Software patentability, section 3(k) and recent controller decisions at the IPO-Part 2/2

In continuation of our previous post on section 3(k), this part discusses the other two section 3(k) cases.  For ease of readability, the entire post was carved in two separate parts.  Part 2 of 2 follows: Warning: Long post:    

Before analyzing each decision, section (k) of our patent act is reproduced (with added emphasis) for ready reference.

“3. What are not inventions: The following are not inventions within the meaning of this Act, —

…(k)              a mathematical or business method or a computer programme per se or algorithms;”      

1695/DELNP/2005: Allowed

1.  A device (10) for storing personal profiles and for controlling the access, from a plurality of remote entities (16, 18, 20) within a telecommunication network supporting a plurality of services, to

databases storing said personal profiles, characterised in that said device (10) comprises a first plurality of databases (44, 46, 48) and interfaces (24, 26) for managing and centrally controlling the access, from any of said remote entities (16, 18, 20), to said first plurality of databases (44, 46, 48) and to a second plurality of databases (50), said interfaces (24, 26) comprising:

a plurality of adapters (20) toward said first (44, 46, 48) and second (50) plurality of databases, each adapter being customized to a particular typology of database and adapted to allow the access to said

first and second plurality of databases independently from the typology of database;

a plurality of application interfaces (28) toward said plurality of remote entities (16, 18, 20) able to manage different mechanisms for accessing databases;

an authentication unit (52), for identification of said remote entities;

an authorization unit (37) for authorizing said remote entities (16, 18, 20) to use said adapters (26), by means of the verification of requirements and the management of a corresponding authorization to use;

an accounting unit (36) for tracking the accesses to said first (44, 46, 48) and second (50) plurality of databases.

This claim makes clear reference to devices, and more importantly provides use of each of the devices, when dealing with databases.  The claim, clears the initial threshold that the invention is for software even though databases are discussed. The Controller here recognizes that claims still require further qualification re the term devices and directs the applicant to include narrowing language.  “....amended to further qualify “device” (10) with its inbuilt or associated technical features  e.g.  server, processor, memories etc. together with their couplings so as to  provide for the workability of the  inventive  device.  The Controller denies other claims related to telecommunication network.  This claim, in my opinion, apart from having the correct terminology, shows that it not software/computer programme per se by including the necessary transformation of the database.  In addition, it satisfies the ‘per se’ test because the desired ‘effect’ is achieved.

5763/DELNP/2005:  Refused

1. A multi-layer graphical user interface method, comprising the steps of:

Rendering in a conventional manner one or more computer file objects of a first type (24) in a layer of a display area within a computer space (22); and

rendering in a de-emphasized manner one or more objects of a second type (930) that are different from the first type (24) in another layer of the display area,    

Wherein at least one of the one or more objects of the second Type represents users who share the computer space (22) and also Functions as a control for accessing a user interface to modify represented user’s access rights to the one or more computer file objects of the first type without a need to change a separate view or application, and wherein the de-emphasized rendering comprises at least  one of dimming, blurring, fading, shading, broken lines and water marking of the one or more objects of the second type relative to the conventional rendering.

This claim is not a clear cut case of falling under the software per se rule because at least some transformations are done to an interface.  Here the ‘technical effect’ seems to have been ignored.  There are no devices that are described in the claim.  The Controller cites to multiple US references that in their claim have some discussion about icons or graphical user interface; and does the obviousness analysis correctly, but fails to see that the references do discuss that it GUIs or their creation and manipulation are not software per se.  The Controller reasons:

“For the purpose of illustration, it is stated that a Computer programs are a  set  of instructions for  controlling  a sequence of operations of a data processing  system and are called a Computer program per se. The  claims  relating  to  software  program  products  are also nothing  but  a computer Program  per se, which is simply  expressed on a computer readable storage medium and as such are not allowable.  It closely resembles a mathematical method. It may be expressed in various forms   i.e. a series of verbal   statements, a flow chart, an algorithm, or other coded form and may be presented in a form suitable for direct entry in to a particular computer system, or may require transcription in to a different format (Computer language). For example, if the new feature comprises a set of instructions (Computer program) designed to control a known computer to cause it to perform desired operations, without special adoption or modification of its hardware components, then no matter whether claimed as “Computing Device ” or  as “A multi-layer graphical user interface  method  is not patentable as per section 3 (k) of Patent Act 1970.”  Emphasis added.

This, in my opinion, is incorrect application of the law.  Section 3(k) bars Computer programs per se.  The Controller has failed to explain why the claims are computer programs per se. 

Two reasons support my conclusion: (a) Partial application of law-Definition of per se should also be included while deciding on the claims;   (b)  The test of computer program per se should be the one used at the IPO, because India has adopted the European practice for section 3(k).  Given that there is a technical effect, the claim passes that hurdle.  A method implemented in a computer system represents a sequence of steps actually performed and achieving an effect, and not a sequence of computer-executable instructions (i.e. a computer program) which just have the potential of achieving such an effect when loaded into, and run on, a computer.  See decision of the Board of Appeal  of the European Patent Office in case T 0411/03 involving Microsoft.  I agree with the Controller on the obviousness analysis.  

Software patentability, section 3(k) and recent controller decisions at the IPO-Part 1/2

In a recent post, we had provided a list of decisions issued by the Controller, at our patent office (“IPO”).  A few of those decisions related to Section 3(k).  This post analyzes those two 3(k) decisions, and one 3(k) recent decision, issued late February at the IPO.  In addition, this post provides a list of Controller’s decisions issued in the month of February 2012.  The 3(k) decisions have been highlighted separately in the table below.  In two of the cases (January), the Controller got it absolutely correct.  The third case (Feb. 2012), sadly, in my opinion, leaves a lot to be desired as it is not clear on the law, and because it applies an incomplete definition of section 3(k) to the application/claims to reject them.  For ease of readability, the entire post has been carved in two separate parts. Part 1 of 2 follows: Warning: Long post:   

APPLICATION #	APPLICANT	DECISION	SECTION/RULE	CONTROLLER
424/DEL/2004	Sona Koyo Steering	Refused	15, 9(1)	P S Rao
200/CHE/2007	Mitsubishi Electric	Allowed	15, 2(j), (ja)	C N Shashidhara
3020/CHENP/2005	Novartis	Refused	2.j.a, 3(e), 10(4)	Dr Subramaniyan
5763/DELNP/2005	Microsoft	Refused	3(k)	S.N.Sav
3102/CHENP/2006	F.Hoffman-Roche	Refused	15, 2(j)/(ja)	Dr Subramaniyan
January 3(k)
1695/DELNP/2005	TELECOM ITALIA	Allowed	3(k)	B.P.Singh
1567/DELNP/2003	NETOMAT,INC.,	Refused	3(k)	B.P.Singh

Before analyzing each decision, section (k) of our patent act is reproduced (with added emphasis) for ready reference.

“3. What are not inventions: The following are not inventions within the meaning of this Act, —

…(k)              a mathematical or business method or a computer programme per se or algorithms;”      

The final examined independent claims of each of the 3(k) decisions have been reproduced, with a few formatting changes, to show to our readers, the difference in application/claim style, and for easy analysis.  Each claim is individually commented upon with reference to 3(k).

1567/DELNP/2003: Refused

“1.  A method of communicating information between an author and a recipient 9 comprising:

formatting a document 115  in a code 112 compiling said code into a file of compiled code;

disseminating  said  file  through  a  computer  network, 119   either  by uploading said file to a server 117 or by making said file available through peer to peer networking; and

forwarding said file to a distribution channel for presenting said document on said  networked device 118, characterized in that:

the code has code for presenting said document in a predetermined manner on a networked device;

compiling said code such that a necessary element for creating or invoking a first application for presenting said document and/or for creating or invoking a second application being presented with said document is included in said compiled code; and

upon said compiled code arriving at said distribution channel, said necessary element creates or invokes said first application for presenting said document in said predetermined manner and/or creates or invokes said second application for being presented with said document.

Even to those of our readers, who have no idea about software, this claim gives some idea that information (underlined in the claim preamble) is being changed or formatted for presentation and the task is achieved by, for the lack of a better name, invoking functions within functions.  This claim falls squarely because it is software per se.  The term “per se” might be better understood from a European perspective:  In Europe, a computer program is software ‘per se’ because there may be no transformation of data/signal/input, or there is no tangible benefit to the device if this software is run on the device.  The benefit to the device may be in terms of efficiency, or increase/decrease in certain attributes.  A method implemented in a computer system represents a sequence of steps actually performed and achieving an effect, and not a sequence of computer-executable instructions (i.e. a computer program) which just have the potential of achieving such an effect when loaded into, and run on, a computer.  See decision of the Board of Appeal  of the European Patent Office in case T 0411/03 involving Microsoft.

The Controller recognizes this fact, and puts it very succintly:  “The claims of the instant application relates in form to an “algorithm” wherein the “characterised” clause defines the computer program and its function. No inventive ingenuity lies in any of the existing hardware. The characterisation of the principal claim reveals existence of a code within a code and compilation of such a code with a necessary element which is again a code used for presentation of information in accordance with description. Therefore, the subject matter of the patent application falls under the excluded category from patentability under Section 3(k) and is of non –patentable nature." 

Guest Post: Mayo v Prometheus-a critique

We are pleased to bring to our readers another guest piece by Sooraj K. Abraham, on the learning of the Mayo v. Prometheus case. The post is a critique of the oral arguments in the ongoing case of Mayo v. Prometheus in the Supreme Court of the United States. The author seeks to analyze the dynamic approach with which the Judges are in the process of tackling the concept of preemption with regard to patenting of life science inventions.  Warning: Long post follows.

Issue: Whether Section 101 of US Patent Act is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally-occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve transformations of body chemistry or whether the correlation between blood test results and patient health is patentable.

The impugned invention of Prometheus was patented. Mayo comes up with their own technique to replicate that invention and offered the same at a substantially cheaper cost. Consequently, Prometheus laboratories filed a suit for infringement. This case has multifarious issues, and I will only be analyzing its patent eligibility. One of the important aspects in this case is the invention of Prometheus which, as argued by the counsel for Mayo, is a principle of natural law and preempts the patentability of the invention. The principles of natural law remain in the public domain in almost all jurisdictions. The classic example since e=mc2 is a law of nature, and the same is not eligible for patent. 

Before dwelling more into the issue in hand, I would like to discuss LabCorp v. Metabolite, Inc. The issue in LabCorp was similar to the issue in Prometheus. To state simply, “The claims of Metabolite's patent include the correlation between levels of homocysteine and vitamins B6 and B12. They sued LabCorp for infringement as they used similar drug administration techniques.” LabCorp claimed that Metabolite’s claims were not patentable because they postulate a principle of nature, which is not a subject matter of patent. However, a majority upheld the validity of patent and held LabCorp liable for infringement.

Against preemption, an consequential argument can be raised. Personal life science is an prominent field in biotechnology. It is a field of science that has been developed over a period of time. It is used to administer drugs according to the statistical analysis of various bio markers of the patient. The amount of drugs administered varies from individual to individual since each of them has different reading. At this juncture, one cannot simply state that it is a law of nature, and that it cannot be patented. This can be easily analyzed from following example. 

Suppose, for this article, stomach problem A is caused by loss in a biomarker B. the discovery of a biomarker B per se is not patentable because it is a law of nature. On the other hand, a machine which facilitates the measuring of that biomarker would be patentable as an invention.  These are a simple example but modern medical science (as argued by Prometheus), especially with regard to stomach diseases, requires the analysis of several bio markers to procure a clear statistical evaluation. The drugs are administered according to this statistical result and consequently, the decision as to the patentability of this cannot be rejected by merely saying that it is a law of nature.

As far as US precedence is concerned Prometheus’s claims articulates a valid claim. The decision of Supreme Court is due. Oral submissions are over, and it will be in favor of Prometheus; I think.  When I was hovering through related precedence and articles, I felt that irrespective of interpretation of law just like Diamond v Chakraborty courts recognized the patent claims in LabCorp to facilitate growth of biotechnology due to the statement of the attorney general. He said that “A decision overturning PTO’s approach could call into a substantial number of patent claims and undermine the settled expectation of numerous participants in technology-based industries.” This, in my opinion, directly influenced the decision of US Supreme Court. Even so, Justice Breyer gave a minority opinion holding that the patent was invalid due to natural law. The lawyer of Mayo will have a good chance of foreclosure of a number of patent applications only if he convinces Justice Breyer. I am pretty sure that this decision will have an implication on the ongoing battle for patentable subject matter. 

Indian IP regime, in my opinion, is more vibrant. It has (at least theoretically) a strong demarcation between public domain and private domain. Section 3 of the patent Act 1971, formidably protects the interest of public at large. In US, there is a strong dilution of patentable subject matter, which is totally anti-competitive and against the principles of law. I categorized it as anti-competitive because the whole idea of exemption of principles of natural law from patentability is to facilitate furtherance of innovation. If one tries to monopolize free thinking, it will obstruct the growth of innovation. It is curious to look into the above-mentioned decisions, especially LabCorp. Sections 3 (a) and (g) exempt the patent claims of LabCorp and Prometheus. The former prohibits the patentability of natural law and later treatments or methods of treatment. 

Section 101 of the Leahy-Smith America Invents Act (AIA) is not defined properly. It is not capable of demarcating between public domain and private domain. As I stated in the opinion of the attorney general, which is against law, directly influenced the judgment. Similarly, in Eli Lilly v Human Genome Science, a UKSC decision, Bio Industry Association (BIA) intervened and submitted following facts.

“As the BioIndustry Association has pointed out in its written intervention, patent portfolios are often the most valuable asset of companies in the bioscience industry. So assessments of the value of a bioscience company’s patent portfolio are likely to be a key consideration in deciding whether to acquire or invest in  such a company. This in turn affects the funding that is made available for research and development, without which effective progress in putting a patented invention to practical use is likely to be very limited. The evaluation of a patent specification for this purpose will depend on whether it discloses an invention that is reasonably capable of industrial application (para 141)”.

This directly influenced the judgment and ruled that “The standard set by the Judge for susceptibility to industrial application was a more exacting one than that used by the Board. He was looking for a description that showed a particular use for the product had actually been demonstrated, rather than that the product had plausibly been shown to be usable for the purposes of research work [para. 151] and [para. 154], which the Board must be taken to have regarded as an industrial activity in itself [paras. 155-156].”

Instead of laws, the market directly influenced the decision of judges.

Guest Post: ‘Highbrowed’ v. ‘Zippy’ Journalism - The Case of the Hindu and the Times of India

Spicy IP brings for its readers the following guest post on the recent controversial comparative advertising campaign that has been going on between two of the leading national dailies. The post has been authored by Shatarupa Choudhury, a 5th year student pursuing her B.A.L.L.B. degree from the National University of Juridical Sciences, Kolkata (who can be reached at shatarupachoudhury@gmail.com).

A tug of war between two giants of the print media sector is on. The Times of India came up with an advertisement portraying the newspaper published by the Hindu, its age old rival, as brutally boring (The link is available here). The Hindu then assumed upon itself the responsibility of responding to the Times of India through another commercial (See here, you may watch the commercials back to back over here).Thereafter, the Times of India published an ad on its front page reflecting the Hindu Mockery on the Times of India (See here). Yes, as is pretty clear, we are once again confronted with the issues of comparative advertising and disparagement. The previous discussion on this very issue (the Rin v. Tide case) can be found here in Spicy IP itself.

Comparative advertising is a kind of advertising where a party portrays its goods or services to be superior to rival goods or services, thereby intending to influence the consumer’s perceptions about the same. Comparison is not always the most pleasant of things. But in comparative advertising such ‘comparison’ is inevitable. In constitutional law, ‘commercial free speech’ can avail of protection extended under A. 19(3). However, such a right is subject to ‘reasonable restrictions’. The duty not to indulge in disparagement is one such reasonable restriction on the act of commercial speech, which has been expressed in the form of prohibiting defamation. ‘Disparagement’ is a very wide term. Product disparagement can be caused even by a third party and not merely by a rival contender of the product. Under Section 29(8) of the Trademark Act, 1999 (“Act”), a registered trademark is infringed by any advertising of the trademark if such advertising takes unfair advantage of and is contrary to honest practices in industrial or commercial matters, is detrimental to its distinctive character or is against the reputation of the trademark. Section 30(1) the Act seeks to ensure that, a trademark can be used by another person (apart from the owner) provided it is used in accordance with honest practices, no unfair advantage is taken and nothing detrimental to the distinctive character of the trademark is done. To ‘disparage’ is to ‘connect unequally’ in a way that it brings dishonour or disrepute to the person or the object. In commercial advertising, disparagement could be an injurious statement, action or indication damaging the targeted party’s reputation. Comparative advertising and disparagement are two separate issues. In a law abiding society, the former is allowed and the latter is not.

The principles of comparative advertising as laid down in Reckitt & Coleman v. Kiwi T.T.K Ltd [1996 PTC (16) 393] and reiterated in subsequent decisions of Dabur India Ltd. v. Colgate Palmolive India Ltd [AIR 2005 Delhi 102] are as follows:
a)The trader is entitled to declare that her goods are the best, even though the declaration is untrue.
b)One may also say that her goods are better than her competitors, even though such statement is untrue.
c)For the purpose of saying that her goods are the best and that her goods are better than her competitors, she can even compare the advantages of her goods over the goods of the others.
d)One, however, cannot while saying her goods are better than her competitors, say that her competitors’, goods are bad. If she says so, she really slanders the goods of her competitors. In other words she defames her competitors and their goods, which is not permissible.
e)If there is no defamation, to the goods or to the manufacturer of such goods no action lies, but if there is such defamation, an action lies and if an action lies for recovery of damages for defamation, then the court is also competent to grant an order of injunction restraining repetition of such defamation.

The case of Annamalayar Agencies v. VVS and Sons Pvt. Ltd. and Ors [2008(38) PTC37(Mad)] , elaborated on the above principles-
a)A manufacturer of a disparaged product which though not identified by name can complain of and seek to injunct such disparagement.
b)Generic disparagement of a rival product without specifically identifying or pinpointing the rival product is equally objectionable.
c)Advertisement campaign on visual media has an immediate impact on the viewers and possible purchasers' mind particularly a well known cinema star is endorsing it.
d)There must be a dividing line between statements that are actionable and those which are not.
e)When a claim of superiority over a rival product is made and until the same is proved by a panel of experts, an order of interim nature should operate against those advertisements.
f)Advertiser has a right, to boast of its technological superiority in comparison with a product of a competitor, however while doing so, she cannot disparage the goods of the competitor. g)If the Defendants highlight its better feature while comparing its product with that of the Plaintiff in an advertisement, no possible objection can be raised thereto.
h)Courts will injunct an advertiser from publishing an article if the dominant purpose is to injure the reputation of the Plaintiff.
i)The factors to be kept in mind while deciding on the question of disparagement are:
(i)intent of the commercial
(ii)manner of the commercial
(iii)story line of the commercial, and
(iv)the message sought to be conveyed by the commercial.
j)The degree of disparagement must be such that it would tantamount to or almost tantamount to defamation.
k)An advertiser can say that her product is better than that of her rival, but she cannot say that the rival's product is inferior to her product.

Inferring from the above facts and discussion, we understand that comparative advertising as a tool remains risk free as long as there is no overt indication to or detailed discussion about the compared product. Elements of malicious intent are prima facie evidences of disparagement.

The case of Annamalayar Agencies v. VVS and Sons Pvt. Ltd. and Ors, illustrates that there is no actionable wrong committed where three tailors having adjacent working counters put up notices in their respective windows saying ‘the best tailor in the world’, ‘the best tailor in the town’, the ‘best tailor in the street’. Puffing seems to be within the boundaries of harmless advertising but trying to promote one specific product or services by clearly abusing another is not appreciated in law. Though in any situation, the choice finally lies with the consumer.

The lack of creative or smart advertisement has indeed taken a toll on the very concept of ‘comparative advertisement’. There is no denial that it is a fiercely competitive market out there but this can never be an excuse for resorting to disparagement of other goods or services.

In this specific case where the Hindu and the Times of India are involved, the abuse on the respective trademarks is clear (The news papers are registered under class 16 of the Act). In the first advertisement by the Times of India, there has been absolutely no hesitation to communicate to the consumers that it is the Hindu, an Indian daily newspaper published in English, which supposedly stands as ‘supremely boring’, putting people to sleep all the time. In the counter response, the advertisement by the Hindu pinpoints with equal ease that it is the Times of India, an Indian daily newspaper published in English, which supposedly has ‘no substance but only style’. The advertisement shows how a bunch of youngsters (their preferred newspaper being the ‘Times of India’) are unable to answer basic questions of national importance whereas they answer without fail when questioned on Bollywood basics. The subtlety employed by the Hindu in the form of the ‘bleeping out’ process is ear-splittingly (metaphorically though) loud to convey the message to its consumers that it is no other newspaper but the ‘Times of India’. It ends with a signature message ‘Stay ahead of the Times’

On a slightly different note, apparently, both the news giants have been happy with the way in which the whole issue has impacted their sales in the last few days. Though, decisions on such an issue shall have to be made only on a case to case basis, yet, the specific war between the Hindu and the Times of India is a perfect instance of disparagement.
Well, the law lords’ will have the last word in case one of the parties is dragged to the courts.

The Spicy IP team thanks Shatarupa for providing us with this insightful piece exploring one of the recent controversies.

National Science Day – The good and bad of Indian policy initiatives for scientific research and innovation

The 28th of February is celebrated as ‘National Science Day’ in India, in memory of C.V. Raman who was responsible for the discovery of what was later known as the ‘Raman Effect’. Raman was the first Indian and also the first ‘non-white’ to be awarded a Nobel Prize in Physics, in 1930. Given the significance of this day, it makes sense to review the policy initiatives to put India back on the research track. Image of C.V.Raman from here. 

In 2010, the President of India has declared the present decade as the ‘Decade of Innovation’ and the Government in the last decade has announced several new policy initiatives to boost research and innovation in India. The problem however with the present government is the fact that several of these initiatives have completely stalled either in Parliament or at the Ministry of Science and Technology. 

For instance, although it has been more than three years since Parliament has passed the Science and Engineering Research Board Act (SERB), 2008 there does not seem to be any notification by the Government operationalizing the provisions of the Act. The SERB was supposed to take over the activities of the Science and Engineering Research Council (SERC) which was working directly under the Department of Science and Technology (DST). The proposed SERB, which was to function as an autonomous institution, has the powers to award substantial grants for basic research into science. 

Similarly there is no news from the government on the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008. This Bill which is touted to be the Indian version of America’s famous Bayh-Dole legislation had proposed the sharing of patent royalties with the inventors of public funded inventions. The Bill had a tumultuous ride through a Parliamentary Standing Committee, which in the end sent the Bill back to the Government with a request that the entire Bill be redrafted. The Department of Biotechnology (DBT), which was responsible for piloting this Bill through Parliament, had carried out substantive amendments to the Bill which were subsequently approved of by the Parliamentary Standing Committee. It has been two years since that Bill was approved by the Parliamentary Standing Committee but the government is yet to make a strong pitch for it in Parliament. This is one of those Bills which will sail through Parliament without any opposition and yet we find the Government dragging its feet on the subject. 

There is however also some good news. In the recent past, the Prime Minister has setup the National Innovation Council (NIC) under the Chairmanship of Sam Pitroda. The NIC came out with its first report in November, 2011. The report has sought to place innovation at the centre of the Indian growth story. Similarly the Prime Minister, who in all fairness seems to be obsessed with ‘innovation’, has announced the creation of a $ 1 Billion dollar fund to finance innovation. While more money towards innovation is always welcome, somebody really needs to audit the existing schemes to fund innovation. For example we already have a Technology Development Board (TDB) and also the National Science and Technology Entrepreneurship Board (NSTEB) which were meant to fund innovation. What has happened to these organizations? How are they functioning? Why are we creating new bodies when we have existing bodies? Similarly we have the National Research and Development Corporation (NRDC) which is supposed to be pioneering technology transfer from public funded institutions to the private sector. So far its earnings or revenues do not seem to be exceptional in any respect. Should there not be some kind of reassessment of these institutions before we set about creating new ones? 

Last but not the least, while talking about innovation and research into basic science, it is important to not forget the need for creating an appropriate regulatory and structure especially for new-age technologies like bio-technology. The controversy over Bt-Brinjal a couple of years ago was a sign of low public-confidence in biotechnology. A major reason for this was the lack of an independent regulator. In the last session of Parliament, the Government finally introduced the much-delayed National Biotechnology Regulatory Authority of India Bill in Parliament in December, 2011. This Bill has already been dissed by several commentators but there is at least hope that now it is in Parliament. Other issues which need to be looked into are existing legislations such as the Biological Diversity Act which has created a suffocating and inefficient bureaucratic setup to regulate any joint research into India’s gene-bank by Indian and foreign researchers. 

SpicyIP Event: Global Pharma Regulatory Summit India 2012, Mumbai

This is a gentle reminder for those of you interested in pharma regulation, from the same folks who organised the Pharma IPR Summit recently. The organisers send us the following details. You can also click through on the banner on the left for further details.

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Event Name: Global Pharma Regulatory Summit India 2012
Dates: 28 Feb - 2 March 2012 [individually bookable days]
Venue: Holiday Inn Mumbai International AirporMumbai, India
URL: www.pharmaregulation-india.com
Contact Person: Ms Asan Bano
Contact Number: +91 (022) 4046 1466
Contact Email: conferences-india@ubm.com

Over 150+ attendees have registered for the Pharma Regulatory business conference (28 Feb-2 March), taking place at the Holiday Inn Mumbai International Airport, Mumbai, India! With only 10 seats remaining, I wanted to ensure you and your team don’t miss out on this comprehensive programme, designed specifically for you as you look to overcome global regulatory complexities, ensure early market entry and drive generics exports worldwide. Register today! Register online, or contact us on +91 (022) 4046 1466 or conferences-india@ubm.com today! Visit www.pharmaregulation-india.com for further details. Region focused agenda: 29 Feb: US regulations - Learn practical insights to ensure flawless submissions for: DMF and ANDA filing procedures CTD and ECTD submissions Variation handling process Critical pharmacovigilance requirements Approval of 505 (b)(2) applications Dosage based deficiencies 1 March: EU regulations - Gain in-depth insights through live examples and comprehensive query handling sessions on: Stability and impurity profiling requirements Generic drug application filing procedure Post approval supplements Variation guidelines Requirements for hybrid applications in the EU 2 March: India, Japan and ROW regulations - Understand and overcome complexities involved in gaining swift regulatory approvals for DMF and generic applications in: India Japan Latin America Australia Russia China South Africa Plus! 28 Feb: If you are a new entrant to the market, you cannot miss our Pharma Regulatory Awareness Workshop - benefit from in-depth understanding of the comprehensive regulatory procedure for filing DMF and generic applications in regulated markets To register contact Ms Asan Bano on +91 (022) 4046 1466 or email conferences-india@ubm.com today!