Monthly Archives: September 2012

Roche v Cipla: Part 1: Validity of Patent

In continuation of our previous post here, and following the availability of the 275 page judgement, we would discuss herein the various facets of the case and discuss one by one. This case actually involved two main issues as follows,

Issue I. Whether Roche’s Indian Patent 196774 is invalid (liable to be revoked under S. 64);

Issue II.  Whether Cipla’s manufacturing, marketing and sale of Erlocip infringes the Patent IN196774

Let’s first discuss the issue of the validity of the IN’774 patent (which runs up to 181 pages of the judgement!)

The defendant (Cipla) prayed for revocation of the IN‘774  patent by way of counter claim on the grounds mentioned in S. 64 of the Indian Patent Act, namely, obviousness (lack of inventive step), anticipation by prior publication and prior claim, insufficient disclosure, false representation, violation of section 8 and section 3(d).

Out of these, the obviousness ground was discussed and argued in detail by Defendant and Plaintiff.

GROUND OF OBVIOUSNESS (LACK OF INVENTIVE STEP)

According to Cipla, arriving at the IN‘774 patent is obvious to the person skilled in the art.  The structure of Erlotinib Hydrochloride as claimed in IN‘774 is:

IN‘774

IN‘774

And the structure of the compound identified as ‘Lead Compound’ by Cipla for their arguments on obviousness analysis is the one disclosed in EP’0566226 (‘226 patent) is:

EP‘226 patent: Example 51

 

EP‘226 patent: Example 51

Cipla contended that substitution of methyl group with ethynyl group at the third meta position would be obvious to a person skilled in the art.

The following points were main points of discussion:

  1. Selection of Lead Compound: Whether Example 51 is the Lead Compound or not?
  2. Motivation to substitute at 3 prime position
  3. Interchangeability of methyl and ethynly groups

1. Selection of Lead Compound: Whether Example 51 is the Lead Compound or not?

Cipla’s contentions:

  • Cipla contended that there is sufficient motivation to do further R&D in the preferred compounds disclosed in EP‘226(patent which is an admitted prior art in the complete specification of suit patent) which discloses a class of quinazoline derivatives having anti-cancer properties.
  • The compounds disclosed in EP‘226 are compounds which are obvious to try permutations and combinations on.
  • EP‘226 discloses 3 preferred compounds amongst which one is example 51 which is the closest prior art.

Roche contentions:

Roche very rightly contended that Cipla has not explained as to how the said EP‘226 will act as a motivation towards arriving at the suit patent invention. Following are some of the main arguments by Roche:

  • Cipla only relied upon the prior arts stated by Roche in their own patent ‘774 patent, all of which disclose -4-anilinoquinazoline derivative compounds possessing anti-cancer properties. Each of these prior arts, EP‘722, EP‘226, EP‘851, EP‘507, and EP‘498 have same core structure and are represented by Markush Structure thus encompassing millions of compounds.
  • The compounds tested in prior arts EP‘722, EP‘851, EP‘507, and EP‘498 were found to have better or similar IC50 values as compared to compounds in EP‘226. The person skilled in the art will in particular look at Example 2(5), disclosed in the EP‘851 which has the IC50 value of 1nm.( Lower the IC50 value, more potent is the drug)
  • Cipla has provided absolutely no evidence to show why EP’226 is the starting prior art as opposed to EP’851. Cipla has selected Example 51 with full knowledge of the structure of Erlotinib Hydrochloride, i.e. the defendant has selected Example 51 as the lead compound purely on the basis of hindsight.
  • EP‘226 discloses 80 examples providing 102 specific exemplified compounds, 32 specifically preferred compounds, 18 claimed compounds and five prominent compounds for which specific IC50 values are given. Example 51 does not feature amongst the five prominent compounds mentioned in EP‘226 for which IC50 value have been provided. Therefore, there is no teaching, suggestion or motivation in EP‘226, regarding any useful properties or potent and promising activity to select Example 51 as the lead compound.

2. Substitution at 3 prime position

Cipla’s contentions: Cipla provides evidence to show that substitution at the third meta position of example 51 can be tried and made following the concept of Bio-isosterism.

Roche’s contentions: Roche contended thatout of all the available substitutions, methyl is kept constant in 3’ position in 80% of the prominent compounds for which specific IC50 values are given and thus the teachings of EP‘226 direct a person skilled in the art that 3’-Methyl should be left undisturbed for good biological activity.

3. Interchangeability of methyl and ethynly groups

Cipla’s contentions

Cipla contended that methyl and ethynyl are interchangeable due to: Bio-isosterism; and Interchangeability of methyl with ethynyl in light of prior arts US’590; EP’700; US’766; US’534.

Roche’s contentions

3’-position in Markush structure (R2) in EP’226 patent stands for 45 different substituents. There is no teaching provided that a person skilled in the art will substitute methyl with only Cyano group and not other 43 substituents as none of the 32 specific preferred compounds include the Cyano substitution.

As far as five prior arts were concerned, Roche contended that these could not be taken into record as they were not disclosed prior to the filing of the Replication to the Counter Claim.

Further Roche contended that of these five patent documents, US’766 and US’534 are not even valid prior arts under Section 64(1)(f) because they were published subsequent to the priority date of the ‘774 patent.

Judge’s Remarks on obviousness

Justice Manmohan Singh rightfully concluded that on the basis of evidence by defendant (Cipla) to establish obviousness, no ground of obviousness is made out under S. 64(1)(f).

GROUND OF VIOLATION OF SECTION S. 3(d)

The onus was on the defendant (Cipla) again to show as to how the plaintiff‘s (Roche’s) compound of Erlotinib Hydrochloride is a new form of known substance.

According to Cipla, Erlotinib is a derivative of Quinazoline, which is known for its anti-cancer activity with no enhanced activity and hence is hit by S. 3(d).

Plaintiff contended that “Quinazoline Derivatives” is a wide class of compounds having diverse uses including non-pharma uses and Erlotinib compound is just one specific compound of this family. Thus merely the term “Quinazoline Derivatives” does not infer that the Erlotinib compound is a derivative (new form) of the known substance.

Roche also provided evidence to show efficacy by way of clinical trials and thus according to Roche even if the said derivative Ertolinib is found to be one of the forms of the EP‘226 patent, still the same being efficacious cannot be presumed to be same substance under Section 3(d). However it could not be proven during cross examination of the expert witness that whether the clinical trials were conducted on the polymorphic form b (which is the marketed product Tarceva) or the Erlotinib compound (comprising both Polymorphic A and B).

The Judge concluded that since Defendant failed to give evidence that Erlotinib compound is a new form of known substance, the ‘774 is not hit by S. 3(d).

GROUND OF VIOLATION OF SECTION 8

A crisp summary of the discussion on this ground is provided herein. The few points are worth mentioning:

1. The IN’774 patent: filed on 13.3.1996; claims combination of polymorph A and B; granted in 2006.

2. The IN’507 application: filed on 1.6.2006; claims polymorphic B version of Erlotinib compound (and which is the marketed drug under name Tarceva); rejected by Controller in 2008 in pre-grant opposition proceedings.

3. US’221 is a corresponding granted patent to IN’507; filed in 2000.

Section 8 mandates the submission of information of corresponding Foreign applications (Form 3) on “same or substantially the same” inventions relating to the Indian application during the pendency of the Indian Application. We have described requirements of Section 8 & Form 3 in detail here.

In this case, the plaintiff did not furnish Form 3 containing information of US‘221 patent. They stated that US‘221 patent is a distinct invention covering different compound. The Judge concluded that since US‘221 patent relates to “same or substantially the same” invention being the polymorphic form B of compound claimed in IN‘774 patent and hence the plaintiff was required to comply with section 8 by providing information of the same. This was the only ground of revocation which was in favour of Cipla.

OTHER GROUNDS

Cipla presented other grounds in its counter claim too, namely

  • Ground of concealments and false representation under Section 64 (1)(j); and
  • Lack of Title/Ownership in respect of plaintiffs

After the detailed discussion on the grounds, very briefly the Judge’s findings are summed up as below:

“The defendant failed to prove that that there were concealments made in relation to the prosecution before the patent office or there is an improper examination done by the patent office. Therefore, the examination and investigation process cannot be called into question by the defendant……..The challenge on the ground of ownership title and other concealments have not been established by the defendant by not discharging the onus casted upon it. No issue was framed. No evidence was led by the defendant.”

FINAL CONCLUSION BY THE JUDGE ON VALIDITY OF THE PATENT

According to Judge,

There lies a discretion in the Court to proceed to revoke or not to revoke the Patent by way of usage of term the word “may” under Section 64 of the Act.”

In the present case, only one ground namely violation of section 3 is made out. However, the inconsistency on the part of defendant and the fact that no other ground relating to the revocation of the patent is satisfied under Section 64, made the Judge to exercise discretion in favour of the plaintiff. The inconsistency of the defendant lies in that the defendant at one instance, to resist infringement, argued that the compounds in US ‘221 and IN’774 are distinct and at other instance to prove violation of Section 8, argued that they are substantially the same.

The Judge thus finally concluded the IN’774 patent to be valid.

In the second part which follows soon, we would discuss the actual issue of the infringement  of the IN’774 by Cipla in detail where the Judge observed that it was scientifically proven that Cipla’s Generic Drug is the Polymorphic Form B which is not Roche’s patented Drug and thus Cipla did not infringe said patent in India.

About the Author: Meenakshi Khurana, Patent Attorney, available at meenakshi@khuranaandkhurana.com

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What’s in a domain name?

The original role of having a domain name was to provide an internet address for computers. With the increasing rate of commercial activities on the web, a domain name is now seen as a way of identifying the business of the company. A potential consumer is always lured to the company after he/she goes through their website. Hence, a company keeps it in mind to obtain such domain names which are easily identifiable and related to their established Trade Marks.

One of the raging crimes in the recent years committed on the web, is ‘cybersquatting’. Cybersquatting is defined as a malpractice where individuals use a domain name reflecting the name of a prior existing company, intending to attain profit from the goodwill of a Trade Mark already belonging to someone else.  Mostly, websites belonging to celebrities or huge companies are at risk. Cybersquatters earn profit in a way that they ride on the fame and reputation already acquired by the company. Additionally, they would ask for higher prices when they sell the domain to the original owner of the domain name. Some cybersquatters also resort to posting derogatory remarks about the personality or the company on their websites, which would only discourage prospective consumers.

Cybersquatting was captured precisely in Manish Vij v. Indra Chugh, AIR 2002 Del 243, where the Delhi High Court held that “an act of obtaining fraudulent registration with an intent to sell the domain name to the lawful owner of the name at a premium”.

The first cybersquatting case under the World Intellectual Property Organization (WIPO) was decided on January 14, 2000.  In World Wrestling Federation Enetertainment v. Michael Bosman, 1 N.C. J. L. & Tech. 3 (2000) the US based World Wrestling Federation (WWF) filed a suit against a California resident who had registered the domain name ‘worldwrestlingfederation.com’ and offered to sell it to WWF at a huge dividend a few days later. The WWF alleged that the domain name in question was registered in bad faith by the registrant in violation of WWF’s Trade Mark. The WIPO held that the respondent’s domain name was identically and confusingly similar to the Trade Mark of WWF and ordered him to transfer it to WWF.

The first case in India with respect to cybersquatting was Yahoo Inc. v. Aakash Arora, 1999 IIAD Delhi 229 where the defendant initiated a website ‘YahooIndia.com which was nearly identical to the plaintiff’s renowed website ‘Yahoo!’ and also provided similar services. The Delhi High Court ruled in favour of the plaintiff and observed, “it was an effort to trade on the fame of Yahoo!’s Trade Mark. A domain name registrant does not obtain any legal right to use that particular domain name simply because he has registered the domain name, he could be still liable for Trade Mark infringement.”

In another instance, in Rediff Communication v. Cyberbooth & Anr. 2000 PTC 209, the defendant had registered a domain name ‘radiff.com’ which was similar to ‘rediff.com’. Holding the view that the value and the importance of a domain name is like a corporate asset of a company, the Bombay High Court decided the case in favour of the plaintiff.

Further, in Tata Sons Ltd. v. Monu Kastrui & others, 2001 PTC 432, the defendant had registered a number of domain names that bore the name ‘Tata’. The Court ruled in favour of the plaintiff and stated that domain names are not only addresses but Trade Marks of companies also, and they are equally important.

On May 15, 2009, in Google Inc. v. Herit Shah, Case No. D2009-0405), Google won a cybersquatting case against an Indian teenager who had registered ‘googblog.com’. The WIPO held that it was confusingly similar and ordered the respondent to transfer the rights of the domain to Google.

The dispute between technology and already existing Trade Mark rights resulted in several legal battles for huge companies like Bennett & Coleman, McDonald’s to name a few. There arose a need for a new legislation to protect domain names and provide remedies against cybersquatters. This also led to the inception of International Community for Assigned Names and Numbers (ICANN) and Uniform Domain-Name Dispute-Resolution Policy (UDRP) who authorized the process of determining disputes regarding domain names. Such an authority was necessary since sometimes it is not even clear who is the owner of the infringing domain name or in instances where the cybersquatter is from another country.

The World Intellectual Property Organisation (WIPO) Arbitration and Mediation Center deals with domain name disputes under the new UDRP which is applicable to generic top-level domain names adopted by the ICANN on August 26, 1999. The WIPO Center’s Domain Name Dispute Resolution service specifically regulates domain name disputes with the e- filing facilities and a well maintained case administration system.

On accord of the Indian case precedents mentioned above, we can see that there is a gaping hole in the arena of cyber laws to prevent cybersquatting. While resolving such disputes, Indian Courts have resorted to the principle of passing off on whether the goodwill of the complainant was endangered or not and whether the marks are confusingly similar.

The menace of cybersquatting has pushed legislatures globally to take serious note of it. The United States enacted the Anticybersquatting Consumer Protection Act (ACPA) to take control of this growing hazard. It is about time India too follows suit and comes up with its own legislation.

About the Author: Ms. Madhuri Iyer, Trade Mark Attorney at Khurana & Khurana and can be reached at: Madhuri@khuranaandkhurana.com

Cipla won the landmark Roche v Cipla Litigation

Indian Generic manufacturer Cipla has won the landmark Roche v. Cipla Patent Infringement case in the Delhi High Court over Cipla’s Generic version of Anti-cancer Drug Erlotinib. The case is the first Patent Litigation in India post India’s 2005 Product Patent Regime which included public interest and pricing issues in addition to India’s Section 3d that prevents evergreening. The case was followed by Pharma Giants worldwide.

Justice Manmohan Singh has passed the judgement in favour of Cipla stating that Cipla did not infringe Roche’s Indian patent IN 196774. According to the Judge, it was scientifically proven that Cipla’s Generic Drug is the Polymorphic Form B which is not Roche’s patented Drug. The complete judgement is not yet available.

Roche sued Cipla in 2008 before Delhi High Court claiming that Cipla’s generic product Erlocip violates former’s Indian ‘774 patent claiming “Erlotinib Hydrocloride”. The trial Judge rejected Roche’s appeal to grant interim injunction restraining Cipla from selling generic version of Tarceva on the grounds of public interest and the fact that there was an ongoing patent revocation proceedings against ‘774 patent. Cipla’s generic version costs about 1/3rd of Roche’s patented drug. Roche’s subsequent appeal to Division Bench also failed when not only did the bench uphold the findings of Trial Judge but also imposed costs on Roche for suppression of material patent information about Roche’s later filed application in India (IN/PCT/2002/00507/DEL). This was the Patent Application which was actually on Polymorph Form B of Erlotinib Hydrocloride but was rejected in 2008 following the opposition filed by Cipla primarily on Section 3d. Cipla argued that Tarceva corresponds to Polymorphic Form B (which is not a product of ‘774 patent but a ‘507 rejected application) and that it is Form B which is more stable and suitable for solid oral dosage form than the compound disclosed in ‘774 patent comprising a mixture of Forms A and B. Roche’s subsequent appeal before the Supreme Court (SC) challenging the order passed by the division bench got dismissed due to the ongoing trial at the Delhi High Court.

Detailed discussion would follow once the judgement is out.

About the Author: Meenakshi Khurana, Patent Attorney, available at meenakshi@khuranaandkhurana.com

The Brand War!

Brands are the biggest source of marketing. A company protects its brands by Trade Marks since they are often the main identity of their business or their key products. If the ownership of the Trade Mark is disputed, it can disrupt the business of both the concerned parties.  A brand operation can undergo huge losses and damages if the brand names of an enterprise are abused by a third party.

The most recent victim of violation of intellectual property rights is FMCG major Britannia Industries Ltd. Britannia is a prominent brand in the bakery and dairy industries. They have achieved revenues in excess of $1 billion. Their products range from bakery, dairy to breakfast options under Britannia Healthy Start brand.

Britannia Industries Ltd. filed a petition in the Madras High Court on the allegation that GlaxoSmithkline Consumer Healthcare Ltd. (GSK)’s Horlicks Nutribic had infringed their brand of NutriChoice Oat biscuits. Britannia’s claim was that the wrapper used by GSK for their brand Nuribic was a replica of Nutrichoice Oat biscuits. It was also alleged that GSK infringed Britannia’s registered Trade Mark Nutribix.

Immediately after the launch of Horlicks Nutribic, Britannia approached the Madras High Court with a stay application for restraining GSK from selling Horlicks Nutribic. In their claim, Britannia said that GSK had adopted a similar packaging style, colour scheme etc. for their brand Horlicks Nutribic to build on the reputation built by Britannia for its Nutrichoice brand, over the past 13 years.

On August 24, 2012, the Madras High Court passed an interim order, restraining GSK, its directors, employees, agents, distributors and retailers from manufacturing, selling and advertising Horlicks Nutribic. Further, they have been restrained from using the trade name ‘Nutribic’.

The sales of Nutrichoice range of products were Rs. 284 crore in 2011-12, compared with Rs. 193 crore for the year before, which marked an increase of around 47 per cent.  Britannia sold 34,603 tonnes of Nutrichoice biscuits during the last financial year. GSK has been simply building on its presence in the biscuits market riding on this enormous reputation and standing of Britannia.

This is not the first time Britannia has been involved in a legal tussle with respect to their Trade Marks. US based Kraft Foods has filed a suit against Britannia for alleged Trade Mark and copyright violation of its Oreo cookie brand. In an injunction suit filed in the Delhi High Court, Kraft claimed that Britannia’s Treat-O snack copied its iconic chocolate and cream-filled sandwich cookie. It further alleged that Treat-O, with an emphasis on ‘O’, was inspired from Oreo and the specific design like florets and etchings was also copied by Britannia.

Another instance of Britannia entering into a legal tussle with a global food company was when Britannia had taken French food company Danone to a Singapore court, alleging Trade Mark infringement of its Tiger biscuit. It settled the case with Kraft since Danone sold its business to the latter.

Another brand dispute was with US cereal maker Kellogg’s where Kellogg’s tried to block Britannia from using the Tiger logo for products other than biscuits. Britannia moved to register the Tiger Trade Mark as its property globally, Kellogg’s objected stating that Tony the Tiger is its proprietary logo for breakfast cereals since 1952. Clearly, Kellogg’s sees Britannia jeopardizing their own brand, as it is using their brand outside biscuits. It is yet to be seen if there was any negotiation between the two parties.

Indeed, it is a never ending battle for any enterprise when it comes to protecting their brands.

About the Author: Ms. Madhuri Iyer, Trade Mark Attorney at Khurana & Khurana and can be reached at: Madhuri@khuranaandkhurana.com