MODIFICATION OF IPR LAWS AND RECENT DEVELOPMENTS IN PHARMACEUTICAL PATENTING
The right of patent is statutory in nature and the said right stems from the statute i.e. Patent Act.
The pharmaceutical patents can be considered as the most important aspect of Indian patent system. Indian Patents were governed by the Patents and Designs Act, 1911 at the time of independence. It had provisions for both the product and process patents. But subsequently, after independence of the country there was a need to protect the patents rights from abuse and misuse of the inventions. On the basis of many deliberations and report analysis, The Patents Act was enacted in the year 1970 and it came into force in 1972.
The Patents Act, 1970 allowed the processing patents of various drugs, food, pesticides, insecticides and including the chemical reactions. But it did not include the product patent for such substances. The term of the process related patents was reduced to the seven years and the general category patents included fourteen years as opposed to categories of pharmaceutical patents. The Patents Act in conformity with the TRIPs agreement was amended accordingly and the term of patenting for all categories was allowed for twenty years with the inclusion of product patenting in the years 2002 and 2005 respectively. After the introduction of 2005 amendment of product patenting, the section 5 and chapter IV A were deleted and the product patenting was allowed in pharmaceuticals, food, agrochemicals involving the chemical reaction products.
As per the requirements of public health crisis (esp. epidemics and pandemics), the provision of compulsory licensefor pharmaceuticals was added in the Actto supply the medicines to the countries with insufficient or no manufacturing on the recommendation of “The Doha Deceleration on TRIPs and Public Health” in 2001. Pharmaceutical Patenting is a very sensitive in India while bad patenting will be considered as a burden to society, the good patents are very essential when it comes to the promotion of inventions and technological developments. As far as the Patent office is concerned, it has been focusing on the quality, consistency, the uniformity in the examination and granting of patents. The Patent office is continuously working on the internal resources for the upgradation of examination for granting patent.
Criteria of Patentability to qualify as Invention:
Invention is a new product or process with a combination of an inventive step and capability of industrial application. Even if an inventive step is accumulated in any process, it will be seen as an invention in the preview of the Act. Invention will be considered with an involvement of any minute improvising to a already existing substance or product by an inventive step. The basic requirements for any invention to be patentable are as follows:
- New invention: The term “New invention” has a very vast meaning stating any technology or any invention which has not been anticipated with publication in any documents and is not used in the country or elsewhere in the world. The most important factor involves that it should be before the filling of patent application stating the subject matter does not fall in public domain or forms any part of state of art.
The term “new invention” gives a flavor of the intention of the Legislature as it has not been used anywhere in the Act. The section 2 (l) (l) specifies that the invention or the technology must not have been previously used or made in India. It specifies two categories stating a document/ practice and concludes that invention will not stay novel or new if it is anticipated in these two categories. Such invention should not fall in the ambit of Public domain and become a part of “state of the art”.
- New or Novel:“The fundamental principle of Patent law is to grant patent for only new and useful invention. It must have novelty and utility. It is a very valid essential for a patent to be inventor’s own discovery and is opposed to the verification of what was already discovered before the date of patent”. It pragmatically depends on the circumstance of the case to declare whether an invention includes novelty or an inventive step. But there is no specific uniformly applicable rule or circumstance to describe the indication of an invention. The prior knowledge of the alleged invention would directly disqualify the invention from getting patent. It could be by the publication via books or other media or by word of mouth.
The question arises whether a patented “manner of manufacturing” was used, practiced or publically known in the country before or at the date of patent? If the answer to the question is in affirmation then the manner of invention would be called as negative invention or “subject matter”. A new manufacture means a new method of manufacturing to produce something new along with new article of manufacturing. In short, it highlights a new application of principle in producing a new method or new manufacture. The new application of principle is not enough but the involvement of novelty is must in the mode of application. The novelty or the invention should be clearly and briefly mentioned in the claim. If the inventor uses the invention secretly till the time it becomes successful, the novelty will be lost and it will not be considered as new invention if applied for patent at most advantageous moment.
In case of Pharmaceuticals; the Supreme Court stated that there should not be a hard and fast rule of something altogether new or not existing before especially in the case of pharmaceuticals. It may include something which is “different from previous one” or “one regarded as better than what went before”.
- Inventive step: An inventive step means involvement of any technical advances in comparison to existing knowledge and economic significance, that may not be obvious to a person skilled in art. The requirement of technical advancement factor is compromised when the patent can be simply granted by the involvement of only economic significance. By the amendment of 2005 , Inventive step has been defined as a feature of invention involving technical advances in comparison to the economic significance and existing knowledge ; not making it obvious to a person skilled in art. It should not be perceptible to any unimaginative person skilled in art or something not published in prior art. Other opinion of court also says that Slight changes or improvement can form very significant results and may lead to great ingenuity.
- Non – Obviousness: Non obviousness of an invention is the most important factor. The nature of invention if turns out to obvious cannot be granted patent. If the manner of manufacturing is same, then there is no involvement of novelty and if no inventive step then it is obvious. The Apex Court also observed that the expression “does not involve an inventive step” is equivalent to “obviousness”. Obviousness has to be strictly judged and objectively judged. The U.S Supreme Court states that obviousness should be judged by looking at the following factors:
- Scope and content of prior Art
- Level of ordinary skills in prior Art
- Differences between the prior art and claimed invention
- Objective evidenced of non- obviousness
The obviousness will only form a part of inventive step when decide in an appropriate manner under a full fledged trial.
- Industrial Application Capability: It means that the invention is made capable to be used in an industry. Even if the invention is incomplete, some work can get patent when it has a commercial values or viabilities. The important factor is to focus on physical substance created having potential of commercial manifestation.
Types of Pharmaceutical Patents in India
The outcome of Pharmacy sector can be inventive, new and useful. It is considered as a very expensive sector and is unpredictable in nature. In this highly competitive arena, it is very important to acquire patent rights to save the invention from unauthorized commercial users. There are various kinds of pharmaceuticals patents which are as follows:
- Drug compound Patents: These kinds of patents are obtained when a drug compound is claimed by its chemical structure. These patent claims are also referred to Markush type claims. It is a type of claim in which multiple “functioning equivalent” chemical compounds are involved within one or more parts of a drug compound.
The drug compounds are considered paramount for the protection of patent.The other companies are not allowed to prepare the same nature of drug by any method of synthesis or to sell it before the expiry of the said patent.
- Formulation or composition Patents: When a specific technology for a formation or quantity of its key ingredient is claimed as a patent, it is called as Formulation or composition patents.
For example: An ayurvedic treatment for Acquired Immuno Deficiency Syndrome was claimed as the patent no. 203986 involving“Guduchi or Giloe (cordifolium): 5 mg-2 gm Panash or Kathal (jack fruit): 2 mg-5 gm Tulsi or Krishna Tulsi (Holy Basil): 5 mg-5 gm Kuda or Kutaja (Kurchi): 2 mg-2 gm BhuiAmla or BahuPatra (Gooseberry): 5 mg-2 gm”, in combination with acceptable pharmaceutical exponents.
- Synergistic Combination Patents: When two or more drugs are interacted with other and they escalates the one or more effects of those drugs, Patent can be obtained on new synergistic combination.
- Technology Patents: The patent can be claimed when some specific technology is used to solve specific technology related problem. Some examples are increase in solubility, stabilization, taste masking etc.
- Polymorph Patents: Polymorphs are used to increase the stability in a compound and it can reduce the scale of impurities in a compound. They are a different physical form or crystal structure of an already existed compound.
- Biotechnology Patents: It is a patent in which there is use of living organisms or Biological materials in Pharmaceutical products. It covers diagnostic, therapeutic and immunological products.
For example :Indian patent no. 234072 was the first patent granted by Indian Patent office ; it 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.
- Process Patents: It only covers new process or inventive step to produce a new product, the process patent does not claim the product.
For example: Indian patent no. 206678 claimed a process to synthesize L-lactone of formula 3,6- dialkyl-5,6-dihydro-4-hydroxy-2h-pyran-2-one.
Transferring of Patent Rights
As patent is considered as a form of property, it can be transferred by the patentee to any other person and it can be done through the terms of assignment or grant of license. The mode of transferring the patent through assignment and license of patent should be in written form. It should clearly mention the terms and conditions of governing rights with obligations of the party.
- Patent Assignment: It is the act of transferring one’s property to another, transferring the rights and interest of the property. It is the transfer by the patentee of all parts of its interests, rights in a patent application to any other person. The person who assigns the rights can be called as assignor and the person to whom the rights have been assigned is called as assignee.
- Patent licensing :A patentee may give license of his work to any other person for making a use of it or exercising it. Otherwise, the patentee cannot allow the other person to use the invention or work. The transferring of a license is limited to a time, geographical area and field of use.
A patent license can be Voluntary license or Compulsory license.
Voluntary license: When the patentee gives rights to other for using a patent invention or exercising it in a written agreement with his own will or wish, it can be called as voluntary license. In the Voluntary License, the Indian Patent office and government has no role in giving access.
Compulsory license:The pharmaceutical patented products can be exported u/s 92 A of the Patents Act, 1970. The compulsory license can be issued to any country which lacks in manufacturing of that particular pharmaceutical or the product can be exported after the issuance of the license.The Controller shall issue the license of the concerned patented pharmaceutical product under some specified terms and conditions for manufacturing or exporting. The compulsory licensing under section 92A only refers to the license issued for public health problems in a specific country and only addresses the countries having insufficient or no manufacturing capacity in pharmaceutical sector. It is done for the implementation of TRIPS council decision of Doha Deceleration on TRIPS Agreement and Public Health. The compulsory license of other products apart from the pharmaceuticals can be granted u/s 84 of the Patent Act, 1970.
Guidelines for the Examination of Patent Applications
The Guidelines are formed by The Patent Office of India with an objective of achieving the uniform standards of examination of patents and granting of patents in the field of Pharmaceuticals. The Guidelines by the patent office substantiated with various illustrations for a better understanding but the application shall be made in accordance to case to case basis. The Guidelines formed are dynamic and shall be updated time to time when required. The Guidelines have been designed in such a manner that it gives a additional clarification and different approach to the aspects for a separate clarification of pharmaceutical patents with same concepts of provisions of law.
The following are the guidelines for examination of Patent Application in Pharmaceuticals:
- With respect to Claims for Pharmaceutical inventions: Normally it is very important that the granting of patent is substantiated with different types of claims but the allied subject matter is not only limited to this. It is a part of giving more clarity to inventive step or novelty. The following are different kinds of claims in granting of patents:
- Product claims: Product claims involve Pharmaceutical products, Kits and Product by process.
The Pharmaceutical products are further divided into the following:
- New Chemical entities
- Formulations and Compositions
- Combinations/ dosage or dose
- New forms of known substances like polymorphs, solvates, Ether and salts including hydrates, metabolites, stereoisomer , enantiomers , pure forms, particular sizes, isomers, mixtures and complexes.
- Claims for the process and methods of manufacturing
- Claims related to new use of known substances, new property, or using claims including second indications
- Claims for the human beings and animals treatment method.
- Claims in relation to the selection inventions
- MarkushClaims :
The Markush claims are the most important type of claims in the process of granting a pharmaceutical patent. The broad patents are granted considering the family of millions of possible compounds. So is the Markushclaim which involves the chemical structure with plurality of chemical groups in one or more parts of compound. These types of claims are drafted keeping in mid the scenario of better protection to a large number of compounds who have not been accessed to property testing. While examining any Markush claim, a few specifications should be examined carefully which are as follows:
- Whether it discloses the best representatives to the applicant related to the possible embodiments.
- Whether they share a common use or property
- Whether a common structure is shared by the embodiment.
- Whether the physical or chemical properties of the embodiments are disclosed by the applicant, which are in his knowledge
- Whether even process for the preparation of compound has lead to whole invention.
If while examining the Markush claims above given first and the last requirement is not met, then it can be objected defining the insufficiency of disclosure stability.
- Prior Art Search: The Examiner should conduct a Prior Art Search which is very important while granting a Patent in pharmaceutical. There should be enabling of a design or frame of exhaustive search strategy which should be carried out on non patenting database and patents database.
The compound can be searched by using several methods which are as follows:
- Molecular and structural formula searching from various database.
- IUPAC nomenclature use while searching Names
- CAS Registry number while searching Compounds
- Generic name searching INN (International Non – Property Names) from various database .
- Compounds search using the International Patent classification (IPC).
Generally most of the pharmaceutical products are the derivatives of known compounds and have been assigned a generic name under INN (International Non Property Names) . It is a mandatory duty of the examiner to check the basis of INN for prior Art search for granting patent.
It is the duty of the examiner to tell the applicant for informing INN in case found claim is the second use of an already known pharmaceutical compound.
- Assessment of Novelty while examining Patenting :Apart from the guidelines of general examining of Patent. The Indian Patent Office has given guidelines detailed Assessment of novelty for Pharmaceutical Patenting. It involves that during examination the prior Art should be construed or interpreted in a way prescribed under section 13 r/w section 29 to 34.
- Documents while assessing novelty: While assessing the novelty, it should be noted by the examiner that the separate items belonging to different embodiments are not combined in one document. It can be only done if such combination is linked to each other or has been specifically suggested. If the compound to be patented falls in Markush claims and also falls in one of the Prior Art , then all Prior art documents are to be cited. A specific disclosure in the prior art can take away the novelty of generic disclosure but generic disclosure in the prior art may not take away the novelty of specific disclosure.
- Appropriate date for a prior document: It is very important that while determining the novelty, the prior document should be read on the very relevant date by a skilled person. An invention will be considered patentable when it is not anticipated in the prior art or is new in prior art.The prior art is the inclusion of all the information related to invention available in any publication before the priority date of patent application. An invention will not be considered new if it has entered in a public domain or has formed a part of prior art.. If any patent application is filed in Indian and is published after the date of subsequent application with the same subject matter, it will be considered as prior art as the previous application will have the earlier priority date.The prior art document should be clear and without any mistake for invention in prior art
- Inherent anticipation: Sometimes it is possible that a prior art inherently discloses any subject matter of the invention. The prior art shall anticipate without any disclosure of a single subject matter of the invention if the missing characteristic is necessarily present. It is very essential that the result is consequence of what was deliberately intended in the invention.
- Combination and composition of claims: The combination or composition of claims most often escapes the novelty examination. But it should be checked as it is possible that some of the combination of pharmaceutical products have already been fallen into public domain.
For example: Claims for healing corneal involves Vitamin A and sterile buffer administered to the eye and prior art discloses the eye drops to rewet involve Vitamin A with sterile buffer, other exciepients.
Analysis: It lacks novelty as prior art already disclosed the features of claimed component.
- Product by process claim method: A claim of a product or product by process can be anticipated by any prior disclosure and it can be claimed regardless of any method involved. In the product by process claims the applicant can get rights for the product by only using the process terms. It must also define a novel and unobvious product. In whole, this patentability of this claim isdependent on product itself. The patentability cannot be solely dependent upon the novelty and the un obviousness of the product.
- Detailed Assessment of Inventive Step: An inventive step should be involved in order for patent protection. Section 2(1)(j)(a) of the patents Act involves the steps in determination of inventive step which are
- The invention should be technically advanced in comparison to the existing knowledge
- It should have economic significance
- Both of the above given and invention should not be obvious to a person who is skilled in art.
It is further given in the manual guidelines of Patent Office practice and procedure for the better understanding of assessment of inventive step.
Furthermore, the guidelines for examination of patent application in the field of pharmaceuticals explain that Prior Artfor an assessment of Inventive step involves “state of knowledge which should be constituted before the priority date of the claim under consideration”.
Inventive step in prior art can be determined when any subject matter is published in document anywhere in the world or used before the priority date of the claim. The expression inventive step does not involve any inventive step used in section 26 (1)(a) of the act but it is equivalent to the word ‘obvious’.
In the case of documents involving the inventive step, there should be mention of the invention to a person with special knowledge at the priority date for patenting.
Skilled person:In the context of inventive step analysis, the person is hypothetically presumed to know all the prior arts on the date and should know all non patents prior available to public. He should have the knowledge of technical advancement on that date, with the knowledge of state of art. He should have certain modicum of creativity. The person with person skilled in art can be called as ‘the obviousness person’ and the person with average skills is called the enablement person.
Hindsight analysis: The ‘obviousness’ should be strictly judged and objectively judged. The skilled person needs to keep aside the hindsight analysis in order to judge the obviousness. It should be judged only on the date of priority not on a later date.
Method for analysis of inventive step objectively:
- Identifying the question of inventive step in claim
- Identifying the “person skilled in art”
- Identifying the relevant general knowledge of person skilled in art on the priority date
- Identifying the difference between manner of “state of art” and the inventive concept of claim.
- Industrial Applicability :Section 2 (1)(ac) of the Act tells about the expression of “capable of industrial application” which means that the invention shall be used in an industry. Section 64 (1) (g) of the Act states if the invention is not useful then it can be revoked. It is very essential that the patent is used successfully in the application of Industry. The specification should disclose the industrial application of the invention and must disclose a practical application. The concrete benefit derived must be direct and the description should be coupled with common general knowledge.
- Sufficiency of clarity, description and support of the claims: As per section 10 (4)(a) and (b) the specification should describe the invention and its methods fully and complete. It should also disclose the best method involved known to only applicant in an invention under which he can claim protection. Section 10 (c) explains that the specification should end with claims or set of claims for defining the scope of inventions. According to section 10 (5) the claims should be clear and should be fairly based on the description.
Sufficiency with disclosure of biological materials and deposits: Wherein it is not possible in the matter of biological material to be described in a sufficient matter or not available in public domain, the application will be completed only by depositing material to the International Depository Authority (IDA) under Budapest Treaty. The deposit shall be made on the date of filling application and reference of the deposit made in specification shall be given within 3 months of the date of filing application of patent. The specification should include the correct identified materials with the name, address of the depository address and date / number of the deposit.
The non disclosure of any geographical consideration in biological materials shall be constituted as insufficient disclosure requirement under Section 10 (4)(ii)(D) of the Act. When any disclosure is not made by the applicant in the specification but is later identified, it cannot be granted patent. The description must be fair and not unnecessarily difficult to follow.
The description in the specification should be substantiated with at least one example covering the full invention which is claimed for a person skilled in art to carry out the invention. The pharmaceutical patents are normally filed in the terms of Markush formula as it may cover innumerable compounds and special care should be given in examining the same.
- Unity of Invention during examination: Under section 10(5) of the Act, it is provided that the claim of complete specification can be granted in relation to the single invention or the unity of inventions leading to one single inventive concept. When there are numerous inventions in any specification, it should linked to a single concept or should be connected technical connection in the claimed inventions. The single common technical inventive relationship is called as “special technical feature”. In case of pharmaceutical patenting sometimes it becomes very complicated because of many compounds and combinations involved. It becomes a question to the examiner whether such claims shall be related to single invention or group of inventions to form single inventive concept.
Unity of Invention inMarkush Claims: In case of Markush claims which are mostly used in pharmaceutical patenting, the alternative claims can be considered of a similar nature. There should be fulfillment of certain conditions for the same which are as follows:
- Inclusion of common property or activity
- All the alternatives must have a common structures shared by all significant alternatives. It includes various chemical compounds which share a common structure occupying a large portion of the compound which is essential to common property or an activity.
Unity of invention in case of intermediate or final products: The term intermediate explains about the ability to have involved in the process of making the final product. When the final product is produced through a chemical or physical change then the intermediate nature is lost. The unity of invention between the Intermediate and final product has to fulfill the following conditions:
- The basic chemical structure of the intermediate or final product should be same or should be technically closely related to each other.
- The technical intermediate also means that the final product is directly derived out of the intermediate or is separated by a very small number of intermediates sharing a similar structure.
In case there is no knowledge of one of the structure while forming the unity of invention between the intermediate and final product, then there should be sufficient evidence stating that both are technically connected. If the unity of invention is already recognized even if the intermediates are exhibiting different property, it will not affect the unity of invention.
A mere absence in the Pharmaceutical product patenting can lead to many Multinational companies limiting their scenario to few patenting products. The obligations under the TRIPS agreement have successfully impacted the pharmaceutical industry. Theonly medium for the pharmaceutical industry to grow is to follow the Research and development policy and by strengthening the Patent policies in pharmaceuticals. Although R &D policy is very essential but better patent protection is the key to development of pharmaceutical industries.
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(1) Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.
(2) The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him.
(3) The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to which pharmaceutical products produced under a compulsory license can be exported under any other provision of this Act.
Explanation.—For the purposes of this section, ‘pharmaceutical products’ means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.
Natco Pharma Ltd., India v. Bayer Corporation, USA2011.
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Contributed by: Shreya Marwaha, A Member of Legal Experts Team at LLL