Find a Lawyer

Suit No.508 and Civil Miscellaneous Application No. 3492 of 1986, decided on 30th April, 1987.

‑‑‑O.XXXIX, Rr.l a 2‑‑Patent and Designs Act (II of 1911), Ss. 31, 29 s 35‑‑Drugs Act (XXXI of 1976), S.7‑‑Infringement of patent of a drug‑‑Application for an injunction for restraining defendant, until further orders, from manufacturing, importing, marketing selling or offering for sale the product which infringes the plaintiffs patent‑‑ Expert opinion that by reading the description on defendant's packet an impression is created that the base of defendant's drug was similar to the drug which is associated with the name of plaintiff as their exclusive product and which had by now earned a worldwide reputation‑--‑Infringement of patent so obvious that plaintiff had been able to make out a strong prima facie case in their favour‑‑No plausible explanation offered by defendant for using the name of patent of plaintiff‑‑Held, in a case where no plausible explanation was forthcoming, the mischief should be suppressed as early as possible and the piracy causing financial losses to the plaintiff and health hazard to the public at large which remained unexplained should not be allowed to continue‑‑Mere registration of drug with Ministry of Health under Drugs Act, 1976 could not immunise the defendant against claims of aggrieved party under the Patent and Designs Act, 1911‑ Defendant was restrained from importing, marketing or publicising any product under the name of plaintiff or reproducing the chemical or structural formula of the said drug on any of their products in any form..

Khalid Anwar for Plaintiffs.

Sultan Ahmed Shaikh for Defendants.

Date of hearing: 2nd April 1987.

By this order application C.M.A. No.3492 of 1986 under Order 39 Rule 1 and 2, C . P. C would be disposed of. This is an application for an injunction for restraining the Defendant, its servants, agents, representatives, dealers and all persons claiming through or under it, jointly and severally, until further orders of this Court from manufacturing, importing, marketing, selling or offering for sale the product which is Annexure 'D' to the plaint and which infringes the plaintiff No.1's Patent Nos.123776, 123990 and 124546 or any variations thereof.

Plaintiffs are a Pharmaceutical Swiss Company and they filed this suit against the Defendants complaining infringement of their Patent bearing No.123776, 123990 and 124546. These Patents cover the production of drug "KETOTIFEN" which they are selling under the Trade name "ZADITEN".

It is alleged by the learned counsel for the plaintiff that as a result of their constant labour and research the Plaintiffs were able to invent a drug with molecular formula NOS C19 H19 and a typical structural representation. The setting of different atoms in the compound are depicted hereunder and also in Annexure 'A' page 2 to the plaint.

O

1

(A‑B= CH2‑C R1=H, R2=CH3)

This invention carries a curing effect for asthma and other bronchial diseases.

After the invention of the drug the plaintiffs applied for registration of the process of production of this drug to the Patent Office and were allowed registration by the Patent Office vide Certificate Annexure 'A‑I'. This was registered under Patent No.123776 dated 17th April, 1974. Sometimes in 1975 the plaintiffs applied to the W.H.O. Switzerland for approval of a generic name of this drug vide their application dated 22nd July, 1975 Annexure 'B' to the affidavit of the Plaintiffs dated 19th March, 1987. They had suggested two names for the drug in order of preference. There were "KETOTIFEN" and "HAPTOTIFEN". The chemical formula of this drug was given as NOS C19 H19. The structural formula was also figuratively depicted alongwith it in details. These details are not material for the purposes of this case. The W. H .0. approved the name "KETOTIFEN" for this drug. The chemical formula as well as structural representation of this formula were also approved by W.H.O. This approval was followed by publication of this drug under name "KETOTIFEN" in the MERCK INDEX which is a prestigious and recognized book in the field of chemicals, drugs and Biologicals and is known all over the world. The name "KETOTIFEN" finds place at page 762 of 1983 edition of this index entry No.5144. From henceforth the drug came to be known as "KETOTIFEN" a product exclusively belonging to the plaintiff‑company with the details and particular detailed under this entry. This entry also shows the structural formula of the drug and the Patent Nos. of this drug in U.S.A. and Germany.

The plaintiffs have since than been selling this drug under the trade name "ZADITEN" with the following description; "each tablet contains "KETOTIFEN" 1 mg (as Hydrogen Fumerate)". The active ingredients of this drug are represented in the name "KETOTIFEN". Each capsule contains 1 mg of "KETOTIFEN" and Hydrogen Fumerate is the preservant of the main ingredient of the capsules. As a result of the registration of this particular drug with the W. H . O . and its publication in the Merck Index the medical profession throughout the world has become familiar with its generic name "KETOTIFEN". Whenever name "KETOTIFEN" is mentioned in the medical world immediately thinks of a drug with a molecular formula C19 H19 NOS and a structural formula.

The atoms peculiarly arranged and set up in an order through a peculiar process carrying the effect of curing asthma and other bronchial diseases.

As stated above this drug is sold in the market as "Z ADITEN" in the shape of tablets and also an syrup. The basis ingredient remaining the same as represented through the generic name of the compound as "KETOTIFEN".

In para 8 of the plaint it is alleged "that recently it came to the notice of the plaintiffs that the defendant has started manufacturing and/or importing and marketing capsules and syrup containing KHF under the trade name of "KATIFEN".

Mr. Khalid Anwar, learned counsel for plaintiffs has placed in Court the packets of the drug of the defendants and has pointed out that they are selling their drug under trade name "KATIFEN" and a description exactly the same as is given on the packet of the Plaintiffs. The learned counsel contends that by reading the description of the drug "KATIFEN" on the Defendants packings any medical practitioner prescribing a curing drug for asthma would be led to believe that the contents of the packet contained the world known "KETOTIFEN" (Hydrogen Fumerate) 1 mg. In other words physicians would immediately think of C19 C19 NOS the different elements of the compound "KETOTIFEN" arranged in a particular form as per description in the Merck Index although the defendants have nothing to do with "KETOTIFEN" as it is the patented drug of the plaintiffs. To lend support to this piracy the defendants have also published on the container the following description namely 'Associates of ARCO S.A. Switzerland" indicating thereby that the product on manufactured bar the defendants is blessed by some company in Switzerland.

The Plaintiffs have filed this application under Order XXXIX, Rules 1 and 2, C . P. C . read with section 31 of the Patent and Design Act with the prayer that the defendants should be restrained "from manufacturing, importing, marketing, selling or offering for sale the product which is Annexure 'D' to the plaint and which infringes the plaintiff No.l Patent No.123776, 123990 and 124546".

During the arguments the learned counsel for the plaintiff had to concede that neither the plaint nor this application is properly worded and he has filed another application during the arguments under section 151, C.P.C., the prayer contained in this application is as follows: --------

It is prayed on behalf of the plaintiff that the prayer in the Injunction Application may kindly be treated as the submission that the Defendant be restrained from manufacturing, importing, or selling the Product/Drug/compound described as KETOTIFEN or such other order as this Hon'ble Court deems appropriate."

In a nutshell the prayer is confined to a relief that the defendants should not put in the market either in the capsule form or in the syrup form or in any other form their drug with a description similar to that on the packets of the plaintiff thereby creating an impression that the drug of the defendants contains 'KETOTIFEN' (with Hydrogen Pumerate) with the potency of 1 mg.

This application was heard for about four days the subject matter, being of purely technical nature. The learned counsel appearing for the parties found it difficult to properly spell out a case. At the request of the plaintiff the Council of Scientific and Industrial Research was requested to nominate a scientist to assist the Court as assessor under section 35 of the Patent and Designs Act, 1911. The Council has nominated Dr. I. H. Qureshi and the learned Scientist has remained present and has assisted this Court. According to him it is not possible to state whether the method and process of production of the drug by the defendants is similar to that of the plaintiffs. But by reading the description on Defendants packets an impression is created that the base of Defendants drug 'KHATIFEN' is similar to the durg 'KETOTIFEN' Hydrogen Fumerate which is associated with the name of the plaintiff as their exclusive product and which has by now earned a worldwide reputation as cure for Asthma.

In my view this opinion of the Scientist from the Council places the case of the plaintiff under section 29 of the Patent and Design Act, 1911 which runs as under:‑--

"29. Suits for infringement of patents.‑‑(1) A patentee may institute a suit in a District Court having jurisdiction to try the suit against any person who, during the continuance of a patent acquired by him under this Act in respect of an invention without his licence or counterfeits it, or imitates it:

Provided that where a counter‑claim for revocation of the patent is made by the defendant, the suit, alongwith the counterclaim, shall be transferred to the High Court for decision.

(2) Every ground on which a patent may be revoked under section 56 shall be available by way of defence to a suit for infringement."

As the infringement of the patent is so obvious the plaintiffs have also prayed for an interim injunction during the pendency of the suit. Learned counsel for the defendants has argued that their drug "KATIFEN" has been registered under the Drugs Act as is, evident from Annexure 'A' to their written‑statement. This Registration Certificate has been issued under section 7 of the Drugs Act by the Ministry of Health informing the defendants that drug "KATIFEN" capsules has been registered with them. The pattern of packing and price to be charged has also been approved.

When it was pointed out to the learned counsel for the defendant that this registration under Drugs Act has no bearing or relevancy to the rights of the plaintiffs infringed under the Patents and Designs Act he had no plausible answer. The other argument of the defendant was that the plaintiffs have filed photostat copies of the documents from the patent office which under section 65 of the Evidence Act cannot be relied upon. This objection may have technical merit but at this stage when the application for interim injunction is being argued photostat copies filed alongwith plaint or affidavits can be looked into and relied upon unless a specific objection regarding their authenticity or genuineness is raised by the other side. In the present case no such allegation is made. Even this objection was raised at the fag‑end of the arguments of defendants counsel and after plaintiff's Advocate had concluded his arguments.

In my opinion the plaintiffs have been able to make out a strong prima facie case in their favour. No plausible explanation has been offered by the defendant for using the words "KETOTIFEN" which I must repeat carries behind it the molecular and structural formual which is the outcome of research labour and expense of the plaintiff. So far as the question of balance of convenience is concerned, I may say that in a case of this kind where no plausible explanation is forthcoming the mischief should be supressed as early as possible and the piracy causing financial losses to the plaintiff and who knows health hazard to the public at large which remains unexplained should not be allowed to continue. Mere registration of the drug with the Ministry of Health under the Drugs Act cannot immunise the Defendants against claims of aggrieved parties under the Patent Act.

The upshot of the discussion is that the defendants should be restrained from importing, marketing or publicising any product under the name "KETOTIFEN" or reproducing the chemical or structural formula of this drug on any of their products in any form.

M. B. A./S.35/K Injunction granted.

Find a Lawyer Near You

Dealing with a matter like this? Connect with a verified advocate in your city — free on SJP Lawyers Directory.