Tuesday, December 11, 2012

Schering Corp’s Patent Revoked in Cipla’s Post Grant Opposition by Chennai Patent Office

In a 20-page decision delivered on December 10, 2012 in a post-grant opposition filed by Cipla, the Chennai branch of the Indian patent Office revoked Schering Corp’s patent 246328 on “An aerosol suspension formulation for inhalation”. The patent was revoked for lack of inventive step.

The patented invention addressed issues related to use of non-CFC (Chlorofluorocarbons) propellants in pressurized aerosol formulations, such as the ones used in inhalers by Asthma patients. In particular, the patent addressed problems associated with use of HFA 227 (1,1,1,2,3,3,3-heptafluoropropane) and HFA 134a (1,1,1,2-tetrafluoroethane) as propellants in inhalers.

Following are certain extracts from the decision:

“From the above disclosure it can be concluded that both HFA 227 and HFA 134a are the propellants that can be used according to invention. Though HFA 134a has the disadvantage of settling the active drug it can be overcome by shaking the canister, hence the argument made by the agent for the Patentee that the Patentee has restricted to HFA 227 in the claims is not convincing.

Had the Patentee thought the HFA 134a cannot be used in the inventive formulations then the description and claims are not in inconsistent with each other? Use of both HFA 227 and HFA 134a not compatible with valve assemblies is concluded to be a known problem and the solution as discussed in the granted specification is also concluded as known solution and does not have any impact on the alleged invention.

Surprisingly in the entire granted specification no comparison has been provided by using a carrier and not using a carrier. As understood the problem to be solved by this patent is the elimination of CFCs from the process of preparing the aerosol suspension formulations. How this problem is related either to the presence or absence of a carrier? The granted specification has no answer for this question.

The entire granted specification addresses to the problems associated with using non-CFCs in the making of aerosol suspension formulations. These problems and the solutions were amply discussed in the cited documents filed by the Opponent. None of the documents i.e D1 to D6 and other documents had discussed on the effects of carrier or the problems that may arose in the absence of carrier.

Then what is the functional difference between a carrier and a propellant? A carrier in general parlance is defined as are substances that serve as mechanisms to improve the delivery and the effectiveness of drugs. Drug carriers are used in sundry drug delivery systems such as: controlled-release technology to prolong in vivo drug actions; decrease drug metabolism, and reduce drug toxicity.

The propellant in general parlance is understood as technically, is the general name for chemicals used to create thrust. A propellant, in other words, is a chemical which is used in the production of energy and pressurized gas that is used to create movement of a fluid or to generate propulsion.

By looking at a plain reading on the definitions, both the carrier and propellant are doing the same job. Though there is a difference in applications, it is needless to say that when drug has to be delivered in aerosol suspended form the propellant is the only option for intended use. Therefore in the present formulations the propellant is used for effective delivery. 

Hence the concept of the Patentee on claiming “substantially free of a carrier” is not understandable in the context of the proposed solution for solving the proposed problem. With respect to the combination therapy and the dosages fixed there is no inventive concept in the impugned patent.

Also there is no inventive step in the selection of non-CFCs for the preparation of the aerosol suspension formulation of the patent. There is no inventive concept on selecting HFA 227 and/or HFA 134a from known non-CFCs. There is no inventive concept on the preferential use of HFA227 over HFA 134a.  The claims are inconsistent with that of description as there is no comparative data with respect to the absence or presence of a carrier in the said formulations.

The claim 1 either on individual parameters or in its entirety lacks inventive step. Consequently the claims dependent on the claim 1 are not inventive. The sole process claim also in its entirety is not inventive as the said claim does not describe any inventive feature.

The descriptive portion of the specification does not throw any light on the carrier itself and hence based on the arguments during the hearing which were made around the presence or absence of a carrier is considered to be insufficiently disclosed.”

Friday, December 7, 2012

Supreme Court Order in Sutent: Opposition Board’s Recommendations Must be Shared with Parties

I had earlier blogged on the Supreme Court setting aside the revocation of the Sutent patent of Sugen Inc. The Supreme Court set aside the revocation on the ground that principles of natural justice were not adhered to by the Controller, since the Opposition Board’s recommendation was not shared with the parties, in particular the patentee. 

A friend and well-wisher of the blog has been kind enough to share a copy of the SC's order in the matter!

Following are the relevant observations of the Supreme Court in its order dated November 27, 2012:

Sub-rule (1) of Rule 62 confers power on the Controller to require members of the Opposition Board to be present in the hearing after receiving recommendation of the Opposition Board. The Controller, after hearing the parties if they so desire and after taking into consideration the recommendation of the Opposition Board, has to decide the opposition giving reasons.

Provisions of the Act and the Rules, therefore clearly indicate that the Opposition Board has to make its recommendations after considering the written statement of the Opposition, reply statement, evidence adduced by the parties with reasons on each ground taken by the parties. Rule 62 also empowers the Controller to take into consideration the reasons stated by the Opposition Board in its Report. In other words, the Report of the Opposition Board has considerable relevance while taking a decision by the Controller under Section 25(4) of the Act read with Rule 62(5) of the Rules.

The Opposition Board in a given case may make a recommendation that the patent suffers from serious defects like lack of novelty, lack of inventive steps etc., so also it can recommend that the patent shall be granted since the invention has novelty, inventive steps etc. Such recommendations are made after examining the evidence adduced by the parties before it. Unless the parties are informed of the reasons, for making such recommendations they would not be able to effectively advance their respective contentions before the Controller. 

Section 25(3)(b) read with Rule 56(4) cast(s) no obligation on the Opposition Board to give a copy of the Report to either of the parties. So also no obligation is cast under Section 25(4) or under Rule 62 on the Controller to make available the report of the recommendation of the Board. But considering the fact that the Report of the Opposition Board can be crucial in the decision making process, while passing order by the Controller under Section 25(4), principles of natural justice must be read into those provisions. Copy of the Report/recommendation of the Board, therefore, should be made available to the parties before the Controller passes orders under Section 25(4) of the Act.

We have gone through the order passed by the Controller and we notice that Controller has placed reliance on recommendation of the Opposition Board, but without giving copy of the report to either of the parties. Hence, order is vitiated for violation of natural justice. Order passed by the Controller on 24.09.2012 is, therefore set aside.

The Apex Court also set aside the orders of the Single Judge and the Division Bench of the High Court in Sugen Inc’s writ and Cipla’s Letters Patent appeal respectively.

The matter has now been remanded to the Controller for disposal of the post-grant opposition within one month from the date of communication of the Supreme Court’s order. 

Thursday, December 6, 2012

Bajaj v. TVS: Chennai Patent Office Rejects Bajaj’s Pre-grant Opposition to TVS Patent Application

In a 13-page order dated November 21, 2012, the Chennai Patent Office rejected Bajaj Auto Limited’s pre-grant opposition against TVS’s application numbered 78/CHE/2004 on “Automatic Device for Providing Optimum Ignition Timing Characteristics for SI Engines”. Under Rule 55(6), a patent was granted to TVS.

The copy of the order which has been uploaded on the website of the Patent Office is not reader-friendly since portions of the order are missing. Also, the order does not make itself amenable to analysis since the prior art references (cited by Bajaj) alluded to in the order have not been identified.

I would be grateful to readers if someone could share with me the references cited by Bajaj against TVS’s application.

In all likelihood, Bajaj is bound to appeal against the grant of the patent or file a post-grant opposition. This promises to be yet another battle between the two-wheeler giants.

Friday, November 30, 2012

Draft National IPR Strategy Discusses Future Regimes for Utility Models and Trade Secrets

In September this year, there were news reports of a National IPR strategy being prepared by the government. The 25-page Discussion Paper on the National IPR strategy is available here and the feedback received from stakeholders is available here.

On Pages 20 and 21 of the Paper, there is a discussion on creation of new IP rights such as Utility models and trade secrets to "address the specific needs of the country and existing gaps". Following are the relevant extracts from the paper on the need for creation of a framework for these rights:

Protection of Utility Model
48. Indian is one of the largest markets in the globe, and while advanced concepts borrowed from developed countries find their audience in India, the bulk of the trade is centered around indigenous products and services. A salient feature of such products and services is incremental innovation - either in technology or business models. Introduction of a separate legal regime that recognizes and protects these incremental improvements which are otherwise not fit for patent grant can address this Indian requirement.

Utility Patents or Utility Models with their less stringent patentability criteria, and faster examination/grant although with shorter term of protection of 5-7 years could also be an efficient and a cost effective way to incentivize incremental innovation and encourage creation of IPRs. Needless to say, there could however be certain sector specific exemptions to ensure that objectives and principles enshrined in Article 7 and 8 of the TRIPS Agreement are respected and followed.

49. A glaring gap in Indian IP system is the lack of awareness and hence adoption of formal methods of IP creation which are expensive from the point of view of individual innovators and small industry units. Utility patents are an answer as they can potentially bridge this gap by reducing the effort, time and cost, which are considered the key entry barriers to creation of IPRs.

Consequently, in the longer term, a utility patent system is bound to develop awareness on benefits of procuring patents which have more stringent requirements of inventive step. Such a model can especially be useful for small industry units, schools and colleges, NGOs and  thousands of grass-root innovators who are silently transforming the lives of the under-privileged and under-empowered.

Protection of Trade Secret
50. Any confidential business information which provides an enterprise a competitive edge may be considered a trade secret. Trade secrets encompass manufacturing or industrial secrets and commercial secrets. The unauthorized use of such information by persons other than the holder is regarded as an unfair practice and a violation of the trade secret.

Depending on the legal system, the protection of trade secrets forms part of the general concept of protection against unfair competition or is based on specific provisions or case law on the protection of confidential information.

51. The subject matter of trade secrets is usually defined in broad terms and includes sales methods, distribution methods, consumer profiles, advertizing strategies, lists of suppliers and clients, and manufacturing processes. While a final determination of what information constitutes a trade secret will depend on the circumstances of each individual case, clearly unfair practices in respect of secret information include industrial or commercial espionage, breach of contract and breach of confidence would come within its ambit.

52. At present trade secret is protected through the contract law in India and is part of the concept of protection against unfair competition. Trade Secret is an important form of intellectual property and most innovative companies rely upon this confidential/proprietary information to gain business advantage. A predictable and recognizable trade secret regime will improve investor confidence and create a facilitative environment for flow of information.

Thursday, November 29, 2012

Snippet: Supreme Court Issues Notice to Govt. in Student's PIL Challenging Section 66A of the IT Act, 2000

The legality of Section 66A of the Information Technology Act, 2000 (the provision has been interpreted on this blog here and here), has been challenged in a PIL (Public Interest Litigation) before the Supreme Court by a Delhi-based law student, Ms.Shreya Singhal.

The PIL has been admitted by the Chief Justice of India, Hon’ble Justice Altamas Kabir. The Apex Court has issued notice to the Government, and the Attorney General has been asked to respond tomorrow, November 30, 3012.

Meanwhile, in the aftermath of the arrests of two girls over a Facebook comment, the Government seems to have finally woken up to the mischievous application of the provision, and has reportedly issued guidelines governing the application of the Section 66A.

According to news reports, prior approval from an officer of DCP level in rural areas and IG level in metropolitan areas will need to be sought before a complaint is registered under Section 66A. The practical efficacy of these guidelines has been questioned by practitioners of the law.

For now, it would be interesting to see the Government's stance before the Supreme Court on the provision tomorrow. 

Snippet: ToI Reports Sutent/Sunitinib Matter Remanded to the Patent Office by Supreme Court

The Times of India has today reported that the Supreme Court has remanded the Sutent patent matter to the Patent Office for a hearing, and also set aside the injunction on Cipla's Sunitinib. This means the revocation of the Sutent patent of Sugen Inc has been set aside. The effect of this on proceedings for alleged infringement remains to be seen.

Wednesday, November 28, 2012

IPAB Dismisses Astra Zeneca’s Appeal Against Order in Review Petition

In an order dated November 26, 2012, the IPAB dismissed Astra Zeneca’s appeal against an order passed by the Controller in a review petition. I thank Mr.Bharat S.Kumar, advocate and friend for bringing this development to my attention!

The ground for dismissal was that there is no provision for appeal against an order passed in a review petition. We had earlier discussed an order passed by the IPAB on these lines in October.

The IPAB also observed that the grounds of review raised by Astra Zeneca in its review petition before the Controller were not in the nature of review, but more in the nature of an appeal.

The IPAB noted that a party cannot seek re-hearing of a matter under the garb of review unless there is an error which is apparent on the face of the record. This position is consistent with the principles laid down by the Supreme Court for entertaining a review petition under Order 47 of the Code of Civil Procedure.

Following is the observation of the Supreme Court on scope of review:

It is well settled that review proceedings have to be strictly confined to the ambit and scope of Order 47 Rule 1 CPC. In Thungabhadra Industries Ltd. Vs. The Government of Andhra Pradesh (1965 (5) SCR 174 at 186) this Court opined:

"What, however, we are not concerned with is whether the statement in the order of September 1959 that the case did not involve any substantial question of law is an "error apparent on the face of the record". The fact that on the earlier occasion that Court held on an identical state of facts that a substantial question of law arose would not per se be conclusive, for the earlier order itself might be erroneous. 

Similarly, even if the statement was wrong, it would not follow that it was an "error apparent on the face of the record", for there is a distinction which is real, though it might not always be capable of exposition between a mere erroneous decision and a decision which could be characterised as vitiated by "error apparent."  

A review is by no means an appeal in disguise whereby an erroneous decision is reheard and corrected, but lies only for patent error."

Again, in Smt. Meera Bhanjia Vs. Smt. Nirmala Kumari Choudhury (1995 (1) SCC 170) while quoting with approval a passage from Abhiram Taleshwar Sharma Vs. Abhiram Pishak Sharma & Ors. (1979 (4) SCC 389), this Court once again held that review proceedings are not by way of an appeal and have to strictly confined to the scope and ambit of Order 47 Rule 1 CPC.

Under Order 47 Rule 1 CPC a judgment may be open to review inter alia if there is a mistake or an error apparent on the face of the record. An error which is not self evident and has to be detected by a process of reasoning, can hardly be said to be an error apparent on the face of the record justifying the court to exercise its power review under Order 47 Rule 1 CPC.

In exercise of the jurisdiction under Order 47 Rule 1 CPC it is not permissible for an erroneous decision to be "reheard and corrected". A review petition, it must be remembered has limited purpose and cannot be allowed to be "an appeal in disguise."

Snippet: Indian Express Reports on SC’s Sunitinib Order

I had blogged yesterday on the setting aside of the Sutent revocation order, and lifting of injunction on Cipla from manufacturing its drug Sunitinib.

Today, the Indian Express has reported on lifting of the restraint on Cipla. The news report, however, does not mention anything about setting aside of the revocation order of the Sutent patent. I guess only a reading of the SC's order will clarify the true position. 

Tuesday, November 27, 2012

Breaking News: Supreme Court Sets Aside Revocation of Patent on Sunitinib?

The news is just rushing in about the Supreme Court proceedings in the Sunitinib matter. It appears that the Apex Court has set aside the order of revocation of the patent on Sunitinib.

Also, from what I am told, the Delhi High Court’s order restraining Cipla from marketing its drug too has been set aside.

I thank a good friend and well-wisher of the blog for sharing this information with me!

Readers may recall that in an earlier post, I had blogged on dismissal of Cipla’s appeal against the Single Judge’s order restraining Cipla from marketing its drug, without staying the revocation of the Sunitinib patent.

Let’s wait for the order of the Supreme Court to understand the reasons for setting aside the Sunitinib revocation, and for allowing Cipla to sell its drug.

Monday, November 26, 2012

Breaking News: Chennai Patent Office Rejects Yet Another Novartis Application

In a 5-page order dated November 20, 2012, the Chennai Patent Office has refused to grant a patent to Novartis in its application 2208/CHENP/2006 on "A PHARMACEUTICAL COMBINATION FOR BRAIN DEGENERATIVE  DISEASES”.

The amended Claim 1 read as follows:

l.  A pharmaceutical  combination  comprising
a) a first agent which is 2-amno-2-12-(4-octylphenyl)ethyl[propane-1,3-diol in free form or in a phannaceutically acceptable  salt form, or FTY72O-phosphate, or 2-amino-2-f2,-(4-octylphenyl)ethyl]propane-l,3-diol hydrochloride, and

b) a second agent useful in the alleviation or teatment of brain degenerative diseases or progressive dementia,  selected from an AIvIPA receptor agonist, a noobopic agent such asi cinnarizine, nimodipine, donepezil  hydrochloride, rivastigmine.  galantamine hydrobromide, dihydroergotoxin, nicergoline, piracetame, extacts from Ginkgo leafs, pentiffllh,  pyritinol,  vincamine or vinpocetine,  and a Painkiller.

The application appears to have been rejected on grounds that the amended claim (pursuant to objections in the FER) did not have adequate support in the specification, and lacked clarity.  Further, the invention claimed in the application was deemed as being obvious in light of the prior art, and deficient in exhibiting synergistic effect of the combination of ingredients used.

Again, the absence of a detailed discussion on the prior art cited by the Patent office makes it difficult to critique/appreciate the order.

Saturday, November 17, 2012

IPAB’s Pegasys Decision: Was the Obviousness Analysis Truncated?

Although the IPAB’s decision (dated November 2, 2012) revoking IN198952 on the Hepatitis C drug Pegasys has been widely reported, I am not sure if the decision’s take on obviousness has been analysed sufficiently. This post is a preliminary look on the analysis in the decision.

The patent IN198952 (1032/MAS/1997) claimed “A Physiologically Active Branched PEG-IFN alpha conjugate”, which is used to treat Hepatitis C. The claims in the patent have been reproduced in Para 22 of the IPAB’s order as follows:

We Claim
1. A physiologically active branched PEG IFNα conjugate having the formula  ( the same formula extracted earlier in page), wherein R and R’ are independently lower alkyl; X is NH or O; n and n’ are integers having a sum of from 600 to 1500; and the average molecular weight of the polyethylene glycol units in said conjugate is from 26,000daltons to about 66,000 daltons.
2. A conjugate of claim 1 wherein the molecular weight of the polyethylene glycol units is from about 35,000 units to about 45,000 units.
3. A conjugate of claim 2 wherein the molecular weight of the polyethylene units is about 40,000 daltons.
4. A conjugate of claim 1 wherein R and R’ are methyl.
5. A conjugate of claim 1 wherein X is NH.
6. A conjugate of claim 1 wherein the IFNα is IFNα2a.
7. A conjugate of claim 1 wherein the average sum of n and n’ is 850 to 1000.
8. A conjugate of claim 1 wherein R and R’ are methyl, X is NH, IFN α is IFN α2a and one or both of n and n’ is 420.
9. A conjugate of claim 1 wherein R and R’ are methyl ; IFN α is IFN α 2a; and one or both of n and n’ is 520.
10. A conjugate of claim 1 which had greater antiproliferative activity than IFNα and less antiviral activity than IFNα.
11. A method for producing a PEG-IFN α conjugate having an increased anti-proliferative activity and decreased antiviral activity as compared to IFNα, which method consists of covalently linking a reagent of Formula II to IFNα to produce said PEG –IFN α conjugate.
12. Pharmaceutical compositions comprising a PEG-IFNα as claimed in anyone of claims 1-10 and a therapeutically inert carrier.
13. A physiologically active branched PEG-IFN conjugate substantially as herein described with reference to the accompanying drawings.

The validity of the invention was assailed primarily on grounds of lack of inventive step and Section 3(d) (Please read Para 33 onwards).

What is the Invention About?
The invention claimed in the patent relates to a class of proteins called “Interferons” which play a pivotal role in the immune mechanism of the body involving eradication of pathogens or tumors.

Claim 1 of the patent is pretty specific and is directed to a specific product which is a branched PEG - Interferon-α conjugated,  where PEG moiety of 26kDA – 66kDA is covalently linked to the Interferon molecule at a specific site. Stated otherwise, the invention related to a Pegylated interferon. Pegylation refers to the attachment of a Polyethylene Glycol (PEG) chain to a molecule.

For me, the strength of the patent lies in the specificity of the claim. Specific substituents at specified sites on the Interferon molecule have been mentioned in the claim. This, to a certain extent, is indicative of the bonafides of the patentee and the fact that the attempt is to not claim something which is unduly broad without sufficient substantiation.

Analysis of the IPAB’s obviousness Reasoning
The IPAB seems to have largely relied upon the Monfardini document to arrive at a conclusion of obviousness. I am not sure if this reliance was justified because the Monfardini document generally spoke of the effect of pegylation on activity of proteins.

The question that needs to addressed from an obviousness point of view is, does the Monfardini document which is dated 1995, combined with the then state of art on effect of pegylation on proteins, contain enough positive assertions to render the specific pegylated interferon claimed in the patent, obvious?

I ran a search on prior art related to pegylation of proteins and I came across the following documents:

-  http://www.ncbi.nlm.nih.gov/pubmed/17101522 : This is a 2001 article, i.e. after the date of filing of the Indian patent, suggesting that pegalylation site did not affect the activity of growth factor protein. In this case, the protein activity was affected solely by the size of PEGylation and was directly proportional to the PEG size attached.

 Excerpts from the article – The improvement of stability in the rat skin wound tissue was dependent on the increase of the PEG size attached.”

 -    http://www.jbc.org/content/280/8/6327 : This is a 2004 article suggesting inverse relationship between Size of PEGylation and therapeutic activity of protein.

 Excerpts from the article – The progressive relationship between decreased activity and increased PEG size suggests that pegylation may interfere with interaction and binding of IFN-α to the IFNAR1-IFNAR2 heterodimeric receptor.”

What these two articles specifically seem to suggest is that the amount of pegylation is a critical parameter since the size/amount of pegylation results in varying degrees of response. More importantly, the relation between the increase in activity and pegylation size is not linear/proportional/direct.

Also, these articles were published 4 and 7 years (respectively) after the filing of the Indian patent in 1997. If there was no clarity in the state of art on the nature of the relationship between the amount of pegylation and activity of proteins in 2004, I am not sure it could be said that the 1995 Monfardini document used by the IPAB, combined with the state of art in the year 1995, could render the Indian patent obvious.

Similarly, the following articles show that the significance of pegylation site was still being understood in 2002 and 2004:

 - https://www.thieme-connect.com/ejournals/abstract/10.1055/s-2003-41635: This is a 2002 article which suggests that while Pegylation of proteins was becoming increasingly common within the pharmaceutical industry as a way of altering the activity of the parent molecule, different proteins showed different pharmacokinetic response when it comes to the different PEG moieties attached to the native protein, the site of attachment and the type of bond involved.

The difference in activity is witnessed even within the Interferon group of proteins, i.e. Interferon 2-α and Interferon 2-β may show vastly different activities in response to the above mentioned PEGylation.

Excerpts from the Article : the different PEG moieties attached to the native protein, the site of attachment and the type of bond involved lead to vast differences with respect to the pharmacokinetics (including absorption, biodistribution, metabolism and elimination) and pharmacodynamics of these two compounds.

-  http://www.jbc.org/content/280/8/6327: This is a 2004 article clearly indicating that site of Pegylation plays an immensely important role in the activity of protein. Positional isomers of IFN-α2b showed vastly different activities, where maximum activity was seen when Pegylated at Histidine site and minimum in case of PEGylation at Cystine site. Pegylation at Lysine sites showed intermediate activity.

Excerpts from the Article - “We prepared purified, homogeneous, positional pegylation isomers of IFN-α2b that were monopegylated using 5–30-kDa linear PEG molecules attached at 7 primary reactive amino acid residues: Cys1, His34, Lys31, Lys83, Lys121, Lys131, and Lys134. The isomers were evaluated for STAT translocation and antiviral and antiproliferative activity.The site of pegylation strongly influenced activity relative to an IFN-α2b control. The highest residual activity was observed with the His34 positional isomers, and the lowest was observed with the Cys1positional isomers. The Lys positional isomers demonstrated intermediate activity, with a general order of Lys134 > Lys83  Lys131  Lys121 > Lys31. “

Clearly, in as late as 2004, independent research and experimentation was required for different proteins on the effect of pegylation site and size on different proteins since the effects were neither uniform nor predictable. Out of the 11 possible sites available for pegylation in the interferon molecule, attachment at different sites could have led to varying results.

The Monfardini document did not contain enough material to teach or suggest or motivate the site or size of pegylation for a conjugated interferon. Also, merely because the Monfardini document does not exclude interferon from its scope, it shouldn’t be concluded that interferons form part of the disclosure in the document.

Simply put, there wasn’t enough material to either apply an obviousness or “obvious to try” standard considering that the state of art even in 2004 was not settled on the effects of pegylation. Consequently, it would be incorrect to place reliance on the Monfardini publication which was published 1995, to arrive at a finding of obviousness in relation to a claim as specific as the one in the '952 patent.

One sincerely hopes to see a much more nuanced analysis of the prior art in IPAB’s decisions in the future, because the Pegasys decision leaves much to be desired on the scientific front.

Breaking News: IPAB Revokes GI on Payyanur Pavithram Ring

In an order dated November 14, 2012, the IPAB set aside the order dated July 14, 2009 by which a GI was granted on Payyanur Pavithram ring to Payyanur Pavithra Ring Artisans and Development Society (PPRADS).

On a cursory reading of the order, it appears that the grant of the GI was set aside on grounds that the application for GI filed by PPRADS was short on crucial particulars which established the right of the society to file the application on behalf of artisans manufacturing the ring.

Critically, it appears that the right of the Society to file the application was seriously circumspect with there being grave doubts if the artisans in the trade were even aware of the application for GI filed by the society. Following are the relevant observations of the IPAB:

28.       We could have allowed the appeal on the sole ground that the application has not been properly filed.  But we thought that we should take a lenient view since this is one of the early GI’s.  There are many shortcomings in the proceedings. It is clear that the applicant/respondent has failed to furnish the crucial particulars.  The applicant ought to have shown that “the producers”” of the rings as defined in the Act had a desire to form the association. There should be evidence to show that the association represents the interest of the producers.   A mere claim that the society is called Payyannur Pavithra Ring Artisans and Development Society will not suffice.  There should be evidence to show that the producers are desirous of coming together to protect the Geographical Indication, that is clearly absent. Above all on their own admission, it is the Choovatta Valappil family which was entrusted with the technique of making the ring, but even the members of that Tharawad had no notice of the application.  Such an application will defeat the purpose of the Act.

 29.       The lawmakers may consider introducing a provision which requires each applicant to effect a publication akin to the Section 4 Notice in the Land Acquisition Act. The fact of the filing of the application must be published in a newspaper having good circulation in the locality and in the language of the territory, region or locality which is the geographical origin of the goods in question.   We are deliberately not using the word “vernacular” since that has such a patronizing colonial flavour, whichever language it may be it is an Indian language.  There must also be affixture of public notice in prominent places in the territory, region or locality as the case may be. Only then, the artisans will know that a Geographical Indication has been applied for in respect of the goods that they are creating.  We are aware that “a producer” includes the person who deals in this goods or selling those goods.        However the main object of the Act is to protect those persons who are directly engaged in exploiting, creating or making or manufacturing the goods.  They have the hands-on experience of the G.I. products.  When these creators or makers complain that the application has been made behind their back  we cannot allow the registration to remain.  The artisans like weavers, goldsmiths and other craftsmen may not be affluent or literate in English language, so the publication must be in the local language. The advertisement in S.13 is in the Trade Journal is of no use and will not serve the same purpose as a public notice akin to the S.4 Land Acquisition Act notice.  The appellant has also complained that the Consultative Group has not visited the place and the Quorum was not formed.”

The following observation in Para 32 is even more noteworthy:

The averments in the appeal and opposition show how the craftsmanship of the ring has been handed down from generation to generation.  In Intellectual Property Right related matters be it G.I., Patents or Trademarks the dispute is really not inter-partes alone, there is always the issue of public interest. The Geographical Indication Registrar and this Board must protect this public interest.  The history of the Payyannur Pavithra Ring, as seen from the statements of all the parties before us shows that though there may be other Rings in the market called Pavithra Ring, this particular design and the manner in which the Ring is made is special  to this area. But the application has not been properly filed and there are other shortcomings in the proceedings as well.   Hence while removing the name of the respondent from the register, we send it back to the Geographical Indication Registrar.”

Accordingly, the matter has been remanded to the GI registrar for reconsideration of the application and disposal within 6 months.

This is one of the first clear pronouncements on the GI Act, with the observations in the verdict having important ramifications for pending GI applications and oppositions before the GI Registry. The most important take-away, in my opinion, is the abundantly clear recognition of the public interest angle of GI rights, and the need to ensure that stakeholders are made aware of the filing of GI applications so that they may object to or seek to be included as part of the application. 

Monday, November 12, 2012

IPAB: Rejection of a PCT Application for Delay is a Refusal under Section 15

In an order dated November 2, 2012, the IPAB held that an order of the Controller refusing a National Phase Patent Application for delay in filing beyond the 31 month period, is an order passed under Section 15 of the Patents Act. Consequently, according to the IPAB, an appeal to the IPAB against such an order is maintainable under Section 117A of the Act. This decision was passed in connection with a PCT NP application filed by Durect Corporation, the facts of which I had earlier discussed here.

The IPAB’s decision is clear on the point. One is just surprised that the Patent Office, which is the respondent in the appeal, has resorted to such unfounded grounds of challenge when the law on the scope of Section 15 with respect to rejection of patent applications must be treated as largely well-settled by now.

Friday, November 9, 2012

Breaking News: Canadian Supreme Court Invalidates Pfizer's Viagra patent

This is truly a bad year for patentees all over the world. In an extremely critical development, the Supreme Court of Canada has invalidated Pfizer's patent on Viagra on grounds of insufficient disclosure (reported here). The decision was a unanimous one (7-0). One is yet to read the contents of the decision, but this is a truly monumental development which is bound to keep us all engaged for sometime to come.

Wednesday, November 7, 2012

Correction: Patent Agent Exam Rules Amended

Correction: I hadn't read Sub-Rule (2), but an alert well-wisher of the blog has just pointed out my blunder. The amended post reads as follows:

In a gazette notification dated September 25, 2012, the Government of India has notified the amendment to the Patent Rules which apply to Patent Agent Examination. The Sub-rule (2) of Rule 110 has been amended to bring down the marks in viva from 100 to 50, thereby bringing down the total score to 250, as opposed to the earlier figure of 300.

The amended sub-rule (3) of Rule 110 reads as follows:

(3) A candidate shall be required to secure a minimum of fifty marks in Paper I and Paper II and shall be declared to have passed the examination only, if he obtains an aggregate of sixty percent of the total marks.

By the amendment, the effect of viva voce has been reduced.

I thank Ms.Disha Jeswani, the topper of the 2010 Patent Agent Examination, for sharing this information with me!

Thursday, November 1, 2012

Does Section 66A of the Information Technology Act apply to Tweets?

Yesterday, one of our commentators brought to my attention the arrest of a businessman from Pondicherry, Mr.S.Ravi, for purportedly “offensive” tweets against the Union Home Minister, Mr.P.Chidambaram’s son, Mr.Karti Chidambaram. Section 66A of the Information Technology Act appears to have been invoked against Mr.Ravi.

In an earlier post, I had discussed in detail the scope of applicability of the provision drawing a distinction between “publication”, and “sending messages” through a communication device or a computer resource. The relevant portions of the post are as follows:

66A.Punishment for sending offensive messages through communication service, etc.: Any person who sends, by means of a computer resource or a communication device,-

(a) any information that is grossly offensive or has menacing character; or

(b) any information which he knows to be false, but for the purpose of causing annoyance, inconvenience, danger, obstruction, insult, injury, criminal intimidation, enmity, hatred or ill will, persistently by making use of such computer resource or a communication device,

(c) any electronic mail or electronic mail message for the purpose of causing annoyance or inconvenience or to deceive or to mislead the addressee or recipient about the origin of such messages, shall be punishable with imprisonment for a term which may extend to three years and with fine.

'Explanation.- For the purpose of this Section, terms "electronic mail" and "electronic mail message" means a message or information created or transmitted or received on a computer, computer system, computer resource or communication device including attachments in text, images, audio, video and any other electronic record, which may be transmitted with the message.

The issue is whether the provision applies to publication of defamatory or prohibited content on websites. I am inclined to say no for the following reasons:

1. I do not think publishing information on a website/portal falls within the definition of "sending". According to me, the provision's use of the word "send" along with "communications device" leaves very little room to include "publication".

2. It must be borne that although publication results in communication, there is no attempt on the part of the legislature to include publication within the meaning of "sending". 

3. Legislations are expected and presumed to be consistent in their use of terms. When the Act uses "publication" in one sense in select provisions (Section 67), but does not use "publication" in Section 66A, it means it does not intend to include mere publication by posting. In other words, although "sending" may result in publication, all publication cannot be equated to sending.

4. "Send" envisages a specific recipient(s). Also the provision refers to transmission and addressee/recipient of the message. This means the nature of the transmission is communicatory.

5. Also, it would be a stretch to argue that "communication/send" includes communication between the person who publishes the information and the system on which the information is published. That would amount to hair-splitting.

6. Further, even when the provision refers to use of computer resource, the legislature still makes no room for "publication" using the computer resource on a website. 
7. The limited circumstance when publication on website would amount to "send" is when information published on the portal is "sent" and "received" by subscribers of the site/blog/social networking site. Simply put, we'll have to distinguish between publication simpliciter on a website/an update on Twitter or Facebook and a message which is communicated.

8. Not just that, there's a reason why the IT Act or Section 66A does not provide for defamation by publication on a site. Section 499 of the IPC is broad enough to apply to defamation using any medium, therefore one does not need any provision under the IT Act for it. This applies to obscenity and the like offences as well.

9. Consequently, since the IPC already provides an offence for the end product of the communication i.e. defamation, my take is that Section 66A forbids use of the medium recognized under the IT Act as a medium for defamation. Specifically, it forbids use of the medium as a "conduit" for sending offensive messages. We must distinguish between a "conduit" and a "place/cyberspace". Section 66A alludes to the use of information technology as a channel of communication, as opposed to a space for publication.

10. The equivalent provision in the “real world” is Section 20 of the Indian Post Office Act, 1898, which reads as follows:

20. Transmission by post of anything indecent, etc., prohibited.—No person shall send by post--

(a) any indecent or obscene printing, painting, photograph, lithograph, engraving, book or card, or any other indecent or obscene article, or

(b) any postal article having thereon, or on the cover thereof, any words, marks or designs of an indecent, obscene, seditious, scurrilous, threatening or grossly offensive character.

The emphasis in the Post Office Act is on "transmission by post" of anything forbidden. Therefore, it follows that even Section 66A, which is the “e-equivalent” of Section 20 of the Post Office Act, also frowns upon use of the medium as a "communication medium", and not as a means of "simple publication."

As regards the application of Section 66A to tweets, to my mind, Twitter as a micro-blogging site is a platform for communication through publication, as opposed to communication by “sending messages”.

It must be borne that the purpose of the provision is to deter and frown upon messages sent via emails/SMS, which though amount to communication, do not necessarily translate to publication always (unless it is a group message). Even when offensive or insulting information is sent as a group message via emails or group texts, the provision’s scope is limited to the act of “sending messages”, with the issue of defamation being covered by Section 499 of the Indian Penal Code.

Therefore, I don’t think Section 66A applies to tweets or status updates on Facebook.

Comments and corrections are welcome! 

Snippet: Complaint filed against Yash Raj Films in the Competition Commission

Reportedly, actor-cum-producer Ajay Devgn, has filed a complaint against Yash Raj Films in the Competition Commission of India (CCI) for abusing its dominant position in Bollywood to prevent the release of Ajay’s film Son of Sardar on the eve of Diwali.

I’ll keep the readers updated on this development. I thank Ms.Sneha Jain for bringing this news report to my attention.

Saturday, October 27, 2012

Snippet: USPTO Issues Non-Final Rejection of Apple’s Bounce-back Patent

In what must surely come as a rude-shock to Apple, the USPTO has issued a non-final rejection (available here) of Apple’s patent over the “bounce back/rubber band” feature which Apple successfully asserted against Samsung in the US.

The non-final rejection was issued in an ex parte re-examination of the patent US7469381. It has been reported that Samsung has brought this development to the notice of District Judge Lucy Koh who presided and continues to preside over the Apple-Samsung patent trial.

All 20 claims of the patent were invalidated, including claim 19 which claims the bounce-back feature.
I thank Ms.Jaya Bhatnagar for sharing this development with me.

Sunday, October 21, 2012

Snippet: Delhi High Court Passes “John Doe” Order for the Movie “Chakravyuh”

On October 19, 2012, in a suit instituted by Eros International, C.S.(O.S.) 3163/2012, the Delhi High Court issued “John Doe” order against unknown defendants in relation to the film “Chakravyuh”, besides restraining named defendants such as Jyoti Cable Network from communicating, making available, distributing, duplicating, displaying, releasing, showing, exhibiting in the film in any manner without obtaining prior authorization/license from Eros International.

I thank Ms.Sneha Jain for bringing this development to my attention.

Saturday, October 20, 2012

Snippet: Cipla Abandons its Patent Application

In an interesting development, Cipla has abandoned its patent application 733/MUMNP/2004 relating to “A combination of Azelastine and steroids” which had 50 claims.  The application was abandoned after a pre-grant opposition was filed against it. Here is the 8-page decision delivered on October 14, 2012 by the Mumbai Patent Office, of which 6 pages contain only the claims of the application.

Friday, October 19, 2012

Division Bench of High Court uses “Hyperbole” defense to Stay Injunction on the use of “Bata”

In what must certainly be one of the fastest appeals and decisions, in a 10-page judgment delivered on October 17, 2012, a Division Bench of the Delhi High Court has stayed (not set aside as I had incorrectly written) the order dated October 15, 2012 of the Learned Single Judge restraining the allegedly defamatory use of the trademark “Bata” in the song “Mehngai” in the movie “Chakravyuh”.

Following are the relevant excerpts from the decision of the DB:

“3. The issue raised in the appeal is of great public importance in the context of fundamental rights of the citizens to freely express themselves on social issues and thus we would be inclined to hear detailed submissions in the appeal but are constrained to pen this short order inasmuch as the cinematographic film in question is scheduled to be released in India on October 24, 2012.  Only two more working days remain as per the calendar of this Court before the Autumn recess commences.  The appellant seeks a stay of the operation of the impugned order.  

4. We are informed that as far as the international premier is concerned, the movie in question has already been launched with a premier show held in London on October 11, 2012 and that the offending lyrics in the song have been on the “You Tube” by way of promotionals since mid September 2012.

5. Since the appeal came up for hearing today in the forenoon and we do not have the requisite time to view the cinematographic film we take on record the statement made by the learned senior counsel appearing for the appellant as well as for the first respondent that the theme of the cinematographic film is the burning social issue of disparity in the distribution of wealth created in the nation : Fight of values and thought between the  “haves” and “have nots”.  

We are informed that the textual setting of the cinematographic film reflects a class struggle between the State,  which is perceived  by a section of the society to be capitalist oriented, vis-à-vis those who believe that  the social philosophy of the State should be of a kind which facilitates a fair distribution of the wealth created i.e. meets the need of all and the greed of none.  It is this esoteric thematic setting which finds an exoteric expression in the movie which shows to the viewer the struggle between the Maoists and the State.

13. Mr.Sandeep Sethi, learned senior counsel appearing for the appellant urges that notwithstanding four business houses being named in the song, the understanding of the song would not be with reference to a particular house but to a class which propagates the ideology of industrialization. And, brings out a call to those who propagate the ideology of socialism to unite and fight.

Following are the operative portions of the order:

19. The movie raises a burning social issue which we find is a matter of public debate on the streets and the press.  The struggle between the “haves” and  the  “have nots”.  The struggle for political power and the control over the philosophy of the State.  

20. Would the traditional legal principles evolved by Courts on the subject of rhetorical language or hyperbole be sufficient guidance for Judges to resolve issues when expressions are used with respect to social issues?  Is a question which needs to be seriously considered and answered.  

This is the reason why we are deferring hearing but penning our thoughts as aforesaid to bring out the richness in the public debate and especially in the modern societies where contemporary entities compete in the interdependent industrialized world and perhaps in this competition the individual organized industry of the common man renders him incapable of fighting an organized industrial establishment. 

To wit : When a prosperous person goes into depression and commits or attempts to commit suicide, what else is the phenomenon other than the individual organized industry falling apart against the onslaught of modernization.

21. Seen with the viewpoint as herein above, we do not prima facie find that in its contextual setting, viewed and heard as a whole, the song is derogatory or defamatory of the House of Bata.  Four leading and well-known industrial houses have been named and the statement naming them is prima-facie not likely to be taken literally by the viewer/listener.  

22. Deferring further hearing of the appeal till November 07, 2012, the operation of the impugned order is directed to be stayed.

The rational appears to be that given the backdrop of the story, use of the names of popular business houses is a reference to capitalism, and not a targeted assault on the entities per se.

Considering that a good section of the audience is not capable of making such a nuanced distinction, I am not sure I agree with the rationale. Also, would the logic of the Court’s decision apply even to public individuals who enjoy a clean reputation?...