Intellectual Property Right for Pharmaceutical Company

  For all products, a trademark should:

·         Identify a single source;

·         Be capable of distinguishing one product from another; and

·         Be protectable under the laws of the country (or countries) in which the product will be marketed;

Marks are categorized on a sliding scale of distinctiveness, from fanciful and arbitrary marks, which are the most protectable, to suggestive marks, descriptive marks and generic terms, which are not protectable since they do not function as trademarks.

Some examples along this spectrum of protection include the following: 

Fanciful – KODAK;

Arbitrary – APPLE (for computers);

Suggestive – COPPERTONE, WHIRLPOOL;

Descriptive –ROLLERBLADE, WEIGHT WATCHERS; and

Generic – ASPIRIN

Generic terms enjoy no legal protection. Companies rarely fall into the trap of choosing a generic term as the trademark for a new product, although it does happen. Furthermore, owners of once-distinctive marks can lose protection by failing to police them. For example, in 1897 Frederich Bayer & Co isolated acetylsalicylic acid and branded a drug product called 'Aspirin', which it registered as a trademark in Germany in 1899. After the First World War, other manufacturers began to sell identical products under the name, which ultimately led to the mark’s inability to identify a single source (ie, Bayer). Therefore, the name no longer functioned as a trademark and ‘aspirin’ is now a generic term in the United States.

On the other end of the spectrum, fanciful and arbitrary marks enjoy the greatest legal protection. A fanciful mark is a newly coined term which had no meaning prior to its adoption. Arbitrary marks are existing words used for goods which bear no logical relationship to the goods for which the term is used (eg, Apple for computers). Although choosing a fanciful or arbitrary mark is the safest route to legal protection, companies tend to shy away from entirely fanciful or arbitrary marks because - initially at least - the mark has no recognizable meaning to the public. Typically, companies need to engage in extensive advertising campaigns in order to introduce new arbitrary or fanciful marks.

The next strongest mark in the spectrum is a suggestive one, where a consumer has to make some mental leap to determine how the mark relates to the goods or service. For example, although the COPPERTONE mark does not describe any significant aspect of a suntan lotion, it suggests the deep skin tone achievable through using the lotion. Thus, COPPERTONE is considered a suggestive and therefore strong trademark. Suggestive marks are powerful because they are memorable, create positive associations with the goods or service and can be registered without proof of the public’s recognition of the mark.

A descriptive mark is one which describes a major property of the product for which it is used. The US Patent and Trademark Office (USPTO) refuse to register purely descriptive trademarks as registration prevents others from using common words to describe their goods or services. However, descriptive marks can be transformed into protectable trademarks in numerous ways, the most common being through marketing and advertising. As a result of advertising, the public may associate a descriptive mark with a single source, at which point the mark could be considered to have acquired secondary meaning. The descriptive mark can then function as a trademark and be registered at the USPTO. In choosing a new brand name for a pharmaceutical, a company should consider the distinctiveness (or lack thereof) of the proposed mark.

Choosing product names:

When developing a pharmaceutical, companies must first choose valid generic names to designate the new drug. Unlike consumer products, which usually have one associated name, a pharmaceutical product typically has three names associated with it: 

·         A chemical name (e.g. Acetylsalicylic acid);

·         A generic name (e.g. Aspirin);and

·         A trademark or brand name (e.g. Bayer).

A company which discovers a new drug cannot simply coin a new generic name for it. Rather, a pharmaceutical company must apply first for a chemical name in the form of a Chemical Abstracts Service (CAS) Registry number. The CAS number is a unique identifier which differentiates a chemical compound from a database of millions of other compounds, each of which may be designated by other chemical names.

After obtaining a CAS Registry number, a pharmaceutical company must apply for a generic name for its new compound.

Obtaining a USAN is required before filing a new drug application with the US Food and Drug Administration (FDA), in addition to proposing a name, companies must provide necessary chemical information about the drug and explain the drug’s indications. Upon receipt of a completed USAN application, the council will examine the proposed name for conformity with certain criteria, including: 

·         Usefulness to healthcare providers

·         Patient safety (i.e., whether patients will confuse the drug with another drug based on similarity of names);

·         Adherence to prescribed nomenclature rules; 

·         Absence of conflicts with existing names;

·         Suitability for international use; and

·         Ease of pronunciation.

Once the assigned staff member is satisfied that the company has met the requisite criteria, the council submits the name to the INN expert group for further trademark clearance and linguistic evaluation. If the group approves the name, the USAN is adopted and is entered into the US Pharmacopeia Dictionary of USAN and International Drug Names and the CAS database. Selecting a USAN is difficult and the guidelines set out by the council’s rules for coining names, which enumerate factors it considers when reviewing an application should be followed.

Furthermore, during the selection process companies should try to anticipate and avoid possible trademark issues. For instance, as a USAN is generic, a pharmaceutical company should avoid any overlap between the proposed brand name and the proposed USAN. Otherwise it could face problems at the USPTO for choosing a generic mark which cannot be protected.

The final stage in the three-part process is choosing the actual trademark name. The name must be chosen so as to try to avoid any confusion, not only with existing trademarks, but also with USANs and common chemical names. Due to the potential health risks involved, the USPTO often requires a lesser degree of likelihood of confusion in order to reject a pharmaceutical mark.

Once a name is chosen and cleared by trademark counsel, the application process for a pharmaceutical trademark is similar to that for consumer goods - it includes filing the mark application with the USPTO with a description of the goods or services for which the mark will be used.

The actual use requirement can be different for a pharmaceutical product compared to an ordinary consumer product, because a pharmaceutical cannot be commercialized without regulatory approval. Therefore, whereas use in commerce for a branded training shoe means actually selling or offering to sell the shoe in commerce, typically there is no such similar use for a pharmaceutical product which has not yet been brought to market. Instead, the courts have typically looked at what kind of use is normal or customary in the industry to which the named product pertains. However, even without use, companies often opt to file applications based on an intention to use the mark before they begin, because the filing date of an application in the United States can afford the filer priority over a subsequent user of the same or a similar mark. Therefore, companies are wise to file such applications to try to preserve priority over names that they intend for future use.

After the application is filed at the USPTO, an examining attorney conducts a search of existing federal trademark registrations and applications to determine whether the mark could be considered confusingly similar to a pre-existing trademark. If the proposed trademark is similar to an existing trademark, especially where the existing trademark is used in connection with similar goods or services, the USPTO may refuse registration based on a likelihood of confusion. Once a company overcomes any outstanding refusal by the examining attorney, the proposed mark is published in the Official Gazette. Any opposition to the registration must be filed within 30 days of publication by initiating a proceeding before the Trademark Trial and Appeal Board. If no opposition proceeding is initiated, the USPTO will register the mark provided that the applicant has shown proper commercial use of the mark.

For pharmaceutical trademarks, prior to filing the company’s trademark attorney should conduct a search of registered and pending trademarks to anticipate those that the USPTO may consider confusingly similar during the examination of the trademark application. For pharmaceutical trademarks, the trademark attorney handling the matter should also consider standard, common and chemical names to avoid problems that might arise before the USPTO. To that end, the trademark attorney should consider whether the proposed brand name is too close to a USAN.

For example, in 2002 TopoTarget ApS sought to register 'Topotect' for “pharmaceutical preparations for the treatment of cancer”. Smithkline Beecham opposed the registration on the basis that Topotect was a slight misspelling or abbreviation of topotecan, which was the generic USAN name of the applicant’s pharmaceutical product. Although the Trademark Trial and Appeal Board denied Smithkline Beecham's request to prevent the registration on summary judgment, TopoTarget ultimately abandoned its application after a lengthy opposition proceeding.

The trademark attorney involved in naming a pharmaceutical should also consider common chemical abbreviations for a drug. Even if a pharmaceutical company secures a trademark registration for a new drug product and the USPTO does not consider the similarity of that mark to a USAN to be problematic, claiming any common chemical name may result in the preclusion of trademark rights.

Trade Mark Protection in India:

In the past 20 years, the pharmaceutical industry has emerged as one of the most dynamic and competitive in the world .India enacted the Trademarks Act 1999 and the Trademarks Rules 2002 (effective September 15, 2003) to ensure adequate protection for domestic and international brand owners, in compliance with the TRIPs Agreement. Pursuant to the Trademarks Act, service marks can be registered. The act states that a trademark includes the shape of goods, their packaging and color combinations. The term of a trademark has been increased to 10 years from six months, renewable upon expiration.

For claiming a priority from an application filed in United States a corresponding application should be filed in India within 6 months of date of filing of original application.

Some cases relating to Trade Mark protection in India -

Case 1:

Worldwide controversy over the harmful side- effects of commonly used Nimesulide tablet notwithstanding, pharmaceutical major Dr Reddy's Laboratories, having high share of the drug in the Indian market, has moved and got relief from the Delhi High Court to protect its brand from being plagiarized by a company. Dr Reddy's Lab filed a suit seeking protection to its "Nimesulide BP 100 mg" under the trade mark "NISE" while alleging that Delhi-based Maiden Pharmaceuticals was manufacturing similar tablets under a deceptively identical brand name "NICE" to cash in on the established brand name.

Advocate Pravin Anand, appearing for Dr Reddy's Lab has alleged that the Delhi-based company adopted the deceptively identical brand name with dishonest intention to misappropriate the goodwill and reputation of the pharmaceutical major. The counsel submitted that the pharmaceutical major had coined the trade mark "NISE" and an application for its registration as trade mark for medicinal preparation was pending with the Registrar of Trade Marks since 1995. He said the adoption of a visually, phonetically and conceptually similar mark by the local drug manufacturing firm was in violation of Dr Reddy's Labs' proprietary rights as it has acquired common law rights to the exclusive use of the trade mark "NISE".

Stating that Maiden Pharmaceuticals was not manufacturing equally superior quality drug, Dr Reddy's Lab submitted that the adoption of deceptively identical brand by the local company in respect of similar product would lead to confusion and deception in the minds of the consumers. The pharmaceutical major submitted that the adoption of the identical trade mark by the Delhi-based company was with an intention to derive unfair advantage by creating an impression that their products have some connection, association with or endorsement of Dr Reddy's Lab.

Case 2:

The Mark "GLUCON-D" was granted registration by the Indian Trade Marks Registry under registration No. 305664/30 on May 21, 1975 in relation to "Glucose (for food), Flour and Preparations Made from Cereals, Bread, Biscuits (Not for animals), Pastry and Confectionary (Non-Medicated), Milk Chocolate" in the name of Glaxo Laboratories (Indian) Limited. In the year 1994 the Mark "GLUCON-D" became the property of Heinz Italia S.R.I. The subject Mark had been consistently used by both the proprietors of the Mark and sold in a package which is green in colour, showing a family of three together with the words "GLUCON-D".

In the year July 2002, it came to the knowledge of Heinz that Dabur India Limited had launched a product under the trademark "GLUCOSE-D" in a packet, which was deceptively similar to the package containing product of the "GLUCON-D". Thereby, Heinz and Glaxo filed a suit for infringement and for passing off accompanied with an application for Interim injunction alleging that the package of "GLUCOSE-D" was so very identical to the package of "GLUCON-D" that the overall impression which came to be given out was that any average man of imperfect reflection was bound to get confused. Dabur, however, admitted the use of the Trade Mark "GLUCOSE-D" but denied that the boxes/package used by them were in any manner similar to that of "GLUCON-D". The Respondent further argued that the expression "GLUCOSE" was a generic description of the product being sold by it and no monopoly could be claimed in respect of such an expression by anyone. The Respondent also argued that the expression "GLUCOSE" signifies well known ingredients used in the composition of the product namely, Dextrose Monohydrates and Vitamin-D which constitute Glucose.

The Additional District Judge held that the Plaintiff, that is, Heinz has not been able to make out a prima facie case for ad interim injunction and accordingly the application fro the same was dismissed. The Plaintiff filed in appeal before the High Court of Punjab and Haryana and this Court reconsidered the same limited question. The High Court looked into the Certified Copy of the Registration Certificate and noted that there were two columns in the registration certificate. Column was pertaining to the goods description and was pertaining to conditions/limitations attached, which read as follows:-

"Registration of this trademark shall give no right to the exclusive use of the letter "D""

The goods described under this trade mark, the High Court noted are GLUCOSE for food and it also includes GLUCOSE for flour and preparations made from cereals, Glucose used in bread, GLUCOSE used in biscuits but not for animals, GLUCOSE used in pastry and confectionary which are not medicated and GLUCOSE used in milk chocolates. Thus, the trade mark is GLUCON-D but under its registration it has been clarified that it will contain GLUCOSE used in the aforementioned items for food. The High Court further observed that the word "GLUCOSE" means grape sugar or Dextrose and it is a word which is included in all the dictionaries of the world. Thus the word "GLUCOSE" cannot be said to be a monopoly or an exclusive property of a particular person or an entity. Further the Judge observed that the letter "D" is a letter of the English alphabet and it also cannot be claimed by any individual or a person to be their exclusive prerogative or monopoly. The Court in Appeal also noted the delay in institution of the infringement suit.

In view of the above it was held in appeal that while Heinz and Glaxo, the appellants are using the word "GLUCON-D", the Respondent, Dabur, on the other hand have used two common English words namely "GLUCOSE" and the letter "D". Accordingly there is no prima facie case made out by the Plaintiff for grant of interim injunction and the order passed by the Additional District Judge was confirmed.

Conclusion:

Although the need for rigorous patent protection will remain ever present in the pharmaceutical sector, companies are increasingly recognizing the effectiveness of trademarks when it comes to securing and enhancing the equity of a product.
            Unlike patents, trademarks have the advantage that they can last forever as long as their distinctiveness is safeguarded and the registration renewed. As John Peacock, trademark attorney at Eric Potter Clarkson, emphasizes: ‘Corporations, no matter what their industry, should be benefiting from the rights afforded by trademark registration by seeking to register distinctive elements of their products – such as name, logo, shape, color and so on. This will make it difficult for other companies to produce products that echo the registered qualities.
            The pharmaceutical and home and personal care industries have consistently filed large numbers of trademarks as new products are developed and existing ones have their brands subtly refined. However, a critical barrier to global branding in the pharmaceutical sector is trademark availability

 

About the Author: Neeta Ramsinghani is a law graduate