Patent and Take Notice

It seems Kunnath Pharma, manufacturer of anti impotency drug Musli Power Xtra, has invested quite a lot on advertising the drug. Musli advertisements can be seen everywhere these days: on electronic displays at metro stations, huge billboards, and hoardings in sporting events. In fact, Musli Power was the “official health licensee” at the recently concluded commonwealth games.

Though Musli advertisements might appear to be stereotypical in many ways, one thing about the advertisements is distinct. The advertisements overwhelmingly use patent notices as a means to highlight the credibility of the product. 

The patent laws allow a patent holder (or a patentee) to imprint or stamp or engrave the words: “patent”, “patented”, “patent pending”, “patent applied”, or any other similar word/ words on products for which a patent has been granted or applied for in India. Therefore, companies either engrave or imprint or stamp the patent words on packaging or marketing materials of their products, or take out a public notice in newspapers informing the public regarding the inherent rights in the product.

The objective of patent notices is two fold. Firstly, it informs the public about the rights of the patentee on the product, and acts as a legal warning to imitators. Secondly, it allows the patentee to highlight that the product is novel. The patent laws also prohibit fraudulent use of such notices to protect consumer interest. For example, the patent laws specify a penalty of upto INR 1 Lakh for any fraudulent use of these patent notices with respect to any product. The patent laws also prohibit the use of such notices for any product for which the patent has expired its term or lapsed.

The example of Musli Power in using patent notices in advertising is just a discernible one. More and more companies are seemingly adopting a ‘patent and advertise’ policy. Somany Tiles, a leader in ceramics industry, has been actively marketing its VeilCraft (VC) Shield technology, for which a patent was granted by the  Indian Patent Office (IPO) last year.  Somany’s Commercial, airing frequently on television prime time, highlights the strength of the tiles by associating the “patented” word. Few years back, Eureka Forbes did an extensive campaign regarding its patented RO device.

It seems that Indian companies have finally realized the potential of using patent notices as an effective means for capturing consumer trust in their products. And, why not? Obtaining a patent after all is not an easy proposition. It involves years of research from inventors/product developers to develop something novel, and then facing a stringent  patent examinationprocedure, which may involve facing numerous oppositions from the patent office/competitors regarding novelty and other parameters of the product.

However, the most important change in mentality of the Indian companies seems to be their openness in associating with the “P” word much more comfortably. Gone are the days, when associating patent with a product meant being party to monopolistic philosophies of the west. Gone are the inhibitions of the past, when patents were seen as an exploitative tool in the hands of foreign companies for exorbitantly increasing prices of drugs, making affordability of such drugs a bane for the consumers. The Indian companies are slowly but surely understanding the worth of patents, and using patent notices as a reliable trust building measure in consumers.

The use of patent notices on products is welcome, however, companies should be wary of misleading the public by such notices. This particular patent notice (accessed here), published in Times of India, exemplifies the point I am trying to make. The patent notice is guilty of misleading the public on two counts. Firstly, it states the patent applicant to be entitled to manufacture and sell the listed device based on the patent application. This is patently incorrect, as just on the basis of a patent application no such rights accrue. The rights only accrue on the applicant, once the patent has been granted by the patent authorities. Secondly, patents provide only exclusionary rights to the patent applicant to prevent others from manufacturing or selling a patented product, and do not provide any exclusive rights to the patentee to manufacture or sell the product. It is a well established fundamental of patent law, that even if a patent has been granted, the patentee CAN NOT exclusively manufacture or sell the device until he/she is sure of not violating third party patent rights.

Now the problem is that though the patent laws provide penal liabilities on companies fraudulently using the patent notices, there is a lacuna in patent law regarding misleading patent notices. I am not commenting on whether other remedies exist to account for such misleading notices. In patent laws there seem to be none. Therefore, the regulation of content of patent notices solely rests in the hands of the patentee, and the companies should try to use patent notices constructively rather than using them as a means for misleading the public regarding the nature of rights existing in their products.

Kshitij Malhotra
Inohelp Consulting Solutions Pvt. Ltd.

Patent Notice

Patent Caution Notice that appeared in TOI, Mumbai. I am reserving an entire post on the same.

Paradigm shift in mindset of off-patent drug manufacturers paying rich dividends

The change in the mindset of off-patent drug manufacturers, or generic manufacturers, is paying rich dividends. Recent reports suggest that an Venus Remedies Ltd, a Chandigarh based company, has received a patent from the Indian patent office on a Novel Injectable Aceclofenac Formulation. The company has also received a patent from the European Patent Organization (EPO) for its anti-infective product, ''Sulbactomax''. The firm is now negotiating licensing deals with multinational pharma giants for the anti-infection product.

On the other hand, Bangalore based drug maker Avesthagen Ltd has received a 'process' patent for an arthritis drug. The arthritis drug is a bioequivalent of Amgen’s blockbuster medicine Enbrel that is used to treat rheumatoid arthritis. The company is planning to launch the drug by June 2012. However, the company says that it has no plans to manufacture drugs, and would outsource it while focusing on developing drugs.

The most important patent success story comes from Ahmedabad based pharma company, Troikaa Pharmaceuticals Ltd. The company has recently received a patent for ‘Dynapar AQ’, a diclofenac or painkiller injection, from the CIS countries CIS countries include Ukraine, Kazakhastan, Belarus, Uzbekistan, Turkmenistan, Kyrgyzstan, Russia among others. This is after the drug has gotten patent approval in Australia, and is awaiting patent approvals in US and Europe. Reportedly, the company has spent `3 crore on the patent protection endeavor.

All this comes after the latest media report estimates that in 2008-09, Indian companies such as Dr Reddys, Ranbaxy and Cadila Healthcare had filed over 500 applications with the Indian Patent Office. Others such as Natco, Sun Pharma, Wockhardt and Cipla have also sought patent for key drugs.

Inohelp Consulting Solutions Pvt. Ltd.

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Are the policies restricting access to quality legal education for professionals?

Gone are the days, when the term lawyer imaged a black robed guy sitting in a court chamber, or sometimes outside with an umbrella atop. Lawyers have moved from court chambers to carpeted bays of corporate offices. The practice has moved from saving shady criminals to merging two multi-national companies. From contending a family feud over a piece of land to getting injunctions over intellectual property infringement. Certainly, the legal profession is rapidly evolving, and so is the legal services industry. Cross-domain expertise is now highly sought. Company Secretaries well aware of business and compliance laws, Charted accountants that are versed with tax laws and PHDs that are well versed with patent laws are accepted with open arms, and of course remunerated very well. There is an optimistic demand in the industry for such professionals. The concerns remain regarding the supply. Is our legal education system able to quality train such professionals? I certainly do not think so.

The Bar Council of India, the body responsible for accreditation of courses at law schools, prescribes two streams of law courses required to be enrolled as an advocate viz. a 5 year integrated LLB degree open for students after 10+2 or 11+1, and a 3 year law course for graduates. The onus of choosing what to offer is on the law schools, and all of the top law schools including NLSIU, NLUI, NALSAR and NUJS, have opted to offer the 5 year integrated LLB degree (although initially few of the top law schools did offer 3 year LLB, but, then they gradually moved to the 5 year year program). This leaves graduates and professionals with very few options to pursue quality 3 year LLB education. The reasons for lack of 3 year LLB programs are best known to these law schools. Some suggest that by offering 5 year programs, students save an year in completing their education. However, most often than not saving an year lack of interest in students is quoted as an excuse. Is lack of interest really a justified reason? Again, I beg to disagree.

Recently, IIT Kharagpur started a 3 year LLB program restricted to engineers, doctors and post graduate in sciences, and it has been a huge success. The 3 year LLB program at University of Delhi (the only program for graduates that has some credibility and quality) has always been well attended by professionals from civil administration, police, corporate, and science and technology. Lately, the number of applications received by the university has increased by about 30 % in last 2 years. All this surely suggests an increase in awareness among professionals in pursuing legal education as a means for obtaining cross-domain expertise, and specifically meeting the demand of the industry, especially the legal industry.

Another reason given by administrators is that professionals do not consider study of law seriously, and only see it as a part time vocation. Law is serious business, and market forces cannot be allowed to govern studies in law. This argument though partly true, is not true in its entirety. Lackadaisical attitude has been prevalent in many quarters regarding legal education, wherein working professionals opt for LLB programs with a typical “ho jayega” (we will manage it somehow) attitude, and wherein graduates opt for LLB programs with a typical “kuch nahin se kuch to sahi” (better study law then do nothing).

However, this does not mandate closing the doors of quality education for professionals who are serious about studying law. I am sure, if given an opportunity of studying at top law schools of the country, a student will definitely think of means to balance his professional occupation with studies, and even might think of taking a sabbatical. If the policy makers believe that a professional is incapable of such balancing act, then I would like to politely mention that these indecisions are better than apprehensions of a typical teenager, who enters these top law schools. Moreover, maintaining minimum standards, such as minimum level of attendance, minimum passing marks, and who should pass and who shouldn’t is always in the hands of the administrators of universities.         

The old BCI rules (rule 5, 7 and 8 of section A) mandated all law schools to provide an option of lateral entry in their 5 year LLB courses, wherein graduate and post graduate students can enter the 3rd year of such programs. Notwithstanding, the concept of lateral entry might not be an attractive proposition anyway for professionals as this would mean studying with fellows, who are easily 5-6 years junior to them. This at least provided flexibility to graduates and post graduates to enter laterally into the 5 year LLB programs. However, these rules seem to have been scrapped and the latest set of BCI rules (rule 13 of Section A), prohibits such lateral entry and exit. 

Therefore, a review of 3 year LLB policy at top law schools is highly desirable, since the onus is completely on these schools to provide access to quality legal education to a sizable mass of students. Also, a review of lateral entry to 5 year LLB by the BCI might also provide means for professionals and graduates to pursue quality education. Until then it will be fair to say that our legal education system, which is supposed to teach justice, might be ignorantly or intentionally imparting injustice to lakhs and lakhs of law aspirants.

Inohelp Consulting Solutions Pvt. Ltd.

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Pharma Cos against patent linkage - Government considering easing the linkage requirement

The pharmaceutical industry in India for long time has been opposing all efforts of Bayer Corporation to connect patent status of a drug to regulatory approvals. Their efforts to oppose have gotten more stronger.

In 2009, honorary High Court of Delhi in Cipla V. Bayer had smeared the efforts of Bayer to connect patent status of a drug with regulatory approvals. The High Court had ruled that grant of a patent on a drug and regulatory approvals for producing generic version of the same are two separate issues. Further, the court concluded that the drug approval authorities are under no obligation to look into the patent status of the drug and consequently deny regulatory approvals to generic manufacturers who want to manufacture the drug. The court also opined that regulatory approvals are only to ensure safety of the proposed generic version of a drug. However, later Bayer challenged the decision of the High Court in the Supreme Court. The hearing of the matter in the Supreme Court is scheduled to commence shortly.

Now, in a recent statement the pharmaceutical industry has appealed to the government to completely lay to rest the patent linkage issue. The industry has appealed to the government to remove the clause on 'Patent status' in Form-44 of D&C rules. 

Recently, reports have emerged that the Indian drug makers met health minister Ghulam Nabi Azad in Mumbai to strengthen their appeal. “The minister saw some sense in our recommendation and agreed to it. Why should the drug regulator have any linkage with the patent status of a drug?” said Daraa B. Patel, secretary general of the Indian Drug Manufacturers’ Association. This clearly shows that the proposal has been considered by the government, and the health ministry may move soon to remove a question on the patent status of a drug from the form that medicine companies. This is a big blow to Bayer’s efforts of connecting drug approval with patent status of a drug. 

Inohelp Consulting Solutions Pvt. Ltd.

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Ahmedabad and Tech Transfer 2010

Ahmedabad is just like any other city. Starts from a railway station situated in a noisy old area, moves into a clean and organized new area, and extends into the glitterati of malls. I have no doubts Ahmedabad can be easily counted in the league of Tier A cities, which includes our four metros, Banglore and Hyderabad. The people are helpful, cultured, and when it comes to doing business: "Guju ne khabar che ke dhando kem karo" [A guju knows how to go about doing business].    

The people of Ahmedabad have yet again displayed their ingenuity by hosting a first of the kind event in the country, The Tech transfer 2010. As I have already blogged, this event focused at auctioning patented/patent pending technologies. In fact, the event auctioned 48 technologies covered by 50 patents. I was fortunate to be the part of the event, and had a chance of meeting people academics and industry, who were serious about technology and highly aware about protecting technologies using the instrument of patents.

The event started with welcome addresses by Dr. Subodh Adeshara, Ex-commissioner food and Drugs Control  Administration, followed by introductory speeches from organizers. The event then moved into presentations on the 48 technologies from domains, such as API, Medical Devices, Herbal Drugs, and Biotechnology. A major attraction at the auction was a novel process for producing Gefitinib (Iressa), a drug which is used in treatment of non-small cell lung cancer. The novel process already has a granted patent in India. Other interesting technologies at the auction included a herbal drink that tastes like beer, a bio-insecticide product that attracts and kills mosquitoes using bird feather, an informational device for the blind, a transdermal patch for contraceptives drug delivery and a technology that can make a snake venom into analgesic that can help cure neuropathic pain. 

Before attending the event, I had an impression of a road show, wherein innovators will put up dedicated stalls displaying their inventions. Therefore, being presented technologies on power point slides by organizers came as a surprise. In my experience, no one can explain an invention better than the inventor. Hence, the event would have been better served if the innovators themselves explained their inventions to the buyers.

However, overall I would rate the event as a success. Wishing the organizers all the best for their future plans of holding such event at even grander stage. 

Ups:

1. Novel concept neatly put together

2. Great stage for innovators to showcase their technologies

3. Increased awareness in industry regarding patents. It was a pleasant surprise to meet people from other industries, such as software, and telecom attending the event.

Down

1. Lack of publicity

2. Small scale of the event

3. Unwelcoming and apprehensive organizers. Registrations were highly restrictive. Further, the organizers refrained from sharing details about innovators, and even patent numbers of the technologies. I think the organizers should appreciate that finding out these details from what all details they provided is not a very difficult task.

Inohelp Consulting Solutions Pvt. Ltd.

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Off to Ahmedabad for TECH TRANSFER 2010

Yes, finally decided to attend this first of this kind exhibition. I am off to Ahmedabad for the weekend. Thanks to Abhishek Pandurangi, Founder of Closer2patents.com for all the help.

Will reserve an entire post describing the event.

Take Care

Inohelp Consulting Solutions Pvt. Ltd.

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Exhibition showcasing patented inventions

While reading today's news bits, I was in for a surprise. The first ever exhibition on patented inventions is being held in the city of Ahmedabad. The exhibition named as “Promoting Innovative Cluster – TECH TRANSFER 2010" is organized by Skyquest Tech Group, a Global Technology Aggregator & Accelerator working in the areas of Life Sciences and Green Technologies.

Interestingly, the exhibition is a first of its kind patent showcase that has been organised in the country, where patent holders (sellers) and companies (potential buyers) will come face-to-face on the same platform to discuss, negotiate and strike a deal.

I could have attended the exhibition if my google alerts could have captured this event on time, too late to get the reservations in place it seems. I need to revise my google alert strategy to include keywords for capturing events like these.

Inohelp Consulting Solutions

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Cipla on a patent knock down spree - Successfully opposes Novartis’ Dulera patent

Cipla has continued its knocking down spree by successfully opposing Novartis’ Dulera patent. Dulera is an anti-asthma drug, which includes a combination Formoterol, and Mometasone furoate in a weight ratio of 1:1 to 1:1000. The drug was granted an Indian patent numbered 202350 in 2007. The grant of patent was opposed by Cipla by way of a post grant opposition filed in February 2008 on grounds including: Lack of inventive step and Insufficiency of Description. It is interesting to note that the drug has valid patents in jurisdictions including Europe, United States, Korea and Israel.

            Lack of Inventive Step or Obviousness

The drug was challenged on count of obviousness on basis of US patent nos. 5874063 (D1), 5674860 (D5) and WIPO publication no. WO9520393 (D2). The patent office acknowledged the following:

1. The prior art D1 teaches already an anti-asthmatic drug having Formoterol, and Mometasone furoate.
2. The weight ratio of 1:1 to 1:1000 as suggested in the impugned patent is obvious in light of D5, which teaches a combination therapy comprising Formoterol and Budenoside (steroid similar to Mometasone furoate) combined in a weight ratio of 1:60.
3. The prior art D2 teaches administration of Mometasone furoate along with other drugs including bronchodilator, such as albuterol. Accordingly, any skilled person will be motivated to combine the teachings of D1 with teachings of D2 to achieve the therapeutic results as taught by the impugned patent.

The ground of obviousness as contended by the patent office though seem easily deducible, might not be reasonable. However, I would like to reserve an entire post on an analysis of the same.

            Insufficient Description

Interestingly, the opponent submitted that the impugned patent though mentions about unexpected therapeutic benefits of the combination as claimed, there is no disclosure or data in the specification to substantiate the same. Accordingly, the claims of the impugned patent are not sufficiently described and ought to be revoked on this ground alone. The patent office seems to have agreed to the contention of the opponent.

           

This ground of Insufficient Description further highlights the importance of amending or altering a patent application based on requirements of Indian patent laws. In the present case, inclusion of data showing synergistic effects of the combination of Formoterol, and Mometasone furoate in a weight ratio of 1:1 to 1:1000 was absolute necessary not only to prevent insufficiency requirements, but also, to circumvent all doubts that may arise under section 3 (e) of the Indian patent act. However, seldom do patent law firms follow such practices. A mere forwarding of an application written by a foreign patent attorney to the Indian patent office may result in problems such as the one illustrated above. Although, the patent attorney handling this case may be let off the hook as the application was filed way back in 2001, before the introduction of the critical 2005 amendments.

We at Inohelp, follow a strict practice of reviewing all national phase or convention patent applications, and suggesting our client possible amendments in the complete specification before filing the application at the IPO. The acceptance of these amendments is on the discretion of the client, who we find seldom disagrees with the suggestions. 

Inohelp Consulting Solutions Pvt. Ltd.

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India’s efforts to protect traditional knowledge - Foils Danish and Chinese attempts of bio-piracy

India's effort to digitize its traditional knowledge in form of Traditional Knowledge Digital Library (TKDL) is paying rich dividends. Recently, Council of Scientific and Industrial Research (CSIR), the proprietor of the database, foiled the attempts of a Danish firm, Claras ApS, and a Chinese Firm, Livzon, of bio-piracy. The Danish firm tried to patent in Europe an invention relating to turmeric, cumin, ginger and onion as slimming agents. On the other hand, the Chinese firm tried to patent in Europe an invention relating to use of medicinal plants 'pudina' (mint) and 'kalamegha' (andrographis) for the treatment of H5N1 avian influenza or bird flu.  These efforts come after CSIR uploaded 900 yoga postures in the library in June to prevent attempts of patenting these postures anywhere in the world.