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Novelty in India Pharma Industry

In the past decades the Indian pharmaceutical sector has witnessed a behemoth growth, In relation to both contribution to the gross domestic produce GDP and getting it on hold on market. This pharmaceuticals sector has cross the market for about US$41 billion in the year 2021 and is expected to cross three folds by the end of year 2030.

Considering this tremendous is growth and promising future of this drug industry in India, the government is carefully and strategically promoting the industry by presenting and imposing regulations which are of global standards. With this exponential growth of industrial sector, its players, IPR protection becomes an essential for the companies.

In this article, we are discussing the scope and ambit of the protection of pharmaceutical trademarks and patents under Indian laws.

Trademark Law and the Pharmaceutical Industry
Trademark cannot be ignored as one of the essentials of Pharmaceutical industry. Trademark registration is integral for protection of drugs and most of the pharmaceutical Company registered a trademark which has them to maintain their goodwill for the drugs they sell in the market. In India the most number of trademarks can be witnessed in the pharm industry itself, the most number of registered trademarks are under pharmaceutical sector.

Protection of drugs as a Trademark
The Shelter for Pharma products under the trademark is relatively more complex than other trademarks. Section 9 (a) of the trademarks act requires a trademark for registration to be very distinctive that means it prohibits trademarks which are descriptive or are of no distinctive feature. It means a trademark incapable of being characteristic of the good or the service from another. And or of a character that is decisive to public or may can cause confusion.

Particularly in pharmaceutical trademarks, the name of the product is usually decided upon the action performed by that drug, the chemical composition of that drug or other related allied medical terminology and because of such usage it loose any distinctiveness but considering the trademarks act for trademark registration distinctiveness is a requisite for qualification of trademark.

Moreover, under the section 11 of the act the new trademark cannot be identical to the old trademark that is probable to cause confusion amongst the customers mind. The main aim or motive behind this is during the purchase of a product the customer should be clearly able to differentiate between the drugs depending upon the name of the brand, name of the drug or tree dress so as to make sure that they do not by accident purchase a drug which they do not intend to. So, the procedure for sheltering the brand names becomes complex and Evidence with regards to secondly meaning or acquired distinctive feature is a parameter to ascertain distinctiveness.

Section 13 of the act can be considered as another vital provision in regards of trademark registration. This section states that the trademark must not contain a chemical element, compound and international non-proprietary name declared by the world health organization and that is being notified by the registrar of trademarks. Any name which is decisive and is very similar to an INN is as well prohibited. In INN the names of genetic active pharmaceutical ingredients are given down, these generic names are on by none and used by all that is no pharma company can have a monopoly over these Generic names.

Thus, for making a trademark free of hassle and to put it perfectly within the trademarks act a trademark should be free from the following:
Generic words or terms:
The trademark should avoid general words in use that is every day world should be avoided to be used as is trademark. For example words such as ANTI, RELIEF, should be avoided as it is indistinctive and it is highly probable that it will fail the trademark requirements. As this type of words only depict the ingredients and not the foundation of the product and is likely to deceive the end customers.

Descriptive words or terms:
Distinctiveness is the basic need for trademark registration and any trademark that represents its characteristic is likely to fail trademark registration. A word describing feature or quality of a product will not pass the test for trademark registration. E.g. - PAINRELIEF for muscle relaxers.

Suggestive words or terms:
Words or terms that suggest qualities or characteristics of the pharmaceutical products and the services without actually describing them, e.g. GRROW for health supplement for kids.

Non-Conventional Trademark Protection
Nowadays, the pharma industry has evolved in development of advanced and innovative processes to gain a distinguishable characteristic for their drugs and to have a distinguishable identity from their competitors in the market. And thus the pharma industry are now putting their faith into Non-conventional ways for trademark protection. This innovative process is in addition to mere brand or drug name of their product. This new method of distinguishing their products helps in creating a clear image and avoiding confusion among the consumers and as well sheds light on the distinctive characteristic of the trademark.

This is non-conventional trademark, especially in the pharma industry include morphology of drugs that is the shape of a drug, the color combination or the trade dress Fascinatingly, sound marks I seem to be registered by the pharma industry in India as a part of trademark for example HA SA MI TSU registered by Hasamitsu pharma co. Inc.

Origin in Japan. Purple pill of a Nexium tablet by AstraZeneca. Another example that can be considered is the color combination of red and white of the Dyazide of SK&F, To be registered as color trademark. This unconventional ways of trademark registration helps the company to create a distinctive and unique image amongst its consumer.

In the case of Cadil Health Care v. Cadila Pharmaceuticals Ltd. The Supreme Court of India, given the crucial factors for ascertaining misleading resemblance between pharmaceutical trademarks, which include:
  • The nature of the marks
  • The degree of resemblances amongst the marks,
  • The nature of products;
  • The class of purchasers, their education and intelligence and the degree of care they are likely to exercise in purchasing and/or using the goods;
  • The mode of buying the products or placing orders for the products; and Any other surrounding circumstances which can be relevant in the extent of dissimilarity between the competing marks.

The courts of Europe Has also provided some elucidations to the nature of misperception in the context of pharma trademarks, which one read with section 11(1) Of the act categorizes the probability of being decisive into different classes such as direct confusion to public, incidental confusion and strict association in which the resemblance of the trademark brings in mind some other trade mark which need not necessarily be similar or confusing.

Moreover, the course of euro has also laid down some fundamentals in the Landmark case of SABEL BV V. Puma AG, in which the ground for assessment of the probability of confusion is proportionate to whether the infringement all the infringer's product cure is the same ailment, as the Customer base is diverse if the disease is different. The quantity of time spent in guaranteeing the correct administration of drugs by the consumer and the Chemist, if it is an over-the-counter or a prescription based treatment, the one who is the Real and user and to the degree to which the uncertain impression is counterweight by the knowledge and dexterity in the field.

This above mentioned principles read together with the case of Smith Hayden & Co v Satya Dev Gupta AIR 1963 SC 449, Collectively give down some principle for testing confusion it states that when in a situation Considerable amount of existing trademarks consumers are not deceived or misled, by the usual intellect and flawed recollection of a common Man and dad sex illusionary resemblance to be only establish by responding to the trademark which is likely to deceive the end user.

Patent Law and the Pharmaceutical Industry
The pharma segment of the industries is seen to be always knowledge intensive and requires substantial monies. The evolving process of the pharma product to reach a promising outcome is noticeably slower as compare to other industries in India. And so, it becomes essential for a pharma industry to get the protection for eight discoveries by getting patents grants or by getting patent rights.

Patent in return promotes innovation by the creators as it safeguards the funds they have put in for such impeccable research and for development as it produces a motive for innovation. Nevertheless, the patent ability of a pharma invention, specifically in India, throughout the ages are under strict scrutiny and passionate deliberation because of the statutory challenges. Apart from the worldwide patent ability necessities that is novelty, inventive step and industrial applicability, for it to be patented in India it must pass and qualify the test laid down under the section 3 of the patents act specifically the section 3 (d), (e) and (I).

With the inception of product patent by the TRIPS agreement is one of its most momentous contribution in Indian IPR history. The patent act as well Played a vital part in taking India to a worldwide global patent domain. There is no denial of the fact that India is a developing country, but it took some time for implementation of TRIPS agreement subject to some situations cited under article 70(7) and (8) Of the agreement. Both of these sub-clauses discusses about transitional agreement.

The sub clause 8 gives that India must have to provide a source to the industries by which they can file patents. Moreover it as well states that if any affiliate of the world trade organization has approved a patent to a product and such product is also in the market of India inevitably gets repeated tried for it. India as well as to give patent to the products. Via the first amendment to the patents act their came in the introduction of The system of transitional arrangements.

Few of the vital amendments can be seen by the second amendment done in the year 2000. These are extension of term of patent, the coverage of subjects to patent, and the final was compulsory licensing system. In the year 2005 there came the third amendment to the act which introduced the product patent in the pharma industry moreover the fee structure, penalty provisions, filing procedures, as well saw some Alterations because of this amendment.

Effect of product patent
Before the advent of new system the only system that exists what is the system of process patent in the pharma industry. This means that while producing a drug only the specific process through which the drug is derived can be patented. Under this system it was impossible to patent the product. In order to manufacture the same product the other companies had to employ new methods for production of the same product.

With the development in the patent regime there came the system for product patent now even the product can be patented. This means that no matter how new or distinctive A process may be for manufacturing the same product under the new regime this product was patented and not to be replicated by any different process.

This means other manufacturers cannot produce a drug which is already patented. Section 5(1) what is removed from the patents act this section talked about process patent in the pharma sector. With all this development in the pharma regime it was evident that from January 2005 the system of product patent was introduced and applied in the pharma sector. It as well comprised of those applications which were made during the transitional phase.

There was an anxiety due to such inception of product patenting that medicines or drugs will become exclusive and would not raise the hands of a common man. Prior to the third amendment various industries liberally use different processes to produce the same drug but with the inception of third amendment in 2005 these options are being exercised by such companies.

For Patent-expired or Non-patented Drugs:
  • Carry on delivering to the carry across and native market.

For Patented Drugs:
  • Production of the medications over compulsory licensing.
  • Carry out R&D for crafting novel medications.
  • Toil organized with new enterprises to produce novel medications.

With this introduction of product patenting, what terrified everyone was the skyrocketing of the cost of drugs, but fortunately that did not happen. Indian pharma sector evolved very quickly to the deviations which were introduced to the patent law. The Indian Industries started leading the Bazaar even post TRIPS agreement implementation. Out of the 20 biggest pharma industries in the sector, 16 were of India and controlled by India and mere four where MNCs.

It was witnessed that various overseas industries started establishing their subsidiaries in India and sell their medications through them. India is preferred because of the research and development cost in the state is very cheap as against to the other options available.

What can be patented?
Section 2 (1) (j) of the patents act sites that invention is equal to a noble product which is portent of industrial application. If such products, and search party has an idea that such product is being used produced or sold within or outside India then its patent ability is lost. If such invention is already within the knowledge of the public it is not considered as noble or exclusive to be patented.

For invention to be patentable It should be not a public knowledge but should be exclusive, thus a product to be patented must be patented before it comes to the knowledge of public. The term new has a global applicability. It can be safely said that when a product which is already in existence, in public domain, or in public knowledge does not fall under the category of patent ability and so no patent will be granted to that product in India.

However there exist few kinds of novelties which are not categorized as inventions, section 3 states such novelties as follows:
  • Every discovery which is conflicting to the laws of nature or on face claims something untrue.
  • A technique of cultivation of horticulture.
  • A procedure for the medicinal treatment of the Fauna.
  • An exhibition of info.
  • A discovery whose practice is in contradiction of communal ethics or public order.
  • A finding of a new Agent or element or discovering ways and uses of the same known element.

Protection of Pharmaceutical Patents:
Section 3 of the Patents Act, 1970, gives out no patentable ingredients, regardless of the fact that they pass the patentability test.

Ever-Greening Strategies
Section 3(d) of the Patents Act, 1970, earns exceptional attention in the situation of the Pharma discoveries and which says:
"Just the discovery of a novel form of an already discovered element that fails to known enhance the efficacy of that element or a mere discovery of a new property or new usage for the known element or just the use of discovered process, machine or apparatus that at least known procedure results in a new product or employs at least one new reactants."

Explanation : "With respect to above mentioned clause, combination, measure of isomers, complexes, isomers, particle size, salts, ethers, polymorphs or other derivative Of a already discovered element shall be considered to be the same element unless only when they do not vary exponentially in the properties with regard to their efficacy."

It is crucial to understand that the mean purpose of section 3(d), Patents act, is to restrict, forbid The ever greening of pharm patents. And does by doing this that is restricting the ever greening it aims to promote research and development for development of new more efficient medication under the ambit of patenting. Under this section it gives out that a discovery Which is already claiming a new form of already discovered element, or second and consequent use of already discovered substance, already possessing a recognized medical utility, is to be deemed to be treated as the same element and will not fall under the ambit of patentability unless such discovery which is in the argument exceptionally shows up improve therapeutic efficacy in respective of the argued compound.

In the case of Novartis AG V UOI The Supreme Court stressed upon the legislative commitment of section 3(d) all the patents act and it was of the opinion that this section meant especially to involve with chemical elements And more specifically pharma products. The amended part of section 3(d) undoubtedly sets up a second tire of qualification standard for chemical element or pharma products so as to have a door open for true and genuine inventions.

This section not only promotes invention and research and development in pharma industry but also keeps a check on any attempt that is made on repetitive patenting and trying to abuse the patent law on bogus grounds. Moreover while interpreting the term efficacy the court was of the opinion that with respect to the pharma patenting.

The term efficacy shall be considered as the ability to produce the intended result. So just a ordinary change in the non-form that does not enhance the efficacy or the therapeutic efficacy, search new form that does not seems to show up enhancement and mere simple and plain changes is excluded from patentability.

It is crucial to note that hearing that the Indian patent office during examination of the application provides an opportunity to supply additional documents or experimental findings, to authenticate the therapeutic Efficacy in the new discovery, which may have been due to some circumstances not disclosed at the time of filing the application

In order to protect commercial interest, the pharma sector evolved with the idea of patent evergreen. What actually ever greening is these pharma companies used to make small and simple changes in the already known product and then file for a new patent. This small change was like I am near change in molecular formula with a different structure or a new ingredient that does not increase its efficacy. Now this new ingredient was used to file a new patent.

Also, many businesses also buy out their opponents of file frivolous transgression of patent suits to preserve their feet in the competition. All such malicious types of tactics increase the rate of the drugs and resulting in drugs being challenging to pay for, for the middle class and poor patients.

In India also the Supreme Court refused to grant a patent to Novartis, in the case of Novartis AG v. UOI. Novartis is a foreign company and wanted to get one of their drugs. Indian Companies raised an objection stating that a very similar product was already patented, and hence, this particular drug could not be patented. Novartis contended that it was a new invention since there

The Supreme Court in the case of Novartis AG observed the following. Novartis AG a foreign company wanted to file patent which was refused it approved the Supreme Court the supreme court was of the opinion that a very similar project was already potentate and hence a particular product by know what is easy loses its patent ability on the other hand know what is AG contended that their product or their medication was through a different procedure and I had some changes in it but the Supreme Court was the opinion that the product made by know what is easy failed a test laid down in section 3(d) and hence Patent will not be granted.

What is section 3 says as a mere discovery of new form of non-element that fails to increase the efficacy of such element fails the test for patentability. The Supreme Court observed that there was no flaw in section 3(d), and by making me a small changes that does not increase the efficacy is the abuse of the patent act, and thus no patent shall be granted when mere mixture or process is changed without there being a substantial "therapeutic efficacy" increase of that product.

Section 3(e) of the Patents Act, is relating to patenting of mixture discoveries, in the field of chemical as well as biotechnological sciences says:
"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 patentable"
There is a well-accepted norm In the Indian patent laws, which says that a simple association of a number of components, which does not work out together to give an inventive faculty and gives out their function separately and not as a compound or a single unit is not patentable. When search mixture of components workout together to form a new improved product that has an increased efficacy and which works together in union can be subject to patent.

The main claim under section 3(e) of the patents act is in relation to the composition or mixture of known components that does not give out any synergetic effect. The confusion in section 3(e) is that the objection that of patent Application where a patent can be granted for a mere admixture and or combination of properties under section 3 (e) of the patents act.

In the case of Lalubhai chakubhai jarivala V. Shamaldas Sankalchand Shah The Bombay High Court while interpreting the phrase "mere admixture" said that Mere admixture is said to be created when an individual merely admixes Already known elements without getting any additive effect of either of this element. Conversely, individual when mixing more than one components while expecting an additive effect then such component is said to be a synergetic composition.

When an element is not known at all, even its properties are unknown, then it becomes impossible to have a composition of such add mixture of that unknown element. Consequently a chemical composition of a new element or compound by rule cannot be considered as "mere admixture". As neither the element of such mixture was known prior to its composition and nor any of its property.

with respects to "aggregation of the properties", the case of Ram Pratap v. Bhaba Atomic Research Centre, illuminates that, a mere combination of features, which are previously identified before the priority date, that has been haphazardly selected from amongst a various different mixtures, is not a patentable invention and amounts to aggregation of properties.
The last one section 3(i) of the Act,- "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 patentable.

In the pharma industry, it is generally seen that the technique of treatment is often claim Entha pretext of composition claims. Nevertheless it is vital to understand that any such claims pertaining to the treatment is not patentable Under the Indian patent law. Although a patent maybe acquired for surgical, therapeutic, or diagnostic appliances.

Compulsory Licensing
In the patents act, under the section 84 which gives conditions about compulsory licensing state that compulsory licensing can be only granted after completion of three years post patent was acquired.

Some of the following cases are as follows in which compulsory license can be granted:
  1. Any patented invention that is not accessible to general public at a reasonable cost. (basically it is a beneficial clause for general public)
  2. The practical obligation of the community for which the patented discovery was created has not been satisfied.
The first case in India versus Byers v. Natco of 2012 in which visa compulsory licensing was granted. When a company gets a compulsory licensing grand it can sell the patented product and develop it at a lower price so that the general public can afford it.

Effect of the changes in the Patent Act on pharmaceutical industry
The post amendment to the Patents Act in India, they saw a confliction balance between safeguarding the patents and up keeping with the fair competition between the pharma Industry saw a growth. This new product patent scenario in India is amended into the patent laws from 2005 which what is believed to lead to a situation's of monopoly.

Earlier to the concept of product patents being implemented the genetic industries what is a tough competition to the major companies in the Pharmaceutical sector These generally companies produce the medicines at a lower price which naturally covers the big companies as well to lower their product cost in order to sustain in the market. As soon as the concept of Pranav patenting was introduced in India the whole scenario turn turtle.

With this new regime there came a play of competition law as well in order to avoid a situation of monopoly or sole play Of the Giants of pharma industries. The competition act 2002 aims to avoid monopoly in any field. With this new evolution in the pharma sector there ever expected several possible competition issues these were as follows first, they can form mergers and acquisition and collusion and misuse of strong market Place.

Resulting into the cost of medicine is becoming so high that it was impossible for poor patients to use them. India being a welfare state believe that it is very important to create a balance between safeguarding the IPR and competition between companies so as to maintain the prices of the product.

Conclusion:
There are always constant debates in India With respect to Intellectual Property Rights and its procedure. The IP department has been prompt to provide documentations to clear such smog amongst the minds of the IP users.

India Judicial sector has always promoted fair and free processes to grant IP rights in order to create a healthy competition in the Indian marketplace. Courts have provided guidelines and interpretations so as to best suit the balance between welfare of the people and competition in pharmaceutical sector.

The research and development that takes place while making a new medicine is not inexpensive. Thus company making new drugs seeks for methods for preservation of its financial interests and one of such methods they received is product patenting. It is important for a company to thrive that they feel safe, it is important for the investors that they feel safe and this safety is assured by product patenting, this provides a security to the sector and safeguards their interests. This interests of the company and the interest of the society i.e. its welfare is been taken care is the main motive of this new patent regime.

The Indian IP scenario can be considered as a combination of both encouragement of development in of Pharmaceutical sector and public welfare as well, on one hand with the inception of product patenting that aims at the interests of the Companies that manufacturing drugs and on the other hand compulsory licensing that aims at Public welfare. It is no doubt that this combination of patent licensing and compulsory patenting is indeed a remarkable legislation by Indian law makers.

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