It’s Déjà vu For Cipla: Patent Office Revokes Another Granted Patent

Written By: Rosalin Dhal

Historic Recurrence is a Natural Phenomenon. When Supreme Court cancelled Novartis’ Patent on Glivec, it was clearly a tragedy for the latter and was expected to create a farse for the other branded drug-makers. But no one would have thought that a small hail-ball will groom into a full-fledged snowball so quickly. A patent granted to the German pharmaceutical company “Boehringer Ingelheim” on Spiriva, an asthma drug by the Controller General of Patent, Design and Trademarks has been revoked on an opposition filed by Cipla, the old player of “generic” arena. The Indian patent office on the application by Cipla, revoked the granted patent on the ground that it failed to demonstrate therapeutic efficacy and is not an invention as per section 3(d) of the Indian patent Act 1970.

Indian patent law prohibits grant of patent to new forms of known substance, unless the new form results in enhanced efficacy of that known substance. The efficacy is therapeutic efficacy that can be proved with the help of conducting clinical trials. Under the brand Spiriva, BI (Boehringer Ingelheim) sells the crystalline salt form of tiotropium bromide monohydrate, which is effective for treatment of pulmonary diseases.

Two years ago, the outcome of the Novartis case had determined the position of patenting new forms of known drugs in India. Novartis appeal petition on patent application of the beta crystalline form of imatinib mesylate, was rejected by the Supreme Court. The court had then contended that section 3(d) of the patent act is a safeguard introduced by the parliament in 2005 to prevent Evergreening. Evergreening is a practice adopted by pharmaceutical companies to extend their monopolies over a drug by patenting new forms of existing substance.

Cipla, India’s fourth largest drug maker who opposed the patent Spiriva has been marketing tiotropium bromide monohydrate under the brand Tiova since year 2003. Cipla must have breathe a sigh of relief on the revocation of BI’s Spiriva patent as it paved way for it to continue selling its brand in the Indian market. The contention of BI that the crystalline salt of tiotropium bromide monohydrate is more stable was questioned by Cipla on the ground that it didn’t demonstrate any significant change in the therapeutic efficacy to which the Patent Office has agreed. Apart from Novartis, this January, even Abbot found itself in a fix when its drug Humira was revoked by the Patent Office after Glenmark objected to the patent Grant before the Delhi High Court. To further substantiate the observation made with respect to this trend, our readers must be familiar with Cipla’s request for revocation of five patents owned by Novartis and the grant of compulsory license to Natco, ordered against Bayer Pharma.

This trend sets a clear message to the world that the US’s axiom of “anything under the sun can be patented” is not acceptable in India. Most importantly, even grant of a patent doesn’t guarantees that the protection will remain unhindered throughout the next twenty years. But what is important is to make sure that in a bid to prevent “evergreening” of Patents, the government doesn’t ends up setting the threshold so high that it starts acting as a deterrence to the major drugmakers from selling drugs in India. A balance has to be struck between the needs of the people vis-a-vis the market interests of branded drugmakers to allay the concerns raised by such decisions.

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Woodland Receives a 'Woody' Cane From Consumer Forum

The recent judgment delivered by the Delhi State Consumer Forum against woodland is an eye opener for entities operating in single brand retail. In a short judgment, the forum reprimanded woodland by imposing a fine of INR One lakh for selling goods of a brand other than its own without giving consumers any intimation about the same. The observation with respect to unfair competition was in addition to the court’s assessment of the situation. As per the facts of the case, the defendant refused to collect goods back from the complainant after they were found faulty, which compelled latter to knock Consumer forum’s doors. However, the whole scenario surfaced only when the customer observed that not only the goods were faulty, they also didn’t belong to the brand woodland, which lead the court to opine that woodland has also resorted to unfair trade practice.

Unfair trade Practices is a wide term that is used to denote numerous activities that run contrary to the fair trade norms and thus effect the consumers in a negative manner. Both the Competition Act 2002 and the Consumer Protection Act 1986 are concerned with consumer interest. The basic difference in both these Acts lies in the kind of protection accorded to the consumer, which can be inferred from the definition of consumer under the two legislation. Definition of consumer under Competition Act is quite wide and includes a person who buys goods and services for commercial use also. But consumer's definition under consumer protection law is limited to person who buys goods and services only for personal use. But when the relief sought is concerned with the market as a whole, only Competition Commission of India (CCI) has the power to decide. While the CCI aims at both competition and consumer interest, the consumer forum is only concerned with individual consumer interest.

India follows a very strict FDI policy for both single and multi-brand retail. After the recent political fuss about UPA government’s decision to increase FDI limit in muti-brand retail and its vehement opposition by the current government (then in opposition), the desired change seems pretty unlikely for now. Though India has cleared the road for foreign brands by allowing 100% FDI in single brand retail four year ago, it has deliberately created some potholes to ensure that MNCs don’t surpass their Indian counterparts that easily. One of the conditions as per the press note obligates MNCs to sell only single brand goods, which means that they cannot sell any other good even if it is manufactured by them only. The current case is a fine example of the said policy wherein the defendant Woodland was selling its own good under the brand ‘Woods’ without procuring necessary permission from the government, thus subverting the interest of other competitors.

Albeit, the current NDA government has given some indications about easing the norms for foreign entities to do business in India, it is still unclear as to what extent it will divert from its own election manifesto wherein it had accredited its stance on FDI policy to be one of its major reasons behind its poll victory.

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And This Time santabanta.com is Not Joking!

Written By: Avasi Mohanty

Bollywood is widely known to be the breeding ground for Masala. Most of this “Masala” is not only limited to gossip, disputes and patch-ups, but also to several legal snags that keep hopping up due to some reason or the other. Intellectual property squabbles nevertheless are the most popular ones.

Filmmakers and producers are often accused of trademark and copyright infringements which easily acquire center-stage because of the sheer media attention they get. In yet another major instance of trademark violation, popular humor and Bollywood website Santabanta.com has filed an infringement suit in the Delhi High court against Cinetek Telefilms Pvt. Ltd. and Viacom18 media’s movie “Santabanta Pvt. Ltd.” which will feature Boman Irani and Vir Das in lead roles. As per the news reports, petitioner has sought court’s decree for permanent injunction against the release of the movie and is also claiming damages along with movie credits for the infringement. The court, however, has not granted an injunction so far. The director of Cinetek Telefilms on the other hands, claims to have made the movie under a valid license from Motion Pictures Pvt. Ltd and it remains to be seen if latter has a better right over the usage of the mark as compared to the plaintiff. As per the recent order released on 27/02/2015, there is a possibility that the matter will be resolved between the parties through mediation.

This is not the first time Bollywood has witnessed a case of violation of trademark rights. Of late, a controversy cropped up when the makers of zandu balm sued producer Arbaaz Khan, for allegedly using their product mark in a popular song of his movie Dabbang. Another popular issue was the “hamara bajaj” case, a hushed up matter where Bajaj auto ltd. filed a suit against J.A.Entertainment Pvt. Ltd, owned by John Abraham for the infringement of their trademark hamara bajaj. The Bombay high court granted a permanent injunction against the defendant and restrained them from using the tagline in the proposed film.

It won’t be hard to conclude that title of a film cannot be a subject matter of trademark if one ponders on the wordings enunciating the essentials of a valid trademark. This is because a trademark distinguishes goods and services of one proprietor from the other and unless this ‘association’ is absent, a ‘mark’ can never qualify for protection as a ‘trademark’. Nevertheless, after decisions from courts based in US and the imitation of their rationales by courts in other common law countries (including India), it is indeed possible to register a movie’s title as trademark. However, the crux of the concept is that it’s comparatively easier to procure registration over titles for series of movie as compared to a single movie because of the differing level of distinctiveness. In case of single movie titles, secondary meaning has to be established to cross the minimum threshold for distinctiveness.

Trademark infringement issues for unauthorized usage of trademarks by movie produces and song makers is bound to create a fuss. With the surge in level of obsession with movies witnessed across the world, copyright and trademark issues are bound to grab the lime-lights. In one the recent blogs only, we had written about a serious copyright claim filed against the directors and producers of movie PK. Amitabh Bachachan’s controversial movie Nishabdh was a subject matter of court litigation in year 2007. Outside India also, a few years back, Disney also filed a trademark infringement suit for unauthorized use of its movie title FROZEN by the alleged infringer. Similarly, release of a movie titled ‘Age of Hobbits’ was successfully stopped by Warner Bros. for being similar to its ‘Hobbit’ series.

Albeit it remains to be seen how Indian Law evolves further on this point, movie producers and common proprietors are leaving no stone unturned to protect their intangible assets. The market implications of such matters can create a big dent in the pockets of both MNCs and filmmakers. Rampant copyright and trademark violations in the recent decade has revealed the high level of plagiarism in the film-making industry. While it was pretty premature to forbid such attempts on the basis of undeveloped or half bred Laws earlier, court decisions and out of court settlements have made it clear that IP issues cannot be taken lightly.

The fuzzy line between creativity inspired by a work and a banal trait copied from the right of others is not that blob any longer. An equilibrium is thus need of the hour where there is a perfect balance between creativity and inspiration, so as to ensure innovation and competitiveness in all sectors of film-making.

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Delhi High Court Revives Gilead’s Patent Application

In a big setback to the Indian Generic Drug-makers, Delhi High Court has allowed the writ petition filed by Gilead Pharmasset LLC against the Union of India for an adverse order passed against it by the Deputy Controller of Patents & Designs. The Deputy Controller had rejected Gilead’s application for failing to satisfy the criterion under section 3(d) of the Indian Patents Act, 1970 stating that the invention lacks efficacy in the eyes of law. Gilead has developed a drug called Sovaldi (INN-sofosbuvir) which is effective in curing Hepatitis C Virus (HPV). The drug is significant in terms of invention because of its low toxic levels and shorter duration of treatment which gives it an edge over earlier treatments involving Interferons (IFNs) and drug Virazole (INN-Ribavirin). IFNs didn’t had a long lasting effect on the virus while Virazole had severe side-effects like causing anemia and increasing level of toxins in the body. If the stats are to be believed, there are approximately 170 million patients worldwide that suffer from HCV Virus with 18 million being from India only. Gilead agreed to grant license over the drug to seven drug makers in India to fulfill the demand, but the agreed price couldn’t convince Generic Drug-makers and therefore to protect its interest, Gilead applied for patent in India.

The proceedings before Deputy Controller in the Parent Order were invoked under section 14 of the Act because of the pre-grant opposition filed by Natco Pharma and Delhi Network of Positive People (DNP+) that opposed the application under various grounds enumerated in section 25 of the Act. The controller rejected the oppositions that alleged lack of novelty and non-obviousness by taking cue from the approach of authorities in US and Japan with respect to the same patent. However, it accepted their contention under section 3(d) which bars patent-ability of an invention which is new form of a known substance and doesn’t results in enhancement of known efficacy of the substance. It supplemented its assertion by referring to the Supreme Court’s judgment in Novartis v. Union of India case, in which it was stated that efficacy stands for therapeutic efficacy which can be proved by clinical trials. The application was thus rejected. However, rather than filing an appeal before the Intellectual Property Appellate Board (IPAB), Gilead filed a writ Petition alleging violation of Principles of Natural Justice.

The detailed judgment of the High Court came out only on 30^th January, 2015 after the initial order was released on 22^nd January, 2015. But the contents of the detailed judgment are pretty surprising. The ground for violation of Natural Justice raised by the applicant sustained because the Deputy Controller didn’t issued (or may be failed to issue) notice to the applicants regarding the applications filed by the opposers under section 25 of the Act. Not to mention the fact that in his order, it was observed that the controller had significantly copied the contents of the application (Yes… “lifting of para and verse from opponents application” as the order puts is) which technically raised suspicion for bias against the applicants. The High Court thus allowed the writ and remanded the matter before the controller for a fresh decision.

Now it will be interesting to see how the Controller decides this matter. For it had succinctly rejected applicant’s submissions before it without proper reasoning and by taking inferences from a document on record, which it didn’t supplied to the applicants before hearing begun under section 14. The matter will require addressing technical questions like whether change in orientation of a component, which not only satisfies the novel and inventive step criterion, but also enhances the effectiveness of already existing compound is sufficient to satisfy ‘efficacy’ norm of the Patent Law? If no, then what “significant” (as pointed out in the order) level of enhanced therapeutic efficacy is required to satisfy the requirement stated under section 3(d)? Besides, can only reports of clinical trials can prove improvements in therapeutic efficacy or well-reasoned scientific data like cytotoxicity data would also suffice. The controller rejected the rationale of Delhi High Court’s decision in Roche v. Cipla without supplying a proper reasoning for the same. This time, Controller will be required to elucidate as to whether substitution of one chemical group with other is akin to orientation of a compound’s group, given that both result in enhancing the curing ability of the compound?

The case study in hand presents a good example of as to why developed countries lose faith in Indian authorities when it comes to Intellectual Property Rights. First they misuse Public Policy norms to favor small corporations and now they go to the extent of violating Rules of Natural Justice. Union of India has decided to appeal against the order of High Court, of which there is no need. Just because you went till Supreme Court doesn’t means you have done your job. Successful Execution of policies requires balancing the needs of masses with the genuine business needs of the corporates, not biased actions intended to garner accolades from media and high-profile activists.

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The Curious Case of ‘Sorafenib Tosylate’

‘Sorafenib Tosylate’ drug, which is sold as ‘Nexavar’, has hit the headlines once again. Brushing off Bayer Corporation's claims, the Bombay High Court ruled out the German based drug maker's challenge of the Controller of Patents decision to grant compulsory license to Natco Pharma Ltd, a Hyderabad based pharmaceutical company. The court rejected Bayer’s plea and thus declined to intervene with the Controller's original decision. A division bench of Justice M S Sanklecha and Chief Justice Mohit Shah observed that the rights of a patent holder of a drug or medicine should not strip a patient from getting the required medication, and hence the IPAB’s decision was upheld.

Let me recap you briefly. The contenders in the arena are Bayer and Natco. Sorafenib Tosylate, a drug used in the treatment of kidney and liver cancer, was developed by Bayer and Onyx. It was traded under the name ‘Nexavar’. Bayer is a drug invention giant company, based in Germany. In April 2011, an Indian company Natco Pharma Ltd, a generic medicine maker, registered an application with the Bayer, asking for a voluntary license to manufacture and distribute 'Nexavar' in India. The request was refused and hence Natco went to the doors of the Controller of Patents to apply for a compulsory license. According to the new WTO rules, the then Controller of Patents, Mr. P.H. Kurian, on March 9th, 2012 granted Natco permission to manufacture generic version of Nexavar in India. This judgment was a landmark in the history India’s Patent Law, as it became the first ever case of compulsory licensing in India. Surely this news broke all grounds, and Bayer was shown a cold cheek.

The Controller General (CG) ascertained three reasons to justify its decision. Firstly as Bayer provided Nexavar only to 2% of the total cancer patient population in India, public requirements were far from being met. Secondly, the pricing of the drug at Rs.2.8 Lakhs was exorbitant and this was suffice to say that it was not a “reasonably affordable” price. And lastly, it stated that Bayer has not shown proof of the patented invention being “worked” in India.

The order is completely justified. While it’s a well-known fact the treatment process of cancer is extremely expensive, Bayer Corporation's tactics of pricing the drug at a whooping Rs.2.84 lakhs does no good to those in need. Given the fact that Bayer has invented this breakthrough drug, I would place it on record, that, Natco is the Robin Hood to all those people counting hopes and days by making the drug available at Rs.8800. I mean, what good is a drug if the one who needs it can't afford it? India is a country where millions still go to sleep hungry, as the food produced does not reach everyone. At least we can expect the medicine to be available to almost every patient who needs it. With Natco now free to manufacture and distribute the drug, there’s another reason for Cancer patients and Natco to celebrate this Diwali!

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Monaco ne peut pas être une marque

                                                      

Being patriotic is one thing and being affectionate about something is different. But in the garb of your patriotism, you can’t just go to the extent of seeking exclusivity over your country name to distinguish your goods and services. The General Court of EU has rejected appeal of Les Marques de (the applicant that replaced Principality of Monaco as proprietor of the trademark) against an order of Office for Harmonization in the Internal Market (OHIM) for rejecting its application for the registration of its trademark ‘MONACO’. Interestingly, WIPO had Okayed the application and forwarded it to EU’s OHIM as a part of its processing of an International Application under the Madrid Protocol. The ground for refusal being lack of distinctiveness owing to the descriptive nature of the trademark for it tend to offer services originating from a geographic territory to which the mark belongs. The only thing that required court’s consideration was to see if the term ‘MONACO’ indeed implies the geographical territory of the same country to the people of Europe or not, of which it found ample evidence. (MONACO shares its boundaries with European Nations like France, but it’s not a member of European Union).

Obviously you can’t trademark a country name. Just imagine a scenario where an American national procures registration for the trademark ‘India’ and starts sending legal notices to proprietors all over the United States who are using the term merely to designate the source of their products. From a legal point of view, such a mark would inherently lack distinctiveness and would always create impression in customer’s mind with respect to the geographical origin of the goods and services. The situation however would change if a country name constitutes merely a part of the whole trademark. In such cases there is still a chance of procuring a trademark registration if it can be established that the goods have originated from the country that is mentioned in the trademark. (For Instance, trademarks like INDIA GATE and TAB INDIA are registered with the USPTO) Only if the usage of a country’s name is arbitrary and has no link with the namesake country, a ground for objection can arise on the ground of its being misleading with respect to the origin of the products.

From the news reports, an application for appeal in the European Court of Justice seems pretty likely. From a logical point of view, I think that the applicant should put an end to its quest for registering its trademark for the decision of General Court looks pretty sound.

(I said 'seems' and 'think' because judgment is not available in English and my Estonian not pretty good :P)

The heading of the blog is in French. It means “MONACO cannot be a Trademark”.

-Courtesy Google Translator :P

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PK: A Copyright Violating Farishta!!

The recent outrage against Rajkumar Hirani’s masterpiece ‘PK’ for hurting religious sentiments was struck down as groundless by the Delhi High Court. But just before the Hirani camp could puff out the sigh of relief from its belly, it found itself knocked over by one more legal notice alleging copyright infringement by a Hindi novelist named Kapil Isapuri.

With his usual signature style, Rajkumar Hirani presents PK movie starring the flamboyant Aamir Khan. With a child like curiosity, Aamir Khan was portrayed as an alien with bulging green eyes and Peterpan like ears coupled with his unique expressions that earned the movie “PK” A MUST WATCH! from several film critiques. However, someone had a real bad feeling about it. What makes this outlandish and fun throne movie to fall into the trap of copyright issue is a plagiarism claim by the aforementioned novelist. He has alleged before the Delhi High Court that the movie PK has been stolen and copied from his written novel Farishta. As per the news reports, the petition alleges reproduction of several expressions in form of both scenes and characters directly from his book without taking prior authorization from him.

Reproduction of a work from one form into the other makes it a derivative work and since it carries the protected elements of an original work, permission of the copyright owner’s is necessary. Adaptation of a literary work like a novel into a cinematographic work also falls under this category. From a legal point of view, this kind of scenario portrays a very unique situation wherein courts have to analyze the thin line of difference that drives the Idea-Expression dichotomy. Copyright doesn’t subsists in a mere idea. It subsists in its expression and while comparing a non-literary work with a literary work to figure this out, the task becomes even more difficult. Albeit there is no straightforward formula that can be applied to determine infringement in such cases, the courts generally look for appropriation of ‘substantial portion’ of the original work to determine infringement. Every minute thing like the plot, theme, characters, sequence of events, etc. are compared to establish if there has been an infringement or not. Courts in US and Canada have already started taking expert assistance in such matters and it’s just a matter of time when Indian Courts may also start thinking beyond the Judge’s wisdom to determine infringement in such cases.

Earlier also, book-writer Chetan Bhagat had accused Rajkumar Hirani & co. for not giving him a due credit for adaptation of his novel ‘Five Point Someone’ in the making of movie ‘3 Idiots’. Akshay Kumar’s Namastey London also became subject matter of a copyright infringement case filed by a Bengali producer some time ago. As for now, it’s very premature to comment anything merely on the basis of news reports. Also there are no established  precedents because some of these cases are sub-judice before courts, while some of them never reach their conclusion because of settlements between the parties. While it’s one thing to say that directors and producers deliberately do this for publicity, it’s also true that nobody likes to face the trait and dust of courts in anticipation of making a few more bucks. Besides, when the chances are 50-50, like in current case, out of the court settlement is the best way out.

Written by: Swasti Panda

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From Birmingham, With Love!!

Marcus Tillius Cicero, a Roman Philosopher who lived in an era before the birth of Christ once said that “soil of their native land is dear to all the hearts of mankind”. The concept of Appellation of Origin was devised in the later half of twentieth century, but it would not be wrong to argue that one of the reasons for its uniqueness among all other streams of Intellectual Property lies in the aforesaid adage. Geographical Indications (or Appellation of Origin) have this inherent ability to drive our attention through their unique terminology. Parma Ham, Roquefort Cheese, Georgian Wine, Pinggu Peaches, Solapur Chaddar, Mysore Agarbathi, Bikaneri Bhujia, etc. are a few examples of registered GIs all over the world. These IP Assets are ear-catchy because of their native terminology which sounds very dear to the citizen of that particular country. This blog is also about one such ear catchy GI that has been making news recently.

It’s spelled as ‘Birmingham Balti’. It’s a special kind of curry that is served in a bowl that is shaped like a pressed steel bucket. Now where Birmingham comes in? Actually in UK, many people believe that the dish has its origin in the British town of Birmingham and thus deserves protection as a Geographical Indication. The dish traces its origin in mid-1970s when residents of a locality, most of them belonging to the Pakistani-Kashmiri community, invented this dish through a unique method. The dish was allegedly imitated by many restraunts in UK and gained popularity as ‘balti curry’ or simply ‘balti’. The term balti thus became generic in UK for curry and thus protection has been sought under the name ‘Birmingham Balti’ rather than just Balti. The dish is so popular that it gave the whole city of Birmingham an altogether new identity, Balti Triangle.

The protection has been sought by none other than the Birmingham City Council and if it is able to procure the registration, it would mean that anyone who is using the said method for making the curry must denote it as Birmingham Balti. Unlike Nations where there is a separate mechanism for registration of Appellation of Origin, in European Union, no individual country mechanism is there. Party seeking registration of a GI has to file an application with the EU, which offers protection through its Protected Food Name Scheme. The city council has sought protection under “Traditional Specialty Guaranteed” head which means that only those curries that follow the exact recipe can use the name.

Europeans have been ardent protectors of their talent. Over 1000 names have been protected in Europe as GIs with Italy and France accounting for approximately 500 GIs. United Kingdom lags on this frontier with approximately 60 GIs registered as of now. If granted with the registration, Birmingham Balti will be the first curry in the Europe which will get a legally recognized status.

To or readers who do not belong to the Indian Sub-continent, please note that the term ‘Balti’ is an urdu term which means ‘Bucket’ in English. However, just because a GI has been procured by an association in UK doesn’t means that the word ‘Balti’ will lose its commercial significance. The term Balti is a generic one and just like trademarks, it doesn’t qualifies for protection as an Appellation of Origin. As for Birmingham Balti, it will be interesting to see if EU would espouse the curry. Protecting a particular recipe, which is basically a ‘process’ (a technical term in Patent Law), as an Appellation of Origin would mean that its owner can actually prevent others from making and using the term ‘Birmingham Balti’ for a dish if it is not made in that particular fashion. The implications will be interesting. Just imagine if French Fries gets a GI tomorrow and if its maker at some local fast-food centre couldn’t get the recipe right, he might actually get into a legal trouble. I know it’s far-fetched to argue something like this at this point of time, but we must not forget that famous delicacies have their own parameters and when you try to copy it for your own benefit, you better comply with the said parameters.

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