Wednesday, December 29, 2010

An Old Pharma Decision: Bombay High Court (1968) - I

It is not often that one gets to read an Indian decision in a suit for patent infringement, where the Court has gone at length to apply principles of claim construction to the subject-matter of the patent (when the practice these days is to limit the “analysis” to mere regurgitation of case law on principles of grant of interim injunction...).

The decision I refer to is the one delivered by Justice Vimadalal of the High Court of Bombay in 1968 in the case of Farbewerke Hoechst & Bruning Corporation v. Unichem Laboratories & Ors (AIR 1969 Bom 255). The decision is a must-read for those interested in Indian patent litigation for several reasons, the first of which, as mentioned above, is clear elucidation of principles of claim construction by an Indian Court.

The second is the application by the Court of Section 114 of the Indian Evidence Act, 1872 to presume infringement of a process patent, in the absence of proof to the contrary.

And the third reason happens to be a happy coincidence for me; it just so happens that the counsels for both the Plaintiffs and the Defendants in the decision are now familiar names thanks to my recent reading of Mr.Fali Nariman’s autobiography “Before Memory Fades”, in which all the counsels in the matter and the Hon’ble Judge find more than just a passing mention.

This case also happens to be one of the precious few IP matters in which Mr. Thomas Anthony Blanco White, Queen’s Counsel and one of the best-known IP (particularly trademark) exponents of his time, appeared before an Indian Court. Given the quality of the counsels who appeared in the matter, it hardly comes as a surprise that the judgment makes for such an enlightening read.

Since the judgment is elaborate in its analysis, I shall discuss it over a series of posts to do justice to it (and to ensure I don’t bore readers to death with my constant droning...)

In a nutshell, following are the details of the patent of the Plaintiff/Appellant, Farbewerke:

Date of Filing: 23.10.1956 (dd/mm/yyyy)
Date of Acceptance/Grant: 07.11.1957 (Just over a year from the date of filing, record time!)
Patent Number: IN 58716
Invention: Manufacture of new sulphonyl-ureas, salts of those compounds and of anti-diabetic preparation containing such compounds

The plaintiff/patentee Farbewerke alleged infringement of its patent by the defendants' act of manufacture of “Tolbutamide”, an anti-diabetic drug which was claimed in Claims 1 and 11 of the plaintiff’s patent, and which the Plaintiffs had been selling internationally under the trademark “Rastinon”.

The defendants on their part claimed that the drug sold by them was indeed Tolbutamide, but was manufactured using a licensed process claimed in another Indian patent 64323 owned by the Haffkine Institute of Bombay (This was a time when there were no products patents for pharmaceutical substances under the erstwhile Indian Patents and Designs Act, 1911. In fact, under Section 2(8) of the Act, “invention” was defined as any manner of manufacture, including an improvement)

The defendants also claimed acquiescence and delay on the part of the plaintiffs because, although the latter were aware of manufacture of the drug in dispute by the defendants in March 1960, the suit for infringement was instituted only in April 1962.

Delay/Inaction by the Plaintiffs

The Court opted to first deal with the issue of acquiescence and delay; it took the view that delay may have come to the aid of the defendants had this been the interlocutory stage. Since the relief sought was that of perpetual injunction, mere delay would not deprive the plaintiffs of their right to secure a perpetual injunction. For that to happen, the defendants were required to establish that the delay/inaction had prejudiced the defendants significantly.

Since no such prejudice had been made out by the defendants in the instant case, the Court decided the issue of delay in favour of the plaintiffs/patentee.

Infringement- Burden and Onus

The defendants contended that since no evidence had been led to establish that the process employed by the defendants was indeed the patented process of the plaintiffs, no case of infringement of the plaintiffs’ patent had been made out.

To this, the Court drew inspiration from Section 41(2) of the Canadian Patent Act, which laid down that in an action for infringement where the invention relates to the production of a new substance, any substance of the same chemical composition and constitution shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process which it is alleged to have infringed.

The Court observed that although there were no equivalent provisions in the then existing Indian Patents and Designs Act, it was available for the Court to apply the general provisions of Section 114 of the Indian Evidence Act, 1872, which in a way provided for reversal of burden of proof (reflected in Section 104A of the Patents Act, 1970 as it stands today).

Applying Section 106 of the Indian Evidence Act, the Court observed that since the process of manufacture of the defendants’ drug was within the “special knowledge” of the defendants, it was only proper that the defendants disclose the process of manufacture to counter the allegation of infringement.

Claim Construction

Specifically, the infringement alleged of in the case was of claims 1 and 11. On how a patent specification must be read in a case of infringement, the Court stated thus:

“It is, therefore, clear that, in an infringement action, the main function of the court is to construe the claims which are alleged to have been infringed, without reference to the body of the specification, and to refer to the body of the specification only if there is any ambiguity or difficulty in the construction of claims in question.”

As to how the Court meticulously went about understanding the science of the invention before forming an opinion on the issues in dispute, I’ll deal with in the next post...

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