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Patent Strategies in Light of the New Rules September 21, 2008

Posted by mais in claim analysis, India, IPM Strategies, patent intelligence, USA.
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Courtsy Russ Krajec’s Anything Under The Sun Made By Man

In Patent Drafting and Claim Writing, Patent Drafting Theory, Practical Tips for Patent Drafting, Patent Strategy, Patents in Business, Business Theory for Patents, The USPTO

The latest rules from the US Patent and Trademark Office are quite sweeping.  The new rules have several facets.  On one hand, the PTO is limiting the number of continuation and continuation in part applications, as well as requests for continued examination (RCE).  On the other hand, the PTO is limiting the number of claims you can have by forcing the applicant to file an Examination Support Document if you exceed the claims.

Another twist is that the Examination Support Document may be forced where two applications are filed nearly simultaneously.  The PTO may assume that they cover the same patentable material and force an Examination Support Document unless you can prove that the applications do not cover the same material.

(As a side note, I have spoken to several patent attorneys/agents about the new rules and I have not yet found one who would even agree to write an ESD, no matter what the cost.  The reasoning is similar to why I will not file accelerated examinations.)

Each of the various requirements put on the applicant presents several problems, including the specter of patent invalidity and possibly inequitable conduct if the various support documents and petitions are not properly done.

In some situations, I used to espouse a kitchen sink approach to patent prosecution, where you load up a patent application with as many ideas as possible, get an early filing date, and file many continuation applications as possible.  This strategy can blanket an area of technology very effectively and makes the best use of early disclosure.  The strategy also could be used to tailor claims to an infringer so that lengthy and costly court battles may be averted entirely.

In view of the new rules, I think another strategy may be better suited.

This strategy is very targeted and narrow, and looks to find specific areas that may be infringed in the future, but does not include any more than it needs.

The targeted strategy is driven from the need to avoid overlapping applications and avoid the potential that a continuation application may need to be filed.

The steps are as follows:

1.  Define a very specific strategy for patent coverage over the entire scope of the technology you wish to cover.  The strategy must be driven by the current and potential business needs of the client, as well as the possible turns a technology may take.

2.  Draft a complete set of claims for each targeted area.  Each element of the claims should be carefully and thoughtfully considered for the language, the scope of coverage, any way the claims may be construed or misconstrued, how an infringer may infringe, and for how it differentiates from the known prior art.

3.  Only after the claims are completed, analyze the claims with the inventor and the business manager, reviewing the areas described in step 2.

4.  Draft a specification that addresses each and every claim and every feature of every claim, and avoid any additional material if at all possible.  Each feature must be described completely, but avoid adding other ideas that may be patentably distinct and that you may wished were a stand-alone patent.

One interesting twist to the new rules is to attempt wherever possible to force a restriction by including patentably distinct sets of claims.  Each divisional application is a separate family of applications for the purposes of continuation applications and RCEs.

The new rules may tend to force less disclosure and much more tailored specifications that may stand or fall on the first couple Office actions, rather than specifications with all sorts of material that may keep an application alive through several continuations.  This may lead applicants to perform good searches based on the claim set of step 2 prior to drafting the specification of step 4.

The net result is a shift from large, comprehensive patents that may disclose a broad range of concepts to those which are very narrow and even skeletal.  Instead of ‘promoting the progress’ by encouraging as much disclosure as early as possible, I think the new rules encourage the exact opposite.

This discussion is by nature very broad and sweeping, but based on the strategies that the new rules seem to favor.  I am sure that many situations may cause other strategies to be used within the new rules, and I will discuss them as they come up.

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Indian Patent Office -invited public opinon on Cigearette patent September 21, 2008

Posted by mais in India, Patent.
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The controller general of patents, designs and trade marks has invited public opinion on a patent sought by Godfrey Phillips on a cigarette packet-cum-match box designed and developed by the company.

Godfrey Phillips, which manufactures leading cigarette brands – Four Square, Stellar, Red and White and Cavanders – aims at giving smokers an option to do away with a separate lighter or match box.

According to the company, which filed application on October 31, 2005, the improved cigarette packet with match box comprised a slide having side flaps on two longitudinal sides and end closures at the two transverse sides. The packet would be equipped with a shell accommodating the slide having flaps on two longitudinal sides, a bundle of cigarettes wrapped in a foil and a match box with sticks in a tray.

courtsy Competitive and Technical Intelligence Toolbox

India’s Konkan Railways filed patent in 124 countries for its safety innovation April 26, 2008

Posted by mais in India, Innovation, Patent.
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Anti-collision Device (ACD) branded as “Raksha Kavach” developed by Konkan Railways has been successfully granted patents by China, Russia, Singapore and South Africa. Konkan Railways has filed patent application in 124 countries.

Raksha Kavach is a self-acting device that warns the train driver of any impending accident-like situation within a 3-km range.The instrument will cost approximately Rs 5 lakh (500,000) for installation in trains and Rs 10 lakh (INR 1000,000) in planes. It has already applied for international patent rights for the product in 124 countries.

Sky Bus, an alternative of metro railways for urban transport, is also innovative solution.

Visit for all patents from Konkan Railways.

My experience with Konkan railways was superb particularly in term of cusine.

Bangalore Municipal Corporation Innovates cost effective urban road solutions April 22, 2008

Posted by mais in India, Innovation, Patent.
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Bangalore City Municipal Corporation (BCC) is enthusiatic for its technical innovation in road construction technology, specifically used for development of underpass, surface pass and overpass. It is planning to secure patent protection for the same. It is going to file the patent for the Concrete Elements as product and erection of such structure as installation process.

The technical innovation also claims to reduce the cost of such constructions from INR 200 Mn to mere INR 10 Mn. Other municipal authorities from Chennai, Chandigarh, Chhattisgarh and Mumbai have shown their interest in the promising technology.

BCC sees this as an opportunity to overtake Banglore Development Authority in Infrastructure development.

Marico Innovation Awards 2008 April 11, 2008

Posted by mais in India, Innovation.
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 Marico innovation foundation has announced winner for 2008. It has recived 146 nominations from business category and 64 for innnovation in Social Sector.

Y 2008 winners under various categories are given below.

CATEGORY WINNERS
Process Innovation Maharani Paints (India) Pvt Ltd PDF
Product Innovation Kirloskar Brothers Ltd. PDF
Motor Industries Co Ltd (MICO) PDF
Titan Industries Limited PDF
Business Model Innovation Evalueserve.com Pvt Ltd PDF
  Su-Kam Power Systems Ltd PDF
Social M/S Bhinge Brothers PDF
Specials Azim Premji Foundation & Govts of Karnataka, MP, Gujarat, Uttrakhand, Rajasthan PDF
Tata Motors For world cheapest car NANO

 

 

 

IIT Kharagpur organised technology Transfer Fest April 11, 2008

Posted by mais in India, Innovation, Technology Transfer.
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On 5th and 6th April 2008, Technology Transfer Group, a student initiative of IIT Kharagpur has  organised exposition IndAc’08.  Thanks Dr. A.S.Rao of  INDIA INVENTS for this information.

There were 59 technologies ready for transfer from sectors

  •  Foods & Beverages (13),
  • Agricultural engineering & Farm machinery (5),
  • Chemical (3),
  • Medical devices & Biotechnology (23),
  • CSE, Electronics & IT (7),
  • Metallurgy & Materials (8).

 Food & Beverages

  1. Production of Mango-milk based fruit bar
  2. Process technology for manufacture of Dahi (Curd) Powder
  3. Process to Manufacture Tomato Powder.
  4. Mango soy Fortified Yoghurt Powder
  5. Novel Technique for Manufacture of Instant Tea
  6. Novel Functional Fruit Juices.
  7. Lipase Mediated Synthesis of Acetates.
  8. Lipase mediated synthesis of Vitamin C stearate
  9. Production of Natural Coconut Water With High Storage Life
  10. A Process for Continuous Production of Chhana
  11. Jacketed Scrapped Surface Vessel for Kneading, Heating and Concentration of High Viscosity Liquids and Pastes
  12. A device for cryogenically individually quick freezing of fish, marine products, meat, fruits and vegetables
  13. A device for cryogenic grinding of spices, vegetables, food grains, plastic, and polymers.

Agricultural Engineering & Farm Machinery

  1. Production of Biodiesel from Vegetable Oils
  2. Self Sustaining Technology for Preservation of Betel Leaves
  3. Mechanical Loading-Unloading System for a Withering Trough
  4. Betel Leaf Oil Extractor
  5. Preparation of Polysacchride-Blended Slow Release Urea
  6. Passive-Passive Combination Tillage Implements for 2WD Tractors
  7. Automated Organic Roof Garden
  8. Membrane Based Water-Extraction of Polyphenols from Green Tea Leaves

 Chemical

  1. Membrane Based Water-Extraction of Polyphenols from Green Tea Leaves.
  2. Extraction of Natural Sweeteners from Stevia Leaves.
  3. Production of Organic Fertilizer from Tannery Effluent.

Medical devices & Biotechnology

  1. Anti-Hyperglycemic Polysaccharide from a Probiotic Bacterium
  2. Bench-Scale Technology For Manufacture of Pro-Biotics
  3. Herbal Skin Nourishing Gel and a Bio Process for Preparation of the Same Gel.
  4. Air Bolus Projection Type Spot Thermoelectric Cooling
  5. Palposcope
  6. Robotic Male Vas Deferens Intraluminal Injection System
  7. Heart Sound Analyzer
  8. Portable infusion pump
  9. A Knee Joint Simulator
  10. Microneedle for Painless Blood Extraction or Drug DeliveryC
  11. Strategic technological approach for exploitation of heterosis in cultivated rice through plant genetic engineering.
  12. Second generation of insect resistant transgenic field crops against major lepidopteran pests.
  13. Technique for generation of high tensile strength jute fiber through microbial retting process.
  14. Generation of genetically modified oil-seed plants to yield altered composition of seed  
  15. Technology for production of virus-free pure seeds of potato.
  16. Strategic use of gene transfer technique for generation of marker-free and site-directed alien gene integration in plant genetic engineering of crop plants for improvement.
  17. Smart-Reversible Inhibition of Sperm Under Guidance (Smart-RISUG)
  18. Reversible Inhibition of Sperm Under Guidance (RISUG)
  19. A Pumping System for increasing Pressure of Blood or a Fluid in a Controlled and Stepwise Mode.
  20. Green Chemistry for recovery of Lead oxide from scraped storage Pb-bettery.
  21. Foliate Tagged nano-particle for delivary of cancer drug  
  22. Removal of mercury vapor from gases (natural gas, hydrogen gas, exhaust gas from power plant based on coal).  
  23. Nano-composite of hydroxyapatite and chitosan derivative for bio-implants.
  24. Magnetic nano-particle for cancer diagnostics.
  25. Compact Disc (CD) based System for Bio-chemical and Bio-medical Analysis 

CSE, Electronics and IT

  1. Realization of a Constant Phase Element and Its Performance Study in a Differentiator Circuit
  2. See-Saw Bio-Reactor
  3. E-Procurement
  4. Online Integrated Materials Management System (OLIMMS)
  5. Indian Language Speech Recognition
  6. SYMBOLS Shakti – An object oriented hierarchical hybrid modeling, simulation and control analysis software
  7. CNC software package for milling of 2-D contours
  8. Micro Heat Pipe for Efficient Chip Cooling
  9. Non-mechanical Valve that manipulates the Motion of a Micro-droplet Using Light
  10. Traction Force Microscopy on Chip
  11. Metallurgy & Materials
  12. Biodegradation of Low-density polyethylene film
  13. Polyimide Nylon Blend Film As a Substitute of Kapton
  14. Processing a Single Phase c-ZrO2 Nanopowder from a Transparent Amorphous Ceramic Gel
  15. Reclaimed Rubber by renewable resource material–>Disposable management
  16. A Stable CrO2 Nanoparticle and A Process for Its Manufacture
  17. A quick setting polymer composition and a method for the preparation of the same
  18. A Process for production wear resistant cast iron by smelting reduction of waste products like red mud and de-silicated sand
  19. An Highly Stable gamma-Al2O3 Mesoporous Structure and Its Process for Manufacture.

 

Novartis’s challenge on validity of Indian patent laws was put down by Indian High Court August 7, 2007

Posted by mais in Drugs, India, IP Systems, Litigation, Patent, TRIPS.
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Swiss pharma giant, Novartis, faced another blow in India, when Chennai High Court rejected its writ petition challenging the validity of Indian Patent Laws.

Novartis had sought to declare Section 3 (d) of the Indian Patents Act as substituted by Patents (Amendment) Act (2005) as being “unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality).”  The section denies patent protection to the discovery of new form of known substance which does not result in enhancement of the known efficacy of that substance.

Novartis also rasied concerns over the discretion of patent authorities to define and determine the “enhancement of efficacy”. The Bench rejected the concerns by saying that the amended section cannot be invalidated solely on ground that there was a mere possibility of misuse of power.

Since Novartis’s 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate and the crystalline forms of imatinib mesylate. The crystalline forms of imatinib mesylate claimed in the application in question does not differ significantly in properties with respect to efficacy. In fact, with respect to efficacy, the current specification of Novartis itself admits that wherever β-crystals are used the imatinib free base or other salts can be used. The various forms of imatinib mesylate can, therefore, very well be considered the “same substance” under section 3(d) of the Patents Act.   view of IP practitioner Swarup Kumar

Novartis unlikely to challenge High court ruling in Indian Supreme Court. Novartis faced first setback  in January last year, when the Indian Patent Office rejected a patent application of its leukaemia drug Gleevec. It had filed appeal against the patent office decision to Intellectual Property Appellate Board and a writ petition in Chennai High Court.

Indian Whisky Producers restrained to use “Scotch” June 26, 2007

Posted by mais in GI, India, TRIPS, WTO.
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Scotch Whisky Association of UK has won a legal action in Delhi High Court to refrain Indian whisky manufacturers to use word “Scot” or Scotch”.

The association filed suit against Indian producer “Golden Bottling Ltd” under the Geographical Indications of Goods (Registration and Protection) Act, 1999. India enacted it under WTO-TRIPS Agreement obligations.

GIs are IPRs attributed to the products of a particular place like Darjeeling Tea, Banarsi Saari, Champagne etc.

Indian firms and brazilian AIDS patients to be benefit from compulsory licensing May 9, 2007

Posted by mais in Drugs, India, Patent, TRIPS, WTO.
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The Brazilian government’s decision to override the patent rights of Merck’s HIV/AIDS drug Stocrin (efavirenz) and buy reverse engineered generic versions of the drug at low cost has come as a boon for Indian pharmaceutical companies manufacturing generic versions of efavirenz such as Cipla, Ranbaxy, Aurobindo Pharma and Strides Arcolab.

On Friday, Brazilian President Luiz Inacio Lula da Silva announced invoking the compulsory licensing provision for pharmaceuticals under the World Trade Organisation’s (WTO) agreement on intellectual property – the TRIPS (Trade-Related Aspects of Intellectual Property Rights) – to buy copycat versions of efavirenz from laboratories certified by the World Health Organisation.

With over 200,000 registered cases, Brazil has the most AIDS patients in Latin America. Of them, only 75,000 patients are currently treated with efavirenz.

Welcoming the Brazilian government’s move, Amar Lulla, joint managing director of Cipla, said it was heartening to note that Brazil has invoked the compulsory licensing provision to treat its HIV/AIDS patients with affordable generic drugs.

“The compulsory licensing provision of the TRIPS help countries to protect the rights of its citizens. We welcome the Brazilian move,” he said.

Lulla confirmed that the Brazilian government was negotiating with Cipla for the supply of these medicines.

Steady Flow Of Patent Application In India December 7, 2006

Posted by mais in India, Patent.
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An Indian Law firm Lex Orbis analyzies the trend in patent application in India.

The revival of the Indian economy and globalization of markets have thrown open new opportunities in the field of foreign investments and a strong patent regime is a key driver for foreign investment in India, particularly when other competing countries in South East Asia, including China offer better investment climate. As technological innovation is facilitated by healthy IPR protection, the onus is on the policy for correct balance between industrial development goals and protection of national interest.

The number of patent filing rate in India had tremendously grown in recent years and it has been growing 30% annually since 2002-03. The accession to PTC and the amendment of the Patent Act and Rules are the contributory factors. But the Indian Patent office infrastructure is still undergoing a change. The IT infrastructure is improving and the government realizing the advantages is planning a 1,300 crore-modernization plan. Currently India is ranked 12th in the world in patent filing. It has been reported that the numbers of applications have increased 400 percent over the past 15 years. Nearly 800 companies submitted international applications to the WIPO in 2004, which is more than a double of what has been filed in 2000. An increased patent filing was witnessed in the year 2005-2006 due to the changes brought about in the Patent Act where the product patent was introduced for the first time in pharmaceutical sector.

Currently, the patent office expects the growth to be maintained at 30% this year also. Delhi office has recorded the largest number of application around the country and majority of the application continues to be from foreign countries and is from the chemicals and pharmaceutical segment, which account for half of the applications filed followed by Information Technology and Electronics.


Open Source Intellectual Property May 14, 2005

Posted by mais in India, Patent.
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Open Source isn’t just for code anymore…

What do fashion, yoga, and libraries have in common? All are dealing with the issues of “intellectual property” and “open source.” The fashion industry has a long history of valuing creativity and accepting the sharing and “remixing” of fashion ideas. Meanwhile, a teacher of the 5000 year old practice of yoga has copyrighted his methods and poses and is being opposed by an “open source yoga” movement. And, at the recent O’reilly Emerging Technology Conference, the theme was “Remix your world” and included Lawrence Lessig speaking about copyright, and Cory Doctorow spelling out the dangers of Digital Rights Management, and a fascinating presentation by Clay Shirky on Ontologies. Read on…

* Ready to Share
On January 29, 2005, the Norman Lear Center held a landmark event on fashion and the ownership of creativity. The event had an incredible variety of participants including John Seely Brown (former Chief Scientist of Xerox Corporation), musician and producer T Bone Burnett, Danger Mouse (creator of the Grey Album), and Siva Vaidhyanathan (Professor of Culture and Communication at New York University).

More than any other industry, fashion treats a far larger portion of its creative output as a commons – shared resources that can be freely reused and transformed by other creators.

Ready to Share is funded in part by a generous gift from the Center for the Public Domain. For lots more information see the press coverage and press releases page. For a quick overview of the issues, see the opinion piece, Control of creativity? Fashion’s secret By David Bollier and Laurie Racine. Christian Science Monitor, September 09, 2003.
* Bikram goes to the mat, By Hilary E. MacGregor. Los Angles Times, March 21, 2005.

After he sued an Orange County yoga studio for copyright and trademark infringement in 2002, a small group of yogis went on the counterattack. Taking a page from the “open source” movement in the computer software world, they called themselves “Open Source Yoga Unity.”

* O’Reilly Emerging Technology Conference, March 2005, San Diego, Ca.
o press coverage
o Doctorow: All Complex Ecosystems Have Parasites by Cory Doctorow, For the O’Reilly Emerging Technology Conference. San Diego, California, 16 March 2005.

Likewise, DRM has exacted a punishing toll wherever it has come into play, costing us innovation, free speech, research and the public’s rights in copyright. And likewise, DRM has not stopped infringement: today, infringement is more widespread than ever. All those costs borne by society in the name of protecting artists and stopping infringement, and not a penny put into an artist’s pocket, not a single DRM-restricted file that can’t be downloaded for free and without encumbrance from a P2P network.

o Lessig: Re:MixMe. Audio (MP3) of presentation by Lawrence Lessig, Professor of Law, Stanford Law School, Thursday, March 17.
o Shirky: Ontology is Overrated: Links, Tags, and Post-hoc Metadata. Abstract of presentation by Clay Shirky, Wednesday, March 16.

Ontology, far from being an ideal high-order tool, is a 300-year-old hack, now nearing the end of its useful life. The problem ontology solves is not how to organize ideas but how to organize things–the Library of Congress’s classification scheme exists not because concepts require consistent hierarchical placement, but because books do.

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Briefed in Banglore April 18, 2005

Posted by mais in India, KPO, LPO.
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A law.com – Article: “Briefed in Bangalore -Legal services are moving offshore — will India’s lawyers help reshape the U.S. legal market? by Helen Coste, The American Lawyer
11-01-2004

In recent months Microsoft Corp. began using Indian professionals to search for prior art — written information about an invention — in preparation for filing patent applications. Other Fortune 500 companies, such as Oracle Corp., have considered it. And law firms, which often follow the lead of their clients on new initiatives, are finally catching on.

Outsourcing may be a dirty word in this year’s presidential campaign. But in the real world — where costs and competitiveness matter — lawyers, like other professionals, have started to recognize the value of tapping into the highly educated, English-speaking Indian workforce to carry out tasks that would typically be performed by junior-level employees. Several outsourcing companies are courting the U.S. legal market, using Indian lawyers, scientists, and other trained professionals in cities like Hyderabad, Bangalore, and Noida. There are a few different emerging models. Vendors like Lexadigm Solutions and Lawwave.com rely exclusively on Indian lawyers to conduct low-level legal work and analysis. Others, like OfficeTiger, use a mix of lawyers and trained professionals to handle legal and nonlegal tasks such as managing conflicts databases and document management and review. A few vendors specialize. Intellevate has hired an Indian staff of lawyers and Ph.D.s to conduct patent research and other IP work. The company has a dedicated team devoted just to Microsoft’s patent work.

Smaller law firms are taking advantage of the range of services offered by these companies. Document review is the most popular task to outsource. In most cases a vendor scans and uploads the documents onto a secure Intranet site. Lawyers in India access the documents, identify responsive and privileged documents, and, when complete, upload their findings back onto the Intranet.

The process varies slightly for lawyers who outsource IP prosecution work, rather than just discovery. “A large company will send us an invention description,” says Intellevate chief executive Leon Steinberg, who oversees 72 Indian employees and offices in Bangalore and Noida, a suburb of New Delhi. “We would have a computer science expert, or some other kind of trained specialist, do research and determine whether the invention can be patented. They use proprietary databases and online tools to conduct research. Then they post their search result on a Web site that only our client can access.”

Some law firms and legal departments have opened their own offices staffed by Indian employees, rather than outsourcing their work to a third-party vendor. This is called offshoring. In 2001 General Electric Co. established a legal team in Gurgaon, India, with lawyers and paralegals who draft documents like contracts. Bickel & Brewer, a 34-lawyer Dallas litigation firm, opened a facility in Hyderabad, India, in 1995. Several hundred Indian employees — both lawyers and nonlawyers — scan, code, index, and abstract documents. Bickel & Brewer’s offshore practice has been so successful, says partner William Brewer, that the firm spun it off as a standalone company.

While cost might be the most obvious incentive for outsourcing legal work to India, lawyers cite a number of other motivating factors. One is the 9-to-13-hour time difference between the United States and India, which gives U.S. lawyers the sense of operating on a 24-hour-basis. “When I go home at six I can have them do the grunt work, research, and proofreading that I would otherwise have other people do,” says Solan Schwab, a New York-based solo practitioner who outsources research projects like analyzing state-by-state insurance regulations with QuisLex, which has 12 lawyers in Hyderabad. “Then when I come in in the morning, I receive a beautiful e-mail with research done exactly how I like it.”

Schwab sees outsourcing as the answer to the age-old dilemma facing solo practitioners: an erratic work flow that doesn’t justify the overhead of a full-time staff. He estimates that by outsourcing legal work, he spends about one-third to one-half of what he would spend on hiring a full-time associate. He adds that because he has the manpower to take on new business, he has been able to generate about $50,000-$60,000 in new revenue. “I usually bill the clients a certain hourly rate and pay these folks a portion of that rate.” Schwab says that the markup depends on whether the client is an individual or a corporation.

Even with the occasional markup, lawyers say that the financial incentive of outsourcing legal work is the factor that most impresses their clients. “None of my clients have opposed it because it saves them money,” says Noah Henry Simpson, of five-lawyer Simpson, Woolley, McConachie of Dallas. “It probably saves them at least half of what they would usually pay.”

Vendors charge an hourly rate or on a per-project basis. Lexadigm charges $60 per lawyer per hour, Atlas Legal Research charges $80, and OfficeTiger will not disclose its fees. (London’s Allen & Overy is currently outsourcing word processing to 74 OfficeTiger employees, a practice that the firm says saves “a seven-figure sum.”) Quislex gives clients the option of being billed by the hour or project. Intellevate offers three pricing mechanisms: a seat license, which can range from $1,200 to $4,500 per month; a straight hourly rate, which varies from $12 to $65 per hour based on experience; and a flat fee for a particular activity, such as $390 for seven hours of prior arts searching.

The lure of inexpensive labor, however, isn’t enough to convince many lawyers that outsourcing legal work to India is a good idea. Their primary concern is security, and how to deal with issues of attorney-client privilege. “If I’m one firm and I’m outsourcing work in India, then I don’t know that another firm isn’t using the same lawyers,” says G. Hopkins Guy, an IP partner in the Silicon Valley office of Orrick, Herrington & Sutcliffe.

Proponents of outsourcing explain that outsourcing work to India is no different from outsourcing scanning and coding of litigation documents to a vendor or legal work to a temporary lawyer. But Guy and others are not convinced. “We need to tightly manage conflicts,” he says. “I’ve heard of instances where just by sending documents out to a place like Kinko’s, lawyers have had problems with conflicts.” Guy adds that while Orrick routinely uses outside vendors to do document imaging and processing, he prefers that those vendors be located fairly close to his office and within easy access to manage the quality of the end product.

Orrick also hires temporary, or contract, lawyers. The difference, says Guy, is the hands-on way that Orrick manages and integrates these lawyers. “We’ll put a group of contract attorneys with Orrick lawyers in a room with eight computer terminals,” Guy says. “[While reviewing documents] someone will often have a question, like ‘I see this here. Is this important?’ and they can ask a supervising attorney. But if I have a contract attorney who is by himself, in India, what do they do with that question? Maybe he can send an e-mail and get a reply a day later. But quite naturally you would think that they would say it’s not important and move on. And I want that question immediately answered. That’s why I don’t see outsourcing of this type working.”

Many lawyers feel uncomfortable with the idea of outsourcing work to professionals whom they’ve never trained, let alone met, yet whose work reflects the quality of the firm. “I would be concerned about the absence of quality assurance,” says Matthew Powers, the head of patent litigation in the Silicon Valley office of New York’s Weil, Gotshal & Manges. “If you ship work to India and there’s a problem and the judge says, ‘How did this happen?’ and you say, ‘I don’t know,’ then there’s an abdication of responsibility.” Powers says that he’d be nervous to rely on legal research completed by someone he doesn’t know. “We invest a lot of time in training and managing our people to ensure that we get a high-quality work product. I’d rather find efficiencies in other forms.”

Other lawyers question the wisdom of outsourcing, citing the time needed to review the work done by Indian professionals or to manage the flow of information. Oracle, for example, decided it wanted its patent professionals closer to the business units. Yet proponents of outsourcing say that the practice becomes increasingly efficient with time. H. Wynne James III, a partner in 250-lawyer Louisville, Ky.-based Stites & Harbison, is realistic about the management required to outsource legal work to India. His firm has outsourced legal research and pieces of M&A transaction and is currently considering forming an alliance with outsourcing vendors and Indian firms. “If I think that I am going to get a high quality from the first day, I’m kidding myself,” he says. “I think that this is not without its real challenges. One is efficiently managing Indians and American lawyers in the same engagement. I think that the internal mechanics of a lot of firms are not structured to handle that very well.”

Lawyers were reluctant to use temporary lawyers when the service started nearly two decades ago. Small firms were the first to embrace the concept. Today, they are present in firms of all sizes. But as some lawyers have found, this kind of universal acceptance doesn’t happen overnight. As James says, “One of my partners said, ‘I thought you were crazy when I thought you meant Indiana.'”

THE INSIDE SCOOP ON LEGAL OUTSOURCERS
Company Web site Personnel Most popular outsourcing requests:
Atlas Legal Research atlaslegal.com 3 lawyers in Bangalore legal research and brief writing
Intellevate intellevate.com 72 employees in Bangalore and New Delhi patent proofreading, prior arts searches, and paralegal functions
Lawwave.com lawwave.com 8 lawyers working on an as-needed basis in Chennai document review and legal research
Lexadigm Solutions lexadigm.com 6 lawyers in Gurgaon research memos, briefs, and surveys of state law
OfficeTiger officetiger.com Declined to say how many lawyers and nonlawyers in Chennai word processing and legal research
Quislex quislex.com 11 lawyers in Hyderabad research and document review

The 2004 Global 100 Database is now available in an electronic spreadsheet. These definitive rankings of the world’s largest international law firms can be sorted, searched and imported into an active database. The rankings include gross revenue for FY 2003, number of lawyers, average revenue per lawyer, profit per equity partner, number of countries in which the firm has offices, percentage of lawyers outside the firm’s home country, key marketing contacts and more.

Navigating the patent maze: Nap Hal November 13, 2004

Posted by mais in India, IP Systems, Litigation, Patent.
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Navigating the patent maze: Nap Hal – Comments Addressed: “Nap Hal – Comments Addressed

An interested reader commented on the post in which I expressed approval for the decision of the Indian Government to not oppose the European Patent, now owned by Monsanto, that used Nap Hal. The reader raised several points that I would like to address. I also hope that it evokes more discussion on this topic area.

(Sidebar – there are currently 5 parties opposing this patent, including Greepeace and the European Flour Milling Association)

The reader raises several points. The first point, quoted below, speaks to whether the patent claims are in violation of the European Patent Convention.

The Patent in question explicitly claims a wheat variety, and so is squarely in violation of the European Patent Convention.??

The short answer is that the patent in question (EP 0 445 929) does not claim any plant varieties. The claims are directed to soft-milling wheat with particular characteristecs, flour prepared from that wheat, dough or batter prepared from the flour, edible products made from the dough or batter, and biscuits made from the flour.

The second point of the reader is that ‘the disclosure of the patent shows that the genetic traits which are key to the patent (double null allele in glu-D1 gene) were wholly derived from the landrace developed in India, namely, Nap Hal.’

I’m not sure what the reader’s objection is other than the landrace came from India. In fact, the landrace was obtained from a public germplasm bank. The accession was placed prior to the Convention on Biological Diversity, so that treaty does not control the situation. Until the CBD, typically there were no restrictions on accessions or, in the case of the CGIAR the restrictions regarding intellectual protection placed on germplasm held in FAO Trust were limited to the variety itself and did not extend to derivatives (such as the wheat claimed in the Monsanto”

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Data Exclusivity � The Indian Perspective (21/09/04) from Mondaq October 22, 2004

Posted by mais in India.
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LEX ORBIS – India – Data Exclusivity � The Indian Perspective (21/09/04) from Mondaq:
by Manisha Singh Nair,
Under Special 301 of the U.S. Trade Act of 1974 India has been put on the ‘PRIORITY WATCH LIST’ of USTR (United States Trade Representative) for failing to provide an adequate level of protection or enforcement and market access for persons relying on Intellectual Property protection. The absence of ‘data exclusivity’ legislation inter alia forms the reason for India’s inclusion in the list. Special 301’ is a part of the U.S. Trade Law that requires the USTR to identify countries that deny adequate protection for Intellectual Property Rights or that deny fair equitable market access for the U.S. persons who rely on IP protection. PRIORITY WATCH LIST’ are the countries or trading partners that have very serious problems in terms of scope and/or impact on U.S. commerce requiring the focus of increased bilateral attention on the problem areas.

The Government of India has constituted a High level Inter-ministerial committee to consider steps to be taken in the context of the provisions of Article 39.3 of the TRIPS agreement for the protection of undisclosed information. As the Indian government caves in to the economic coercion of the U.S. government backed by the omnipotent Pharmaceutical lobby of U.S this paper attempts to analyze what India stands to lose or gain and what alternative we have to come out of this conundrum victoriously. There are several burning questions that come to the forefront with regard to the issue of data exclusivity –

does Article 39.3 of the TRIPS agreement mandate ‘data exclusivity’ or mere ‘data protection’?
should the developing countries like India adopt measure of data protection other than data exclusivity?
would data exclusivity sound death knell for the India pharmaceutical industry with a strong generic base?
what would be the ramifications of such legislation on Indian Population more than half of which lives under abject poverty?
It is imperative to find answers to these questions, as we have to reconcile the apparently opposing mandates of public health and strong IP protection. The predicament before the developing countries like India is how to strike a fine balance between public health and the demand of increased IP protection. Before attempting to analyze these issues it is important to understand the meaning of ‘data exclusivity, its genesis, impact on drugs and the reasons for conferment of this privilege.

Data exclusivity –meaning, genesis and impact

Data exclusivity is generally defined in United States as a period of exclusive marketing rights granted to a new drug application (NDA) upon obtaining marketing approval by the regulatory authority if certain statutory requirements are met.

The regulatory bodies require the pharmaceutical companies to submit extensive data establishing the safety and efficacy of a new drug before approving it for sale. This data arises out of many years of research and clinical trials and is the most expensive part of drug development. It is estimated that the total cost of drug development and marketing is approximately $500 in industrialized countries. Data exclusivity laws prevent the regulatory bodies from accessing the originators data when considering an application for a generic competitor seeking approval to sell an equivalent competing product. Thus in the countries where data exclusivity is granted the regulatory authorities can take up the applications for generic versions only after the expiry of data exclusivity period. In the alternative the competitor is required to generate his own marketing approval data. The period of data exclusivity is provided by the national legislation of a country and as such there is no uniform period.

Data Exclusivity legislation was for the first time enacted by United States of America in the year 1984.The 1984 Drug Price Competition and Patent Term Restoration Act popularly known as Waxman-Hatch Act provides for there different terms of marketing exclusivity depending on the type of drug. Each type of exclusivity has specific requirements and results in various lengths of time for which the applicant is granted the exclusive marketing rights. Three main Types of exclusivity are Orphan, Waxman-Hatch and Pediatric granted for 7years, 5years and 3 years respectively from the date of approval of the drug. Exclusivity for the first time approval of a new chemical entity in the US is for a period of 5 years.

Interestingly data exclusivity provision is seen in US as balancing the interests of innovator or pioneer drug firm that bear the research and development and the interests of the generic drug industry that can increase competition and lower the cost of the drug

The reasons for granting exclusivity in United States have been enumerated as-

to achieve balance between the pioneer drug industry and the generic drug industry
Costly clinical trials that established the safety and effectiveness of the drug would not need to be repeated in order for a generic drug to enter the market place. Once information has been established about a drug, there is no requirement for a second sponsor to prove the safety and efficacy a second time.
exclusivity is an incentive to a new drug development in particular in the absence of patent protection.
unnecessary death of and suffering to the animals due to duplication of tests could be avoided.
Side effects to the human subjects due to repetitive trials can be obviated.
European Community adopted data exclusivity in the year 1987 vide the Directive 65/65 EE (amended 87/21/EEC). The period of data exclusivity in European community varies from 6 to 10 year. Data exclusivity arose in the European Community during the time when there was no patent for biotech products in order to protect the biotech industries and afforded the biotech products some form of market protection. U.K., Sweden, Netherlands, Germany, Italy, France and Belgium grant 10 years data exclusivity. More than half of the members of European union provide 6 years of data exclusivity.

In Japan, the data exclusivity period varies from 4 years (for medicinal products with new indications, formulations, dosages, or compositions with related prescriptions) to 6 years (for drugs containing a new chemical entity or medicinal composition, or requiring a new route of administration) to 10 years (for orphan drugs or new drugs requiring pharmaco-epidemiological study). In New Zealand the protection period is 5 years. There is no data exclusivity period for data relating to new uses or formulations of old active ingredients

Data exclusivity is primarily granted for pecuniary reason that is to enable the initial registrant to recover investment made by him in obtaining the marketing approval. In the absence of data exclusivity period, generic drugs could be introduced onto the market on the basis of bioequivalence tests without the having to replicate the time consuming and expensive clinical trials that are used to establish safety and efficacy of the product. The duplication of the tests would be inefficient use of the resources.

Bioequivalence means-‘the absence of a significant difference in the rate and extent to which an active ingredient or active moiety becomes available at the site of drug action when administered at the same molar dose under similar conditions’

If bioequivalence is established, the products will have the same clinical effect and safety profile, and are considered to be therapeutically equivalent and interchangeable.

TRIPS Agreement

As a part of the Uruguay Round of the World Trade Organization (WTO) multilateral negotiations a new and rigorous treaty on intellectual property rights- the TRIPS was established in 1994. Beginning on the 1st of January 1995, the Agreement on Trade Related Aspects of Intellectual Property Rights administered by WIPO became the standard for protecting IPRs in those nations seeking to engage in international trade and enhance their prospects for economic growth. Thus the members of WTO are obliged to adhere to and provide for the minimum protection prescribed by the TRIPS.

Accordingly, member countries are required to amend their laws to bring them in conformity with the substantive standards laid down by TRIPS. Failure to do so within the conceded time would certainly lead to referral of the matter to the Dispute Settlement Body of WTO. An affirmative finding of the Body and non-compliance may culminate into trade retaliations by the member nations.

Developing countries where product patent was not being granted at the time of adoption of TRIPS were given time till 1st January 2005 to bring their patent law in line with TRIPS. India being one of them is legally bound to make the requisite amendments in its domestic patent law by the said date.

However there are certain controversial and unsettled provisions in TRIPS, which have triggered considerable deliberations and debate in the international fora. The scope, meaning and the manner of their implementation remain nebulous. Article 39.3 dealing with data protection is one such provision. Article 39.3 runs thus:

3. Members when requiring as a condition of approving marketing of pharmaceutical or of agricultural chemical product which utilize new chemical entities, the submission of undisclosed test or other data, the originator of which involves considerable efforts shall protect such data against disclosure, expect where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use”

Thus, if in respect of pharmaceutical or agricultural chemical products which utilize a ‘new chemical entity’, the regulatory authority of a country requires submission of ‘undisclosed clinical and test data’ for granting marketing approval it is under obligation –

protect the data against ‘unfair commercial use’
protect the data against ‘disclosure’ expect where it is necessary to protect the public or unless steps are taken to ensure that the data are protected against ‘unfair commercial use’.
The diclosure is permitted only in two circumstances-

Where it is necessary to protect the public
Where the data is protected from unfair commercial use
As it is evident from the language of the Article, latitude is given to the individual members to take such steps as they deem fit for protecting data against ‘unfair commercial use’. The purpose of Article 39.3 can be inferred from paragraph 1 of the same article that is to ‘ensure effective protection against unfair competition’. Article 39.1 provides-

39.1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 below with data submitted to governments or governmental agencies in accordance with paragraph below.

Unfortunately the agreement refrains from defining the practices that would constitute ‘unfair commercial use’, thus allowing the several interpretations to creep in. The term ‘unfair competition’ has been defined in article 10bis of Paris Convention but that does not aid in identifying the practices that would fall within the gamut of the ‘unfair commercial use.

Reference may also be made here of the WIPO model provision on protection against unfair competition (1996). Article 6 of the model provisions lays down the acts that would amount to unfair competition in respect of Secret Information. It reads as follows:

Article6 (1) -Any act or practice, in the course of industrial or commercial activities, that results in the disclosure, acquisition or use by others of secret information without the consent of the person lawfully in control of that information (hereinafter referred to as “the rightful holder”) and in a manner contrary to honest commercial practices shall constitute an act of unfair competition.

Two points emerge from this general principle:

Firstly the disclosure, acquisition or use of the secret information must be without the consent of person lawfully in control of that information.
Secondly it must be in a manner contrary to the ‘honest commercial practices’.
Applying it to pharmaceutical products utilizing new chemical entity, when the undisclosed data is submitted to the drug Regulatory authority, it becomes the trustee of that data and the originator remains the person lawfully in control of the data or ‘the rightful holder’. The authority thus not being the ‘rightful holder’ cannot use the data for any purpose other than for which it is submitted without the consent of the ‘rightful holder’. The sole purpose for which the data is submitted by the originator is to enable the authority to evaluate the data for ascertaining the safety and efficacy of the drug before granting marketing approval. Therefore the regulatory authority should not be allowed to rely on that data without the consent of the originator for testing the safety and efficacy of the subsequent applications.

Further where considerable cost is incurred by the originator in order to earn reward for his investment, it would be unjust to deprive him of the legitimate and reasonable profits by allowing the other persons to avoid the cost of undertaking the similar procedure and rolling out the same drug at much lower price. Thus compelling a person to suffer loss would tantamount to acting in a manner contrary to honest commercial practices.

The model also provides some examples of unfair competition in respect of secret information. It provides that disclosure, acquisition or use of secret information by others without the consent of the rightful holder may, in particular, result from

(i) industrial or commercial espionage;

(ii) breach of contract;

(iii) breach of confidence;

(iv) inducement to commit any of the acts referred to in items (i) to (iii);

(v) Acquisition of secret information by a third party who knew, or was grossly negligent in failing to know, that an act referred to in items (i) to (iv) was involved in the acquisition. [Article 6(2)]

This list is however inclusive and not exhaustive in nature and can very well include use of data to grant approval for those drugs for which it was not meant. Information is regarded as secret if –

(i) It is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;

(ii) It has commercial value because it is secret; and

(iii) It has been subject to reasonable steps under the circumstances by the rightful holder to keep it secret.

Article 6(4) of the said model correspond with Article 39.3 of the TRIPS agreement and is full of the same ambiguities as the latter. The model also deliberately refrains to define unfair commercial use.

Article 39.3 of TRIPS has bifurcated member nations into two camps viz: – One consisting of developed countries reading ‘data exclusivity’ into Article 39.3.The most vociferous advocates include United States of America and European Union. The second Group consisting of Developing countries who subscribe to the view that data protection does not extend to granting ‘data exclusivity’ as data exclusivity invariably leads to market exclusivity, which is not envisaged by Article 39.3.

Opponents of data exclusivity rely on the negotiating history of TRIPS to refute the contention that TRIPS mandates ‘data exclusivity’. The United States and European Union had made the proposal to the GATT signatories to adopt explicit language that would obligate members to Guarantee data secrecy and exclusivity for “a reasonable period” except upon compensating the initial registrant for the “reasonable value” of any use that offered a “commercial or competitive benefit” to any other person, including the government. However the proposal was rejected by the negotiators who finally adopted the present provision. An insight into the background of the Article 39.3 would make it amply clear that the interpretation forwarded by the developed countries does not withstand scrutiny. Moreover, an author argues that if the intention had been to have such exclusive marketing rights, this term, which is used in Article 70.9 of TRIPS, would have been used here too. Therefore, she avers, that a reasonable interpretation would be that the obligation on the authorities would be to keep the test data secret and to prohibit others from accessing this test data for unfair commercial use, such as sale to rival firms and this substantive obligation would exclude use by the authorities without disclosure of the data (Jayashree Watal, 2000).

It is evident from bare reading, that Article 39.3 does not per se mandate data exclusivity.

However many countries recognize marketing approval data as ‘trade secret’ of the drug developer and hence justify the data exclusivity laws. Proponents of this view give cogent reasons for regarding ‘clinical and test data’ as trade secret. The reasons forwarded are-

Protection in form of confidentiality obligation, granted to the data is consistent with the treatment of the data as trade secret.
Article, 39 falls in section 7 of the Part II of the TRIPS Agreement, which is concerned with Trade secrets and the Drug Marketing approval provided in Paragraph 3 is just a subset of the trade secret.
Article 1.2 of the TRIPS Agreement labels the subject matter protected by Section 7 as a category of ‘intellectual property
Article 1.2 reads thus:

For the purposes of this agreement, the term “Intellectual Property” refers to all the categories of intellectual property that are subject to Sections 1 to 7 of Part II

Therefore it is argued that prohibition on unfair commercial use when considered in the backdrop of trade secret principles does require data exclusivity (Aaron Xavier Felmeth, 2004).

Should India adopt measure of data protection other than data exclusivity?

Developed countries traditionally take the view that strengthening IPR protection fosters economic growth in developing countries by facilitating international investment while simultaneously rewarding domestic innovation. By contrast developing countries see IPR protection as impeding the flow of knowledge by increasing cost and decreasing access to new technology. Developed countries argue that IPRs therefore slows economic development and decrease social welfare, at least in short term (Gary Smith, 1999).

This argument against IPRs becomes all the more vehement in respect of Pharmaceutical products, as patented drugs are costly and unaffordable for the poor population. Moreover developing countries do not have the economic resources to provide health insurance cover to the people.

Data exclusivity protection is often charged of being a superfluous or sui generis form of protection. Many arguments are advanced against data exclusivity, which can be summed as follows-

Undermines genuine innovation as it encourages originator companies to focus their activities in changes in the product rather than focus on developing new innovative and beneficial product.
All the TRIPS members to 20 years have uniformly extended the product patent period.
Patents are increasingly being granted for new uses, indications, dosages and change in formulations.
Data exclusivity period is granted without originator having to demonstrate any of the basic principles of novelty or inventiveness.
Data exclusivity leads to ever greening of patents. Hypothetical example is often cited-suppose X Company applies for marketing approval of its drug in 17th year of patent, assuming data exclusivity period to be of 5 years, the total period of protection will increase to 22 years. Thus it could keep the generic drug producers out of the market for longer duration.
Poor consumers of medicines would suffer as a result of lack of competition in the market.
The battle lines over data exclusivity are predictably drawn between net exporters and net importers of intellectual property. The developing countries including India are reluctant in granting exclusive marketing privileges to affluent foreign drug companies for the fear that it would escalate the prices of drugs. On the other hand the developed countries fail to see any incentive to market such drugs in India in the without adequate recompense in form of data exclusivity.

Many sections of Indian Society fear that the data exclusivity will cause slew of problems for the consumers in India, would give excessive benefits and protection to the MNC pharmaceutical companies, deprive people of the generic equivalents, prices of the drugs would become exorbitant as a result a large chunk of the population will have to go without even the essential drugs.

Before we consider the ill effects of data exclusivity we must bear in mind that India is different from the other developing countries in various aspects. India has a well-developed Pharmaceutical industry, which has already notched up a large share in US generic market. Unlike other countries India has excellent outsourcing opportunities for clinical trials, R&D and technical services. In addition, fleet of highly trained scientists makes India an attractive destination for research projects. More than 15 percent of the scientists engaged in pharmaceutical R & D in US are of Indian origin.

Empirical evidence suggests that a stronger intellectual property protection would facilitate the flow of FDI in the developing countries. A study conducted by Mansfield indicated that effective intellectual property rights protection could be an important factor in securing foreign direct investment and technology transfer, especially in high technology industries. The findings indicate that, in relatively high-technology industries like chemicals, pharmaceuticals, machinery, and electrical equipment, a country’s system of intellectual property protection often has a significant effect on the amount and kinds of technology transfer and direct investment to that country by Japanese and German, as well as U.S. firms (Edwin Mansfield, 1995).

Some of the international researches clearly indicate that a close relationship exists between level of Intellectual property protection and R & D expenditures. It was found that foreign R & D expenditures by Research based pharmaceutical firms was concentrated in Western Europe where patents are adequately protected and the R &D expenditures decreased by 6.6 percent over a period 1977 to 1987 in Latin America where the protection is relatively very poor (Rapp and Rozek, 1990)

According to a US representative protection of test data is key to company decisions on location of clinical trials. According to the U.S. National Institutes of Health (NIH), lack of data exclusivity in India is the primary reason why India only ranks 9th (compared to China which ranks 2nd), in funding given by the NIH outside of the U.S. U.S. pharmaceutical companies spent $30 billion on R&D in2001.

Pharmaceutical industry is a research and development intensive industry. Indian Pharmaceutical companies on an average allocate only 2 percent of their sales for R&D activities (only some allocate 6 percent). The growth of this highly competitive, technology-based industry is not possible without substantial investment. Most of the Indian companies do not have the requisite financial resources to conduct extensive researches for bringing out novel drugs.

If data exclusivity legislation is enacted in India it would provide the necessary incentive to the originators to market their drugs in India without the fear of generic manufacturers and other multinational drug manufacturers free riding on their data. The benefits that would flow would be numerous. The Data Exclusivity laws would set the environment that would

Afford the opportunity to the Indian Research based pharmaceutical companies to bag important research projects form top pharmaceutical companies of US and European countries.
Increase the diffusion of knowledge and technology. Indian pharmaceutical industry needs to be aware and in possession of latest technologies used in developed countries in order to acquire a cutting edge in this sector. India is lagging behind in developing technology for the latest drug delivery system.
Create demand for Indian scientists in the domestic research organizations and thus would be effective in checking brain drain from India. Most of the talented Indian scientist migrate to the greener pastures in US, UK and other European countries. These scientists would have less incentive to emigrate if their creative work was adequately protected in India.
The research organizations once equipped with the structural resources can conduct researches that are specific to the diseases prevalent in India. Diseases such as tuberculosis, malaria, leprosy, plague and dengue fever continue to pose serious problems in India and take millions of lives each year. It is unlikely that such researches would be undertaken by the research firms located in developed countries.
Facilitate the entry of new drugs in the market particularly those that are not protected by patent.
Employment opportunity in the pharmaceutical sector would increase manifold.
Bring about scientific and technological integration.
More over if the Indian Pharmaceutical Industry has to give strong competition to countries like China and Israel we must create an environment, which allures the foreign firms to invest in India rather than to these countries. In china, the period of data exclusivity is 6 years and a data exclusivity law is already in the offing in Israel. China in September 2002 PRC Drug Administration Implementing Regulations introduced a new data exclusivity right. Under this law, the government (that is the SFDA) has an obligation to “protect against [the] unfair commercial use by any other person the undisclosed clinical data and other data … submitted by a manufacturer or marketer in obtaining the approval of manufacturing or marketing a drug containing new ingredients. During this six year period, any person who relies on data which is subject to the exclusive right shall be refused marketing approval unless the data relied upon is generated by himself or on his behalf.

Data Exclusivity and pharmaceutical industry in India

The Indian pharmaceutical industry is one of the most advanced among those of the developing countries. The ranking of the industry in the global market is fourth in volume (eight percent share in world market) and thirteenth in terms of value (1 percent share in the world market). The industry exports products worth rupees 141 billion to over 65 countries. The annual turn over is rupees 226 billion. Besides all the above, India has the largest number of US Food and Drug Administration (FDA) approved manufacturing facilities outside US. The number of Drug Master Files (DMFs) filed with the US FDA is twenty six percent higher then Spain, Italy, China and Israel.

The Indian pharmaceutical industry has availed tremendous advantage of the absence of product patent regime in the past. By using the copycat technique of reverse engineering, it has succeeded in bringing out generic versions of almost every new drug developed in the other parts of the globe within 5 to 6 years of its introduction in the market. At present there are over 60,000 generic brands in 60 therapeutic categories in the market.

The generic pharmaceutical companies of India offer cheap alternative for expensive branded drugs. Bristol-Myers Squibb (BMS) an American firm sells stavudin treatments for $3,400/year in US and $55/year in Africa, Cipla an Indian firm can sell the same drug for $40/year. Similarly Cipla and Ranbaxy laboratories can provide a daily dose of three antiretroviral for $244 and $292 per patient per year. A similar treatment from major US Pharmaceutical costs at least $562 per year.

National Sector units like Ranbaxy, Dr. Reddy’s laboratories, CIPLA, Sun Pharmaceuticals, Wokhardt, Zydus Cadila and others have come out with original research on development of new drugs, delivery system and even new molecules, acquiring patents in countries US and others. The products of Indian manufactures are accepted on the WHO list of essential drugs and also approved by the regulatory authorities in EU and US.

The pharmaceutical industry is not unanimous on the issue of grant of data exclusivity in India. There are two Trade associations representing the Pharmaceutical industry – Organization of Pharmaceutical Producers of India (OPPI) and the Indian Drug Manufacturers’ Association (IDMA). OPPI has requested the government to amend Schedule Y of the Drug and Cosmetic Act to include provisions for Data Exclusivity for period of 4 or 6 years from the date of marketing approval whereas IDMA opposes data exclusivity legislation in India. IDMA attributes the growth of the Indian pharmaceutical industry to the Indian Patent Act of 1970 or in the other words to the absence of product patent regime. OPPI is of the view that the discovery, development and bringing to market a new drug the originator requires to conduct extensive chemical, pharmacological and clinical research and testing and generate data for submission to the Drug Regulatory Authority for marketing approval of the new drug. This activity takes 8-10 years of painstaking efforts. The data generated in such work is proprietary to the originator and needs to be protected

OPPI is composed of both the national as well as multinational firms. Most of the leading pharmaceutical companies are its members.foreg- Aventis Pharma ltd, Novartis India ltd, Pfizer ltd, Eli Lily &Co. (Ind) Pvt., Workhardt ltd, Johnson &Johnson ltd, Merck Ltd, Glaxo Smith Kline etc. IDMA represents the national sectors of the of the Indian Manufacturers. It has a membership of 500 Indian large, medium and small companies. Members include: Ajanta Pharma Ltd, Cadila Health Care Ltd, Cadila Pharmaceuticals Ltd, Dabur India Ltd, Dr. Reddy’s Laboratories, Lupin laboratories, Merrill Pharmaceuticals etc.

Unlike Indian Pharmaceutical industry, generic industry of US strongly advocates strengthening of the Intellectual property regime by accepting the data exclusivity laws.

Once the period of exclusivity is over the generic drug producers can prove bioequivalence on the basis of the clinical and test data submitted to the regulatory body. Thus the interest of consumers can be balanced with that of the intellectual property holders.

Impact of data exclusivity on access to health care

“The Hatch –Waxman period of data exclusivity works in this country because the people in US have Health insurance that pays for essential drugs and because we have a safety care net to assure that the poorest in our society are not left without medical care and treatment. But to impose such a system on a country without a safety net, depriving millions of people of life of life saving drugs is irresponsible and even unethical. In developing countries we must do every thing in our power to make affordable drugs for the life threatening diseases available now”- Henry Waxman

In India, however the drugs, which are put in the Indian essential drug list, are not patented and the prices of these drugs will not be affected by strong patent protection. Moreover the product patent would only apply to new drugs, which would make a very insignificant percentage of the total market.

The empirical data is not clear whether data exclusivity definitely has adverse impact on the prices of drugs. The multinational Pharmaceutical companies practice the policy of differential pricing that is to say that the prices of the drugs vary from country to country depending on the purchasing capacities of the consumers. Differential pricing policy provides a mechanism, which ensures that the consumers in the developing countries are not excessively burdened with the high prices of the drugs.

The flexibilities, which are inherent in Trips like compulsory licensing under Article under Article 31 or the parallel importing from other countries can always be used as a tool for making the drugs more affordable in cases of emergencies and on the grounds permitted by the TRIPS agreement. Compulsory Licensing is “an authorization given by a National authority to a person, without or against the consent of the title-holder, for the exploitation of a subject matter protected by a patent or other intellectual property rights”: (Correa, 1999)

An author divides the middle income countries like China, Argentina, India etc the consumers of medicines can very well be bifurcated into two groups viz: – rich and the poor. On humanitarian and social grounds the poor people can be exempted from paying the additional cost of a patented product but the rich, must contribute to the cost of research and development that goes towards creating a patented product. So he is opines the Rich cannot be allowed to reap unjust advantage by free riding on the clinical and test data produced by the originator (Arvind Subramanian, 2001).

Benefits of granting data exclusivity to the Pharmaceutical products utilizing new chemical entities would certainly outnumber the drawbacks Intellectual Property protection encourages innovation, which is a key factor that contributes to improved health care, through promoting both development of new medicines and economic growth generally. (Nozek and Tully, 1999)

Therefore the Indian Government must expedite the enactment of the data exclusivity legislation in India.

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No Progress on Bio/TK Disclosure for Patents September 30, 2004

Posted by mais in EU, India, IP Systems, Patent, TRIPS, WTO.
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I/P Updates: TRIPS: No Progress on Bio/TK Disclosure for Patents – News and Information for Intellectual Property Practitioners: “TRIPS: No Progress on Bio/TK Disclosure for Patents
According to an article in BRIDGES Trade BioRes, Vol. 4 No. 17 23 September, 2004
, the Council for Trade-related Aspects of Intellectual Property Rights (TRIPS) considered a proposal by Brazil, India, Pakistan, Peru, Thailand, and Venezuela on September 21, 2004 suggesting a checklist of issues to be covered in negotiations on biodiversity, traditional knowledge and folklore. The proposal elaborates on possible disclosure requirements in patent applications relating to the source and country of origin of a biological resource and/or traditional knowledge used in an invention.

The US and Japan again voiced their opposition to using the checklist. No substantive progress was made and the meeting closed after one day rather than the scheduled two. The next TRIPS Council is reportedly scheduled for December 1-2.
posted at 1:58 PM ”

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