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Delhi High Court Sets-forth the Innovation Assessment: A Case of Patent Rejection for Probiotic Formulation

Case Title: ALIMENTARY HEALTH LIMITED Vs. CONTROLLER OF PATENTS AND DESIGN

Case No.: C.A.(COMM.IPD-PAT) 458/2022

Order on.: MAY 14, 2024

Quorum:  HON’BLE MR. JUSTICE SANJEEV NARULA

Facts:

The prima facie of the case deals represents that Alimentary Health Limited, herein the appellant, applied for a patent in India for a probiotic formulation containing a specific strain of bacteria called Bifidobacterium longum NCIMB 41676 (AH1714). This formulation is proposed to be used in various forms like capsules, tablets, or food products. The Indian patent office rejected their application, stating that the invention lacked an inventive step and was not significantly different from existing knowledge about similar probiotics. The office cited several prior studies and patents involving similar bacterial strains and their health benefits. Alimentary Health Limited responded by amending their claims and providing additional data, but the patent office remained unconvinced. They argued that the specific strain and its formulation did not show enough innovation over what was already known. The company appealed the decision, highlighting that similar patents were granted in Europe and the US and that their formulation had unique and beneficial properties. The case is now being reviewed by the High Court of Delhi.

Contentions of the Appellant

The primary contention of the appellant relied upon their argument, highlighting the point that their probiotic formulation, containing a specific strain of Bifidobacterium longum (NCIMB 41676 or AH1714), is unique and inventive. They contended that the Patent Office inappropriately rejected their patent application by not fully considering their experimental data showing the superior benefits of this strain compared to others. They also pointed out that similar patents were granted in Europe and the United States, suggesting that the formulation meets global standards for innovation. Additionally, they argued that the Patent Office’s assessment relied too heavily on prior documents without adequately analysing how their specific strain differed and offered significant advancements in health benefits.

Contentions of the Respondent

The respondent, i.e., Controller of Patents and Design, argued that Alimentary Health Limited’s patent application for their probiotic formulation was not inventive or new. They claimed that similar strains of Bifidobacterium longum and their health benefits were already known from prior research. The respondent believed that any skilled person could have created a similar formulation using existing knowledge. Therefore, they concluded that the probiotic formulation did not meet the requirements for a patent under Indian law, as it did not show a significant improvement or unique invention over what was already known

Legal Provisions:

Section 15 of the Patent Act, 1970: It empowers the Controller to refuse or ask for amended applications if it doesn’t stand to be satisfied.

Section 2(1) (ja) of the Patent Act, 1970: It defines the term ‘inventive step’ within the context of patent law.

Section 3(c) of the Patent Act, 1970: It outlines what cannot be patented, which includes mathematical or business methods or computer programs etc. or posits a mere discovery.

Issues framed by the Court

  1. Whether the formulation of Bifidobacterium longum NCIMB 41676 (AH1714) demonstrates a sufficient inventive step beyond what is already known in prior art, as required under Section 2(1) (ja) of the Patent Act, 1970.
  2. Whether the claimed probiotic formulation can be considered non-patentable under Section 3(c) of the Act.
  3. Whether the claimed invention falls under provisions of the Act.
  4. Whether the granting of similar patents in other jurisdictions should influence the patentability assessment in India.

Court’s Analysis and Judgement:

In this case, the appellant applied for a patent for a probiotic formulation using a specific strain of Bifidobacterium longum bacteria. Based on the court’s analysis it had to decide if this formulation was unique and inventive enough to warrant a patent. Further, the court looked at whether this formulation was significantly different from what was already known in the field. Despite arguments from both sides, the court agreed with the decision to reject the patent application. They found that the formulation wasn’t different enough from existing knowledge, so it didn’t meet the requirements for a patent. Essentially, the court said that the formulation wasn’t special or new in a way that deserved legal protection.

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Judgement Reviewed By- Shramana Sengupta

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No patent error can be traced in the well-reasoned Award of the Labour Court: Bombay HC

Case Title: Prakash S. Hande Versus Hindustan Lever Limited

Case No: WRIT PETITION NO. 6125 OF 2007

Decided on: 25th APRIL 2024.

Quorum: HON’BLE JUSTICE ANDEEP V. MARNE

Facts of the case

From June 1, 1987, to January 21, 19981, Prakash S. Hande worked as a Clerk/Steno-Typist at Hindustan Lever Limited. Without a formal job contract or letter of appointment, he asserts that he has been working in a permanent position. Hande claims that on January 22, 1998, his services were terminated informally without following the required legal procedures

Issues

1. Whether Prakash S. Hande accrued the 240 days of service in multiple years necessary to be eligible for permanent employee status?

2. Whether Prakash S. Hande’s employment terminated without according to the legal due process?

3. Whether Prakash S. Hande qualified for full back pay upon reinstatement as of January 22, 1998?

Legal Provisions

Article 226 gives the High Courts the authority to give orders, directives, or writs to any person or authority, including the government, within their territorial jurisdiction. These writs may take the form of prohibition, quo warranto, habeas corpus, mandamus, or certiorari. These writs are intended to protect and uphold the rights guaranteed by the Fundamental Rights, which are contained in Part III of the Constitution. Article 227 gives the High Courts the authority to superintend over all courts and tribunals operating within the jurisdictional boundaries of the territory they have jurisdiction over. The High Courts have the supervisory authority to step in when procedures in subordinate courts or tribunals do not follow

Appellant’s Contentions

The appellant may argue that the terms of employment and applicable labor laws were broken by his termination, which occurred without cause and without a valid explanation. He can contend that he should have been granted permanent status and all related advantages, but that he was not. The appellant may claim that the termination procedure did not adhere to the legal requirements for due process, such as the requirement for a fair hearing and written notice. Hande may be able to obtain benefits from the alleged illegal termination, including back pay, reinstatement, or compensation.

Respondent’s Contentions

Hindustan Lever Limited can contend that Prakash S. Hande was not eligible for the benefits of a permanent employee as he was hired on a temporary basis and was aware of the terms of his contract. The employer may argue that any layoffs were implemented in accordance with the law and the provisions of the employment agreement. The respondent may claim that the company’s policies and performance were the basis for all employment choices, including termination. Prakash S. Hande might have been denied reinstatement or back pay because he failed the exams required for permanent employment, according to Hindustan Lever Limited.

Court Analysis and Judgement

The Bombay High Court ruled that the petitioner bears the burden of demonstrating that they completed 240 days of employment in any given calendar year. The petitioner claimed in court that he was fired without following the proper procedures after working as a clerk/steno-typist from June 1, 1987, until January 21, 1998. The petitioner’s reference had previously been rejected by the Labour Court, but the respondent company was still free to extend an employment offer to him if he passed eligibility requirements. The petitioner must demonstrate that they have completed the required number of service days in order to be eligible for benefits under the Industrial Disputes Act, 1947 according to the High Court, which supported this ruling. This ruling emphasizes the significance of documentary proof in disputes pertaining to employment and the duties associated with preserving and presenting such evidence for both employers and employees.

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Judgement Analysis Written by – K.Immey Grace

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Pfizer’s Landmark Victory: Delhi High Court Upholds Patent Rights, Affirms Innovation Protection in Pharmaceutical Industry

Case Name: Pfizer Products INC v. Renovision Exports Pvt. Ltd. And Anr. 

Case No.: CS(COMM) 378/2018 

Dated: May 1, 2024 

Quorum: Justice Sanjeev Narula 

 

FACTS OF THE CASE: 

The facts of the case are so that by requesting a permanent injunction and other ancillary reliefs, Pfizer Products Inc., the Plaintiff, hopes to protect its trademark rights in the well-known allopathic drug “VIAGRA,” which is used to treat erectile dysfunction. The defendants are trying to stop Pfizer Products Inc. from marketing their homoeopathic medicine under the confusingly similar trademark “VIGOURA,” which is purportedly used to treat sexual disorders.  

Pfizer’s primary goal in filing the lawsuit was to defend their common law rights to the aforementioned mark. But later, the scope of reliefs was expanded, and Pfizer also claimed passing off in addition to trademark infringement, after securing statutory rights through the trademark registration of “VIAGRA.” As a result, the case calls into question the cross-border reputation and trademark protection of medications with names that are similar but are used for different purposes—one is a conventional allopathic drug, while the other is a traditional homoeopathic medicine.  

By answering these queries, the Court will decide whether or not the Defendants’ use of “VIGOURA” constitutes a passing of trademark infringement on Pfizer’s “VIAGRA” brand.  

 

CONTENTIONS OF THE PETITIONER: 

The petitioners adamantly maintain that Pfizer is a preeminent international pharmaceutical corporation that is largely involved in the development, production, and distribution of medications for use in human and veterinary medicine. Pfizer was named the “No. 1 Company” by Fortune Magazine in 1998, and their goods are widely available in more than 150 countries.  

Pfizer registered the trademark “VIAGRA” in 1995 for their ground-breaking erectile dysfunction medication, sildenafil citrate. The medication “VIAGRA” was released into the US market in 1998 after the Food and Drug Administration of the United States Department of Health and Human Services approved it on March 27, 1998, stating that it was a significant advance in the treatment of erectile dysfunction.  

It was found by Pfizer that Defendant No. 1, operating under the name Renovision Exports Pvt. Ltd., was using the trademark VIGOURA to sell goods marketed as “Nervine Tonic for Men” and “Homoeopathic Medicine Invented in Germany.”  

Later research uncovered “VIGOURA” product variations, including “VIGOURA 2000,” “VIGOURA 5000,” and “VIGOURA 1000.” Defendant No. 2 is said to be the producer of these items. The defendants received a cease-and-desist letter from Pfizer’s lawyers on February 3, 2005, as soon as they responded to the matter. The first day of March, 2005, a reminder letter was sent.  

On March 11, 2005, Defendants received a response to the aforementioned letters in which they refuted Pfizer’s allegations and reaffirmed their ownership of the “VIGOURA” trademark. Applications for the registration of the marks “VIGOURA 2000” and “VIGOURA 5000” were submitted by Defendant No. 1. 

The petitioners added that. The “VIGOURA” mark of the defendants is confusingly similar to Pfizer’s well-known “VIAGRA” trademark. The defendants’ deliberate endeavour to profit from the goodwill and reputation attached to “VIAGRA” is evidenced by this resemblance. Both marks are similar in that they have three syllables, start with the letter “Vi,” and end with the letter “Ra,” making them phonetically similar. Furthermore, there is a greater chance of confusion regarding the source and association of the products because they both cater to the same market segment—those looking for solutions for medical ailments. 

 

CONTENTIONS OF THE RESPONDENTS: 

The defendants contended that the defendants are well-known experts in the field of homoeopathy. Defendant No. 1 is a licenced oil company that has a solid track record of producing homoeopathic remedies, such as “VIGOURA 1000,” “VIGOURA 2000,” and “VIGOURA 5000.”  

The products in dispute are specific medications designed to treat various medical conditions. “VIGOURA 1000” is different from the Plaintiff’s product, which treats male erectile dysfunction, in that it concentrates on women’s vitality and menstrual regulation. The product “VIGOURA 1000” is no longer relevant to the current controversy because of this differentiation.  

The homoeopathic remedies “VIGOURA 2000” and “VIGOURA 5000” are made to act as non-steroid aphrodisiacs by promoting metabolic processes. Homoeopathic remedies function according to distinct principles from traditional allopathic medications, such as Pfizer’s “VIAGRA.” While “VIAGRA” is used to provide immediate relief, the defendants’ “VIGOURA” has effects that take two to three months to manifest. Customers are less likely to become confused because of the two medications’ different types and compositions as well as the fact that they are both prescribed medications.  

It is sincere, real, and legitimate that Defendants have adopted the contested mark “VIGOURA.” The whimsical symbol is a play on the word “vigour” in English. Additionally, “VIGOURA 2000,” which was initially produced and sold by the Defendants in 1999, has a long history in the market for the products under dispute. In addition, on January 21, 2003, Defendant No. 1 requested trademark registration for “VIGOURA 2000” and on December 30, 2003, for “VIGOURA 5000” in class 05. Furthermore, on April 27, 2005, Defendant No. 1 accomplished the registration of a copyright for the creative work contained in the “VIGOURA 2000” package. Therefore, a considerable amount of time passed before Pfizer registered its trademark for the products made by the defendants.  

Long before Pfizer, a number of other organisations obtained registration rights in trademarks that used the same name as “VIAGRA” for pharmaceutical or Ayurvedic medical products classified as class 05. 

The defendants maintained that Pfizer Inc., the trademark’s owner, had not granted the plaintiff an assignment of the mark “VIAGRA.” The Plaintiff is therefore unable to assert proprietorship over the aforementioned mark. 

 

LEGAL PROVISIONS: 

  • Section 38 of the Trademarks Act- Assignability and transmissibility of registered trade marks. Notwithstanding anything in any other law to the contrary, a registered trade mark shall, subject to the provisions of this Chapter, be assignable and transmissible, whether with or without the goodwill of the business concerned and in respect either of all the goods or services in respect of which the trade mark is registered or of some only of those goods or services. 
  • Section 18(1) of the Trademarks Act- Anyone claiming to be the owner of a trademark that they have used or intend to use and who wants to register it must submit an application in writing, following the prescribed process, to the Registrar. 

 

ISSUES: 

  • Whether the Defendants are infringing the registered trade mark of the Plaintiff “Viagra”? 
  • Whether the Plaintiff is the proprietor of the trademark “VIAGRA”? 
  • Whether the Plaintiff is entitled to any damages? If so, the extent thereof? 
  • Whether other trademarks resembling and similar to the trademark of the Plaintiff have been registered, as alleged by the Defendants? If so, to what effect? 
  • Whether the use of the mark “VIGOURA” by the Defendants amounts to passing off the goods as that of the Plaintiff? 

 

COURT’S ANALYSIS AND JUDGMENT: 

The meaning and concept of a “proprietor” are crucial to this issue, the court noted brand. A “registered proprietor” is described as under the Trademarks Act as the individual named in the Trademarks Register as the owner of the brand. Consequently, the legitimate owner is acknowledged as being the registered proprietor of the brand, with the sole authority to use the brand in relationship with particular products or services.  

The court also decided that a “proprietor” means anyone who has exclusive possession of a property, not only the registered owner. rights to use the trademark in connection with particular goods or services. This possession can be proven by using the trademark in commercial actions in the market, giving rise to common law rights. Furthermore, these rights could be obtained by officially registering with the Trademarks Register. So, proprietorship can be thought of as a spectrum- from its first application in the market to its official acknowledgement by signing up. 

Legal principles and factual analysis are combined in the evaluation of trademark infringement and passing off. The degree of resemblance between the contested trademarks and the events leading up to the adoption of the challenged mark are the main areas of overlap in the appraisal of each claim, even if each one calls for different legal considerations. Despite the fact that the infringement claim surfaced after the initial lawsuit filing, it is appropriate for the Court to address it first given this overlap.  

The court held that misrepresentation can take many different forms, such as using identical trademarks, packaging, or marketing techniques that lead to confusion among consumers regarding the source of the products or services. The Plaintiff’s final burden of proof is to demonstrate that the Defendants’ deception caused them harm or that they will likely cause them harm. Possible manifestations of this harm include a decrease in sales, a dilution of goodwill, or damage to the Plaintiff’s trademark’s reputation. 

The Defendants’ argument failed to persuade the Court. A well-established rule in trademark law states that a plaintiff may still obtain an injunction against a particular defendant in a trademark infringement case even if they choose not to file a lawsuit against other parties who might own marks that are similar to their own.  

The court held that the defendants or any representatives working on their behalf are irrevocably prohibited from producing, offering for sale, or marketing, promotion, or in any other context where the trademark “VIGOURA” or any mark that is misleadingly similar to the plaintiff’s “VIAGRA” trademark in respect to any of their products as would constitute violating or passing off the Plaintiff’s registered trademark “VIAGRA.”  

 

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Judgment reviewed by Riddhi S Bhora. 

 

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Colourable imitation of a product shall be restrained : Delhi HC

Citation : CS(COMM) 757 of 2023

Decided On : 19th October, 2023

Coram : Justice Prathiba M. Singh

Introduction :

The plaintiff filed a suit under the XXXIX Rules 1 & 2 CPC to restrain the defendants from using the design and selling the products on online platforms. The plaintiff had given an opportunity to resolve the dispute prior to the defendant but upon having no response, filed a suit in the HC of Delhi

Facts:

Sunshine Teahouse, the plaintiff is the owner of the popular brand name Chaayos and also runs and maintains cafes with tea, snacks, beverages etc. The name “CHAAYOS” was registered in the year 2017 after adopting it in 2012. The plaintiff has also manufactured and launched various other products under the same brand name. The products are manufactured and marketed in their own distinctive style with different flavour names. 

The plaintiff had a successful turnover of Rs.10 cr in the year 2022-23 for under the brand name “CHAAYOS” and has also sold various other goods in different countries. They have a website under the domain name, www.chaayos.com and sell their products in various other platforms including Amazon, flipkart, Bigbasket, Instamart etc.

The defendant, Grey Mantra Solutions sells their tea based products on online platforms and the plaintiffs have alleged the defendants in selling their products online in amazon under the name “TEACURRY” and “JUST VEDIC”

The plaintiff claimed that the defendant had copied and adopted distinctive elements of their packaging and the design format. The word “Chaai” and “masala” in both the manufacturers were alike including the colour combination, writing script, and the depiction of flavour in pictorial format.

Courts Analysis and Judgement:

 The court observed that there is a physical resemblance between the products manufactured by the plaintiff and the defendant. The defendant had acted with malafide intention and has imitated the plaintiff’s products. It was also observed that the defendant had done it to present their products is the same as the plaintiff and had copied the online listings as well.

The court passed an order and directed the defendant to restrain from manufacturing, selling the products which have copied elements of “CHAAYOS” and the online listings to be taken down within a week from the date of passing the order as there is no colorable distinction present.

The matter would be next listed on 29th January,2024

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Written by- Sushant Kumar Sharma

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Patenting and Malpractice of Evergreening of Patents

What is a Patent:

A patent is an exclusive right regarding a invention or process granted by a sovereign authority for a specified period of time. It is a incorporeal right and it is mostly valid for 20 years of time.

A patent may be obtained by anybody who creates or discovers a novel and useful machine, method, manufacturing, composition of matter, or novel and useful improvement thereof, according to the terms and regulations of the relevant legislation.[1]

Types of Patent:

There are majorly three types of patents mainly used which are Utility Patents, Design Patents and Pharmaceutical Patents. Each of these patents differ from durations and specifications.

  • Utility Patents: Those who develop a novel and practical method, a manufactured good, a piece of equipment, or a composition of matter are entitled to legal protection through utility patents, sometimes known as patents for innovation. Over 90% of all patents granted by the US government fall under the category of utility patents, which are the most prevalent kind of patents. This patent lasts for 20 years from filing date on payment of maintenance fees.

 

  • Design Patents: Patents on unique, novel, and ornamental designs for manufactured goods are known as design patents. Design patents safeguard an object’s appearance or design. They demand that the design originates from a unique and practical invention. For applications submitted after May 13, 2015, design patents are valid for 15 years. Patents for applications submitted prior to May 13, 2015, expire after 14 years. Design patents are not subject to maintenance costs.[2]

 

  • Pharmaceutical Patents: It’s a highly knowledge-driven industry where the billion-dollar process of developing new drugs is one of the most expensive. It is crucial that innovators withdraw their capital from the economy as a result. Development and innovation will be impeded otherwise. In this sense, by giving inventors exclusive control over the advantages of their inventions, patents are essential for preserving innovation. Different kinds of patents are available for medical inventors or businesses to safeguard and profit from their invention(s).

Evergreening of Patents:

Ever-greening, as the name suggests, is a corporate, legal, business, and technical strategy for prolonging an issued patent’s term in a country where it is set to expire in order to maintain income streams through the acquisition of new patents. In this process, patent holders strengthen their diligent possession powers through legislative and regulatory measures. Evergreen patents allow you to take advantage of their benefits for an extended length of time.

To put it simply, patent evergreening is the process of continuously extending patent rights. It also describes the procedure of getting multiple patents for the same product. These patents cover numerous facets of a single product by accumulating patents on improved versions of already-existing products. Pharmaceutical patents typically have evergreening patents. The most significant strategy employed by multinational pharmaceutical corporations is drug patent evergreening.

The global pharmaceutical industry is estimated to be worth more than $1 trillion based on reports from 2014. US companies have been using it since 1983, and Canadian provinces have been using it since 1993. The long-term financial security that comes with high sales volume is known as the “evergreening” of patents.

India’s law and stand on Evergreening of patent:

A drug doesn’t just pop on the countertops they all have a long history behind them, the first step that pharmaceutical corporations take on discovering an entirely new drug is to secure intellectual property rights for it in the form of a patent. A primary patent, covering a new molecular/chemical entity, rewards innovation with a free reign over the marketplace for a period of 20 years, which is the term of the patent. However, this also sets the clock ticking since innovators need to reap the fruits of their inventive labour and maximize revenue within this period. Once this time ends the pharmaceutical companies resort to innovative ways to reclaim the patent.[3]

But Indian Patent Act of 1970 which deals with the patents in India has a protection against evergreening in section 3 which defines what are not an invention and sub clause (d) in that states that[4]“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.”

Section 3 (d) in itself is an innovative clause as it specifically deals with minor modifications done for the sake of evergreening of patents. This section lays down the standards for the follow up of the patents with clarity. This standard was tested and upheld by the Supreme Court in a landmark decision in 2013 involving a patent application for Novartis’ anti-cancer drug Glivec. This was heralded by many as an example of India leading the charge on curbing evergreening, thereby safeguarding its access to public health.

After seeing that India already has a law which bars evergreening one must be thinking that there will be less or no evergreening or secondary patents happening in India, but to their surprise from 2009 to 2016 there were 2300 patents for drugs granted. And out of these 2300 patents around 72% were secondary patents. This signifies the incompetency of government when it comes to the execution of the law.

Conclusion:

The patent system is a complicated and crucial subject that impacts both inventors and patients. On the one hand, patents encourage innovation by granting inventors exclusive rights to their creations. This could lead to the creation of novel and potentially life-saving medications. Patents, on the other hand, might limit access to medications, particularly in low- and middle- income nations. This has major implications for public health.

There is no simple solution to the problem of balancing the interests of innovators and patients. However, it is evident that a strategy to create a balance between these two crucial goals is required. One method is to create a system of compulsory licensing that allows governments to develop generic versions of proprietary medications under specified conditions. This can aid in making drugs more affordable and accessible to those in need.

Finally, the patent system is a vital instrument for encouraging innovation. However, it is critical to ensure that the patent system does not impose undue restrictions on access to medicines. Compulsory licensing and public health research and development are two approaches to balancing the interests of inventors and patients. We can assist ensure that everyone has access to the medicines they need to live healthy lives by finding a method to strike a balance between these two critical aims.

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Written by- Sushant Kumar Sharma

[1] United Nations Conference on Trade and Development. (2015). The relationship between intellectual property rights and public health: Towards a balanced approach. Geneva: United Nations Conference on Trade and Development.

[2] Supra

[3] Rajagopal, Feroz Ali, Sudarsan. ‘Rampant Evergreening in Indian Pharma Industry’. Mint, 26 Apr. 2018, https://www.livemint.com/Opinion/aIqAgfMWLyel1uPEfEcEtI/Rampant-evergreening-in-Indian-pharma- industry.html.

[4] Patents Act, 1970 (Act 39 of 1970)

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