If the rejection of the patent application of Novartis for Gleevac (imatinib mesylate) early this year was any kind of indication for the things to come, then the number of patent applications rejected consequent to pre-grant opposition proceedings should not be much of a surprise. The rejection of Wockhardt's application for its drug Nadoxin (nadifloxacin) (No.308/MUM/1175) on May 18, 2006 [Wockhardt Ltd vs Cipla Ltd 2006 (32) PTC 261 (P.O.Mum.)] will be remembered more for the manner in which it evoked similarities within the Novartis case if not for anything else.
Like Novartis, Wockhardt too was successful in obtaining an Exclusive Marketing Right (EMR) for its drug. And as in the case of Novartis, Wockhardt had to approach the court to enforce its EMR and to stop its competitors. Unfortunately, for Wockhardt the similarities continued down to the tee as the Patent Office rejected the patent for Nadoxin citing similar reasons.
A deluge of litigation
The Nadoxin episode illustrates the alarming frequency at which parties had to approach the courts for relief. Wockhardt had to file a writ petition before Delhi High Court making the DCGI in connection with a grant of licence to manufacture nadifloxacin 1% cream. The licence was later granted for manufacturing nadifloxacin 1% cream by the Controller General of Drugs. After Wockhardt had made an application for a product patent as per sub-section (2) of section 5 of the Patents Act, it was granted EMR for Nadoxin. One of Wockhardt's competitors, Hetero Drugs Ltd, filed a writ petition in the Bombay High Court challenging the constitutional validity of the grant of EMR and sought an order to restrain Wockhardt from taking any action based on the said EMR and prayed for the revocation of the EMR granted. With the grant of EMR for Nadoxin, Wockhardt moved the court for restraining its competitors. Hetero was manufacturing nadifloxacin 1% cream under the trade name Nadiderm which was licensed from patents in the US and Japan. An ex parte order of injunction was initially granted but was later vacated by the High Court. The Single Bench of the Madras High Court was of the prima facie view that Hetero could not be injuncted from manufacturing and marketing Nadiderm on the strength of the manufacturing licence given by the Controller General of Drugs and by the fact that the product of the competitor was manufactured and marketed based on the US and Japan patents [Wockhardt Ltd vs Hetero Drugs Ltd 2006 (32) PTC 473 (Mad)].
On appeal before the Division Bench of the Madras High Court, the order of the Single Judge was reversed. The Division Bench based its reasoning on the fact that no material was produced by Hetero to show that the product was manufactured and marketed by adopting the US patent and the Japan patent. It also stated that the patent documents relied upon by Hetero did not show the product in the form of a cream, which was the subject matter of EMR [Wockhardt Ltd vs Hetero Drugs Ltd 2006 (32) PTC 65 (Mad) (DB)].
The matter was taken to the Supreme Court where the order of injunction granted by the High Court was modified and confined to the manufacture of Nadifloxacin cream 1% only [Hetero Drugs Ltd vs Wockhardt Ltd 2006 (32) PTC 479 (SC)].
Order of the patent office
The order of the controller disposing the patent application of Wockhardt on merits is surprisingly brief. The invention pertained to a pharmaceutical composition (topical cream formulation) containing racemic benzoquinolizines and optical active benzoquinolizines (nadifloxacin) for the treatment of mupirocin-resistant bacterial infections and diseases and disorders caused by mupirocin resistant microorganisms wherein the % w/w ratio of the active component is 0.1-10% along with pharmaceutically acceptable carrier to form a cream.
The controller observed that pharmaceutical composition of racemic nadifloxacin and its antibacterial activity in the form of oral, parenteral and topical form is disclosed and taught in US Pat No 4399134 (Publication date: August 16, 1983) and US Pat No 4552879 (Publication date: November 12, 1985). The optical active benzoquinolizines [S(-) nadifloxacin] which is twice as active as racemic nadifloxacin [RS (+ -) nadifloxacin] against gram positive and gram negative bacteria is also reported.
Section 3(d), it was observed, made it clear that the invention was a mere discovery of the new property or the new use of racemic benzoquinolizines. Hence the invention was disclosed and was not an invention under section 2(1)(j) of the Patents Act, 1970. It was also observed that certain documents showed the use of cream based nadifloxacin composition whose launching date was before the priority date claimed by Wockhardt. In response to this finding Wockhardt had not rendered its reply. Hence, the controller concluded that nadifloxacin based cream compositions existed already and was in public use before the priority date claimed by Wockhardt and the novelty was anticipated by prior use and prior publication.
The importance of section 3(d)
As expected, section 3(d) was the main ground on which the patent application was rejected. The introduction of section 3(d) is a significant step, which would check the claiming of patents for new forms of known substances and for new properties or new uses of known substances. As there are more than 7000 applications pending before the Patent Office, much of which is believed to be for claims covering pharmaceutical substances already in use, the proper application of section 3(d) can have far-reaching consequences. It is for this reason Novartis has recently challenged the constitutional validity of section 3(d) before the Madras High Court.
Courts as the final arbiter
Ultimately it is the order passed by the Patent Office which becomes the subject matter of challenge before the courts. As it was seen in the case filed by Novartis challenging the order of the controller of patent rejecting its patent for Gleevac, the order was challenged on many grounds including the one that the controller had not passed a reasoned and detailed order, it becomes all the more important to strengthen the case at the first instance so that it may stand the challenges that may come its way later. Citing references on point of law is one aspect that will be well-appreciated by the courts. It is to be noted that appeals from an order of the controller are entertained primarily on points of law. The order of the controller can be challenged on many legal grounds including the ground that the principles of natural justice were not complied with in giving a reasoned order. For the moment, the appellate machinery (Intellectual Property Appellate Board) is not entertaining appeals from the controller. Hence, the immediate remedy lies in invoking the writ jurisdiction of the High Courts.
Though patents may involve complex technology and scientific facts, the final finding with regard to its validity will rest with the courts of law. Howsoever complicated the technology may be, in the existing scheme of things, it is the higher judiciary that will sit as a final judge in deciding disputes pertaining to patents. As the fate of a patent, so to say, will be decided by the court of law manned by judges strong in legal learning but new to scientific advancements, it casts a duty on the professionals appearing before the patent office, especially in pre-grant opposition proceedings, to adequately equip the controller to pass a reasoned order based on the well-establish legal principles governing patent law.
(The author is an advocate, Madras High Court. Feedback to fak@dataone.in)