CONSPECTUS OF PATENTING
An overview of patentability and patenting in Pharmaceutical Sector
Patent is an exclusive right granted by the government to the applicant for an invention. A patent can be applied by the inventor or any other person/ company assigned by the inventor. It is the right to exclude others from unauthorized making, using, offering to sale, selling or importing the invention. Patent is a negative right that means it is a right that empowers the patentee (patent owner) to prevent or stop the use of his/her invention by third parties without his/her permission.
Patent offers technical solution to a technical problem. Patent is granted only to those inventions which satisfies certain conditions known as criteria of patentability. Patents have limited term of 20 years counted from the date of filing the patent application. Patent is a territorial rights thus it can be enforced only in the country where it is granted. Therefore, any legal action against the infringement or violation of the patent rights can be sought only in that country only. For getting patent protection in different countries patent has to be applied in each of the countries. Patent Cooperation Treaty (PCT) provides a route to file an international patent application through with patent can be filed in a large number of countries through a single patent application. However, after filing the PCT application grant of patent remains under the discretion of the individual patent office only.
Criteria of Patentability
Patents are granted to those inventions which satisfy certain conditions called as criteria of patentability. According to the Indian Patent Act, a patentable invention is defined as “a new product or process involving an inventive step and capable of industrial application”
One of the prerequisites for granting a patent for an invention is that the invention must be new or novel. Novelty is a vital and absolute condition for patentability. An invention is considered 'novel' if it is not in the public domain anywhere in the world, and is analyzed using existing expertise in the relevant field of technology.
Sections 2(1)(l) of the Patents Act defines a 'new invention' as:
“any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.e., the subject matter has not fallen in public domain or that it does not form part of the state of the art”
Lack of novelty is usually referred to as 'anticipation' and is determined by factors such as prior publication, public knowledge and public use, commercialized products and selection inventions. While anticipation is not expressly defined in the Patent Act, Sections 29 to 34 identify what anticipation is not. In India, a patent application is considered to be anticipated if the invention is disclosed in a patent or any other document which is published before the priority date of the application. However, if the inventor proves that the matter published was obtained fraudulently and was published without his or her consent, then it may not be considered to be anticipated.
In Lallubhai Chakubhai Jariwala v Chimanlal Chunilal and Co (1935) 37 BOMLR 665 the court observed that:
“the two features necessary to the validity of a patent are novelty and utility, but the real test is the novelty of the invention. Novelty is essential, for otherwise there would be no benefit given to the public and consequently no consideration moving from the patentee [while interpreting the factor related to public knowledge and public use.]”
In India, with the inclusion of a definition for new inventions, the test for anticipation now considers absolute novelty. The scope of prior art has widened under the Patents Act because, apart from prior publication worldwide and prior use in India, even prior use outside India forms part of the prior art; and traditional 'ancient' knowledge in India also constitutes prior art.
2. Inventive Step-
The Act defines the term ‘inventive step under Section 2 (1)(ja) as “a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art”. As per the definition of inventive step, a feature of an invention can be considered to possess an inventive step if it satisfies two conditions: (i) the feature either adds to existing technical knowledge, i.e., the prior art, or is substantially better in terms of commercial viability; and (ii) it makes the invention non-obvious to a person skilled in the art.
If, a product or a process is novel, the next question that arises is "Is the approach obvious and if it not then what is the depth of the inventive measures taken by the inventor”. To determine obviousness is to find out whether the person, with ordinary skill in the art, would have come up with similar innovation for the technical problem under similar circumstances without being provided with the solution. The person of ordinary skills in the art must be given the problem and asked whether he can solve it. This is what is referred to as the 'Hindsight Element'. Therefore, it is not permissible to look at the invention and try and figure out the logic behind it and then look for prior art documents which support disclosures throwing light on such logic.
3. Industrial Applicability-
The third Criteria of patentability is that the invention should be capable of industrial application. It is defined in Section 2 (1) (ac) of the Patents Act as “Capable of Industrial application”, in relation to an invention, means that the invention is capable of being made or used in an industry.
a. If the subject matter is devoid of industrial application it does not satisfy the definition of “invention” for the purpose of the Act.
b. “Industry” should be understood in its broad sense as including any useful and practical, as distinct from intellectual or aesthetic activity. It does not necessarily imply the use of a machine or the manufacture of a product and covers such thing as a process for dispersing fog or a process of converting energy from one form to another.
c. Vague and speculative indication of possible objectives that might or might not be achievable by carrying out further research with the tool as described is not sufficient for fulfillment of the requirement of industrial applicability. The purpose of granting a patent is not to reserve an unexplored field of research for an applicant.
d. Processes or articles alleged to operate in a manner which is clearly contrary to well-established physical laws, such as perpetual motion machines, are regarded as not having industrial application, as was held in Paez's Application (BL O/176/83) and Webb's Application (BL O/84/88)
e. An invention for a method of treatment of the human or animal body by surgery or therapy or of diagnosis practiced on the human or animal body shall not be taken to be capable of industrial application.
f. Parts /pieces of the human or animal body to be used in transplants are objected as not being capable of industrial application
Inventions Not Patentable
There are certain inventions which do not fit in the criteria of patenting. These are listed in The Patent Act 1970 in Section 3. The section gives a list of 16 inventions which are not patentable in India. The inventions which are not patentable in the Pharmaceutical Sector are listed under sections 3(d), 3(e) and 3(i) and thus are discussed hereby. The section states as follows-
Section 3: What are not inventions:-
The following are not inventions within the meaning of this Act, -
(d) the mere discovery of a new form of a substance which does not result in the enhancement of a known efficacy of that substance or the mere discovery of a new property or new use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation of Section 3(d)-
For the purpose of this clause, salts, easters, 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
Interpretation of Section 3(d)-
Mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not patentable. Which means different forms of a known substance must differ significantly in the properties with regard to efficacy.
The examiner makes comparison with regard to properties or enhancement of efficacy between the known substance and the new form of known substance. In case the new form is further converted into another new form, the comparison is made between the already existing form and another new form but not between the base compound and another new form.
The efficacy need not be quantified in terms of numerical value to determine whether the product is efficacious because it is not possible to have a standard numerical value for efficacy for all products including pharmaceutical products.
(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;
Interpretation of Section 3 (e)-
To understand the Section 3(e), one has to clear about the term “mere admixture”. A mixture would be called as mere admixture, only when someone merely admix the known substances, with an expectation to get an additive effect of both the substances.
However, when someone gets more than additive effect, the admixture is not mere admixture and is considered as synergistic composition. When a substance is not known at all, its properties are also not known, and hence, it is not possible to prepare an admixture of such an unknown substance.
However, compositions consisting of combination preparations comprising of two or more known active ingredients are patentable if “synergism” or super additive effect is shown clearly, for example pharmaceutical compositions or any other chemical compositions.
(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.
Interpretation of Section 3 (i)-
So as per Section 3(i), medicinal treatment includes a process of administering medicines orally (in form of tablets, capsules etc.) or through injectables, or topically or through a dermal patch and method of treatment by surgery for therapeutic or cosmetic purpose are not considered patentable. For instance, a stitch-free incision for cataract removal cannot be patented. Curative method includes a method of cleaning plaque from teeth whereas a prophylactic treatment includes a method of vaccination are not patentable. Also, “a method of sampling body fluid”, which comes under diagnostic purpose, cannot be patented.
Also, as per section 3(i) and the draft of Manual of Indian Patent Practice and Procedure, 2008, “in-vivo” diagnostic procedures are not patentable. Further, “use of substance for treatment or therapeutic application” claims are not patentable. However, the method of diagnosis performed on tissues or cells or fluids outside human or animal body i.e. “in-vitro” diagnostic procedures and diagnostic kits are considered patentable. Also, manufacture of prostheses or artificial limbs and taking measurements thereof on human body are patentable.
Types of Pharmaceutical Patents in India
The Pharmaceutical industry is one of the most intense “knowledge driven” sectors. Pharmaceutical research is very costly and unpredictable in nature. Outcome of the research can be in the form of a new, inventive and useful product or process. In this highly competitive market, it is imperative for the pharmaceutical companies to protect their inventions from any unauthorized commercial use by acquiring patent rights over the invented product or process. Pharmaceutical patents in India can be classified under following categories.
1. Drug compound patents
These patents claim a drug compound by its chemical structure per se. These patent claims are usually referred as Markush type claims. A Markush claim is a claim with multiple "functionally equivalent" chemical entities allowed in one or more parts of the drug compound.
Drug compound patents provide the broadest possible protection to the company’s product, since other companies are not allowed to prepare such drug by any route of synthesis or produce/ sell any formulation comprising this drug before the expiry of said patent.
2. Formulation/ composition Patents
These patents claim a specific technology to prepare a formulation and/or quantity of its key ingredients. For example, following ayurvedic anti-retroviral composition for treatment of Acquired Immuno Deficiency Syndrome was claimed in the Indian patent no. 203986.
3. Synergistic combination Patents
Drug synergy occurs when two or more drugs interact with each other in such a way that it enhances or magnifies one or more effects of those drugs. Patents can be obtained on new synergistic combinations of the drugs.
For example, a synergistic combination of roflumilast and salmeterol was claimed in the Indian patent no. 206328.
4. Technology Patents
These patents are based on the techniques used to solve specific technology related problems like stabilization, taste masking, increase in the solubility etc. For example, following taste masked formulation was claimed in the Indian patent no. 227933. “A pharmaceutical formulation having a masked taste, the masking of which persists during administration of the formulation, in particular in the form of a suspension in an aqueous vehicle, characterized in that it comprises at least the following elements: a) a cellulosic polymer which is soluble in organic solvents but practically insoluble in water, regardless of the pH; a methacrylic polymer which is soluble in an acid medium and practically insoluble at a neutral or alkaline pH and an active ingredient distributed in a homogeneous manner and in the molecular state in the mixture, which is in the form of an atomized matrix; b) an alkaline agent of an organic nature or an alkaline salt, which is pharmaceutically acceptable; c) an adsorbent agent.”
5. Polymorph Patents
Polymorphs are different physical forms or crystal structure of an already known compound. Polymorphs are usually prepared to reduce impurities or increase stability of the compounds.
For example, Indian patent no. 237261 claims the crystalline form B4 of atorvastatin magnesium characterized by X-ray powder diffraction pattern. Said crystalline form shows purity greater than 98%.
Role of Section 3(d) in polymorph patenting
Grant of polymorph patents in India is mainly governed by the section 3(d) of the Patents Act, 1970.
The section 3(d) aims to prevent the “ever greening of patents” by providing that only those pharmaceutical derivatives that demonstrate significantly enhanced “efficacy” can be patented. The section 3(d) ensures that the new forms can be patented only if they are really meritorious, and thus patents shall not be granted for trivial inventions. It throws light on the Indian government’s policy of rewarding the inventors/ researchers on their true intellectual efforts and at the same time preserving the public interest and making them available essential commodities such as drugs at affordable prices.
6. Biotechnology patents
Biotechnology involves the use of living organisms or biological materials in the preparation of pharmaceutical products. Biotechnology patents cover a wide range of diagnostic, therapeutic and immunological products.
For example, Indian patent no. 234072 claims an aqueous, human serum albumin-free Interferon solution containing an interferon-alpha, a non-ionic detergent, a buffer for adjusting pH 4.5-5.5, benzyl alcohol and optionally an isotonizing agent.
Incidentally, above Indian patent no. 234072 was the first product patent granted by the Indian Patent office after the enactment of product patent regime in 2005. The patent is owned by F. Hoffmann-La Roche Ltd., Switzerland.
7. Process patents
A process patent does not claim the product per se, rather it only covers a new and inventive process to produce a particular product.
For example, Indian patent no. 206678 claims a process to synthesize L-lactone of formula 3, 6- dialkyl-5, 6-dihydro-4-hydroxy-2h-pyran-2-one.
1. Novartis v. Union of India & Others (2013) 6 SCC 1
In 1998, one of the largest international pharmaceutical companies i.e. Novartis International AG filed an application as per the TRIPS agreement before the Chennai Indian patent office for the grant of a patent for an anticancer drug 'Glivec'.
In 2005 patent application of Novartis for the drug Glivec was taken into consideration but was rejected by Madras Patent Office on the ground that the drug was anticipated by prior publication and failed to satisfy the requirement of novelty and non-obviousness, further stating the alleged invention as un-patentable under the provision of section-3(d) of Patent Act, 1970 as the said drug did not exhibit any major changes in therapeutic efficacy over its pre-existing form i.e. Zimmermann patent.
They filed 2 writ petitions in Madras High Court claiming section-3(d) to be unconstitutional as it violates Art. 14 of the Constitution. The petitions were then transferred to Intellectual Property Appellant Tribunal. The same were rejected and thus Novartis filed a SLP in the Supreme Court.
In April 2013, the two judge bench of Supreme Court of India rejected the appeal filed by Novartis and upheld that the beta crystalline form of Imatinib Mesylate is a new form of the known substance i.e., Imatinib Mesylate, wherein the efficacy was well known. Supreme Court made it crystal clear that in the case of medicine "Efficacy" in section-3(d) only means "Therapeutic Efficacy" and states that all properties of drug are not relevant, the properties which directly relate to efficacy in case of medicine is its therapeutic efficacy. Supreme Court in third issue ruled that about 30% increase in bioavailability qualifies as increase in therapeutic efficacy under section-3(d) of Patent Act, 1970 if evidence is provided for the same. Supreme Court compared the efficacy of "Beta Crystalline form of Imatinib Mesylate" with "Imatinib Mesylate" with reference to its flow properties, better thermodynamic stability and lower hygroscopicity, and held that none of these properties contribute to increase in therapeutic efficacy according to section-3(d) of Patent Act, 1970 and Novartis not provided any document that shows that the efficacy of "Beta Crystalline form of Imatinib Mesylate" is more as compared to the efficacy of "Imatinib Mesylate".
2. F. Hoffmann-La Roche Ltd. & Anr. v Cipla Ltd.
Roche has an Indian patent over a drug, “Erlotinib hydrochloride”, for treating lung cancer. It was reported in January 2008 that Cipla is planning to launch a generic version of “Erlotinib” under the name “Erlocip”. Roche followed by initiating infringement proceedings against Cipla in January 2008.
Roche’s plea for interim relief by way of injunction was rejected by single judge with an opinion that injunction against Cipla’s manufacture was against public interest. Notably, Tarceva costed around INR 140,000 (~USD 2300) for a month’s dosage, whereas Elrocip costed only INR 48,000 (~USD 800). Subsequent appeal by Roche was mostly unsuccessful.
The turnaround in the case happened in 2015, when the case was moved to the Divisional Bench of the Delhi High Court where the judgement was in favour of Roche. The Divisional Bench held that Cipla was infringing Roche’s patent.
Followed by the judgement, Cipla filed a Special Leave Petition (SLP) requesting for appointing a technical expert, which was accepted by the Apex Court in 2016 after which the matter was adjourned. After almost decade long legal proceedings, on 30th May 2017 both the pharmaceutical companies finally came to an agreement and reached a settlement. In June 2017, Cipla moved the apex court seeking to withdraw the Special Leave Petition (SLP) filed against the DHC divisional bench’s decision given in 2015.
• Single Judge Judgement-
The single judge in the judgment dated 19th March, 2008 mainly pointed out two important issues with the patent to Roche
The claim by Cipla to hold the patent invalid on the ground of obviousness as ‘Erlotinib’ was a derivative of a known compound and hence the requirement under section 3(d) of the Patents Act was unfulfilled as the ‘increased efficiency’ criteria was also not met forth was out rightly denied by the single judge bench and they held that the plaintiffs contention that is was not obvious for a person skilled in the same art to have replace methyl for ethynyl.
The second claim that was made by Cipla which was in public interest and which was accepted by the single judge bench was that the generic version of Erlotinib which was marketed and manufactured by Cipla was actually available for one their price. Moreover this was a lifesaving drug and the drugs by Cipla was manufactured in India and not imported from elsewhere. The court had to choose between ensuring lifesaving drugs at a cheap price and injunction order during the pendency of the trial. The single judge bench very rightly choose the first over the second and rejected the plea of injunction on Cipla as many innocent person who are not even parties to the suit would be unnecessarily affected.
• Final Judgment
The division bench finally stated that there was no infringement as the patent which was in question was a mixture of Polymorphs A and B, whereas the drug Tarceva drug consisted of only Polymorph B. The point here to be noted was that Roche had applied for patent of Polymorph B but was denied by the Indian Patent office as it did not satisfy the criteria of Section 3(d) and the test of patentability was not satisfied. Moreover, the court considered the intent of the legislature in enacting Section 3(d) and anti-ever greening laws and held public interest above everything. The court realized that in here a lifesaving drug was in question, and hence the drug which was made available by Cipla was three times less priced than the drug which was manufactured by Roche.
3. Turmeric Case
Turmeric is a tropical herb grown in east India. Turmeric powder is widely used in India as a medicine, a food ingredient and a dye to name a few of its uses. For instance, it is used as a blood purifier, in treating the common cold, and as an anti-parasitic for many skin infections. It is also used as an essential ingredient in cooking many Indian dishes. In 1995, the United States awarded patent on turmeric to University of Mississippi medical center for wound healing property. The claimed subject matter was the use of “turmeric powder and its administration”, both oral as well as topical, for wound healing. An exclusive right has been granted to sell and distribute. The Indian Council for Scientific and Industrial Research (CSIR) had objected to the patent granted and provided documented evidences of the prior art to USPTO. Though it was a well-known fact that the use of turmeric was known in every household since ages in India, it was a herculean task to find published information on the use of turmeric powder through oral as well as topical route for wound healing. Due to extensive researches, 32 references were located in different languages namely Sanskrit, Urdu and Hindi. Therefore, the USPTO revoked the patent, stating that the claims made in the patent were obvious and anticipated, and agreeing that the use of turmeric was an old art of healing wounds. Therefore, the TK that belonged to India was safeguarded in Turmeric case.
4. Neem Patent
The patent for Neem was first filed by W.R. Grace and the Department of Agriculture, USA in European Patent Office. The said patent is a method of controlling fungi on plants comprising of contacting the fungi with a Neem oil formulation. A legal opposition has been filed by India against the grant of the patent. The legal opposition to this patent was lodged by the New Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), in co-operation with the International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament (MEP). A tree legendary to India, from its roots to its spreading crown, the Neem tree contains a number of potent compounds, notably a chemical found in its seeds named azadirachtin. It is used as an astringent in so many fields. The barks, leaves, flowers, seeds of neem tree are used to treat a variety of diseases ranging from leprosy to diabetes, skin disorders and ulcers. Neem twigs are used as antiseptic tooth brushes since time immemorial. The opponents' submitted evidence of ancient Indian ayurvedic texts that have described the hydrophobic extracts of neem seeds were known and used for centuries in India, both incurring dermatological diseases in humans and in protecting agricultural plants form fungal infections. The EPO identified the lack of novelty, inventive step and possibly form a relevant prior art and revoked the patent. Apart from this, several US patents were recently taken out Neem-based emulsions and solutions