IP Training Services

This is to announce that a basic IP Training workshop was held at ABB’s INCRC by the team at PatNMarks. The audience was primarily research leads, product leads and potential patentees within ABB’s Indian Research Center, based out of Bangalore, India.

Our training modules come in four flavors, ranging from basic IP issues to specific training on subjects such as Software, Biotechnology, Mechanical Engineering and other specific topics. The content varies from what consitutes a good disclosure to jurisdictional allowances of subject matter across the globe, culminating in Innovation Workshops, where the goal is to identify a dozen ideas for patenting, in one shot.

Our string of consultants are varied in their technical and legal expertise and make this training service complete and well-rounded.

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Rebutting Novratis

As mentioned in Case Study II of the previous article on pharmaceutical patenting, Novartis obtained US patent 6894051 on 17 May 2005 for a new crystalline form of its blockbuster blood cancer drug Gleevec/Glivec. This crystal modification was termed the b-crystalline form of imatinib mesylate. Novartis applied for an Indian patent for this polymorph but the application was rejected by the IPO (Indian Patent Office) under Section 3(d) in January 2006 after an appeal by Indian generic manufacturer Natco.

The Swiss pharmaceutical major has now filed a case in the Chennai High Court protesting the Indian patent law. Novartis is challenging the validity of Section 3(d), claiming that this section discriminates against the pharmaceutical industry and is not in line with TRIPS (Trade-related aspects of intellectual property rights). To comply with TRIPS, India must allow patents for all inventions irrespective of the technological field, provided they are new, involve an inventive step and are capable of industrial application. According to the Indian Patent Act, an inventive step would feature a technical advance over existing knowledge or have economic significance or both, and would make the invention non-obvious to a person skilled in the art (1).

Section 3(d) was framed in 1970 as a safeguard to prevent the evergreening tactics (practice of prolonging IP rights) of pharmaceutical firms on existing drugs. This section prohibits the patenting of new forms (including polymorphs), new uses or minor modifications of existing drugs unless an appreciable difference in drug efficacy is indicated. Salts and other derivatives of known substances will be considered as the same substance unless there is a significant increase in efficacy. However this section is only with regard to the pharmaceutical industry. Novartis claims this violates Article 14 of the Indian Constitution, which promotes equality before law. The Indian generic drug industry represented by the Indian Pharmaceutical Alliance (IPA) is contesting the case (2).

Novartis states that the patent protection in India would be only for the paying market and that it will make Gleevec available to any Indian person diagnosed with cancer who cannot afford the cost of treatment (3). Treatment with Gleevec costs Rs 1,20,000 per month for a patient compared to the generic price of Rs 8,000 (4).

US6894051 claims a crystalline form of the monomethanesulfonic acid addition salt of a compound of formula I, which is non-hygroscopic in a glass climatic chamber at 25°C and relative humidities up to and including 93%.

Compound of formula I
N-phenyl,-2-pyrimidine amine derivative
Where N-H represents amine groups and cyclic N=N the pyrimidine structure

Due to its non-hygroscopic nature, the polymorphic b-crystalline form with non-needle shaped crystals is stated to possess better flow characteristics and to be better suited to storage than the previously known needle shaped a-crystals that readily absorb moisture. The preferred process for the preparation of the b-crystalline form includes:

(i) Digesting another crystal form or amorphous starting material of the methanesulfonic acid addition salt of a compound of formula I in a suitable polar solvent at a temperature between 20° and 50°C.

(ii) Dissolving another crystal form or amorphous starting material of the methanesulfonic acid addition salt of a compound of formula I in a polar solvent at a suitable temperature of 25°C up to the reflux temperature of the reaction mixture, and then initiating crystallization by adding a small amount of the d-crystal form as seed crystal at a temperature between 20° and 70°C.

The preference for the b-crystalline form appears to be based on its better storage characteristics and the fact that it does not liquefy easily when compared to the a-crystal form, which turns amorphous to some extent at relative humidities of 93% or greater. However the more readily biosoluble form of a chemical compound is often preferred by manufacturers, as the body will better absorb it. An analysis of the US patent in question does not reveal any other reason for the polymorph to be preferred over the previously existing salt. All therapeutic uses claimed for the polymorph especially have also been claimed for the methanesulfonic acid addition salt of a compound of formula I and there is no extension of its therapeutic properties.

Article 35 under Section 101 of US patent law states that whoever invents or discovers any new and useful process, machine, manufactures, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof (5). The U.S. Patent and Trademark Office (USPTO) requires an invention to be non-obvious and to possess an inventive step. The USPTO may reject a drug terming it obvious on the basis of its structural similarity to existing chemical compositions. The applicant can overturn the rejection by demonstrating the improved results of the drug (6).

In India, the inventions not patentable under The Patents Act, 1970 include any process for the medicinal, surgical, curative, prophylactic (diagnostic/therapeutic) or other treatment of human beings. This is in the interest of keeping those inventions that most closely impact upon life and living beings accessible to all within the public domain. The argument against patenting derivative versions of existing pharmaceutical products may be extended with reference to this provision. For a curative or prophylactic treatment to be readily available in a country like India, generic drug manufacturers must play a leading role. The production of a generic drug requires that the brand name drug be off patent. Attempts by non-generic pharma companies to perpetuate their patent rights by patenting derivatives with minor differences in efficacy will only delay generic production and inhibit public access in India and the rest of the developing world.

REFERENCES

1. Drug efficacy may be open to interpretation- Article in The Hindu Business Line; 25 Feb 2007
2. Novartis case raises fresh controversy- Article in India Business (The Times of India); 21 Feb 2007
3. Novartis rejects Glivec link to S.Africa AIDS row- Interview, Reuters India; 21 Feb 2007
4. Health organizations urge Novartis to drop patent case- Article in The Hindu Business Line; 30 Jan 2007
5. Report of the Technical Expert Group on Patent Law Issues- Indian Drug Manufacturers Association; Dec 2006
6. Taking TRIPS to India- Novartis, Patent Law and Access to Medicines- Article, Commonwealth Secretariat; 8 Feb 2007

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Direct and Indirect Benefits of Protecting (IPRs)

There are several private and public benefits of protecting intellectual property rights (IPRs) and the existence of such protection is as a result of both these benefits. However, the direct and indirect private benefits are often not recognised or underestimated. The underlying message of this article is to encourage innovation, protection and enforcement by setting out the benefits of IPR protection.

Intellectual property protection in India is growing at an exponential rate, even if one is to observe it without resorting to statistical bases and numerical calculations. There are several reasons for this rapid growth, but the single largest contributor is probably the liberalization of the Indian economy and India’s membership of the WTO. The obvious consequence of these events has been the entry of foreign multinationals who have, much prior to their entry, realised the value of protection and therefore continue with a protective policy; and the extension and streamlining of India’s own system of securing and granting IPRs. Another significant contributor to this growing trend is the emergence of Indian businesses as players in the global space. Indian companies doing business with foreign counterparts and even those setting up greenfield projects abroad soon realise the value and importance attached to IPRs. It is of course elementary that intellectual property alone cannot ensure the success of any business. Other factors such as business models, marketing policies, consumer trends and some amount of luck go a long way in ensuring the overall success of any business. However, the direct and indirect benefits of intellectual property protection justify a higher level of attention and protection.

The grant and subsequent successful enforcement of any IPRs effectively grant a legal and limited monopoly over certain acts that may be performed with anything embodying those rights. Whereas monopolies may exist in different forms and due to different reasons, the underlying reasoning that supports the grant and enforcement of these monopolies is the existence of some strong justification for such grant and enforcement. Monopolies over inventions, brand names, aesthetic designs and other works of the mind requiring skill and effort are protected based on the justification that any benefits flowing from such creations should be the property of the creator as a result of the creator’s contribution in terms of time, effort, skill and financial investment. In this context the direct and indirect benefits of such legal monopolies cannot be overemphasized and it is indeed the monopoly which serves as the first and foremost direct benefit of intellectual property protection. The value of such a monopoly cannot be estimated until it is fully realised, however, it is important to recognize that the maximum value will far outweigh the investment incurred in protection and enforcement and even minimum or marginally value may recoup such investment.

The other direct benefit of intellectual property protection is the creation and establishment of credibility and confidence in the business space and consumer space. Businesses with strong intellectual property portfolios are generally regarded more favourably especially by professional investors. It is not uncommon for companies to apply for protecting their IPRs en masse immediately before an IPO or other equity distribution. In order to fully exploit this benefit, business would need to not only protect their IPRs but also effectively enforce them since this is the real test of validity and creates unparalleled credibility. The existence and value of this benefit is further supported by the creation of goodwill in the minds of the consumers as a result of the intellectual property rights. The utility of, for example, a protected invention; a catchy brand name; an appealing design; or a good book or painting; in creating and establishing a permanent identity in the minds of consumers cannot be overstated.

Some of the other and maybe, in some views, less significant and less common benefits of intellectual property protection include the motivation and attraction of human resources. The recognition of employee contributions during the identification, protection and exploitation of IPRs provides strong incentive for employees to innovate and develop a protective culture. Prospective employees are also drawn to companies that will encourage and recognise their contributions and the reputation of the companies among investors and consumers further amplify their attractive force among prospective employees. Extended forms of IPRs may also, to some extent, be effectively used as a deterrent against employees carrying the sensitive information after their term of employment and against poaching of employees.

It may be wholly impossible to spell out the benefits of IPR protection in their entirety but the foregoing benefits are highly relevant and important in a private context. They also provide strong justification for protection apart from the traditional drivers of IPR protection which for most Indian companies have been IPOs and foreign collaborations.

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Pharma Patent Primer

An analysis of pharmaceutical patenting reveals the various trends in the types of patents being granted. The earliest product patents focused on chemical compounds, which later gave way to biological products such as antibiotics. Now the emphasis is on genetically engineered products and hybrids of successful drugs. The international pharmaceutical companies claim that the cost of conducting innovative research often consumes their profits owing to the huge generic market, which produces cheaper alternatives. However the generic product is required to be bioequivalent to the original and generic companies are also carrying out innovative research.

The recent patents granted to Indian generic manufacturers such as Ranbaxy, Cipla, Nicholas Piramal and Dr Reddy’s include a large number of product patents alongside the expected process patents. The product patents mainly involve novel forms of classes of compounds known to be effective in the treatment of various disorders. The process patents provide easier techniques for manufacturing a particular product. The new methods also have the benefit of being more economical than the original method.

As an increasing number of highly successful drugs come off patent, it is seen that the parent companies try to defend their patent rights by various delaying tactics such as applying for secondary patents on particular intermediates or forms of the key compound that are not truly innovative. Recent cases of interest include Ranbaxy versus Pfizer on atorvastatin (Lipitor) and Natco versus Novartis on imatinib mesylate (Gleevec). The cost of the branded drug is usually much higher than that of its generic counterpart and this causes problems in developing countries. Big companies often have strangleholds on particular markets for a certain drug (Bayer with Ciprofloxacin-Cipro) and during epidemics this can create problems as availability runs low and prices remain high.

The non-generic companies claim that high prices are required to sustain the costs of research and development. Patent analysis however reveals that discoveries of entirely new compounds are rare and most of the product patents focus on novel derivatives or substituents of the known compounds not differing much from those granted to generic manufacturers. Combination products consisting of several successful drugs are increasingly being developed.

This article has three case studies on Ciproflaxcin, Imatinib Mesylate and Atorvastatin.

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Innovative Indemnity

I’ve struggled with a major writer’s block, all of June. I have been pondering what a good first article might be, for our blog here at PatNMarks. In the end I decided that Intellectual Property (IP) in India is still, for all intents and purposes, a fresh sheet of paper. No start can be a bad start.

In my experiences with innovators, I face a common theme that continues to amuse and disturb me equally. First, most innovators are afraid to disclose sufficient information. No amount of pleading with the brightest minds that only what is disclosed can be protected works, sometimes. Second, there is some bewilderment about what the valueof IP really is. I attribute this to the vast disconnect between practitioners and innovators. Each one sits in their own cloister and is afraid to look outside. Hopefully, discussion generated here will help rid some of the myths.

In the past few years, I have been constantly amazed at the amount of intellectual capital we possess right here. Even though, most of our sectors seem to strictly play within the service arena. If there be more debunking of folklore about IP, maybe some of these really smart people will feel more encouraged to hold on to some of their ideas. There is a real need for this for several reasons. Establishing such capital will go a long way to procure the mileage smaller and medium sized businesses need to differentiate themselves in the market. Protecting ideas always provides the leverage to run farther with the products generated as a result of those ideas. Encouraging research and development and more abstractly, critical thought, is the hallmark of progress. R&D need not be limited to the areas of pure science or medicine. Small and medium sized businesses should definitely consider putting in place teams to plan and innovate, in order to stay ahead of the curve. In doing so, they should also recognize the rewards IP rights bring with them and utilize them. The wealth in IP is not limited to future forecasts. The history of thought behind big ideas is well maintained by reasonable checkpoints in the literature that is available. This is another tool that small and medium businesses can fully utilize.

One of my favourite authors, John Steinbeck, wrote several lines that I live furiously by. In his book called East of Eden, he introduces a character called Sam Hamilton who is a shining man, constantly inventing things. Often in my first meetings with inventors, I wonder if I will meet the next Sam Hamilton. Some one who is your average next-door-neighbor, who invented the next big thing.

And like Robbie Maltby (another of Steinbeck’s characters) would say: “It behoofs us to be ready!

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Welcome

Hello! Welcome to the PatNMarks web log. Starting June 2006, we hope to take you through several worthy discussions on Intellectual Property Law, generate worthy conversation on policy and procedures and make for better interaction amongst practitioners, inventors and officials. All of the articles in this blog are invited articles. This helps us keep random web-users from populating the blog (which is a common occurrence) and streamline the content to relevant topics.

Please give us feedback on how we can make things better by writing to us.

Let the cavalcade begin!

Anu Vaidyanathan
CEO.

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