Tag Archives: commercialization

Practice Pointer: Form 27 Requirement in India (Statement Regarding the Working/Non-Working of Issued Patents)

It is needless to say that one core mandate of protecting one’s intellectual property is to promote the progress of science for the benefit of humankind. At the same time, it is also important to ensure that a patentee’s right of excluding others from making, selling, using, offering to sell, and importing the protected subject matter is not misused and does not lead to non-practicing or non-commercialization of the IP by anyone, which would defeat the abovementioned purpose in entirety.

One such tool for the Indian Patent Office, to prevent misuse or rather non-use of patented inventions is to seek periodic information from the patentees as to the extent of commercialization done (also interchangeably referred to as working of the invention), wherein the extent includes informing the Patent Office of the number of licenses granted (if any), revenues/sales generated from the sale/license/commercialization of the patent, parties/stakeholders involved in or responsible for actual commercialization of the patent. Working of a Patent can include but not limited to manufacturing the products in India (either by the patentee or the license) for use in India or for export, importing the patented product in India, and licensing the patent rights.

The above information is covered under Section  146(2) of the Indian Patent Act, 1970, which states that “Every patentee and every licensee (whether exclusive or otherwise) shall furnish in such manner and form and  at such intervals (not being less than six months) as may be prescribed statements as to the extent to which the patented invention has been worked on a commercial scale in India” read with rule  131(1) of the Indian Patent Act 1970 which requires that this “information should be filed every calendar year, within three months of the end of each year.” The deadline for filing this information therefore is 31’st March of each year and is applicable only to Patented inventions. The statute specifies a provision for submission of information in Form 27 regarding the details of ‘working of a patent’ granted in India, which is a statutory requirement.

The information sought by the IPO in Form 27 can be summarized as follows:

A. For not ‘working of patent’: the reasons for not working and steps being taken for ‘working of the invention’ to be provided by the patentee.

B. In case of establishing ‘working of a patent’, the following yearly information needs to be provided:

i) The quantity and value of the invention worked; which includes both local manufacturing and importation.
ii) The details to be provided if any licenses and/or sub-licenses have been granted for the products during the year.
iii) A statement as to whether the public requirements have been met partly/adequately to the fullest extent at a reasonable price.

It would be noted herein that even if the patent is commercially not worked in India, the patentee or the licensee needs to explain the reasons for not working and steps being taken for working of the invention. Such information on commercialization of patented products/method, along with other provisions such as Compulsory Licensing, at least in principle, would make the Patentee prompted to work the invention at the earliest rather than merely having a negative mindset of waiting for third parties to use/work the patented subject matter and then subsequently sue them for infringement actions and claiming their accounts of profits.

The Patent Act has also provides that if any person refuses or fails to furnish information as required under Sections 100(5) and 146, he shall be punishable with imprisonment that may extend to 6 months or fine which may go up to rupees ten lakh (one million).

Gopanjali Singh, Patent Associate, IIPRD, Gopanjali@iiprd.com

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Technology Transfer Opportunities for Pharma/Biotech/Diagnostic Companies in the SME Sector

IIPRD (IIPRD) is among the leading Indian IP Consulting Firms focusing on Technology Transfer and Licensing for numerous Indian and Global Corporates and Research Institutes. IIPRD is highly active in the Technology Transfer and Licensing of Patent Backed Technologies/IP’s in the domains of Pharmaceutical, Life Sciences, Diagnostics, Telecommunications, Software and Medical Devices among others.

IKP Knowledge Park: IKP Knowledge Park (formerly known as ICICI Knowledge Park) is a non-profit Science and Technology Park based in Hyderabad, and is recognized as the premier biotech park in India. It is playing an active role in developing the biotechnology and pharmaceutical industries.

Foundation for MSME Clusters: Also known as FMC, the body is a non-profit registered Trust conceived by the Entrepreneurship Development Institute of India (EDII), Ahmedabad, India with technical support from the United Nations Industrial Development Organization’s Cluster Development Program in India. FMC strives towards making cluster initiatives inclusive with the help of a pool of distinguished national and International experts.

IIPRD is happy to announce its association with IKP Knowledge Park and The Foundation of MSME Clusters for being its Official Partner for scouting for new and innovative technologies (preferably backed by a strong Patent Portfolio) Technology Transfer opportunities for Small-Medium Size Pharmaceutical Companies. The ultimate aim is to accelerate the development of innovative companies in biotech, pharma, diagnostics and medical device areas through cluster development, technology acquisition and innovation fostering.

It is an excellent opportunity for the Indian/ Foreign companies, universities and Institutes for technology transfer/out-licensing/commercialization of their technologies in the following technology areas.

Technology Areas:

  1.  Therapeutics & vaccines in phase 1 clinical trials (infectious diseases, cancer)
  2. Biosimilars with significant data for regulatory approval (MAbs, therapeutic proteins)
  3. Point of care diagnostics that can be low priced
  4. Molecular PCR diagnostics – infectious diseases, genetic diseases
  5. ELISA based diagnostics – infectious diseases, genetic diseases
  6. Rapid diagnostics (paper strip tests)
  7. Enzymes for diagnostics biochemical tests (GOD, POD, etc)
  8. Enzymes with industrial applications
  9. Economic and green production of pharmaceutical intermediates and API’s
  10. Cardiac stents improvements, designs
  11. Inexpensive medical devices

In brief, the mandate of the exercise is to identify technologies in one or more of the above highlighted technology verticals and present them to established and interested group of In-Licensees/Buyers of the technologies. Product or process Technologies of potential out-licensees/sellers, which are either Corporates or Individuals, having adequately supporting clinical data or commercial use data relating to the respective technology, are welcome to send their technologies to us for brief evaluation post which we would be sharing these technologies with potential in-licensees/buyers in India.

The potential technologies would be showcased in January 2012 in Hyderabad and Ahmedabad, India and we therefore request all interested companies having technologies in the above mentioned categories to write to us at Dayanand@iiprd.com or iiprd@iiprd.com or contact Dayanand Reddy at 0120-2342010.

Mr. Dayanand Reddy

IIPRD

IFAIA Centre, S/20-22,
Greater Noida Shopping Plaza
UPSIDC Site – IV,
Plot No. S-7/2, Kasna Road
Greater Noida – 201 308, UP,
National Capital Region, India.

Specific Requirements:

API and intermediate production:

  1. Few intermediates which are imported from China. Indian companies are interested in cost-effective methods of manufacture that can be in-licensed. Examples: 2,4-Dichloroflurobenzene (Intermediate for Ciprofloxacin), 6 – AminoPenicilic Acid (6-APA; intermediate for Peninicillin),  Erythromycin (fermentation intermediate)Vitamin C, Difluorobenzene(Intermediate for Flucanazole).
  2. Biocatalysis for stereoselective reduction.
  3. Chiral synthesis, enzymatic stereoreduction, Novel catalysts to make process more efficient, Stoichiometric yield improvement (theoretic/atom yields).
  4. Cheaper process, green processes, more efficiency. Raw materials. Want to enter new markets-open to new APIs.
  5. Custom synthesis of Impurity/metabolite: Cost effective synthesis, novel methods of synthesis.
  6. Process improvements, Intermediate manufacture.
  7. Open to considering new synthesis pathways. Open to making new analogs of APIs.
  8. Open to new processes that are more economical. Reduction, chloromethylation and bromination green technologies, Methylation of phenols, Water based methylation using methanol and phase transfer catalysts.
  9. Ketone and amine technology for statins.

Formulations and drug delivery:

  1. NDDS, Novel formulations, production technologies (Directly Compressable Granulation technology; Dissolution Technology (key requirement))
  2. Gastric retentive technology (GRT). Transdermal patches-HRTs, hypertension. Liquid orals technologies. Solid oral- controlled release, Intra rumenal capsules. Dry powder inhalation products
  3. NDDS for asthma drugs, for respiratory delivery
  4. Mouth dissolving tablets

Biotechnology:

  1. High value, low volume.  Energy, probiotics, waste water treatment etc.
  2. Childhood vaccines/ candidates, adult vaccines, novel vaccines, novel fermentation technology, adjuvants, vaccine delivery, cold chain breaking technologies..novel formulations
  3. Want microbial identification techniques
  4. High yield vectors to produce monoclonal antibodies, better production techniques. Similar techs for biosims
  5. Most robust technological systems for manufacturing, processing and analytical advantages(HPLC, PCR, etc-fewer steps). Methods for increasing yields, or reducing down-stream processing costs. Antibodies for purification: product specific. Raw materials too high-disposable bioreactors, plastics, pipettes, etc.New vaccine candidates, novel adjuvants, novel expression systems, Bacterial or yeast expression systems for influenza antigens, HPV antigens, MAbs, etc
  6. Monoclonal antibodies-biosimiliar. Open to acquiring new area (oncology focus, TuMabs). Surface resonance frequence meters for testing Mabs.
  7. Genetically modified organism for yielding DHA, less expensive raw materials
  8. Effluent treatment.
  9. Fermentation based technologies, technologies that can improve conjugation of vaccines, anything that can increase yields, etc.better vaccines that. Better adjuvants, better stability appearance, etc
  10. Fermentation based technology for pharma – Immuno-surpressions. Seretiopeptidase, Nattokinase, Fungal-destase, acitic protease, Lectase (enzymes), Improved versions. They have 40,000 litre fermentation capacity, which is ready, which they want to use. Sub-merge biotechnology. Good vaccine technology, like polyvalent, penta-valent. They don’t want to be disease specific. Open for multiple disease areas
  11. Vertical integration. Biofuels: Jatropha seed to oil. Value added technologies. (for e.g. decrease toxicity in seed cake). Anything that adds value to any step in the biodiesel production. Any clean energy technology- algae, etc. Resin column technologies, hydrodynamic conversion, catalytic depolymerization. Nutraceuticals:  innovative herbal extraction, low- value, high value plant based products.

Diagnostics:

  1. Access to good quality MAbs. Immunoturbidometry techniques.Open to sub-licensing. Enzymes such as Glucose oxidase-GOD , peroxidise-POD, Urease, cholesterol oxidase and cholesterol esterase : can enter these verticals.
  2. R&D Equipments is a major problem, bio-equipment is a major opportunity area (No/very few people operate)…..Following areas they are interested in: Novel Rapid diagnostics technologies, markers,  Glucometer, Hb-meter, molecular diagnostics…..POCT .
  3. Better, less expensive instrumentation technologies. Enzymes for biochemical tests. Rapid test technologies-list- pregnancy then HIV, HBV, tropinin, etc. (See website of Association of Diagnostic Manufacturers of India :www.admi.org).
  4. Smart-phones: Android (google) based solutions for diagnostics…to ally with Elisa reader/spectrophotometer. MAbs for Diabetic markers (C-peptide, HA1C): CVD markers. Check with ATCC. Rapid test technologies. All hand held diagnostics
  5. Its only through innovative technologies we can penetrate the market nationally and internationally and create a brand value for ourself. Like for example you see most of the products in diagnostics sectors are not stable above say 37 °C, if we have a products which are stable at even 45 °C and above then there is huge potential. Say insulin oral delivery  again has good potential market. Biosimilars stable at 40°C might sound good.

Medical devices:

  1. Drug-delivery, elution kinetics. Novel alloys for stent systems, biocompatible material in stents. Also entering oncology drug delivery material. Stents in non-cardiac areas (peripheral stents). Self-expanding or shape memory stents.
  2. Anything that optimizes/miniaturizes the controller components or iontophoresis. Sumatriptan succinate, GNRH, etc. Formulations for transdermal patch-friendly drugs.
  3. Implant and fixator grade SS steel and titanium manufacture technologies. Forging of titanium and cobalt-chrome.
  4. Hydroxy-apatite, ceramic and other biocompatible coatings for implants
  5. Tech transfer of design.

NATCO FILES INDIA’S FIRST COMPULSORY LICENSING APPLICATION

Natco Pharma has filed India’s first Compulsory Licensing (CL) Application (in accordance with Section 84(1) of the Indian Patents Act) against one of the Bayer’s patented drug Sorafenib, marketed by Bayer as Nexavar for treating Kidney and Liver Cancer. Patent on Sorafenib is granted in India on 03.03.2008 having number IN 215758. This will be a landmark development of such licensing in India and being a test case would set a precedent for the forthcoming similar cases. The CL Application is published in the Official Journal of the Indian Patent Office and can be seen here.

Section 84(1) of the Indian Patent’s Act allows any interested person to make an application to the Controller for grant of compulsory license after the expiry of three years from the date of grant of patent on any of the following grounds:

a. that the reasonable requirements of public with respect to the patented invention have not been satisfied

b. that the patented invention is not available to the public at reasonably affordable price,

c. that the patented invention is not worked in India.

As documentary evidence, Natco has presented a number of facts in support of a prima facie case of reasonable requirements of public not being satisfied.

Natco has stated in its CL Application that Sorafenib is not manufactured in India but is being imported and sold by Bayer at an exorbitant price in India. The average price of the treatment with Sorafenib per month per patient is Rs. 2, 80, 428/- and almost out of reach of the public. Round Natco has stressed that they will be able to sell the drug for Rs. 8,880/- per month! Natco has showed that at least 30,000 patients are diagnosed of Liver or Kidney cancer every year in India and out of these 99% of patients are unable to afford the drug and die every year.

Further Natco stated that there is a limited availability of the drug and is available only in metros cities, for example, Delhi, Mumbai, Chennai and Kolkata with an exclusion of second tier and smaller cities. Also the distributors of Sorafenib are only in Delhi, UP, Punjab, Gujarat, West Bengal, Bihar, Kerala and Tamil Nadu. Natco points that it has the distribution network in all almost every city and district of India.

Natco earlier requested Bayer to receive Voluntary License to manufacture and sell the drug in India by writing to them on 06.12.2010. The letter which was submitted along with the Application as an annexure is not available for its analysis. However, it would interesting to note whom the letter was addressed to and by whom was the same replied as the concerned stakeholder to whom a request Voluntary License (VL) was sent could play a role in deciding the reasonable efforts taken by the Applicant to obtain the VL. We believe that the person being contacted should be a person having due authority to take decisions on such matters, be it in the business development team or the Sr. Management team. Contacting any person not having the necessary authority would not add value and would not be construed as making appropriate efforts to obtain a license from the patentee. This however is a general issue and not pertaining to the case in context. Also, as a practice, the request for VL should disclose the proposed terms and conditions by the party trying to obtain the CL, in absence of which, the offer would not be held explicit.

Further, Natco stated in its Application that Bayer refused on 27.12.2010 without any further discussion whatsoever. According to S. 84(6) (iv) which says that one of the factors which Controller will take into account while considering a CL Application is whether the applicant has made efforts to obtain a license from the patentee on reasonable terms and conditions and such efforts have not been successful within six months. Natco’s CL Application was filed on 28th July 2011.

Another important factor which the Controller will take into account while considering a CL Application is the ability and capability of Natco to manufacture and cater to the needs of the entire public. Nacto has stated in the Application that it can manufacture 20,00,000 tablets  a day when there is need of 4,80,000 tablets a month. Natco has asserted that it can manufacture the drug by employing existing facilities without requirement of any additional investment/plant etc. as Natco has been already manufacturing other anti-cancer products for the last 20 years.

Earlier this year, Natco has also sought for a voluntary license from Pfizer to manufacture and sell Pfizer’s HIV drug maraviroc (marketed as Celsentri), the application is still pending. It is much expected that Pfizer will decline to give such license owing to high R&D investments incurred and it is quite likely that another CL Application might be coming from Natco soon.

This application by Natco has already started motivating the pharma companies in India in preparing to file CL Applications against patented drugs by Foreign players in manufacturing and selling their generic versions in India. A few of these drugs might not yet even have been marketed and might be in the clinical phase, wherein  S. 84 (a) (iii) could be a ground of filing CL in those cases namely the non-working of the patent in India. However, how strong such an application would be on grounds of S. 84 (a) (iii) is debatable as the drug itself is in the clinical phase and cannot anyways be worked upon by any company till the time it is registered with the regulatory authority.

A key point being stressed here is that the first CL Application has not even been granted by the Controller as yet and there is a feeling of urgency that is being felt right away in the Indian Pharma community to file multiple CL’s as possible. I wonder how Natco’c victory in this case could motivate the Indian generic industry to go ahead with the compulsory licensing. However, it is foreseen that the outcome and the ultimate result of this CL will be long awaited owing to the expected court battle between the two as the losing party is likely to challenge the decision. One thing is for sure, grant of the CL to Natco will motivate a large number of Indian pharma players to apply for the same against costly patented drugs (being sold by big Foreign players) mainly on price affordability ground as the Government in many of Indian pharma patent battles has already seemed to be inclined in favor of the generic companies selling cheaper drugs in public interest.

About the Author: Ms. Meenakshi Khurana, Patent Specialist at Khurana & Khurana and can be reached at: meenakshi@khuranaandkhurana.com

 

INVENTORS, ALL TECHNOLOGIES AREN’T WORTH BILLIONS

Working in the IP/Technology Commercialization and Out-Licensing domain makes you assess and evaluate commercial viability of numerous IP backed inventions across technology domains.  Apart from learning about and assessing new technologies, we also tend to learn quite of lot about Inventors mindset, specifically about their perspective of their own inventions. This article relates to our experiences in dealing with some of such Inventors and/or Applicants and making a humble submission to them to analyze their own work, not only from a technology point of view, but more important from a commercial viability and marketability perspective before initiating their research and investing in protecting IP relating thereto. It would be appreciated that the below comments are not being generalized in any manner and that these are only Author’s views based on his own interactions with Clients.

We understand from our Associates in Israel and some European Countries including Denmark, that there are hardly any patents filed in these countries without proper due-diligence on the future return on investment on the patent and without some of kind tie-up already having being done for commercialization or Out-Licensing of the technology. In India, a land where there exists a mandatory requirement for submission of details on working of the invention by the Patentee, where there are numerous agencies supporting technology transfer and commercialization, there exists no such practice, and in fact far from out, to my knowledge there wont be even .01% of patents being granted to Indian Applicants, that would ever see light of the day.

Although, a partial reason for such a low rate of successful commercialization and Out-Licensing could be the mentality of Indian Corporates not to invest in new technologies, not to consider innovation as an integral part of a company, not appreciating Intellectual Properties and enforceable rights given thereby, to have a practice of designing around technologies to avoid infringement, to have an impression of the Courts being slow in granting damages, among many other reasons.  In addition, sections such as Sec. 111 (1) of the Indian Patent Act, which state that “In suit for infringement of a patent, damages or account of profits shall not be granted against a defendant who proves that at the date of infringement he was not aware and had no reasonable grounds for believing that the patent existed.”, really boost up the confidence of Legal Entities not to In-license or buys strong IP’s as reports such as freedom to operate can come to rescue. Having personally seen literal infringers get away from any civil damages under the protection of this clause and the plaintiff’s merely getting injunction granted to them, reinforces this thought of how successful Licensing Efforts can be in India. Anyhow, this article does not even pertain to Licensees or hurdles present in the systems per se, but rather relates to Licensors and their approach towards commercialization.

Hundreds of patent applications across technology domains are filed every month, with a number of them being from Individual Inventors and Research Institutes. Having said so, as individual inventors and R&D entities, most of the times have limited resources for commercialization of their technologies, including but not limited to manufacturing and marketing capabilities, they look out to Out-License or sell the patent right either before or after the grant of the patent. Further, as even Licensing needs dedicated efforts, strong potential licensee analysis, marketing strengths, and convincing capabilities, a number of times Licensing firms are chosen to represent such patented technologies and approach appropriate licensees and understand their interest levels in the technology before proceeding for discussions on terms and conditions for licenses and valuing the technology for the same. As most of the times, such Licensing efforts are taken on success basis, it becomes crucial for the licensing firms to assess and evaluate commercial strength of the patent and the technology protected there through before committing to proceed with the Out-Licensing process.

The challenge however is to convince the patentees as to why this commercial evaluation is an important step in the Out-Licensing process and why it lays down the basis framework for all future efforts through an understanding of the market, the in-licensing behavior of the market, the major players involved, which of these players are approachable based on their background, the costing involved in substitute technologies, strength of patent, among many other parameters. Unfortunately, as we have experienced, its most of the times a one way thinking strategy, wherein the Patentees, believe their technology to be a superior one and that technology is all what counts. As if a sense of how the market and existing products behave would not matter. As if a sense of whether the patent, as granted, is strong enough to be enforceable does not matter. As if all potential licensees are eagerly waiting to consider such technologies for possible in-licensing opportunity. As if the geography in which the patent is granted and intended to be commercialized does not play a role. Most importantly, as if the need for the technology in the concerned domain can not be refuted and that the market is eagerly waiting for the technology.

I strongly believe that it is high time that technology commercialization, as a field of IP, be looked upon from a matured perspective, in which novelty and patentability of technology is only one parameter to be considered while assessing of the chances of successful commercialization. A host of other attributes play an even more important role during commercial evaluation, some of which have been very briefly discussed below with respect of certain examples. These examples are mere illustrations and no other interpretations should be drawn from the analysis:

The first technology relates to a method and system for administering life cycle of Health insurance policy holder, in particularly a web-based solution for managing complete life cycle of Health insurance policy holder. More specifically, the disclosure relates to a web based system that is capable of managing the entire life cycle of a health insurance policy holder, right from the time he/she subscribes to a policy till the final settlement of insurance claims. The system and method described in the said patent application particularly discloses various interfaces and modules to connect the policy holder to the different stakeholders in his treatment, specially, the Doctors, the Drug Store Attendant, the Lab Assistant, the Nurses, and the Surveyor at the Insurance Company etc.

The second technology relates to a topical formulation for treatment of Warts comprising of two carrier systems, with one being a soluble sulfide and the other being a mixture of two drugs in an oil in water emulsion.

Market Perspective: Under the assumption that the Patent has been granted, it is extremely important to understand the market of the concerned domain and whether the same is receptive to new technologies, especially royalty expecting products/technologies. For instance, in the warts application, the existing treatments available for warts include Chemical Destruction, Cryosurgery, Surgical removal method, and prescription medications using agents including Pondophyllin, Cantharidin, Bleomycin, Dinitrochlorobenzene, and Fluorouracil. The proposed formulation, on the other hand, is a topical formulation, based on sulphides alkali metals, which inherently have stability and toxicity issues. Further, sulphides based products, are typically not OTC products and hence have to be prescribed by Doctors, which is non-preferred route of curing the warts by the patients. The market scenario also tells us that companies such as GSK, Merck, Dr. Reddy’s, and Cipla are the major players in the domain, and being a skin disorder product, which is already heavily populated, most of the focus of these companies lies in other medical indications including cervical cancer etc. Further, with a flood of salicylic acid based and non salicylic acid based products in the market, there seems to be little scope for companies to invest in such products. This is more in cases where there is limited clinical data available to the Potential In-Licensees.

Existing Technology Perspective: As was discussed above, with respect to the warts technology, a snapshot of products being right now marketed was analyzed and over 45 products including Duofilm, Salicure-17, Shaloxy-FW, Salicylix-SF, and Dr. Scholl’s were found out in the same domain. Being a heavily populated domain, introduction of a new product, which combines an active ingredient with a pain reliever, which also is quite known, would have a hard time creating excitement.

Patent Strength/Enforceability Perspective: Being granted a patent is completely different from being granted a strong and enforceable patent. A number of times, we encounter patents which good and bypass the market and product level analyze, but are drafted and protected so narrowly that instead of in-licensing, there of more chances of the potential licensee designing around the technology. Taking for instance, the first independent claim of the web-based health insurance software, which claims a

“A web based method for managing complete life cycle of health insurance policy
holder, said method comprising acts of:

a.        registering subscriber to policy…;

b.        prescribing clinical tests for the insured person …;

c.        performing the prescribed tests and updating the test results …;

d.        commencing the treatment by admitting the patient based on the test results …;

e.        generating discharge summary upon completion of the treatment …;

f.         forwarding claim documents along with discharge summary to the surveyor…”

Even if we assume that the above subject matter is patentable under S. 3(k) of the Indian Patent Act and also overcomes the novelty and obviousness issues, with the above exemplary claim being so narrowly drafted, enforceability would always be questionable and significantly hamper efforts of Out-Licensing the patent rights.

Potential Licensees Perspective: There are often cases in which the technology has strong market application and that there does exist a need for such a technology to improve the manufacturing process. However, even under such circumstances, the out-licensing efforts might not go through because of the target potential licensees that might be involved. For instance, a wire mesh machine that allows a continuous strip being used for making a welded metal lattice is a product that would do very well in EP and US geographies but Indian companies, most of them being unorganized in this domain, would be reluctant to in-license or buy patent rights of such a machine due to parameters such as cost involved, ease of replication, among others.

Supporting Data/Prototype/Clinical Data Perspective: Another important parameter used for evaluating products/technologies, especially in the pharmaceutical domain, is the level to which the Clinical tests have been done. With most in-licensees, particularly in India, looking to evaluate in-licensing proposals based on prototypes being developed and the clinical data available, it becomes integral to provide as much supporting data as is possible along with the IP details being given in the commercialization proposal.

It would be appreciated that above mentioned parameters are only an exemplary set, and many other attributes such as patent validity, extent of estimated effort and time involved in the process of commercialization, expectations of upfront and royalty payments, research being carried out with other competing technology companies, other available in-licensing opportunities, among many others play an equally important role.

I therefore believe that the Patentees should appreciate that there is more to a successful technology transfer than merely having a patent in hand and a superior technology in mind. Many other considerations play a role in determining whether the patented product would be acceptable in the market and these are the considerations that need to be analyzed before even initializing the R&D process so that there is little resentment in case after the complete R&D and patent process, one realizes that the applicability and commercial viability of the concerned subject matter is limited.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.

INDIAN GRANTED PATENTS…ENFORCEABLE?

The Indian Patent Act, 2005, like for most other geographies, does accord to and follow the disclosure guidelines put forth by the TRIPS and has similar Patentability grounds, especially for non-Pharmaceutical subject matters, in which the contention over 3(d) leads to a different interpretation over efficacy grounds. Furthermore, special provisions such as those provided under Section 8 of the Patent Act, enable the Indian Patent Office to retrieve additional and more relevant information about the prosecution that happens with the family foreign Patent Applications of the Indian national phase patent application. Moreover, additional prior art available by means of results cited by ISR, literature/patents cited by the Applicant, earlier Patent/Prosecution History of the Applicant, gives way for searching more relevant and anticipating applications.  Furthermore, with the Indian Patent Office being accorded as an ISR, is it now time that the Indian Granted Patents have certain extent of serious patent prosecution done, not from a formality compliance perspective, but more importantly from novelty/obviousness standards.

For the present discussion, let’s take an exemplary and recently Indian granted Patent 245829 (‘829), having a publication of grant on 11/02/2011, the Application No. for which is 4445/CHENP/2006 and the Applicant being Utstarcom, Inc. In summary, the invention relates to address-based network communications and more specifically to determination of a prefix portion of an address. Abstract of the granted Patent states:

A network element (10) can retain a plurality of prefix identifiers as are used to formulate an address to be used by individual network users. Pursuant to a preferred approach, one or more of these prefix identifiers are pre-correlated to a given domain name while at least one other prefix identifier is pre-correlated to the absence of a domain name. So configured, a specific prefix identifier can be allocated for use by a given network user as a function, at least in part, of the domain name (or lack of a domain name) as may be presented by that network user when seeking to establish a network connection.

The first independent claim as granted as per the Indian Patent Office is:

1. A method comprising:

receiving a communication from a network user seeking to establish a network connection;

when the communication presents a domain name as corresponds to the network user:

identifying a first prefix identifier as having been pre-correlated to the domain name;

providing to the network user the first prefix identifier;

when the communication does not present a domain name as corresponds to the network user

providing to the network user a second prefix identifier, which second prefix identifier is reserved for use with network users that do not present a domain name.

As it is evident from the first claim itself, the invention relates to two scenarios of mapping between “Domain name” and “Prefix Identifier” or “IP Address” or “Network Address”. In case the domain name is given by a network user, an IP Address corresponding to the same is returned back and in case the domain name is not provided by the network user, a new/second prefix identifier is generated and provided to the user. This is typically a well known function of a DNS system, wherein the claimed novelty seems to relate to generating a second prefix identifier in case domain name is not presented by a user.

As at the time of writing this article the Application Status search of the Indian Patent was not working, I am assuming that as the patent was granted in Feb 2011, the FER was issued somewhere around Jan-Feb 2010. From a strategic perspective, it would not have made sense to see the prosecution status of the corresponding applications in geographies such as EP or US, more so given the fact that Section 8 of the Indian Patent Act asks the Applicant’s to submit detailed updates on filing/publication/prosecution/abandonment/grant activities related to the corresponding foreign applications. It is to be noted that for the Corresponding application EP 1759300, the application was withdrawn by the Applicant on 28.08.2009, before the Indian Patent Office issued the FER. The same was the case in the corresponding US Application, wherein the Applicant itself failed to respond to the Final Office Action.

A close look at the cited portions of the Prior arts cited in the ISR, specially US 6324585, could also have given help in identifying anticipating documents, specially with the claimed subject matter being broad and relating to the overall functionality of a standard DNS system. Furthermore, prior arts discussed in US prosecution including ‘585 and US 2004/0258005 and US 2002/0172206 give clear pointers to claimed subject matter.

Furthermore, even if the above due-diligence was not considered worth, a very brief and quick search with the most basic keyword string (Dynamic AND “domain name” AND “network address”) would have revealed so many below mentioned and relevant patents, based on which the patentability of the subject matter involved could have been evaluated. Based on our quick due-diligence, we found following relevant patents that covers ‘829 subject mater partly or wholly.

IIPRD – Search Results

Search Result 1: US 6338082 – (Cited Portion for the first element of the independent claim which claims mapping between a domain name and a prefix identifier (IP Address)): A client of the DNS is called a resolver 114 . Resolvers 114 are typically located in the application layer of the networking software of each TCP/IP capable machine. Users typically do not interact directly with the resolver 114 . Resolvers 114 query the DNS by directing queries at name servers, which contain parts of the distributed database that is accessed by using the DNS protocols to translate domain names into IP addresses needed for transmission of information across the network. DNS is commonly employed by other application-layer protocols—including HTTP, SMTP and FTP—to translate user-supplied domain names to IP addresses. When a browser program 112 (e.g., an HTTP client), running on a user’s machine, requests a URL having a resolvable domain name, in order for the user’s machine to be able to send an HTTP request message to a server 120 , the user’s machine must obtain the IP address of the domain name. The user machine then runs the resolver 114 (DNS client) on the client-side of the DNS application. The browser 112 extracts the domain name from the URL and passes the domain name to the resolver 114 on the client-side of the DNS application. As part of a DNS query message, the DNS client 114 sends the domain name to a DNS server system 120 ′ connected to the Internet. The DNS client 114 eventually receives a reply, which includes the IP address for the domain name. The browser then opens a TCP connection 116 to the HTTP server process 120 located at the IP address.

Search Result 2: US 6425003 – (Relevant Cited Portion for the second element of the first independent claim which claims mapping between “no domain name” and a “second (new) prefix identifier”):  A method and apparatus for resolving where to forward DNS (domain name service) requests for a user simultaneously logged into more than one service existing on a data communications network utilizes an active service list (ASL) to keep track of the services that the user is currently logged into. The active service list includes a list of services sorted in a particular order based on information about the service and sometimes the order in which the user logged into the services. Each service has a profile that defines, among other things, the IP Address space for the service and a Domain attribute. To determine the appropriate service and, therefore, the appropriate DNS server for a DNS request, the QName from the DNS request is compared to the configured Domain attribute(s) for each service in the order of the ASL. If a match is found, then the DNS request packet is modified to re-direct the DNS request to the DNS server configured for the matched service. If no domain match is found and the user is logged into an Internet Service, then the DNS request packet is modified to re-direct the DNS request to the DNS server configured for the first Internet Service found in the user’s ASL. If no domain match is found and the user is not logged into an active Internet Service, then the DNS request is not re-directed, but rather forwarded unmodified.

 Search Result 3: US 6,944,167 – In one embodiment of the present invention, a domain name server receives a request for the public address of a private network host, using a public Internet Protocol (IP) address. The domain name server then determines if a valid public address for the private network host exists in an address data structure maintained by the domain name server. If a valid public address is found, the domain name server returns it to the requesting host. If a valid public address is not found, then the domain name server requests a public address from a network address translator identified with the private network. The network address translator then determines whether a public network address is currently assigned to the private network host. If not, and one is available from a pool of public network addresses available to the network address translator for the private network, then the network address translator allocates a public network address for the private network host. The network address translator then sends the domain name server the public network address or an indication that such address or the host was unavailable. An appropriate public network address might not be assigned for many reasons, including all public numbers are currently used or reserved; the private network host is not running; or security considerations preclude public access to the private network host.

It would be appreciated that the above prior arts have only been given for exemplary purposes after a very brief search merely to draw relevancy to the concern and no comprehensive evaluation of patentability has not been done based on these.

It further needs to be considered of how the first independent claim passes the bar for Section 3(k). The claimed method merely aims at providing a new IP address to a user request which does not have a domain name. The method clearly does not involve any change in structure of the mechanism of data/packet communication, or packet format, or increases the efficiency of transmission, or produces a tangible output in any manner whatever to qualify the concerned test and merely gives an IP address from a pool of prefix identifiers, a step that DNS is already is configured to do.

There are many more allied issues that might crop up for discussion when many more of such patents are evaluated for actual merit but the two I would last put across are: What worth would be such patents, both from enforceability and commercial perspective, if they would be invalidated the day they are litigated? Secondly, what credibility would such Indian Granted Patents have if the Patentees themselves are not even confident that they would be able to enforce their rights when the need arises?

References:

1. Indian Patent office database

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.

INTERNATIONAL PATENT PROTECTION IN ELECTRONICS & IT (SIP-EIT) SCHEME BY DIT

It is enriching to hear and read so much of focus going these days into Innovation at Grass Root and Startup level. With initiatives being taken at all levels by Stakeholders including FICCI, MSME, DIT, and NASSCOM, the next wave of the so called Start-up innovation can really be envisioned. As has correctly been stated by the article of Vivek Wadhwa of 14’th December ‘2010, a new breed of Indian Start-ups now is developing high-value products based on Intellectual Property. Having out-licensed some of such out-of-box telecom and network security products, I couldn’t have agreed more.

This article essentially relates to about a 2 year old but not so actively participated scheme that DIT has for Indian Information and Communication Technologies (ICT) based Start-ups and SME’s. Having worked with many Indian Start ups in the domain of Software and Electronic technologies, I have regularly seen unfunded Corporates turning down potential IP’s which could have had significant valuations when put across to the Investors. This is more so the case when the Applicants avoid filing the PCT and National Phase Applications outside India knowing full well that the real valuation of an IP at the present moment is only considered as a value proposition if its protected in US and EP.

The proposed scheme is called the SIP-EIT (Support International Patent Protection in Electronics and IT), wherein the scheme reimburses the costs incurred by SMEs and Technology Start-Up units in filing International Patent Applications (in the field of Electronics & ICT) for their indigenous inventions.

The highlights are as follows:

1. Registered MSME, DSIR Certified companies, and Technology Incubation enterprises are eligible to apply for the scheme.

2. The funds are given as a grant – i.e., no refunds expected.

3. The Applicants are free to hire any Attorneys whose fees are included in the schedume and would be refunded subject to the below mentioned maximum limit.

4. 50% of all expenses, including lawyers fees, is reimbursed by the DIT. However, this “50%” must not exceed Rs. 15 Lakhs

5. Along with the registration and financial details, the Applicant needs to provide a prior art search report indicating the chance of patentability of  the invention, product brochure, and Official copy of Indian Patent Application Filing.

6. The Start-up/SME need not be an ICT company, it can be a Pharmaceutical or any othr company having an ICT product, apparatus and/or process.

The details of the scheme are available here. We believe this to be an excellent support that if utilized properly can yield effective Licensing and Product Commercialization opportunities for the company.

The only caveat in my perspective, at the moment, would be the appropriateness in grant of ICT based Patents in India and their enforceability in the Court of Law keeping the Section 3(k) in mind. We have already seen examples of Computer implemented patents being granted in India of whose corresponding Patents have been rejected by the EPO and other geographies which have tests based on technical effect and tangible results. Therefore, keeping in consideration the inconsistency of patents being granted based on the technical effect bar of the Indian Patent Office, probably its high time that objective tests be set to ensure reliability in the outcome of the patentability to produce defendable and enforceable ICT patents.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.

Asian Electronics Ltd. vs. Havells India Ltd.

Working of the invention playing a role in deciding Balance of convenience

This time Asian Electronics Ltd., referred to as Asian hereinafter, owner of the Indian Patent Application No. 193488 titled “Conversion Kit to change the fluorescent lighting units inductive operation to electronic operation” claimed injunction and consequential reliefs including damages against the Defendant, also referred to as Havells hereinafter.

Mr. Shah, Chairman, Asian, developed an improved conversion kit to change the 4 feet long T8 or T12 from inductive operation to electronic operation without any re-wiring to avoid the problem of flicker while starting and discharge of invisible gas which cause inefficiency in the energy spent and claimed the following features in the first independent claim:

“Claim No. 1.

Conversion kit to change fluorescent lighting units from inductive operation to electronic operation, comprising a pair of sleeve like adaptors which are adapted to be mounted at the ends of a straight fluorescent lighting tube, and a wiring assembly for electrically connecting the adaptors, the structural components forming the electronic ballast being mounted in one or both of the adapters, or being mounted in the wiring assembly.”

Following claims and/or arguments were made by Asian in support of the intended novelty of the invention

ü      Patent being granted in 26 other countries

ü      Awards being awarded for innovation

ü      Publicity on the novelty of the invention giving the invention the due popularity

ü      Sales Figures

A claim mapping study by Asian revealed that one of Havells fluorescent lighting unit comprises of all the elements of the claimed subject matter. The learned counsel of Asian argued that the novel and unique features of the Asian products are the two adaptors based on 2 sides which assist in the process of conversion to electronic current from induction and thus minimize flickering which is normally associated with fluorescent lights. The plaintiff also argued that the Defendant had got enough opportunity to oppose the grant of the application.

Havells, on the other hand, contended that the Indian Patent of Asian is completely based on US Patent 4246629 and further claimed that the Plaintiff’s Patent lacked the necessary inventive step as being a mere workshop improvement and mere re-arrangement under S. 64 (1) (d) of the Indian Patent Act. Havells further argued that all indications in the suit are that Asian does not work its patent, and that therefore, the balance of convenience if at all, is against the grant of ad-interim injunction.

If analyzed carefully, claim 1 of ‘629 US patent states the following:

(c) two end caps and means retaining same at respective ends of said housing; and

Two end caps as claimed by the US Patent clearly anticipates the novelty as claimed and proposed by the learned counsel of Asian. Havells also made further arguments relating to working of the invention in India and that the plaintiff had no proven sales in India.

The court also more importantly stated that in Franz Xaver Humer v. New Yash Engineers, ILR (1996) 2 Del 791, a Division Bench ruling of this court, suggests that if the product is imported, or not sold widely in India (not “worked” in India) the court should be cautious in granting injunction. It was therefore held that the plaintiff has failed to establish that the balance of convenience is in favor of grant of an interim injunction. This was further substantiated by no filing of Form 27 by Asian to demonstrate use and/or significant commercialization of the invention in India.

Case No. IA No. 8205/2009 in CS (OS) 1168/2009

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.