Patent war – ROCHE v. CIPLA

 

Patent has been defined under the Indian Patent Act as “a patent for any invention granted under this Act.” However for the sake of convenience and brevity, considering the definition of term patent as articulated by Justice Black in the dictionary as “A patent is a legal document which provides protection to the ideas of any individual. Usually issued by the Patent Office of a country, the patent is granted to any firm or individual. Usually, patents constitute of four different classes: Machine (a device or apparatus created by a person for the performance of a specific task, process (a process created by an individual), manufacture (any fabricated or manufactured product) or the composition of matter (any chemical mixture or compound created by a person). Patents can be sued for.”

 

 

ABOUT ROCHE’S PATENT:

Roche claims that on march 31,1991, it filed an application for grant of patent in usa pertaining to Erlotinib hydrochloride, resulting in grant of patent US’ 498 on August 5,

  1. During pendency of its application in USA, on March 13, 1996 it filed an application in India for grant of patent for the same molecule which was granted to it vide IN’774 on February 23, 2007. The marketable physical form of the molecule comprised polymorph A and B. Further research revealed that polymorph b was more thermodynamic and as per Roche would qualify for enhanced efficacy and thus on November 09, 2000. It applied for grant of patent for polymorph B of Erlotinib hydrochloride in USA resulting in grant of patent US’ 221. Similar application filed in India. On February 06, 2002 i.e. Del’507 was rejected.

 

 

AN OVERVIEW OF THE DISPUTE:

This is the case between two pharmaceutical giant over the patent rights infringement. The two companies involved in this case were the F. Hoffmann-La Roche Ltd and Cipla Ltd. Roche had received information from the media in respect of Cipla launching Erlocip i.e. the generic version of Tarceva. Tarceva is a patent registered with Roche. Tarceva (erlotinib) is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body and is used to treat non-small cell lung cancer or pancreatic cancer that has spread to other parts of the body (metastatic).

Based upon the media information, Roche filed a petition before the Hon’ble Delhi High Court seeking restraining injunction to bar Cipla to market the Erlocip. However, this application for injunction was dismissed by Single Bench Judge which was later appealed before the Double Bench Judge and again the same was met with the same fate and the same was rejected. However, this matter received escalation when Roche Filed a Special Leave Petition under Art. 136 of Indian Constitution which was also denied and then it was subjected to a trial.

 

 

Trial:

During the trial a number of issues were framed which were the essence of this matter in order to determine the crux of the case. The issues framed in order to judge the merit of the case were:

  • Whether Roche’s patent stands to be revoked?
  • Whether the Cipla’s manufacture of Erlocip infringes Roche’s patent?

The first question in order to frame the solution for the issues raised the court had to answer certain questions one of which being the test of invention i.e. is compound of Roche really an invention in real sense?

Defence by Cipla: In respect of the first issue, the observation of the judiciary was peculiar in terms of its technicality. The Single judge observed that the Roche IN 774 was in no way an inventive step. Cipla in this issue had contended that the IN’774 in the prior art was similar to EP’ 226 as both depicted similarity materially. This issue was dealt with perfect technical specifications of both the elements. It was brought on record that the specifications of IN’774 did not in any way prove the essence of patent i.e. it being invention involving inventive steps as defined in Section 2(ja) of Indian Patent Act, which led to come up to an inference that IN’ 774 was not an invention but a mere combination.This issue frames was answered by hitting unto the technicalities of the chemical. Cipla had brought in to the picture the difference between the IN’774 and EP’226 i.e. was the substitution of a methyl group with ethynyl at the third meta (3‘) position.

 

Defence by Roche: However Roche used the concept of “inhibitory concentration” as their defence and highlighting that the inhibitory concentration of IN’774 was in no way similar to EP’226 since the latter one was not in top five nearest necessary to the former. Roche highlighted unto the defaulted chemical composition brought before the court by Cipla. It highlighted the difference bond angles, bond strengths and bond lengths in comparison to its invention.

 

Observation of the Judge:

Upon application of natural justice of “Audi Alteram Partem”, the Single Bench Judge was convinced over the fact that in case of pharmaceuticals no hypertension approach can be adopted and relying upon the case of Biswasnath Prasad Radhey Shyam v/s Hindustan Metal Industries, cast the opinion that “person skilled in an art” as a competent craftsmen and a skilled worker but nothing further. Further the court sought reliance on the decision by courts of English and Wales i.e. the case of Dr. Reddy’s laboratories(UK) Ltd. v/s Eli Lilly& Co. Ltd as the position expressed in reference is consistent with the Indian Patent Act. The learned Judge in this case sorted the list of ingredient in order to qualify the test of patent i.e. the invention must be a technical advancement in comparison to the existing one and that the invention must not be an obvious to a person skilled in art and that both need to qualify conjunctively. The Modern Law of Patents to create a matrix of material facts required to be shown by a defendant to prove obviousness in a revocation inquiry:

  1. The selection of the impugned invention is taken from the examples

of the known prior art.

  1. That the selected invention is not far removed from the known range illustrated in the example. Rather, the same is closer to the known range.
  2. That the selection area is not on the basis of any purpose of the inventor and is merely an arbitrary picking up the compound.

 

Therefor upon total consideration the Single Bench Judge was of the view that Cipla has failed to establish sufficiently in order to seek order of revocation of the patent. The defendant had failed to substantively prove that the invention of the Roche was a mere “a new invention to an old one” and therefore the necessary orders under section 3(d) of Indian Patent Act could not be sought and consequently passed.

Cipla had further argued that Roche had acted maliciously by concealing and supressing essential and mandatory information from the Controller which was again met with a fate as the court sought reliance on the landmark case of Chemtura Corporation v. Union of India, wherein it was strictly held that  disclosure of information will be a firm ground to seek revocation, and the contrary does exist was the view of the court in the case of Roche.

 

Cipla‘s infringement case was based on the claim that IN’774 is a mix of Polymorphs A and B of Erlotinib Hydrochloride but Tarceva is just Polymorph B, which corresponds to US’ 221 (and the rejected DEL’ 507). In the absence of clinical tests on record by Roche to compare the constituents of Roche‘s and Cipla‘s drugs and specifically whether Roche‘s drug corresponded with the Claim 1 of IN’ 774, it is crucial that Roche merely led evidence to show that Cipla‘s drug was also Erlotinib Hydrochloride and claimed that manufacture of Polymorph B by Cipla was sufficient to trigger infringement of Claim 1 of IN’774. (Clearly, it flows in sequitur that any process involved in making Polymorph B would first involve the preparation of a combination of Polymorphs A and B; even US ‘221 states that Erlotinib Hydrochloride in Polymorph B form results from re-crystallization of Erlotinib Hydrochloride using different solvents and temperature conditions).

 

CONCLUSION:

This was a case which involved extensive arguments because of two primary reasons, one being that it was a war over intellectual property rights between two giant pharmaceuticals and secondly it was a case of grave technicality. There was a reliance of a catena of judgement. The court established the case of constructive purposiveness (where the claim in invention contains some part or variants of products infringing the rights) by seeking reliance on the case of Catnic Component Ltd.& Anr v. Hill and Smith Ltd., where the concept of constructive possessiveness was extended to chemical compounds as well.

 

Written by Sarvesh Giri

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