Case Analysis: F. Hoffmann-La Roche Ltd. & Anr. v Cipla Ltd.

OVERVIEW OF THE CASE

Roche, along with Pfizer as  joint applicants, claimed that it had been granted a patent in February 2007 for, the molecule medically termed as a “Human Epidermal Growth Factor Type- 1/Epidermal Growth Factor Receptor” (HER/EGFR) inhibitor, popularly known as Erlotinib. The said drug was a major breakthrough for the treatment of cancer. The drug was in the tablet form and was sold under the trademark name ‘Tarceva’. The said drug was approved by the U.S Food & Drug Administration and thereafter by the European Union. The Controller General of Patents, New Delhi had also granted patent in respect of Erlotinib with a certificated dated 23rd February, 2007. On the record as per the amendments of 2005 in the patents act Erlotinib stood patented.  The patented product, which Roche introduced onto the Indian market in 2006, was marketed under the brand name TARCEVA.

Meanwhile Cipla Limited (`Cipla), a company incorporated under the Companies Act 1956

And having its registered office at Mumbai announced to launch a generic version of Tarceva(Erlotinib). The news regarding this appeared in an English Daily Mint.

The plaintiff alleged that the drug Erlotinib had been developed after long years of research and enormous expenditure had been incurred and moreover the innovation was protected by law. Henceforth the defendant company had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva (Erlotinib) and that such action of the defendant, as announced by it, would be in blatant violation of the legal rights of the plaintiffs.

The plaintiff had filed a suit for infringement of right on the 15th January 2008, along with it an application seeking ad-interim injunction was also filed. Two major points to be noted at this very stage was that :

• It was stated that the certificate bearing patent No. 196774 dated 23rd February, 2007 recorded in the Register of Patents on 6th July, 2007 pertained to Erlotinib Hydrochloride which was marketed as Tarceva
• In the plaint no details of the specification of the aforementioned patent or the x-ray diffraction of the product (tablet) Tarceva or the defendants Erlocip was indicated

 

RESPONSE OF CIPLA TO ROCHE

In response of the claims made by Roche Cipla replied that

• The generic version of Erlotinib was sold by Cipla under the name Erlocip from October 2007. Also according to the Patents Act, Section 5(2) the right of the patentee accrues only from the date of grant of the patent. Though the certificated gained by Roche Limited was dated February 2007, but the pre grand opposition was disposed off in July 2007 and hence the certificate granted was incorrect.
• Secondly Cipla said that patent granted to Erlotinib was invalid as Erlotinib was a derivative of a known patent ‘Quinazoline’. Also that the composition of Erlotinib was same as that of Quinazoline except for one substitution which was “obvious to any skilled person”. Under Section 2(1)(ta) of the Patents Act 1970 pharmaceutical meant invloving one or more inventive steps and something which had not been anticipated by any document or publication in any country . Meaning thereby that  Roche’s invention, as disclosed in the complete specification and claims was obvious or did not involve any inventive step, having regard to what was publicly known or publicly used in India, or what had been published in India or elsewhere before the priority date
• Thirdly they pointed out that for any drug to be qualified as patentable under Section 3(d) it is essential that one shows that there is “any improved efficacy of the said drug.
• Fourthly, it was specifically averred that “the alleged patented product is nothing but a derivative from Gefitinib of Astrazeneca for which a patent was refused in India” by a decision dated 30th August 2007 of an application of Astrazeneca.
• Fifthly, what Cipla pleaded was public interest. It pointed out that the huge difference in price between Roche’s drug (Rs.4,800 tablet (approx. US$ 100) and Cipla’s drug (Rs.1,600 (approx US$ 33) should be taken into account when deciding whether or not to grant an interim injunction. Cipla strongly argued that because the drug in question was a life saving drug, the public interest issue was an important factor to be taken into account.
• Lastly Cipla contended that that the plaintiff has intently withheld important information regarding the drug and that it is actually a mixture of polymorphs and which is useless for pharmaceuticals.

 

SINGLE JUDGE JUDGEMENT

The single judge in the judgement dated 19th March, 2008 mainly pointed out two important issues with the patent to Roche

1. The claim by Cipla to hold the patent invalid on the ground of obviousness as ‘ Erlotinib’ was a derivative of a know compound and hence the requirement under section 3(d) of the Patents Act was unfulfilled as the ‘increased efficiency’ criteria was also not met forth was out rightly denied by the single judge bench and they held that the plaintiffs contention that is was not obvious for a person skilled in the same art to have replace methyl for ethynyl.
2. The second claim that was made by Cipla which was in public interest and which was accepted by the single judge bench was that the generic version of Erlotinib which was marketed and manufactured by Cipla was actually available for one their price. Moreover this was a life saving drug and the drugs by Cipla was manufactured in India and not imported from elsewhere. The court had to choose between ensuring life saving drugs at a cheap prise and injunction order during the pendency of the trial. The single judge bench very rightly choose the first over the second and rejected the plea of injunction on Cipla as many innocent person who are not even parties to the suit would be unnecessarily affected.

 

FINAL JUDGEMENT

The division bench finally stated that there was no infringement as the patent which was in question was a mixture of  Polymorphs A and B, whereas the drug Tarceva drug consisted of only Polymorph B. The point here to be noted was that Roche had applied for patent of Polymorph B but was denied by the Indian Patent office as it did not satisfy the criteria of Section 3(d) and the test of patentability was not satisfied. Moreover, the court considered the intent of the legislature in enacting Section 3(d) and anti ever greening laws and held public interest above everything. The court realised that in here a life saving drug was in question, and hence the drug which was made available by Cipla was three times less priced than the drug which was manufactured by Roche.

 

CRITICAL ANALYSIS

The main question was whether denying infringement to the drug of Roche was correct or not, as it highlighted ever greening of patent which has been expressly denied under the section 3(d) of the Indian Patent Act.

Section 3(d) “What are not inventions. The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.[1]

If we carefully analyse section 3(d) of the Indian Patent Act we can see that it clearly lays down denial of patent in three circumstances

• Mere discovery: Mere discovery According to the Webster’s Third International Dictionary of the English Language, the expression “discovery” refers to “the act, process or an instance of gaining knowledge of or ascertaining the existence of something previously unknown or unrecognised.” Therefore discovery would mean simply finding out something which is know in the world whereas innovation involves an inventive step.
• New form of a known substance: This would mean that the existence substance is being presented in a different manner or in other words other derivatives of a known substance. This would not be patentable unless it is proved that they differ significantly in reference to efficacy.
• Does not increase efficiency: Meaning thereby that a new form of a know substance will be allowable only when it is shown that they differ in properties and that this difference has led to enhanced efficacy. The efficacy can be in the form of enhanced stability or freedom from specific disadvantages or even perhaps increase in bioavailability but it should not be an eye-wash increment in efficacy but a significant increment[2]

The intent of the legislature behind such a Section was clearly to make Anti- Evergreening laws by restricting obvious forms and substances.

Patent is basically a monopoly right which is given to the inventor as a reward for his hard work and years of research. It is given only when there is an inventor who has invented something useful and non obvious. Patent in India is allotted for a time spam of 20 years after which it is in the public domain to be used. The concept of non obviousness basically men that it should not seem obvious to a person who is an expert in that field.

In the case of Dhanpath Seth& Others v. Nil Kumal Plastic Crates Ltd[3]. where a patent was claimed on the mere fact that the device was made of polymeric material instated of the traditional bamboo material. The court held that there was nothing new in manufacturing a traditional Kilta made of natural material from synthetic material. Similarly in the present case the fact that Roche had derived Polymorph B out of the combination of Polymorph A and B was not an inventive step as the fact that Polymorph B was a more stable form of Erlotinib Hydrochloride was a well know fact to anyone in the same field.

In the present case the application to the Controller for patent on Polymorph B was rejected on the grounds that it did not show enhanced therapeutic efficacy over the closest prior art. Prior art would mean the knowledge existing in the public domain. The existing technologies can be understood to mean prior art. In the case of Garham v. John Deere Co[4]. the U.S Supreme Court had laid down few steps to check whether the patent involves an inventive step or not.

• the scope and content of prior art
• whether there is a difference between prior art and the claim which has been made.
• the level or ordinary skills which is involved in the pertinent art.

The term has no where been defined in the patent act, but the fact that it was common for a person who is an expert in the field would be sufficient to make the claim fall under the connotation of prior art.

The intent of the legislature behind inserting an anti- Evergreening section in the Patents law was to do away with the practice in the medical field where the pharmaceutical companies had a habit to change a small component and gain the patent again, after the expiry of 20 years of the patent term. Patent law provides monopoly to the inventor but it’s not that it gives one a complete monopoly rather it is a restrictive monopoly. Evergreening methods which are used by the industries involve:

• Meaningless creation next generation Drugs and then patenting it as a new application.

The pharmacy companies have tendency of making inconsequential changes to the existing drug and then basically creating an Evergreening of patent on that drug. In the present case also the fact the application for patenting Polymorph was rejected by the Controller Authority was because of the reason that it was subsumed in the patent of Polymorph A and B that Polymorph B was also included a separate application for the same was not needed as it would then amount to Evergreening of an already existing prior art.

The Controller of Patent had rejected the patent application dated 2008 as the applicant had failed to provide comparative data compared to prior art U.S.498 to show any enhancement in the therapeutic efficacy of the polymorph B. Even for the stability and bioavailability they claimed, no data was provided vis-à-vis the prior art U.S.498 compound. This was also seen in the case of Asian Electronics Ltd. v. Havel’s India Ltd.[5] where the patent  could not be sustained as being an obvious one and that it did not show any difference in the efficacy hence being hit by the exception under Section 3(d)

In the present case the court quoted that “A mere difference in physical property is a well known conventional variation of the same pure substance not showing unobvious properties. Therefore, the changes alleged by the applicant are in the physical properties and not in the therapeutic efficacy. This clearly amounts to Evergreening tendency which has been denied by Section 3(d).

Section 3(d) basically keeps a check on the over ever-greening as it in turn affects the public health of a country, as the manufactures may charge heavy prices which are not affordable by the public at large and still continue to enjoy their monopoly and this is completely against the concept of patents. In the present case also it is quite evident that the drug which was being made available by Roche was three times more expensive than the drug which was available by Cipla. While granting patent and passing injunction orders what is more important to see the public benefit at large. In the present case the drug was a life saving drug which was being manufactured in India and at a comparatively lower price and hence the claim of infringement was rejected.

It is not that a newer version of an already patented drug is not patentable in India it’s just the fact that if the newly developed drug gives better performance to the existing one then it is patentable. But this enhanced efficacy has to be proved experimentally only then will the patent application be eligible for its acceptance. Section 3 (d) promotes subsequent expansion of existing chemical substances, compounds, technologies which are helpful in fulfilling the health requirement of the public and balance public goods.[6]

In the case of Novartis Ag v. Union Of India & Or[7]s it was seen that Section 3(d) was interpreted as to the therapeutic efficacy of the drug and not just the improvements in the physical characteristics or stability of the product. Similarly in the present case also there were signs of only improvement in stability and the physical composition of the drug however there were no statistics which were presented before the court which showed that there is any improvement in efficacy in the drug usage.

The main contention which was raised in the case of Novartis Ag v. Union Of India & Ors [8]was that Section 3(d) ought to be removed as it was against the TRIPs agreement. But what the court instead said was that the main aim of the patent system is to provide benefit to the inventor for a period of 20 years but restrict the expansions of such term once the term has expired. The Court said that the Amendment was intended to:

• Preventing ever-greening;
• To provide easy access to the denizens of this country for life saving drugs; and
• To discharge their constitutional obligation of providing health care to its citizens.[9]

What is to be noted in the present case and in cases which involve the drug is that Right to health is a cause of concern in major parts of the world specially Africa and Asia and in such situations price plays a major role. If the price of these life saving drugs are allowed to be fixed at a higher rate by allowing monopoly and not restricting Evergreening then companies like Roche will keep on creating drugs which are thrice as expensive as that which was created by Cipla. In such cases what is of most important is public concerns which are to be given a upper hand.

 

CONCLUSION

The amendment of 2005 showed that India has adopted an IP regime that showcased the spirit of WTO, but at the same time keeps a provision for prohibiting ‘Evergreening’ by making available expensive medicines available at nominal rates by encouraging market competition. What has been showed by the Indian judiciary through cases like Novartis and Cipla is that Section 3(d) is acting as a guard against Evergreening of patens as the pharmacy companies have a habit of simply changing just one component which does not in any manner change the efficacy of the product and re apply for product, this basically restricts the research and development pace and leads to the downfall of the country. Secondly what has been made clear through these cases is that while granting and considering patents applications what will be of at most importance is the Public benefit at large. Had the patent been granted to Roche by the Controller of Patent in New Delhi then the medicine for treating Cancer would have been out of reach for numerous patents because of the cost of the medicines.

Patent laws in India encourage inventions but are against providing absolute rights, they provide a restrictive right whereby encouraging more research and development and development of better medicine in the market.

[1] India Patents Act, 1970

[2] http://www.ip-watch.org/2007/06/01/scope-implications-of-section-3d-of-the-indian-patents-act-1970-as-amended/

[3] AIR 2008 HP 23, MIPR 2008 (2) 370, 2008 (36) PTC 938 NULL

[4] 383 U.S 1(1966)

[5] 2010 (44) PTC 66(Del.)

[6] Kant A, Section 3(d): ‘New’ Indian Perspective, Journal of Intellectual Property Rights, 14 (9) (2009) 385-396

[7] Civil Appeal No. 2728 Of 2013

[8] Civil Appeal No. 2728 Of 2013

[9] Novartis Ag V. Union Of India & Ors