means of a technical process, including the sequence or partial sequence of a gene, was considered to constitute a patentable invention.

LEGAL POSITION OF STATES FOR BIOTECHNOLOGICAL INVENTIONS

A large number of heterogeneous biotechnological patents have been granted since the 1970’s across various European countries as well as United States since the prerequisites for grant of patent varied remarkably amongst the granting states. A legally binding answer was not forthcoming to the question as to how the harmonization of laws regarding patentability of biotechnological inventions that differently interprets the term “human life” should proceed.

Moreover, the actual protection offered under patents is further subjected to state imposed prohibitions or obligation for actual exploitation of patent rights. Multilateral agreements and arrangements arising out of instruments such as Patent cooperation Treaty, 1970; Convention on Biological Diversity, 1992 and the Agreement on Trade Related Aspects of Intellectual Property Rights, 1995 accords legal uncertainty to biological particularities.

The first ever decision that held genetically engineered bacterium patentable was Diamond v Chakraborty, 1980 wherein the patent protection was accorded to genetically modified micro-organisms that were useful for cleaning oil spills. The alteration of a naturally occurring organism challenged the traditional distinction made in patent law between an unpatentable discovery and a patentable invention, as well as the "natural phenomena" doctrine. In Diamond v Chakraborty, the main argument was that in contrast to previous cases which were decided according to the "natural phenomena" doctrine, Chakrabarty's bacterium did not exist in nature, but was rather a man-made product with different characteristics than any naturally occurring bacterium. The decision defined limits and distinguished between discovery as an extended knowledge form and invention as an act of creating something that did not previously exist, and which increases human practical abilities.

PATENTABILITY OF BIOTECHNOLOGICAL INVENTIONS

Novelty Assessment: The “Novelty” and first criteria of patentability for a biotechnological invention is easily justifiable if the end product of genetic research contributes to the development of an artificial biological material. Since the modification of naturally occurring genetic structure and characteristics yielded a new and useful substance, it is considered novel. However, the application of the novelty test to biotechnological inventions deserves special consideration, not the least because many biotechnological inventions are based on natural material.  In this respect it is important not to confuse the objection that e.g. a polynucleotide sequence lacks novelty with the objection that the polynucleotide is unpatentable because it is merely a discovery.  Basically, it is established practice that a natural substance which has been isolated for the first time and which had no previously recognized existence, does not lack novelty because it has always been present in nature. Also, the prior publication of a polynucleotide sequence may be novelty destroying as it occurs i.e.as it is embedded within the human genome. However, this prior publication would not impugn the novelty of the sequence when it is claimed in an isolated state.

Now, let us understand the significance of “selection invention”. In a usual scenario, a claim directed towards an isolated polynucleotide may overlap the unrestricted polynucleotide of larger sequence. On the other hand, a claim generally to any isolated fragment of an identified sequence would lack novelty because it would be anticipated by a single, isolated nucleotide.  However, a claim to a specific fragment might be allowable as a “selection invention” where it can be shown that the fragment has some advantage or useful quality not previously recognized, such as a specific polymorphism.

Next, if any earlier existing sequence inherently possesses the activity of later sequence but the same has not been indicated while writing the enabling disclosure for the former sequence, it is not deemed to be anticipated because the person skilled in the art was not able to determine the activity of earlier sequence from earlier disclosure as it merely disclosed the sequence and not its activity, later found.

Similarly, polynucleotide claimed by its tertiary structure if the same polypeptide previously has been isolated from the same source, with the same function, and with approximately the same molecular weight; it can be assumed that the earlier polypeptide has the same tertiary structure as the claimed polypeptide. However, a claim to a crystallized form of a known polypeptide may be novel if the prior art does not disclose crystals of the polypeptide or methods of making the crystals.

Whilst it could be argued that it is implicit that the sequence of a protein, which by name and function is identical to the polypeptide claimed, would also be identical in sequence, it could also be argued that due to the extent of variation between peptide sequences of the same family the sequence may differ significantly.  Therefore, a document should not be cited under novelty unless it is certain that only one unique form of a particular polypeptide exists.  If this certainly does not exist, then a document should only be cited under novelty if the peptide sequence is explicitly disclosed.

A claim to an isolated and purified molecule which comprises the binding pocket of a known protein, which is defined by structural coordinates, is not considered to be novel as the isolated known protein would inherently comprise this binding pocket.  However, an isolated polypeptide consisting of the binding pocket, and which is demonstrated to retain the binding and signalling activity of the protein may be novel if no such isolated polypeptide fragment is known in the prior art.

Inventive Step Assessment: However, a different approach is appropriate with regard to an isolated or otherwise produces natural biological material. Its isolation or production through other means outside of its natural environment requires the use of a technical process. This process might be considered as qualifying second criteria of patentability-“inventive step” as the technical process and means incorporated in the isolation and purification of a biological material are often not obvious to experts in the field. 

In general terms whether eg a sequence comprises an inventive step is determined in a similar fashion to that which applies to chemical compounds, ie whilst identity of structure will be enough to prove lack of novelty, similarity of structure will not be enough to prove lack of inventive step unless the activity is identical in at least qualitative terms. There is another way in which a sequence may be shown to lack inventive step and that is where an earlier disclosure points to the inevitably of arriving at a particular sequence even though the actual structure of the 

sequence is not determined until sometime later.

In the case where an applicant has prepared a known protein by recombinant means it would be rare these days to allow claims to related sequences. Similarly, claims to a new orthologue of an already known gene in a further strain or species are ordinarily regarded as being obvious. However, under these circumstances, it might be possible to allow narrow (probably process) claims restricted to what the applicant had done.

Following the sequencing of various genomes, there is unlikely to be an inventive step in identifying from within a sequenced genome any new gene, even those without known homologues. It is obvious to trawl the genome for previously unidentified genes, and any skilled worker would have some expectation of success.  If the person skilled in art witnesses number of obstacles it does not account for anything inventive. However, imagination beyond an imagination of a skilled person in the art does provide an inventive step. Identifying a polynucleotide or polypeptide homologous to a polynucleotide or polypeptide, having a known function or activity, will not normally involve an inventive step.  Moreover, while a specified degree of homology may serve to distinguish the newly identified sequence from one or more known, homologous sequences, it cannot usually serve to establish an inventive step.  It therefore follows that the identification of a human homologue of a previously characterized gene from another species is not inventive, and this is regardless of the methods used to identify the homologue. 

The identification of the function of a novel gene that has not been identified by any form of homology searching may be inventive; this will depend upon the methods used to determine the function and by what is known in the prior art.  Thus, claims to uses or applications of genes, where the invention lies in the function of the gene, may be allowable, provided that the function has been demonstrated, and is inventive. Similarly, the identification of a new single nucleotide polymorphism(s) within a known gene may be inventive provided that a novel and non-obvious function can be assigned to it, for example a relationship between a particular polymorphism(s) and the predisposition towards a certain disease. However, any prior art disclosure of any polymorphisms within the same gene and their association with the same disease will usually render obvious the discovery of further polymorphisms.  Likewise, new haplotypes of a known gene may also be inventive provided a new and non-obvious function can be assigned to them.

The “selection invention” criteria can also be applied to the specific combination of probes on a microarray.  For example if the exact combination of probes on a microarray meant a more accurate detection and / or a more precise diagnosis than the use of the probes individually, then the particular selection of probes may provide a surprising effect and inventive step. Moreover, this surprising effect may confer a unity of invention to the probe combination.

Patentable and Non patentable Inventions: TRIPS offers that biological matter, human body at various stages of its development, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. The situation differs in the case of an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, “even if the structure of that element is identical to that of a natural element”.  

Further, patentability of inventions whose commercial exploitation would be contrary to order public or morality is excluded. Suitable examples of such non patentable inventions includes  processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, and uses of human embryos for industrial or commercial purposes. As a regular prerequisite a biotechnological invention shall qualify novelty, inventive step and utility criteria of patentability. However, the utility aspect of such inventions is spelt out more clearly and requires the applicant to specify “the industrial application of a sequence or partial sequence of gene more succinctly, and concretely together with a specification of the function performed by the sequence or partial sequence”, while making the patent application. 

The patent legislation stands distinct in each state in many respects- scope, subject matter, and ethical limits of substance protection and actual exploitation of validly granted claims. For instance, patent protection for embryos and of cloning triggers turbulence and in other instance,  the issue is the patenting of stem cells to be derived from cloned embryos, and in another, the possible formation of chimeras – that is, hybrids of animal and human material.

The patents protection in previous years included both the process of isolating genes and the isolated genes themselves, which invited severe criticism. Objects were also raised against diagnostic procedures, therapies and productions of pharmaceutical products. The disputes also revolves around the additional function performed by the receptors of allowing penetration of virus into the cell beside serving a possible site of action of drugs to treat inflammatory diseases. With regard to processes of protection of human cells, it was viewed that the isolation of animal stem cells to produce genetically modified organisms will also include human embryos. The contention was resolved by limiting the patent protection to non-human stem cells. For the processes of production of neural precursor cells from embryonic stem cells, it was critiqued that the embryos from which the stem cells are obtained are always consumed.

Observing all technology specific critiques and objections, the general objections observed are as follows:

• Patents inherently on “life” are not permissible- It is therefore acknowledged that life bearing characteristics like cellular organization, metabolism, variability, the capacity to react to stimuli and the capacity to reproduce are not exhibited by genes, nucleic acids and proteins, considered in them – that is, independently of and in isolation from living organisms – hence patentable, though “life” form is not patentable except for bacteria and microorganisms;

• Human genome is a common asset, not subjected to private protection: Since genomes are not the product of human ingenuity and intellect, they cannot be refrained from research and application by others; 

• Genes are not substances, but the material form assumed by information; however concrete function of a gene segment can be a matter of protection: The issue arises during assessment of “inventive step” aspect of patentability as a natural substance like a piece of deoxyribonucleic acid having a specific composition appears more to be both- a material (chemical composition DNA) and also a media of genetic information used by the cells for the biosynthesis of proteins. For assessing novelty and other criteria it is adjudged if the description of the information contained in a DNA sequence, or of a specific function performed by it, is novel. 

• Cells and genes are discovery and not inventions: The situation is however different if the gene is isolated and is subsequently used for any application, which in itself is an inventive step. It is argued that regardless of the provisions of patent law, the first-time isolation of genes by novel technical means and the resulting provision of these genes for subsequent relevant applications do not constitute an invention. This is because it is not the genes but the technical process for their isolation that has been invented. In this case too, genes are therefore considered not to be patentable.

Therefore, the inventions that are held unpatentable where their exploitation is usually against the public policy or morality are: 

• processes for cloning human beings;

• processes for modifying the germ-line genetic identity of human beings;

• uses of human embryos for industrial or commercial purposes;

• processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

SCOPE OF PROTECTION

The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention extends to any biological material derived from that biological material through propagation or multiplication and possessing those same characteristics. The protection conferred by a patent on a product containing genetic information extends to all material in which the product is incorporated. The exceptions to this rule are:

 a) Biological material that is obtained from the propagation or multiplication of biological material, where the multiplication or propagation necessarily results from the application for which the material was marketed by the holder of the patent or with his consent, provided that the material obtained is not subsequently used for other propagation or multiplication;

b) Plant-propagating material or breeding stock sold to a farmer by the holder of the patent or with his consent, provided that the farmer uses the biological material or livestock for his own agricultural purposes.

Now, let us understand the scope of protection for different parts of biotechnology:

 Proteins: Patent protection for a protein may be granted if, not been previously characterized, has been isolated from a natural resource in pure form. A novel or known protein obtained via recombinant DNA technology may be patentable. E.g. a hormone expressed from a recombinant vector.

 Micro-organisms: A new strain of micro-organism produced artificially which may include a micro-organism transformed by a recombinant vector. A micro-organism newly isolated in pure form from a natural source, it stands patentable. Similarly, a novel product produced by a micro-organism is patentable – e.g. antibiotics. If a product produced by the micro-organism is known, the process of producing the product using the micro-organism may be patentable.

Molecular Biological Techniques: Novel techniques/processes for producing a particular product (protein/clone) may be patentable. A known process used to produce a novel product is generally not patentable.

Cell Lines: Yes, if artificially produced the cell lines are patentable.

DNA, RNA, Amino Acid Sequences: Random isolated sequences generally will not be patentable if they have no utility, i.e. they have no known use at the date of filing the application.

Gene: Newly isolated genes in pure form or a gene to which alterations have been made or a gene in recombinant form is patentable.

DNA/RNA Vectors: Novel vectors created in the laboratory and used for cloning or expressing gene sequences may be patentable.

A Plant or Animal: At present, there is much controversy over the patentability of plants and animals. In many countries, it has generally been considered that an animal or plant or a process for producing an animal or plant is not patentable. However, views on this are changing and a number of patents have already been granted. E.g. the Harvard Oncomouse.

REQUIREMENTS TO OBTAIN A BIOTECHNOLOGICAL PATENT

Besides fulfilling the three basic elements of patentability i.e. novelty, inventive step and utility, additional requirements to obtain a valid patent in case of biotechnology are:

An Enabling Disclosure – The constraint for an enabling disclosure is central to one of the main aims of the patent system; to promote disclosure of information to the public. The specification filed with the application for a patent must sufficiently describe the invention along with the best method by which it may be performed in enough details to allow a person of average skill in the relative field to rework the invention with no further experimentation or invention. To the extent it is to include a clear description of how to use an invention, this requirement overlaps with the utility principle.

In one of the rulings US Patent Office abandoned patent application filed by National Institute of Health (NIH) for failing to provide an enabling specification that can enable other person skilled in the art to put the EST’s to use without first characterizing them and identifying which of the many sequences were of interest for one of the particular purposes alluded to in the specifications.

The Deposit of Micro-organisms – This is essential to the need of filing an enabling disclosure. This is necessary as it would be near impossible to accurately describe in writing all the characteristics of the micro-organisms. A sample can be deposited in a recognized depository, e.g. American Type Culture Collection.

CONCLUSION

As evident from the discussions above, the laws effecting biotechnological inventions should be more convincing and effective. The relevant legal instrument should provide that the scope of protection of a claim to a DNA sequence isolated from the human body and not newly synthetically developed should be limited to the technical application of a function specifically set forth in the patent description and claim. The concrete function should be specified that would determine the legally binding limits offered by patent protection. Similar is the situation with human gene sequences.

Further the relevant law shall explicitly state that reproductive human substances (oocytes, sperm cells or gonadal tissue), human organs and embryos, as well as human embryonic stem cells and stem cell lines, are not patentable. The same applies to processes for the formation of chimeras using human germ cells and to parthenogenetic processes involving the use of human genetic material, as well as to the organisms and/or biological entities obtained by these processes.

To conclude, the scope of protection for elements of the human body must not extend beyond the concrete technical application of a function, which must be precisely described in the patent application; that is, the claim in the patent application and in the granted patent must be confined to this technical application. This is the only way to preclude “strategic patents”. The statutory obligation to furnish evidence of origin of the biological substances shall be more stringent.

PAYING HOMAGE: EUPHEMISHM, RIPPING-OFF: DYSPHEMISM FOR COUTURE COLLECTION

       With on-trend sartorial sense impregnating the fashion-savvy commoners, the skillful creators of these iconic artworks should now take a pause to see if the silhouette of their couture collection is clinching the right clientele. More often than ordinarily, the knockoffs and counterfeiting goods are touted as a convenient choice under the pretext of paying customary homage to the designer’s avant-garde luxury piece. Really? It's all full of psychoanalytic mumbo-jumbo.

       Now a straight talk-it’s nothing less than a rip-off, and as these dark clouds of piracy embraced the whole sky of aesthetic creations, a ray of hope emerged when recently a magazine reported of designers becoming fully aware of copyright laws and successfully “patenting” their design portfolios (See Link). For now, I would bide my time to comment on media’s bold and blithe use of some serious legalese, and chose to focus on what the IP creators shouldn’t be saying wrong. Agreeably, it’s not their field of practice and they are not the ones to be satirized for not knowing it right; yet as generators of intellectual wealth they should be cursorily informed of the intricacies of wealth protection & its strategic management in order to effectively safeguard their wealth and coin money therefrom.  .    

As can be deduced from the media report, availing copyright or trademark form of coverage for creative expressions is certainly trending amongst the designers. But, it is equally pertinent to know what kind of protection is extended by these IP forms singly or in combination, or if there is something else to deal with when instituting infringement proceedings against unscrupulous free riders.

Indeed, copyright is sought for original and unique artistic creations and trademarks for personalized logos and slogans as epitome of finely accrued IP rights by designers. But is this effort fulfilling when it comes to protecting something more fundamental-like shape and design of clothing, apparels, garments, jewelry, ornaments, fabric or the like, in its entirety? So, how to promise protection of something that actually matters----innovative DESIGN, which pushes the artiste to travel an extra mile, and compose designs that goes beyond traditional boundaries of style.

Industrial Design Act of 2000 comes to rescue. However, with ambiguous and overlapping IP laws governing design works in India, it is rendered rather more difficult to narrowly tailor the IP rights that are less expensive to obtain, are easier to enforce and are broad enough to secure as much of the innovative design as possible. This suggests developing an IP portfolio that includes both broad and narrow rights rendering different range of protection under differing circumstances. As can be adjudged from legal dispute between Ritika Private Limited (Plaintiff) and Biba Apparels Private Limited (Defendents) over creations in fusion fashion (See SpicyIP), neither forms of IP protection can solely suffice to stop knockoff or near knockoff products from entering the market. But, prior to this it is critical to analyze where these IP forms overlap, if they do and how well to draw a clear line of separation between them.

 Logically, it flows that while Section 2(d) of Designs Act offers protection only to the features of shape, configuration, pattern, or ornament, or composition of lines or color or a combination thereof applied to an article by any industrial process, Section 15 of Copyright Act states that a copyright shall not subsist in a design protected under the Design Act. Precisely, no copyright shall exist in a design, which is capable of being registered under the Design Act, and which has been reproduced more than 50 times by an industrial process. 

           The judicial precedence established by Courts until today, for instance referring to Microfibers Inc v. Girdhar and Co., suggests defining the artistic work into “original artistic work” and “commercial or industrial manifestation of such artistic work”. It further mandates that though copyright exists in original artistic work per se, the design would have to be registered under the Design Act to institute case of infringement against the accused.  If such protection is not sought under Design Act for specific set of classes stipulated in the Act, the copyright in these works shall cease to exist after the design is applied to articles for more than 50 times by an industrial process.

           But isn’t it intriguing that while the most prevalent forms of protection vis-à-vis copyright and trademark that remain subdued in representation sheets at IP offices, or are hidden as labels beneath the branded apparels or stitched into the fabric as a midget representation of one’s protected brand, are accorded a longer period of protection than the design form. Understandably, it is rather the design form which enables the artist recoup the cost of his intellectual and financial investments using his underlying work upon a 2D or 3D article of production. Furthermore, while the infringement of copyright and trademark constitute civil and criminal wrongs, the infringement of designs is purely a civil wrong. So, should we assume that designers should now assert copyrights in blueprint to prevent manufacture of 3D artistic models beyond unpleasant threshold of 50? 

Definitely one size does not fit all, and no one strategy can be extrapolated to all cases. The Design Act of today does not allow sectional views, descriptive matter and reference numerals in the representation of article during filing of design application, but more favorably, it allows combination of solid lines and dotted lines to depict both the claimed features of shape and also the elements which are not part of claimed designs, respectively.

Such a depiction claims much more by way of drawings, photographs, tracings to yield a broader form of protection to non-utilitarian design, compared to a copyright application that merely serves as a substrate for artistic matter and may be lost when the article is offered for sale. Also, even if copyright intends to protect the work longer, it might not be of much relevance in fashion industry owing to seasonal and cyclic nature of work generated, unless of course it becomes any classic like Hermès Kelly Bag.

Though the remedies offered under copyright law are more moderating than those offered under the Designs Act, yet if the question of enforcement of legal rights over a bundle of protected papers and an article of commercial significance arises, then inarguably latter shall be the obvious choice. To conclude, the kind of protection which the designers of today should be ambitiously aspiring needs to be twofold- under both of copyright and design regimes. Unless the dual protection is attained, the creator shall loose copyright protection, though gain design protection once a design is registered. On the other hand, the creator relying solely on copyright protection might lose the protection when the design is applied industrially beyond 50.  

SNAPSHOT OF USPTO DECIDED CASES ON PATENT ELIGIBLE SUBJECT MATTER

The table is a quick reference to USPTO decided cases between 19th to 21st centuries that have a significant impact in charting a course to today’s popular two-step framework for determining patent eligible subject matter.  The present listing of cases does not constitute an exhaustive sample space of all landmark cases, but are essentially drawn from recently issued USPTO report of July 2017.

S. No.	Case Name		Year	Subject Matter	Decision	Inference
SIGNIFICANT CASES OF 19TH CENTURY
1	O’ Reilly v. Morse	1854		Method for marking or printing intelligible characters, signs or letters at any distances using electromagnetism	Ineligible	The use of magnetism was not restricted to a particular process. Attempt towards Pre-empting the use of principle of electromagnetism
2	The Telephone Cases	1870 to 1880		The claims were directed to use of current in closed circuit for transmission of vocal and other sounds, and using it that condition only for a limited purpose	Eligible	The art of using principle of electricity to reproduce at a distance vibrations caused by the voice, into a practical use or under specified condition, thereby not attempting to pre-empt all other possible solutions
SIGNIFICANT CASES OF 20TH CENTURY
3	American Fruit Growers v. Brogdex	1931		The method involved treatment of citrus fruits with a borax solution to render the fruit resistant to mold	Ineligible	The process could not be called “manufacture” or “manufactured article” within the meaning of Patent Law. The addition of borax to the rind of citrus fruit does not produce from the raw material an article for use which possesses a new or distinctive property, form or quality. The added substance only protects the natural article
4	Funk Bro. Seed v. Kalo Inoculant	1948		The invention claimed an inoculants for plants comprising a combination of different bacterial stains to improve nitrogen fixation	Ineligible	There is no invention in combining species as no new bacteria were produced; rather each species had its same effect as it always had. Thus, there should be more than mere combination as else it will be discovery of some of handiwork of nature
5	Gottschalk v. Benson	1972		The method of programming a general purpose to convert binary coded decimal (BCD) signals to pure binary numbers	Ineligible	Claims were abstract within the statute as they attempt to cover both known and unknown uses of BCD to pure binary conversion. Thus, there is a pre-emption of mathematical formula and hence patent on algorithm strictly
6	Parker v. Flook	1978		A method for updating alarm limits during catalytic conversion using a mathematical formula	Ineligible	A mathematical formula cannot support a patent unless there is some other inventive concept in its application. Any post-solution activity can be appended to almost any mathematical formula. Therefore, its limitation to a specific field shall not suffice; the implementation should be novel and non-obvious
7	Diamond v. Chakraborty	1980		A bacterium genetically engineered with 2 plasmids providing separate hydrocarbon degradative pathways for use in treatment of oil spills	Eligible	Improvement on a composition of matter. It is a first case on allowing a live human-made micro-organism as it constitutes a “manufacture” or a “composition of matter” within the definition of statute.
8	Diamond v. Diehr	1981		A process for molding synthetic rubber product using Arrhenius equation to calculate cure time. It comprises series of steps that enable more efficient solution of Arrhenius equation	Eligible	The process enables transformation of raw, incurred synthetic rubber (an article) into a different state or thing within a specified field.
SIGNIFICANT CASES OF 21st CENTURY
9	In re Bilski	2010		A method of hedging risk in commodities trading. The steps comprises initiating a transaction between a broker and purchaser-users who buy the commodity at a first fixed rate, identifying producer-seller of the commodity, and initiating transaction between the broker and producer-seller at a second fixed rate such that the purchasers and the sellers respective risk position balance out.	Ineligible	This was a business method including an abstract idea of hedging risk in energy market and added only token post-solution components, use of well known random analysis technique to establish input. Hedging was determined as a fundamental economic practice and by patenting this, there was an attempt to pre-empt use of risk hedging in all fields.
10	Research Corp. v. Microsoft	2010		Rendering a halftone image of a digital image by comparing pixel by pixel, the digital image against a blue noise mask	Eligible	It’s a functional and palpable application of a method to computer technology
11	Mayo v. Prometheus	2012		A method for optimizing drug dosages for treatment of autoimmune diseases in humans based on relationship between concentration of metabolite in blood following administration of drug, and likelihood that administered dosage would be ineffective or produce harmful side effects	Ineligible	A two-step framework was introduced for the first time  to determine: i) if the claims were directed to judicially recognized exceptions ii) if the claims do significantly more than simply describe these natural relations
12	Association of Molecular Pathology v. Myriad Genetics	2013		The claims were directed to an isolated DNA associated with an increased risk of breast cancer, and a synthetic DNA created from RNA, known as complementary DNA (cDNA)	Isolation of genes-Ineligible BUT cDNA-eligible	The isolation of genes falls within the law of nature exception and discovering location of genes does not render genes patent eligible, nor does an act of separating them from their surrounding genetic material. There should be a marked difference in the characteristics of a new product resulting from isolation when compared to its natural form. However, cDNA are allowable as they differed from naturally occurring DNA by absence of intron regions.
13	Alice Corp. v. CLS Bank	2014		A computer implemented method for mitigating settlement risk wherein the claims are directed to financial trading systems on which trade between the two parties who are to exchange payment are settled by a third party	Ineligible	Abstract idea of intermediated settlement. Failed the two prong test: 1) determine whether the claims are directed to a patent-ineligible concept; and (2) determine whether the claim’s elements, considered both individually and as an ordered combination, transform the nature of the claims into a patent-eligible application
14	DDR Holdings v. Hotels.com	2014		A system for generating a composite web page by combining certain features of a “host” website with content of a third party merchant. By clicking on advertisement for a third-party product displayed on a host website, the user is directed to a hybrid web page that combines the “look and feel” of the host website and product information from the third party merchant	Eligible	The claimed solution is necessarily rooted in computer technology and do not attempt to pre-empt every application of idea by increasing sales by making two web pages look the same.
15	Ariosa v. Sequenom	2015		A method for detecting cell-free fetal DNA (cff DNA) in maternal blood and diagnosing a pre-natal condition based on such DNA. The method enabled detection of paternally inherited cffDNA in maternal blood to diagnose certain genetic defects	Ineligible	Here, the process begins and ends with a natural phenomena. The claims were too broad, and should have rather be narrowed to cover applications actually reduced to practice
16	Rapid litigation management v. Cellz Direct	2016		A method of cryopreserving hepatocytes (liver cells). The cells are subjected to density gradient fractionation to separate viable and non-viable hepatocytes, recovering the viable cells and refreezing them	Eligible	It is a new and useful technique for preserving hepatocytes and not merely directed to ability of hepatocytes to survive multiple freeze thaw cycles
17	Enfish LLC v. Microsoft	2016		A data storage and retrieval system for a computer memory that incorporate a self referential logical model, for faster searching and more effective storage of data	Eligible	It claimed towards specific improvement in the way computers operate, embodied in self-referential table
18	Bascom v. AT&T	2016		A system for filtering internet content wherein a filtering tool is installed at a specific location, remote from the end-users, with customizable filtering features specific to each end user	Eligible	No pre-emption of all ways of filtering content on internet, but a specific, discrete implementation of an abstract idea of filtering content.
19	McRO v. Bandai Namco Games America	2016		A method for automatically animating lip synchronization and facial expression of 3D characters	Eligible	An improved technique to allow computers to produce accurate and realistic lip synchronization and facial expressions in animated characters that previously could not be produced by human animators. There is a combined order of specific rules that renders information into a specific format which is then used and applied to create desired results: a sequence of synchronized animated characters
20	Amdocs Ltd. v. Openet Telecomm, Inc.	2016		A method for collecting and processing network accounting records over a network. A computer code used accounting information with which the first network accounting record is correlated to enhance the first network accounting record	Eligible	No presumption of any and all generic enhancement of data in a similar system. Further, it purposely arranges the components in a distributed architecture to achieve a technical solution of a technical problem specific to networking