Exacting Standards for Pharma Trademarks and their Dominant Parts

In an infringement and passing off case filed by Sun Pharma against Glenmark, the Court was asked to determine if the trademark “INDAMET” used for asthma infringes upon the trademark “ISTAMET XR CP” used for diabetes. Sun Pharma’s “ISTAMET XR CP” was registered in 2014 by its predecessor in title, and the mark ‘ISTAMET’ was in use since 2011. Glenmark’s trademark, INDAMET, was registered in 2021.

Sun Pharma’s ISTAMET XR CP was a Schedule G drug, which came as a capsule, and Glenmark’s INDAMET was a Schedule H drug, which had to be taken using a DPI or rotahaler. Sun Pharma and Glenmark used different product packaging that could be differentiated.

After analyzing the facts, the Single Judge came to the prima facie conclusion that INDAMET was infringing upon the trademark, ISTAMET XR CP of Sun Pharma, and granted an interim injunction. Glenmark appealed, and the Division Bench affirmed the Single Judge’s decision. To start with, the Division Bench reiterated that pharmaceutical product related trademarks have to be scrutinized stringently because even the slightest confusion can cause disastrous consequences to health and life of consumers. Some similarities may pass with respect to non-pharma trademarks, but the same cannot be permitted with respect to pharma trademarks. Whether they are drugs given on prescription or not, and though pharmacists and doctors are experts, any possibility of confusion must be avoided.

Considering the marks in the case, the Court stated that ISTAMET is the dominant part of Sun Pharma’s trademark, and when this is compared with Glenmark’s INDAMET, there is phonetic, structural, and visual similarity. It rejected the argument that ‘met’ is a common word used for pharma products and refused to remove it from the marks for comparison. Though the products fell under different schedules, and they were being used for different disorders, the Court stated that a person with average intellect and imperfect recollection is likely to be confused based on first impression, and therefore, Glenmark’s trademark is prima facie infringing.

Stringent Pharma Trademark Scrutiny: Relevant Paras from the Judgment

The relevant paras from the Judgment although long have been produced hereunder. They are worth a read as they summarize the law relating to the assessment of pharma trademark infringement quite well. If you do not have time, please skip to the last paragraph, which summarizes the principles.

“51. We at the outset note that the issue which stands raised would have to be examined bearing in mind and at the forefront the stringent, exacting and uncompromising standards which are liable to be adopted when we test an action for infringement or passing off pertaining to competing marks in the pharmaceutical sector as opposed to any other genre of products. It would be pertinent to recollect that in Cadila Healthcare the Supreme Court was concerned with the asserted similarity between the brand names ―FALCITAB™ and ―FALCIGO™.

The Trial Judge had refused interim injunction on the basis that they differed in appearance, formulation and price. The aforesaid order of the Trial Judge was affirmed by the High Court.

Although the Supreme Court in Cadila Healthcare refused to interfere with the judgment impugned and had disposed of the Special Leave Petition with directions for expeditious conclusion of the trial itself, there were notable observations which came to be rendered and which are of significant import.

  1. Indisputably, our courts have consistently held that the question of confusion is essentially one of first impression. It is in the aforesaid backdrop that courts have held that the issue of deceptive similarity has to be answered from the point of view of a man of average intelligence with imperfect recollection. The tests which were propounded in Re Pianotist Co application28 as far back as in1906 have consistently guided courts in answering issues of deceptive similarity. In Pianotist those principles were explained in the following words:

―You must take the two words. You must judge of them, both by their look and by their sound. You must consider the goods to which they are to be applied. You must consider the nature and (1906) 23 RPC 774  kind of customer who would be likely to buy those goods. In fact, you must consider all the surrounding circumstances; and you must further consider what is likely to happen if each of those trade marks is used in a normal way as a trade mark for the goods of the respective owners of the marks. If, considering all those circumstances, you come to the conclusion that there will be a confusion–that is to say, not necessarily that one man will be injured and the other will gain illicit benefit, but that there will be a confusion in the mind of the public which will lead to confusion in the goods–then you may refuse the registration, or rather you must refuse the registration in that case.

  1. It has also been recognized by courts that while a close scrutiny or comparison of the two competing marks may disclose some points of distinction, the question itself is liable to be answered from the point of view of the unwary purchaser and who is unlikely to expend sufficient amount of time examining the marks scrupulously or with a degree of exactness. Yet another precept which precedents require us to bear in consideration is the essential features of a trademark and in such situations marked or slight differences in get-up, packaging or the manner in which the marks are written fading into insignificance. Ultimately a challenge of infringement or passing-off would have to be answered on the anvil of a resemblance so near and unerring that it is likely to deceive or cause confusion.
  2. We note that F. Hoffmann-La Roche was dealing with the issue of deceptive similarity in the context of usage of the words ―DROPOVIT™ and ―PROTOVIT™. While examining the challenge which stood raised, the Court pertinently observed that the question of likelihood of confusion is neither liable to be considered nor answered on a meticulous comparison of two words nor our courts liable to undertake a “letter by letter and syllable by syllable” comparison. All of the aforesaid principles, so enunciated, are a reiteration of the underlying precept being of the marks being examined from the gaze of a man of average intelligence and imperfect recollection. In F. Hoffmann-La Roche the Supreme Court ultimately came to conclude that the two words were so dissimilar that there existed no reasonable probability of confusion either from a visual or phonetic point of view.
  3. However, Cadila Healthcare assumes significance insofar as medicines and drugs are concerned in light of the following observations which were rendered:

“21. It will be useful to refer to some decisions of American courts relating to medicinal products. In the case of American Cynamid Corpn. v. Connaught Laboratories Inc. [231 USPQ 128 (2nd Cir 1986)] it was held as under:

―Exacting judicial scrutiny is required if there is a possibility of confusion over marks on medicinal products because the potential harm may be far more dire than that in confusion over ordinary consumer products.

  1. It may here be noticed that Schedule H drugs are those which can be sold by the chemist only on the prescription of the doctor but Schedule L drugs are not sold across the counter but are sold only to the hospitals and clinics. Nevertheless, it is not uncommon that because of lack of competence or otherwise, mistakes can arise specially where the trade marks are deceptively similar. In Blansett Pharmaceuticals Co. v. Carmick Laboratories Inc. [25 USPQ 2nd, 1473 (TTAB 1993)] it was held as under:

―Confusion and mistake is likely, even for prescription drugs prescribed by doctors and dispensed by pharmacists, where these similar goods are marketed under marks which look alike and sound alike.

  1. In the case of Glenwood Laboratories, Inc. v. American Home Products Corpn.

[173 USPQ 19 (1972)455 F Reports 2d, 1384 (1972)] the Court of the United States had held that:

―The fact that confusion as to prescription drugs could produce harm in contrast to confusion with respect to non-medicinal products is an additional consideration for the Board as is evident from that portion of the opinion in which the Board stated:

The products of the parties are medicinal and the applicant’s product is contraindicated for the disease for which the opposer’s product is indicated. It is apparent that confusion or mistake in filling a prescription for either product could produce harmful effects. Under such circumstances, it is necessary for obvious reasons, to avoid confusion or mistake in the dispensing of the pharmaceuticals.’ The board’s view that a higher standard be applied to medicinal products finds support in previous decisions of this Court, Clifton v. Plough [341, F 2d 934, 936, 52, CCPA 1045, 1047 (1965)] (it is necessary for obvious reasons, to avoid confusion in the dispensing of pharmaceuticals’), Campbell Products, Inc. v. John Wyeth & Bro. Inc.

[143, F 2d 977, 979, 31 CCPA 1217 (1944)] (it seems to us that where ethical goods are sold and careless use is dangerous, greater care should be taken in the use of registration of trade marks to assure that no harmful confusion results’).

  1. In the case of R.J. Strasenburgh Co. v. Kenwood Laboratories, Inc. [106 USPQm379 (1955)] as noted in the decision of Morgenstern Chemical Co. case, it had been held that:

 

―Physicians are not immune from confusion or mistake. Furthermore it is common knowledge that many prescriptions are telephoned to the pharmacists and others are handwritten, and frequently handwriting is not unmistakably legible. These facts enhance the chances of confusion or mistake by the pharmacists in filling the prescription if the marks appear too much alike when handwritten or sound too much alike when pronounced.

  1. The drugs have a marked difference in the compositions with completely different side effects, the test should be applied strictly as the possibility of harm resulting from any kind of confusion by the consumer can have unpleasant if not disastrous results. The courts need to be particularly vigilant where the defendant’s drug, of which passing-off is alleged, is meant for curing the same ailment as the plaintiff’s medicine but the compositions are different. The confusion is more likely in such cases and the incorrect intake of medicine may even result in loss of life or other serious health problems. In this regard, reference may usefully be made to the case of Glenwood Laboratories, Inc. v. American Home Products Corpn. [173 USPQ 19 (1972)455 F Reports 2d, 1384 (1972)] where it was held as under:

―The products of the parties are medicinal and the applicant’s product is contraindicated for the disease for which opposer’s product is indicated. It is apparent that confusion or mistake in filling a prescription for either product could produce harmful effects. Under such circumstances it is necessary for obvious reasons, to avoid confusion or mistake in the dispensing of the pharmaceuticals.

  1. The aforesaid principles as propounded clearly point towards a more exacting and stringent test being adopted when an action of infringement or passing-off comes to be laid in respect of drugs. As was pertinently observed by the Supreme Court in Cadila Healthcare, in the case of drugs, the tests to be adopted is that of “exacting judicial scrutiny”. It was further held that the mere fact that the drug was being sold on the basis of a prescription or dispensed by pharmacists would also not constitute a reliable determinant which would dilute the strict view test as articulated by it while attempting to answer the question of possibility of confusion. This the Supreme Court so held bearing in mind the injurious or detrimental possibilities attendant to an inadvertent purchase, sale and consequential consumption of a drug. It also took into consideration the harmful effect that a usage of a drug may have even though the competing products may be meant for curing an identical ailment. Not stopping at this, the Court also found that notwithstanding the pharmaceutical market being regulated by prescriptions and the dispensation of products being overseen and supervised by trained physicians, those factors would not allay the fears and apprehensions attendant to an incorrect or inappropriate drug being accidentally dispensed. This is evident from the following observations appearing in Paras 27 and 28 of the report:

―27. As far as the present case is concerned, although both the drugs are sold under prescription but this fact alone is not sufficient to prevent confusion which is otherwise likely to occur. In view of the varying infrastructure for supervision of physicians and pharmacists of medical profession in our country due to linguistic, urban, semi-urban and rural divide across the country and with high degree of possibility of even accidental negligence, strict measures to prevent any confusion arising from similarity of marks among medicines are required to be taken.

  1. Here it will be useful to refer to the decision of Morgenstern Chemical Co. case where it has been held as under:

―(5) In the field of medical products, it is particularly important that great care be taken to prevent any possibility of confusion in the use of trade marks. The test as to whether or not there is confusing similarity in these products even if prescribed and dispensed only by professionally trained individuals does not hinge on whether or not the medicines are designed for similar ailments. The rule enunciated by Judge Helen in Cole Chemical Co. v. Cole Laboratories [DC Mo 1954, 118 F Supp 612, 616, 617, 101, USPQ 44, 47, 48] is applicable here: The plaintiff and the defendant are engaged in the sale of medical preparations. They are for ultimate human consumption or use. …

They are particularly all for ailments of the human body. Confusion in such products can have serious consequences for the patient. Confusion in medicines must be avoided. *** Prevention of confusion and mistakes in medicines is too vital to be trifled with.’ The observations made by Assistant Commissioner Leeds of the Patent Office in R.J. Strasenburgh Co.v. Kenwood Laboratories, Inc. [106 USPQ 379 (1955)] USPQ 380 are particularly apt, that: ‗Physicians are not immune from confusion or mistake. Furthermore it is common knowledge that many prescriptions are telephoned to the pharmacists and others are handwritten, and frequently handwriting is not unmistakably legible. These facts enhance the chances of confusion or mistake by the pharmacists in filling the prescription if the marks appear too much alike when handwritten or sound too much alike when pronounced.’

The defendant concedes that physicians and pharmacists are not infallible but urges that the members of these professions are carefully trained to detect difference in the characteristics of pharmaceutical products. While this is doubtless true to dos (sic) not open the door to the adoption by manufacturers of medicines of trade marks or names which would be confusingly similar to anyone not exercising such great care.

For physicians and pharmacists are human and in common with the rest of mankind are subject to human frailties. In the field of medicinal remedies the courts may not speculate as to whether there is a probability of confusion between similar names. If there is any possibility of such confusion in the case of medicines public policy requires that the use of the confusingly similar name be enjoined (see Lambert Pharmacol Ltd. v. Bolton Chemical Corpn. [DCNY 1915, 219 F 325.326] ).

  1. More significantly, the Supreme Court proceeded to hold and spoke of a lesser degree of proof being applicable in the case of medicinal products while answering the question of confusing similarity and the same being warranted in order to subserve large public interest. These observations are found in para 32 of the report, which is extracted hereinbelow:

“32. Public interest would support lesser degree of proof showing confusing similarity in the case of trade mark in respect of medicinal products as against other non-medicinal products. Drugs are poisons, not sweets. Confusion between medicinal products may, therefore, be life threatening, not merely inconvenient.

Noting the frailty of human nature and the pressures placed by society on doctors, there should be as many clear indicators as possible to distinguish two medicinal products from each other. It is not uncommon that in hospitals, drugs can be requested verbally and/or under critical/pressure situations. Many patients may be elderly, infirm or illiterate. They may not be in a position to differentiate between the medicine prescribed and bought which is ultimately handed over to them. This view finds support from McCarthy on Trade Marks, 3rd Edn., para 23.12 of which reads as under:

―The tests of confusing similarity are modified when the goods involved are medicinal products. Confusion of source or product between medicinal products may produce physically harmful results to purchasers and greater protection is required than in the ordinary case. If the goods involved are medicinal products each with different effects and designed for even subtly different uses, confusion among the products caused by similar marks could have disastrous effects. For these reasons, it is proper to require a lesser quantum of proof of confusing similarity for drugs and medicinal preparations. The same standard has been applied to medical products such as surgical sutures and clavicle splints.

  1. Equally instructive are the following principles which came to be identified by our Court in Novartis AG:
  2. I do not accept the submission of the learned counsel for the defendant as I feel that it is more dangerous if the pharmaceuticals products bearing the same mark is used for different purposes for the same ailment or even otherwise. I also do not accept the contention of the defendant’s counsel that there would be no confusion if the product contain different ingredients/different salt. In my opinion, it is more dangerous and harmful in the trade if the same trade mark is used for different ailments. The Apex court has already dealt with this proposition of law in the case of Cadila Healthcare Ltd. v. Cadila Pharmaceuticals, (2001) 5 SCC 73 : (2001) 21 PTC 300 (SC) and held as under:

 

―25. The drugs have a marked difference in the compositions with completely different side effects, the test should be applied strictly as the possibility of harm resulting from any kind of confusion by the consumer can have unpleasant if not disastrous results. The courts need to be particularly vigilant where the defendant’s drug, of which passing off is alleged, is meant for curing the same ailment as the plaintiffs medicine but the compositions are different. The confusion is more likely in such cases and the incorrect intake of medicine may even result in loss of life or other serious health problems. In this regard, reference may usefully be made to the case of Glenwood Laboratories,  Inc. v. American Home Products Corp, 173 USPQ 19(1972) 455 F. Reports 2d, 1384 (1972), where it was held as under:

―The products of the parties are medicinal and applicant’s product is contraindicated for the disease for which opposer’s product is indicated. It is apparent that confusion or mistake in filling a prescription for either product could produce harmful effects.

Under such circumstances, it is necessary for obvious reasons, to avoid confusion or mistake in the dispensing of the pharmaceuticals.

  1. The other argument of the counsel for the defendant that the plaintiffs product is available in tablets and oral suspension form and the defendant’s product is available in injection form has also no force as it has been seen from experience of th pharmaceuticals products available in all over the world that most of the companies are making pharmaceuticals products in both the forms i.e. tablets as well as in injection form under the same trade mark. As per well settled law, the actual confusion and deception is not required in order to prove the case of passing, off even if the defendant has adopted the mark innocently and the court comes to the conclusion that the two trade marks are deceptively similar, injunction under the said circumstances has to be granted.

Actual deception is not required in an action of passing off. Century Traders v. Roshan Lal Duggar & Co., AIR 1978 Del 250 : 1 Supp PTC 720 (Del) (DB). Therefore there is no chance of confusion and deception.

  1. As is evident from the aforesaid extracts, our Court found that a difference in ingredients or salts which make up competing pharmaceutical products, would not be aspects which could be said to be germane when it come to the question of likelihood of confusion. It also negated the mode and method of ingestion as well as the form of the competing products. This is evident from para 22 of the report and where the Court held that the fact that the competing products were dispensed either in the form of a tablet or an oral suspension would be wholly irrelevant.
  2. We find that the aspect of heightened scrutiny was also emphasized by a Division Bench of the Bombay High Court in Macleods Pharmaceuticals. While enunciating the first principles which must be borne in mind, the Bombay High Court in paras 21 and 22 held as follows:

“21. This Court in the decision of Boots Company Plc, England (supra) after considering various judgments held that there are three tests which have to be considered for deciding the question whether the trade mark is deceptively similar to the other mark or not and they are:–

(1) The mark has to be considered as a whole,

(2) It is a question of first impression and

(3) The question has to be considered from the view point of a man of average intelligence.

  1. The Delhi High Court in Win-Medicare Pvt. Ltd. (supra) after considering the relevant decisions on the question of misrepresentation or deception between two trade marks held that following Rules of Comparison can be culled out from various pronouncements of the Courts from time to time:
  1. Meticulous Comparison not the correct way.
  2. Mark must be compared as a whole
  3. First Impression.
  4. Prima Facie view not conclusive.
  5. Structural Resemblance.
  6. Similarity in Idea to be considered.”
  1. The test of ―exacting judicial scrutiny‚, when we are called upon to deal with medicinal products was reiterated and re-affirmed as would be evident from para 23:
  2. The Supreme Court in the decision between Milment Oftho Industries (supra) after reviewing the law on the subject held as follows:

―8. In respect of medicinal products it was held that exacting judicial scrutiny is required if there was a possibility of confusion over marks on medicinal products because the potential harm may be far more dire than that in confusion over ordinary consumer products. It was held that even though certain products may not be sold across the counter, nevertheless it was not uncommon that because of lack of competence or otherwise that mistakes arise specially where the trade marks are deceptively similar. It was held that confusion and mistakes could arise even for prescription drugs where the similar goods are marketed under marks which looked alike and sound alike. It was held that physicians are not immune from confusion or mistake. It was held that it was common knowledge that many prescriptions are telephoned to the pharmacists and others are handwritten, and frequently the handwriting is not legible. It was held that these facts enhance the chances of confusion or mistake by the pharmacists in filling the prescription if the marks appear too much alike.

(Emphasis added)

  1. After noticing the decision in Cadila Healthcare, the Bombay High Court culled out the following principles:

“25. The principles which are emerging from the decisions set out hereinabove are summarised in the following manner:

(a) When a particular medicinal or a pharmaceutical product is involved as the impugned trade mark which may deceive the public or cause a confusion with respect to another trademark, it is the Court’s primary duty to take utmost care to prevent any such possibility of confusion in the use of trademarks.

(b) Confusion in case of a non-medicinal or a nonpharmaceutical product may only cause economic loss to the person, but on the other hand, a confusion in terms of medicinal or a pharmaceutical product may have disastrous effect on the health.

Hence, it is  proper to require a lesser quantum of proof of confusing similarity for such products.

(c) The Court may not speculate as to whether there is a probability of confusion between the marks. Mere existence of the slightest probability of confusion in case of medicinal product marks, requires that the use of such mark be restrained.

(d) While arriving at a conclusion with respect to the similarity and confusion between medicinal products, the same should be examined from the point of view of an ordinary common man of average intelligence instead of that of a specialised medicinal practitioner. Courts must decide the same from the view point of man with average intelligence considering multiple factors such as the first impression of the mark, salient features of both the products, nature of the commodity, overall similarity and the possibility of the same creating a confusion amongst the public at large.

(e) The primary duty of the Court is towards the public and the purity of the register.

Duty of the Court must always be to protect the public irrespective of what hardship or inconvenience it may cause to a particular party whose trade mark is likely to deceive or cause confusion.

(f) The following rules of comparison can be culled out from various pronouncement of Court from time to time.

(i) Meticulous comparison is not the correct way.

(ii) Mark must be compared as whole.

(iii) First impression.

(iv) Prima facie view is not conclusive.

(v) Structural resemblance.

(vi) Similarity in idea to be considered.

(g) The main object of maintaining trade mark register is that the public should know whose goods they are buying. It is therefore essential that the register should not contain the trade mark which is identical by which purchaser may likely to be deceived by thinking that they are buying the goods of a particular company/industry whereas he is buying the goods of another company/industry.

  1. On an overall consideration of the aforesaid, we are of the considered opinion that the finding of deceptive similarity and likelihood of confusion as ultimately rendered by the learned Judge clearly merits no interference. The learned Judge has on a prima facie evaluation come to conclude that a comparison of the marks ―ISTAMET and ―INDAMET meets the test of structural and phonetic similarity.

That conclusion cannot, by any stretch of imagination, be said to be either manifestly erroneous or perverse. We are inclined to accept the principles as lucidly culled out in Macleods Pharmaceuticals and where their Lordships propounded the test in respect of drugs to be the “mere existence of the slightest possibility” of confusion. The aforesaid enunciation of the legal position is clearly in accord with the tests laid down by the Supreme Court in Cadilla Healthcare. In our considered opinion, the question of likelihood of confusion in case of competing drugs would have to be answered on a basis distinct from those that we may employ for ordinary consumer products. We would be erring if we were to fail to adopt strict principles of proof when it comes to drugs bearing in mind the need to completely obviate the possibility of an error or mistake. The test of confusing similarity, as McCarthy in his seminal work explains, stands “modified” and spoke of a “lesser quantum of proof” being required when the subject be drugs and medicinal preparations.”

Disclaimer

The case note/s in this blog post have been written by IP Attorneys at BananaIP Counsels based on their review and understanding of the Judgments. It may be noted that other IP attorneys and experts in the field may have different opinions about the cases or arrive at different conclusions therefrom. It is advisable to read the Judgments before making any decisions based on the case notes.

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