Monthly Archives: July 2011

Two Day International Symposium On Strategies for Managing Pharmaceutical, Biotechnology & Chemical Patent Portfolios

IIPRD (Institute of Intellectual Property Research & Development) is happy to announce its International Symposium on Strategies for Managing Pharmaceutical, Biotechnology & Chemical Patent Portfolios. Presentation of all important patent issues such as identification of potential inventions, Biosimilar Legislation, preparation of claim sets, prosecution and examination practices, drafting of responses of Office Actions, ANDA Litigation, and recent case law updates can be expected at the symposium.

The two day international symposium will be held at Hotel Hilton, Mumbai on 10th and 11th Oct. IIPRD is organizing the international symposium with the help of international law firms Sughrue Mion PLLC and Khurana & Khurana, IP Attorneys, India.

Key speakers include

  1. Mr. Chid Iyer from Sughrue Mion, USA
  2. Mr. Kenneth Burchfiel from Sughrue Mion, USA
  3. Dr. William Simmons from Sughrue Mion, USA
  4. Mr. Michael R Dzwonczyk from Sughrue Mion, USA
  5. Ms. Azy Kokabi from Sughrue Mion, USA

The speakers are a unique gathering of Patent Attorneys, who have extensive years of experience in their professional fields, and will put across to the delegates the real insight of Patent Laws and Practices as prevalent and practiced in United States. The Workshop will provide an opportunity to receive first-hand information including recent Judgment on various issues from the experts in the fields. The speakers are selected such that the attendees can get to know the real insight and nitty-gritty followed at United States. The speakers would share real-life cases and experiences that can help the attendees in following the best practices for building their respective patent portfolios. The speakers would also talk at length on the recent case laws and how courts of different geographies interpret the same application in different ways so that best practices for each geography can be put across.

About the Organizers:

IIPRD is a premier Intellectual Property Consulting and Commercialization / Licensing Firm with a diversified business practice providing services in the domain of Commercialization, Valuation, Licensing, Transfer of Technology and Due-Diligence of Intellectual Property Assets along with providing complete IP and Patent Analytics and Litigation Support Services to International Corporates and Global IP Law Firms. IIPRD also provides industrial training to Indian business houses. In this direction, IIPRD has been regularly holding International Seminars as one of its focused activities on its own and in collaboration with various Government and International agencies. IIPRD has held scores of National and International Programmes. IIPRD also conducts tailor made educational programmes for better known corporates at their premises specific to their needs. IIPRD has been established as an earnest and sincere effort by corporate trained IP practitioners to assist Global Business Houses in strategizing their growth by leveraging their IPR’s through effective Creation, Promotion, Protection, and Commercialization of IP. IIPRD has a legacy of over ten years of existence and is among the first Indian IP Firms to have core focus on Commercialization, Technology Transfer, and Licensing for numerous Indian and Global Corporates, with Patent practitioners from across technology domains.

Please contact http://www.iiprd.com/seminar_October_Pharmaceutical_2011.htm for further details.

One Day Symposium On Advanced Patent Issues Related To Software, Electronics, Telecommunication Business Methods & Network Computing With Focus on US, EP, and Indian Scenario

IIPRD (Institute of Intellectual Property Research & Development) is happy to announce its International Symposium on Advanced Software, Electronics, and Business Method Patent issues. Presentation of all important Patent Issues relating to Prosecution and Enforcement Strategies, Identification of potential inventions, Types of claims allowed in each geography, and their relevance to the broadness of claims, Preparation of set of claims, including an experience sharing session on Drafting of Patent Applications, and Patent Prosecution can be expected from the speakers.

International symposium will be held at Mumbai on 11th Oct ’2011 at Hilton Hotel and at Hyderabad on 12th Oct 2011 at Hotel Taj Banjara. IIPRD is organizing the International Symposium in association with Birch Stewart Kolasch & Birch LLP, USA (BSKB), Carpmaels & Ransford, UK, and Khurana & Khurana, Advocates and IP Attorneys, India.

Key speakers include:

  1. Mr. Michael Mutter from BSKB, USA
  2. Mr. John Brunner from Carpmaels & Ransford, UK,
  3. Dr. Viswanathan Seshan, Head IP&S, Phillips, India
  4. Mr. Tarun Khurana from Khurana & Khurana.

The speakers are a unique gathering of Patent Attorneys, who have extensive years of experience in their professional fields, and will put across to the delegates, a real insight of Patent Laws and Practices as prevalent and practiced in European Patent Office, United States, and India. The Workshop will provide an opportunity to receive first-hand information including recent Judgment on various issues from the experts in the fields. The speakers are selected such that the attendees can get to know the real insight and nitty-gritty followed at European, United States, and Indian Patent Offices. The speakers would share real-life cases and experiences that can help the attendees in following the best practices for building their respective patent portfolios. The speakers would also talk at length on the recent case laws and how courts of different geographies interpret the same application in different ways so that best practices for each geography can be put across.

About the Organizers:

IIPRD is a premier Intellectual Property Consulting and Commercialization / Licensing Firm with a diversified business practice providing services in the domain of Commercialization, Valuation, Licensing, Transfer of Technology and Due-Diligence of Intellectual Property Assets along with providing complete IP and Patent Analytics and Litigation Support Services to International Corporates and Global IP Law Firms. IIPRD also provides industrial training to Indian business houses. In this direction, IIPRD has been regularly holding International Seminars as one of its focused activities on its own and in collaboration with various Government and International agencies. IIPRD has held scores of National and International Programmes. IIPRD also conducts tailor made educational programmes for better known corporates at their premises specific to their needs. IIPRD has been established as an earnest and sincere effort by corporate trained IP practitioners to assist Global Business Houses in strategizing their growth by leveraging their IPR’s through effective Creation, Promotion, Protection, and Commercialization of IP. IIPRD has a legacy of over ten years of existence and is among the first Indian IP Firms to have core focus on Commercialization, Technology Transfer, and Licensing for numerous Indian and Global Corporates, with Patent practitioners from across technology domains.

Please contact http://www.iiprd.com/Seminar_October_Patent_software_2011.htm for further details.

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.

With newly amended Design rules, will India keep up the pace with other global countries?

The Indian Design Act 2001 with some significant changes incorporated in the Amendment Rules, 2008 is serving its purpose well to keep pace with the rapid changes in the technology and international developments.  In view of the globalization of the economy, India is becoming a major hub in the field of industrial designs and Indian Design Law and its administration is suitably aligned with the changed technical and commercial scenario and conforms to international trends in design administration.

The Design Wing of the Indian Patent Office has taken some bold steps and corrective measures to streamline the procedure in the Design Wing and to make the system more transparent and efficient. As per Controller General of Patents, Designs & Trade Marks, complete automation of the Designs Wing is in progress and the entire process will be made fully e-enabled shortly, which will result in provision of online availability of the status of application, Register of Designs and file documents. E-filing of Design Applications and further documents will be introduced soon.

The Design Wing has also come out with a Manual to provide detailed information to the public and users of Design Registration System on the practice and procedures followed by Designs Wing of the Indian Patent Office, for processing of Design Applications and other related procedures.  It is pointed out by the Design Wing that 90% of the applications are objected to at the time of examination based on formality issues only. Very few applications are objected on substantive grounds such as novelty and originality.  The Wing has observed that in majority of cases the delay in registration of design is mainly due to faulty filing which can be avoided by adhering to proper filing procedures. The Designs Wing expects to register a properly filed Design Application within a period of three months from the date of filing.

Though the prosecution of a Design Application is done only at Patent Office, Kolkata, The Designs Act and Rules provide for filing of a Design Application in any of the four Patent Offices i.e. Patent Office Delhi, Mumbai, Chennai or Kolkata.

Following are some pointers that need to be kept in mind to avoid formality rejections:

  1. Instead of naming the views as “Front Elevation View”, the Design Office requires the naming to be simple and convention such as “Front View”. Similarly, instead of using “Bottom Plan View”, “Bottom View” should be written.
  1. Below the signature of the Agent, the Applicant/Agent must write the name of the signatory.
  1. No exploded views should be illustrated in any of the designs. Only the article as a single constructional piece should be included.

Views such as below therefore would not be accepted by the Design Office.

  1. No extraneous matter should be added into any of the design representation and all the views should only represent the article under consideration. Views such as below would therefore not be accepted at the Design Office as the view includes extraneous matters/articles which are not under the subject of design protection.

  1. Name of the article should be very simple and self-explanatory. For instance instead of naming the article as “Multi-Roll Retractable Mast System”, the name should be put across simply such as “Equipment for Target Acquisition”.
  1. Both the Disclaimer paragraphs namely “No claim is made by virtue of this registration in respect of any mechanical…” and “No claim is made by virtue of this registration to any right to the exclusive”, should be written in separate paragraphs.
  1. In case objections are received relating to clarity of title, while responding to the Office Action with simple and revised titles, we should also write the structural functionality of the article in the response to Office Action for clarity of the end of examiner as to the purpose of the article.
  1. Finally, the best way to respond to Office Actions is to discuss the objections with the concerned examiners at the Design Office and understand their expectations from the Objections so that an appropriate response can be prepared. Fortunately, the present Design Examiners are doing a great job in clarifying concerns and queries regarding the Office Action and adhering to the strict Six-Month deadline for deciding the fate of the Application.
  1. Examiners can also be very conveniently reached through emails at controllerdesign.ipo@nic.in, which are responded back very promptly.
  1.  Following is a snapshot of the specimen sheet for a granted Design Application:

We hope the above discussed guidelines would help the Applicants in filing Applications which do not receive formality or minor subject matter clarity rejections and this step would help bring down the overall Office Action percentage considerably from 90%. We would be happy to have more of such practices for the readers so that a stakeholder guideline can be prepared as a checklist for all future applications.

About the Author: Mr. Mohinder Vig, Senior Trademark Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: iiprd@iiprd.com.