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LEGAL UPDATES

Intellectual Property Rights Cases: PATENT CASES

1. Wockhardt Limited Vs. Hetero Drugs Limited & Ors.

Facts:
Wockhardt Limited (Wockhardt), a pharmaceutical company, an Appellant in the instant case is the holder of a Process Patent (Patent No. 188847), Exclusive Marketing Right (EMR) and Drug License for the manufacture of a pharmaceutical preparations, viz; Nadifloxacin 1% Cream (benzoquinolizines) for the treatment of mupirocin-resistant bacterial infections which is being sold in formulation form under the trademark NADOXIN.

On 28th March, 2002 WOCKHARDT made an application for a Product Patent which was treated as a Mail Box application.

On 27th April, 2002 WOCKHARDT obtained a manufacturing license to manufacture a pharmaceutical preparations containing NADIFLOXACIN 1% cream from the Drug Controller General of India (DCGI). After obtaining the license WOCKHARDT commenced manufacturing and marketing the said products.

On 6th June, 2003 WOCKHARDT was granted the above said Process Patent under Patent No. 188847.

On 17th July, 2003 WOCKHARDT applied to the Controller General of Patents for grant of an Exclusive Marketing Right (EMR) in respect of the said product under Section 24-A (erstwhile) of the Patents Act, 1970. After necessary scrutiny and examination, the Controller General of Patents, granted an Exclusive Marketing Right (EMR) for a period of five years to exclusively sell and distribute in India the pharmaceutical product being NADIFLOXACIN 1% cream.

Hetero Drugs Limited (HETERO), the Respondent in the above case started manufacturing and selling the said product and hence, WOCKHARDT filed a suit for infringement of above said process patent and for EMR. HETERO contended that the said product was being manufactured after obtaining a necessary manufacturing and selling license from the DGCI, which license was granted to HETERO to manufacture the said product in accordance with the processed disclosed in US Patent and Japanese Patent granted to M/s. Otsuka Pharmaceuticals, Japan. In fact prior to filing of the present suit WOCKHARDT had filed a Writ Petition before Delhi High Court making the DGCI and various other parties as Respondents in connection with a grant of license to manufacture NADIFLOXACIN 1% cream.

No Interim Relief was granted by Delhi High Court to Wockhardt in the said Writ Petition and the same was pending at the time of institution of the present proceedings. Immediately, after the Delhi High Court proceedings HETERO filed a Writ Petition in the Bombay High Court challenging the grant of constitutional validity of Exclusive Marketing Rights and sought an order to restrain the WOCKHARDT from taking any action based on the said EMR and further sought a revocation of the same.

No Interim Relief was granted to HETERO in the said Writ Petition and the same continued to be pending at the time of institution of the present proceedings. An ex-parte order of injunction was granted in the present proceeding which was later vacated by the Single Judge of Chennai High Court and hence, an appeal was filed by WOCKHARDT challenging the order of the Learned Single Judge vacating an ex-parte order of injunction granted in favour of WOCKHARDT and against HETERO.

Decision:
After hearing the submissions of the parties and perusing the documents of various proceedings pending between the parties in various courts the Hon’ble Appellate Court held that HETERO itself has submitted in the writ petition presented before the High Court that it is manufacturing the same product which is being manufactured by WOCKHARDT in pursuance of their EMR therefore it is not in dispute that the WOCKHARDT is the holder of the Process Patent and EMR, for manufacture of Nadifloxacin 1% Cream under the trademark NADOXIN and the manufacture of identical Nadifloxacin 1% Cream under the trademark NADIDERM by HETERO is a clear violation of the Process Patent and EMR of the WOCKHARDT therefore HETERO should be prevented by an injunction so as to protect and preserve the WOCKHARDT’s right with respect to the said process patent and EMR. The Court emphasized that the EMR has been granted for a limited period and as long as the same exists in favour of WOCKHARDT the same should be protected. The Court further heavily relied on the experts opinion with respect to the comparison of WOCKHARDT’s process patent and EMR with that of the Otsuka Pharmaceutical’s US Patents and Japanese Patent concerning Nadifloxacin (Benzoquinolizines). Relying on the experts opinion the Court held that HETERO cannot manufacture 1% Nadifloxacin cream with the process disclosed in the earlier granted patents except without following the WOCKHARDT’s process patent. The Court further held that the mere payment of Royalty would not be sufficient to make good the loss which WOCKHARDT would suffer by allowing HETERO to manufacture 1% Nadifloxacin Cream during the pendency of the suit. The Appellate Court eventually reversed the order of trial Court and allowed the Appeal of WOCKHARDT and restrained from manufacturing and marketing 1% Nadifloxacin Cream.

Supreme Court:
Being aggrieved by the order of the Appellate Court, HETERO has filed a Special Leave Petition before the Hon’ble Supreme Court of India which has been admitted and is pending for final hearing.

Pre-Grant Opposition:
In the meantime, HETERO and CIPLA initiated pre-grant opposition to WOCKHARDT’s product patent application relating to Nadifloxacin 1% cream. CIPLA’s pre-grant opposition was heard by the Patent Office and WOCKHARDT’s product patent application relating to Nadifloxacin 1% cream was refused grant. This refusal results in coming to an end of an EMR granted to WOCKHARDT.

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