Non patentable biotech inventions-ppt

Oms Patent Services Pvt LtdBy: Vidya

Non Patentable Biotech Inventions

Oms Patent Services Pvt Ltd

Patent Law

In order to be patentable an invention must fulfill several requirements. The requirements may be broadly classified as • novelty, • utility (industrial application) and • non-obviousness (inventive step).


Patentable Biotech Inventions

Patentable biotechnological inventions can be broadly categorized as: • Products in the form of chemicals, microorganisms, plant extracts,

fermented material;

• processes/methods for using useful products and compositions/ formulations of product such as vaccines, proteins, hormones.


Not Patentable-Section 3

(d) The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not an invention. (e)A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not an invention.


Not Patentable-Section 3 (Contd)

(i) Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products is not an invention.

(j) Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not inventions.


Not Patentable-Section 3(d)

“For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.

The Madras High Court held that efficacy means therapeutic efficacy.It was held that:“going by the meaning for the word “efficacy” and “therapeutic”… what the patent applicant is expected to show is, how effective the new discovery made would be in healing a disease having a good effect on the body? In other words, the patent applicant is definitely aware as to what is the “therapeutic effect” of the drug for which he had already got a patent and what is the difference between the therapeutic effect of the patented drug and the drug in respect of which patent is asked for.”


Not Patentable-Section 3(d)

• Claim: Pre-protein A being one of the factors which primarily control glucose metabolism in mammals having C-peptide, wherein said C-peptide comprises two amino acids selected from XY, YZ and ZX.

• Glivec1. Novartis AG filed patent application No. 1602/MAS/98 on July 17, 1998

for “crystal modification of A N-Phenyl-2-Pyrimidineamine derivative, processes for its manufacture and its use”

2. Specifically beta form of N-{5-[4-(4-Methyl-piperazino-methyl)-benzoylamido]-2-methyl-phenyl}-4-(3-p yridyl)-2-pyrimidine-amine salt.

3. No enhanced efficacy shown 4. Established β form was pre-existing


Glivec

The applicant in the appeal contented on two issues:• Section 3(d) is unconstitutional as it violates the provision of the TRIPS

agreement.• The Indian patent act doesn't define the term 'efficacy' and provides

unguided power on the Controller. Hence it is arbitrary, illogical and vague.In response to the above contention the court held that:• The WTO's Dispute Settlement provides the exclusive remedy and a

comprehensive dispute mechanism for violation of TRIPS Agreement. • The court also rejected the second contention that the provision is

providing unguided power to the patent controller being arbitrary on the basis of the term 'efficacy' was undefined and therefore the court observed that "Efficacy means the ability to produce a desired or intended result”.


Not Patentable-Section 3(e)Claim:• A composition of innovative combination of dormant spore of naturally

occurring Paecilomyces lilacinus and Arthrobotrys sp. fungus with enzymes, fats and growth promoting molecules to control plant-parasitic nematodes.

Novarits vs Cipla

•Cipla filed pre grant opposition against Novartis with regard to the document Dispersible tablets comprising deferacirox under the grounds of sections (25(1)(e), (25(1) (f), and (25(1)(h) of the Patents Act 1970.

•The Controller (Dr. Subramaniyan, Chennai office) decided the issue of novelty in favor of the Applicant, and decided the issues of inventive step and non inventiveness (section 3) in favor of the opponent, Cipla.


Not Patentable-Section 3(e)Novarits vs Cipla

• There is no detailed method for the preparation of the dispersible tablet with four phases.

• It appears that the applicant is not clear on the phases involved in the method of preparation of the dispersible tablet.

• Moreover there are no specific teachings pertaining to process parameters for preparing phase I and adding the phase II onto the phase I provided in the description.

• The dosage of the invention fell within the range as provided in prior art and altering the dose and dosage regimen within the range of the art could not be considered to be inventive.



While considering the arguments made by the opponent Cipla, the Controller laid down three specific requirements that the applicant Novartis had to follow:

(1) All the components of the invention shall be incorporated in the principal claim to make invention novel and inventive.

(2) All the necessary ingredients and excipients shall be incorporated with proportion of each ingredient in the principal claim.

(3) Support relating to unexpected synergistic effect shall be incorporated in the specification.



• The Controller mentioned that " Even subject matters of claim 1, 2, and 10 have been combined to form a composition claim, it is still considered to be an admixture, because each of the ingredient present in the composition functioning as per the intended purpose, the total effect is an additive effect.“


Not Patentable-Section 3(i)

According to this provision, the following are not inventions:1. Medicinal methods2. Surgical methods3. Curative methods4. Prophylactic methods5. Diagnostic methods6. Therapeutic methods7. Any method of treatment of animal to render them free of disease or to

increase their economic value or that of their productsPatent may however be obtained for surgical, therapeutic or diagnostic

instrument or apparatus.


Not Patentable-Section 3(i)

Claim:A method of monitoring drug response in a patient suffering from cancer treated with a combination of Gemcitabine and P1446A, comprising detection of a gene signature with at least two drug response markers, wherein the said drug response markers are selected from the group consisting of P21, REV3L, FGF5, PTK7, POLH, P27 and SSTR2.


Not Patentable-Section 3(j)

The subject matters excluded under this provision are:1.plants in whole or in part2.animals in whole or in part3. seeds4.varieties and species of plants and animals5. essentially biological process(es) for production or propagation of plants

and animals.• A new process of preparation of a vaccine under specific scientific

conditions, the vaccine useful for protecting poultry against contagious bursitis infection was held to be patentable by the Court on the ratio that the statute does not make a manner of manufacture as unpatentable even if the end products contains a living organism.


Not Patentable-Section 3(j)

Claim:A method of producing at least one of substantially pure hybrid seeds, plants and crops, comprising the steps of (i) producing a male parent which is male fertile, (ii) breeding the male parent with a female parent which is substantially

male sterile, and (iii) harvesting seeds from the female parent which contain pure hybrid

seeds.


Product Patents

All products of molecular biology: whether for use as drug or food product1. Novel micro-organism (isolated/genetically engineered)2. Novel gene and peptide sequences 3. Promoter, Marker4. Vaccine5. New viral strain


Microorganisms

•Not defined by the act•But with effect from 20.05.2003 India has started granting patents in respect of invention related to microorganisms though India was not obliged to introduce laws for patenting microorganisms per se before 31.12.2004.•Possibly includes yeast, bacteria, recombinants, DNA sequences, vectors


Microorganisms

The most vital and important distinction between the legal practices of the India and developed countries is that India (developing countries) does not allow patenting of microorganisms that already exist in nature as the same is considered to be a discovery as per the provisions of the section 3(d) and therefore not patentable.

But genetically modified versions of the same microorganisms that result in enhancement of its known efficacies are patentable.

Article 27(3)(b) of TRIPS Agreement allows member states to deny patents for “plants and animals, other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.”


Microorganisms-US position

The US Supreme court in Diamond v. Anand Chakrabarty started a new jurisprudence with respect to biotech patentability. In this case Respondent filed a patent application relating to his invention of a human-made, genetically engineered bacterium capable of breaking down crude oil.

In this case patent claims were of three types: first, process claims for the method of producing bacteria; second, claims for an inoculum comprising a carrier material floating on water, such as straw and the new bacteria; and the third, claims to the bacteria themselves. The patent examiner accepted the first two claims but rejected third claim on the basis of product of nature and living things are non patentable under US laws.


Microorganisms-US position

• It was held that a non naturally occurring manufacture was a product of human ingenuity. • DNA compounds having naturally occurring sequences are eligible for

patenting when isolated from their natural state and when it meets the statutory criteria for patentability. Hence by a 5-4 ruling it was held that a live, human made microorganism is a patentable subject matter under section 101 as a “manufacture” or “composition”.


Microorganisms-EP position

Europe was ahead of the United States regarding issue relating to patenting of living beings.

In the early 1970s, five years before the United States the German Federal Supreme Court upheld patent protection for new micro-organisms.

It was held in T356/93 that micro-organisms are patentable as products of microbiological processes. Micro-organisms were defined as generally unicellular organisms with dimensions beneath the limits of vision, which can be propagated and manipulated in laboratory.


Genes

• The patenting of genes and/or DNA sequences is popular in the US, the European Union (EU) and Japan. However, patenting of genes/DNA sequences per se was not allowed in India until January 2005,

• But processes involving recombinant DNA technology to produce proteins involving a gene or DNA sequence was patentable subject matter.

• Product patents for DNA, RNA or genetic inventions are patentable subject matter from January 2005 following the third amendment.


Genes

• A gene is a structural unit of inheritance in living organisms. It is a segment of DNA that has a particular purpose, i.e., it codes for a protein or a specific enzyme.

• A gene is the DNA that encodes the primary sequence of some final gene product, which can be either a polypeptide or an RNA with a structural or catalytic function.

• Patenting of DNA and genes sequences is a broad term that refers to the patenting of a process that involves identification, isolation of DNA or associated materials like RNA as well as chemical substances related to DNA such as proteins, and peptides.


Genes

The DNA related inventions may include one of the following:• mRNA• cDNA• isolated and purified DNA sequence• Proteins or polypeptides• Genetically modified organisms such as genetically modified bacteria,

fungi, plants and animals


Genes- India Position

• Genes are naturally occurring and not new;• Genes are basically discoveries, i.e. the invention claimed is actually a

disclosure of something already in existence; and• The process involves gene isolation and cloning ,which are well known

processes.(a) Gene sequence/amino acid sequence(b) A method of expressing above sequence(c) An antibody against that protein/sequence(d) A kit made from the antibody/sequence


Genes- US Position

Patentable:•An isolated and purified DNA molecule, RNA molecule, or amino acid molecule•isolated chemical compounds•Full-Length Genetic Sequences•amino acid sequences


Genes- US Position

• The US Supreme Court held that an isolated human gene is not patentable, as it is a "product of nature", which is excluded from patentability under the US Patent Act.

• The Supreme Court found that it was well established in the scientific community that DNA fragments of the human genome, including the BRCA1 and BRCA2 genes, occur routinely in the human body when cells die and the constituent DNA is broken into fragments.

• As a result, the Supreme Court held that the genes were products of nature and that mere isolation of the genes did not change the character of the genes as such. Accordingly, the genes were not patentable.

• However, the decision does not affect the patentability of gene testing, gene diagnostic methods, and the products of those methods (including cDNA versions of naturally occurring genes).


Genes- EP Position

• “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, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.”

• According to a recent estimate, patents have been granted or patent applications have been filed for nearly 20% of human genes. For instance, major genes for monogenic disorders (eg Huntington's disease, Cystic fibrosis) and some common predisposition genes have already been patented. However, after the publication of the human genome in 2001, there was a clear decrease in patent filings, and gradually the bar on patentability has also been elevated.


An Expression Vector or Cloning Vector Encoding a Filarial Parasite Polypeptide-246865

Abstract:• The present invention relates to a filarial parasite polypeptide and includes

polypeptide sequences, gene sequences encoding the polypeptide, vectors containing those sequences, and host cells transformed with vectors which include nucleotide sequences of the polypeptide sequences. The invention also provides antibodies directed against the polypeptide. The invention also relates to the use of the polypeptide as a therapeutic agent for the prevention and treatment of filarial parasite infection.



• In the first examination report, the patent office had objected to several claims. This also seems to be a case where the original claims were objected on the basis of Sections 3(c), 3(n) and even Section 3(j).

• The claims 1-6 were subject to a challenge under Section 3(c).• The patent office objected to a cDNA sequence stating that it was

obtained from what was already existing in nature.• All these claims were ultimately withdrawn; the grant was ultimately for

expression vectors containing the particular sequence for the polypeptide.

Non patentable biotech inventions-ppt

Law

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