India’s desi AK – 47

India may soon have its desi AK – 47, reported Times of India. It is expected to be more potent than the Russian made AK – 47.  As per the report, the weapon which is developed by Tiruchirapalli Ordnance Factory in Tamil Nadu, is undergoing final rounds of evaluation. Not formally christened so far, the weapon is known as Tiruchirapalli Assault Rifle (TAR).

The report traced the development of the desi version back to a Defence Expo in New Delhi in 2000. Apparently, a replica of desi AK-47 was put on display which invited the wrath of original designer, Mr. Mikhail Kalashnikov himself. On his threat to file a copyright infringement suit, the plans for a desi AK-47 were put on hold. Further, the report noted that the technology has been tweaked in the desi version to preclude any allegation on copyright violation.

Assuming the veracity of the report, I am intrigued by the idea of filing copyright infringement suit against the placement of replica of AK-47 in the Defence Expo. As you are aware of, copyright can subsist in a) Original literary, dramatic, musical and artistic works; b) Cinematograph films; and c) Sound recordings. If Mr. Kalashnikov contemplated filing a copyright infringement suit, the only plausible option is to file the suit claiming it as an "artistic work". As per S. 2(c), “artistic work” means (i) a painting, a sculpture, a drawing, an engraving or a photograph, whether or not any such work possesses artistic quality; (ii) work of architecture and (iii) any other work of artistic craftsmanship. Evidently, it would have been an arduous task for Mr. Kalashnikov to prove it as an “artistic work” and claim infringement.

Further, I am unable to comprehend the idea of tweaking technology to preclude allegations on copyright infringement. Copyright protects “expression” of an idea and not an “idea” by itself. In fact, when idea and expression become inseparable, copyright is not granted since protection of latter will lead to monopoly over the former (doctrine of merger). Even if the report meant tweaking of technology to preclude allegations on patent infringement, it would have been still incorrect - since the technology behind AK – 47 (adopted by Soviet Army way back in 1949) does not enjoy patent as it already formed part of prior art.

 

Considering the aforesaid aspects, I don’t think anyone can be blamed if he/she calls the report to be a puerile piece of writing!!

New Franklin Pierce Centre for IP opens at the University of New Hampshire School of Law

(Image taken from here)
The IP activities in the University of New Hampshire School of Law just got a boost with the new Franklin Pierce Centre for Intellectual Property that is scheduled to be formally inaugurated over September 30 and October 1, 2011. The inaugural ceremony is going to feature among other things a high-profile academic conference on IP and the Innovation System [involving current issues in patents, trademarks, and copyright, as well as property theories and security interests], a panel discussion and a formal event attended by legal luminaries and scholars from all over the country.

Justice Donald J. Horowitz, a renowned figure known for his insights into the manner in which new inventions and technological developments can be harnessed to ensure equal and fair access to justice for all, will deliver the keynote lecture, titled ‘From Information to Knowledge to Wisdom’. The panel discussion will consist of a panel of distinguished judges, such as Chief Judge Rader, Judge Pauline Newman, and Judge Arthur Gajarsa of the US Court of Appeals for the Federal Circuit, as well as a policy-makers' panel, comprising the former US Register of Copyrights Marybeth Peters and former Under-Secretary of Commerce for IP Jonathan Dudas, who is currently president of FIRST (an organization founded by inventor Dean Kamen in 1989 to develop ways to inspire students in engineering and technology fields).

The Spicy IP team congratulates the Franklin Pierce Center for Intellectual Property of adding yet another feather in its cap that is bound to facilitate its laudable goal of bringing together the leaders of the IP community to address issues of contemporary relevance surrounding IP and the innovation system.

Guest Post: Taking a closer look at the Nexavar litigation

In April last year we had carried our first post on the Bayer-Cipla litigation. This particular lawsuit was unique because Justice Bhat had fast-tracked the case with some unique innovations. While we have covered the progress in the litigation we have not really covered the arguments being put forth by both the parties to this litigation. In this post, Ms. Taapsi Johri, an experience patent lawyer, who has represented several originator pharmaceutical companies, has written us this in-depth analysis of the arguments being raised in this case. We will be having some more follow up posts from Taapsi in the near future. Image from here.

Taking a closer look at the Nexavar litigation

By,

Taapsi Johri

Picking up from Prashant’s last post, this post will take a closer look at the Bayer v. CIPLA litigation over Bayer’s patent for Sorafenib (Nexavar). But before we begin here is a brief round up of the events up till now.

I. The story so far

The last significant moment in this litigation was when J. Ravindra Bhatt framed questions on which the scientific experts appointed by the Court were to submit reports to assist the court. The matter was then listed on 23^rd March 2011. As of 23^rd March 2011, the court appointed experts had filed their reports, both parties had sought time to analyze the reports and the matter was adjourned to 5^th May 2011. The next effective date was 13^th July 2011 when the Court considered a request made by the Plaintiff to refer one of the issues framed on 16^th November 2010 to the technical experts. Their assistance was sought on issue no. 2(e) which deals with the objections raised by the Defendant on failure of the applicant to comply with Section 8 requirement and a request was made that an additional report be submitted on this aspect. The Court observed that at the present stage of the suit there was no need for such an evaluation and it can be deferred to a stage after the Defendant has led evidence. Justice Gita Mittal stated that the Plaintiff could raise an objection at that time, if necessary. The Court then granted time to the parties to conduct admission denial of documents.

Now that we have taken upon ourselves this task of following this litigation closely, let’s begin from where it all started.

II. The dispute

The dispute between Bayer and Cipla is over a pharmaceutical product, N-(-4-chloro-3-(trifluoromethyl) phenyl)-N’-(4-(2-(-N-methylcarbamoyl)-4-pyridyloxy) phenyl) urea, called Sorafenib and its pharmaceutically acceptable salt Sorafenib Tosylate. It is used for treatment of primary kidney cancer and advanced primary liver cancer. The Plaintiff obtained a product patent for the drug under Indian patent number 215758 dated 12^th January 2000, (Indian application was filed on 5^th July 2001 and Indian patent was granted on 3^rd March 2008) titled “CARBOXYARYL SUBSTITUTED DIPHENYL UREAS”. Sorafenib is imported by the Plaintiff’s Indian subsidiary (Bayer Polychem) in the form of Sorafenib Tosylate and marketed under the brand name “NEXAVAR”. In February 2010 the Defendant, CIPLA, announced the probable launch of a generic version of Nexavar. The Plaintiff has sued the Defendant for infringement of its patented product exercising its rights under Section 48 of the Indian Patent Act and has prayed for permanent injunction against the Defendant and damages.

The claims of the Indian patent are available over here.

III. Cipla’s case

The Defendant, Cipla’s submission is that they have been manufacturing and marketing Sorafenib Tosylate tablets under the brand name SORANIB since April 2010. The Defendant’s case is based on showing a credible challenge against the validity of the patent. In addition to raising defenses in the Written Statement, the Defendant has also filed a Counterclaim praying for revocation of the Plaintiff’s patent. There is also a post-grant opposition pending against the Plaintiff’s patent application.

As we know, proving invalidity of a patent is a defense to infringement. What is interesting to note is that in most Indian Patent litigations the Defendant does not spend too much time on asserting non-infringement. Their line of defense is limited to challenging the validity of the patent. Since recent case laws have refused an interim injunction in cases where the accused has raised a credible challenge against the patent, the initial hurdle of an interim injunction is easily crossed by simply throwing every section that is available in the Patent Act as a challenge to patent validity. We have seen numerous instances in recent past where the Defendants have openly declared that their product is based on the patented drug. So, if any Patentee has the good luck and immense good fortune of overcoming an invalidity challenge, what would be left is a case of admitted willful infringement by the Defendant.

The Defendants have challenged the validity of the impugned patent on various grounds. I will try and briefly discuss them:

1. Lack of inventive step under Section 64(1) (f).

The Defendant has relied upon certain prior art documents (US5773459 and US4904668) to show that the impugned patent of the Plaintiff is obvious to a person ordinarily skilled in the art (POSA).

According to the Defendant, while these two patents do not explicitly disclose Sorafenib, they provide motivation to arrive at compounds having structural similarity with Sorafenib. The Defendant has made various submissions asserting that the Plaintiff’s invention is obvious as it was always worthwhile for a POSA to study efficacy of various substitutes by trial and error.

What one should be careful about while raising such defenses is that it should not look like hindsight reconstruction. Is it reasonable to state that even when there is scope for trial and error, and a patentee has undergone this process of trial and error and arrived at the appropriate substitute, he is not entitled to protection because now that we know the appropriate substitute, it seems obvious? What will help in such a situation is to show that the prior art documents relied upon in fact provide motivation and teaching to combine the results of these documents to arrive at the alleged inventive product. It is here that the expert’s affidavit should come handy.

2. Not patentable under section 3(e) read with Section 64(1)(k).

As per the Defendant certain composition claims in the Plaintiff’s patent specification do not stratify the requirement of a composition and in fact are only an admixture and hence cannot be patented.

3. Not an invention under Section 64 (1) (d).

The Defendant has submitted that the Plaintiff’s impugned product is not an invention as it is obvious to a POSA. Not just this, according to the Defendant there is no technical advancement shown by the impugned invention over what was already known i.e. no enhanced therapeutic efficacy. As we know, Section 3 of the Indian Patent Act lays out what is not an invention. Section 3(d) specifically relates to the concept of enhanced efficacy. However, the Defendant has made no mention of Section 3(d) and simply argued that the Plaintiff’s product is not an invention since it is obvious to a POSA. The Defendant also submitted that Sorafenib is a mere modification of compounds which can be clearly envisaged from prior art. So, does this means that according to the Defendant, Sorafenib is a structurally different product from what is known but it is obvious and with no enhanced efficacy? If the Defendant submits that Sorafenib is a new product then this pretty much closes all chances of raising a Section 3(d) objection, because Section 3(d) deals with new form of a known substance but not with a new substance altogether. Secondly, if Sorafenib is a new product then is it imperative to show “enhanced efficacy”? If yes, then enhanced efficacy in comparison to what? Lastly, should not the increased acceptance and popularity of a drug be evidence of efficacy?

4. Lack of enablement or insufficient description under Section 64 (1) (h).

The Defendant asserts that the patent specification does not disclose the best mode of working the invention and is insufficient.

5. Failure to comply with Section 8 requirements and hence revocable under Section 64 (1) (m).

The favorite ground for revocation in most patent challenges in India, it states that a patent can be revoked where there is a failure to comply with section 8 of the Patent Act. Section 8 requires the Patentee to disclose to the Indian Patent Office the status of all corresponding foreign patents/applications and all such relevant details. The patentee is also under an obligation to update this information as and when anything significant occurs in relation to these applications/patents. The Defendant has submitted that the Plaintiff failed to make such disclosures at the prosecution stage and the Indian Patent Office was unable to examine the prior art.

6. False suggestion and misrepresentation under Section 64 (1) (j).

The Defendant submitted that the patent should be revoked since the Plaintiff-patentee had suppressed material information from the Patent Office such as the prior art documents and prior filed patents which disclose the compound N-(-4-chloro-3-(trifluoromethyl) phenyl)-N’-(4-(2-(-N-methylcarbamoyl)-4-pyridyloxy) phenyl) urea.

7. Objections on working of the invention under Section 83(g) of the Indian Patent Act

A pertinent issue raised by the Defendant is that the Plaintiff’s product is not manufactured in India but imported. In Section 83 the Indian Patent Act expressly provides the general principles for working of a patent. As per the Defendant’s contention the Plaintiff is not working the invention since the Plaintiff is not manufacturing the product in India but importing it. This adds to the cost of the final product as well. The Plaintiff’s drug Nexavar costs Rs. 2336.9/- per tablet while the Defendant’s drug Soranib is Rs. 233/- per tablet.

While non-working of a patent within the territory of India is a ground for obtaining a compulsory license under the Indian Patent Act, Section 85 (3) of the Act also provides that the Controller can revoke a patent on grounds of non-working in the territory of India. Please note that non-working is not a ground before the High Court for revocation of a patent.

IV. Issues framed

As our readers already know the Court has already framed issues in the suit (discussed here (http://spicyipindia.blogspot.com/2010/12/justice-ravindra-bhat-frames-issues-in.html). They focus on the standard three things i.e. proving infringement the burden of proof for which is on the Plaintiff; proving invalidity the burden of proof for which is on the Defendant and relief sought.

In addition to these, the Court had framed questions on which the assistance of the court-appointed scientific experts was sought. While the questions seem complex, they are overlapping in their scope. The controversy basically revolves around two prior art documents US’459 and US’668 and an analysis of whether and to what extent these two patents disclose the subject matter of the impugned patent.

V. The course ahead

The matter is now listed on 20^th October 2011 when the parties would appear before the Joint Registrar to mark the documents filed by them. What we hope for is that the matter is not stalled any further. Since the subject matter of the suit is a product patent, the structure, function and constitution of which is not in controversy, validity is all that is to be shown. (No dispute over enantiomers/isotopes etc.) Then there isn’t, as of now, any other controversy clouding the basic patent issues (read missing files/patent linkage etc.) This seems like a suit where the controversy is only on hard core patent principles with little else to distract us.

Justice Sridevan’s report exposes the Central Govt’s apathy towards the IPAB

C.H. Unnikrishnan of the Mint carried an interesting story, yesterday, on the state of affairs at the IPAB. As most of you may know Shamnad had filed a PIL before the Madras High Court in January of this year against the creation of the IPAB on the grounds that it is unconstitutional for violating the doctrine of separation of powers. A secondary aim of the PIL was to bring urgent attention towards the absolute lack of resources at the IPAB.

In this regard, the Division Bench of the Madras High Court, headed by the Chief Justice, had asked the Chairperson of the IPAB, Justice Prabha Sridevan, to submit a report on the infrastructure and resources which had been available to the IPAB. In response to this request from the Madras High Court, Justice Prabha Sridevan submitted a detailed 13 pages report along with 36 pages of annexures detailing the state of affairs at the IPAB. (The report can be accessed over here, a few pages are missing, we’ll try and put up a better copy soon) Some of the important points raised by Justice Sridevan in her report are:

• The government has failed to conduct a ‘judicial impact assessment’ to assess the resources required by the IPAB;
• That the IPAB is currently functioning out of an office of only 5500 sq. ft. despite requiring over 20,000 sq. ft. as per the CPWD norms;
• That the pay scales of the non-judicial staff at the IPAB are below the pay-scales fixed for the staff of other tribunals. The IPAB is therefore being discriminated against by the Government;
• That there is an urgent requirement to create several more posts at the IPAB to assist the judicial members in deciding cases;
• That the 6th Pay Commission recommendations have not been implemented with respect to the Chairperson and Vice-Chairperson of the tribunal.

The Division Bench after hearing brief submissions from Senior Advocate Arvind Datar, counsel for the petitioner and the amicus curiae Senior Advocate P.S. Raman, passed orders directing the State of Tamil Nadu and the Union of India to report on a new location with sufficient space for housing the IPAB. The matter has now been posted for September 29th, 2011.

I strongly recommend reading Justice Prabha Sridevan’s report. It is incredibly detailed and it is very clearly supports the arguments that were raised in the PIL.
(P.S. A big thank you to Advocates Ananth Padmanabhan, Vineet Subramani and Snior Advocate Mr. Arvind Datar for all the effort that went into preparing for the last hearing. We were hoping for the matter to be argued at the last hearing but the Court will now take up arguments on the constitutionality only at a later undecided date)

Conducting a post-mortem on Astella’s Indian Patent No: 234753

Continuing from my last post on Astella’s patent infringement lawsuit against Micro-Labs, I’ve managed to access the details of the file wrapper from the IPAIRs system and I thought it would be interesting to point out a few of the other issues that may arise in the challenge Astella’s Indian Patent No: 234753. Let me also insert the caveat that the accuracy of this post is directly dependant on the accuracy of the information uploaded on the IPAIRs system and nothing in this post can be presumed to be conclusive. Also please feel free to join the debate in the comments section.

(i) Proof of inventor-ship: As per Section 7(3) of the Patents Act, 1970 all patent applications will have to be accompanied by proof of the right to make the application. Further Section 10(6) of the same Act also requires a declaration as to the inventor-ship of the invention. The Patent Rules prescribe the forms etc. in which this information is to be given. For e.g. please click on Form 1 and Form 5 to view the manner in which this information is requested for by the patent office. Now please click here and here to see the initial patent application filed by Astellas along with a copy of all the letters written by their Patent Agents to the Patent Office in the course of the patent prosecution. Each letter mentions the enclosures and none of these enclosures mention anything about a proof of the right to apply or even a declaration as to inventor-ship. Which begs the question, how did Astellas establish the right to file the patent application that resulted in Indian patent no: 234753. Of course, it is also possible that the patent office has not placed this correspondence on the IPAIRs system.

(ii) Power of Attorney: Very, very surprisingly the original patent application was not accompanied by a ‘power of attorney’. Page 2 of the correspondence file available over here, is the covering letter for the patent application. In the list of enclosures, the patent agent states that the ‘power of attorney’ will ‘follow’. This letter is dated the 25th of May, 1997. On the 10th of March, 2008 the Examiner of Patents issued the ‘First-Examination Report’ (available here) and one of the objections mentioned is the absence of a ‘power of attorney’. This means that this patent application continued for 11 years without a power of attorney. The remaining correspondence too is silent on the filing of a ‘power of attorney’. Why in God’s name did the patent office even examine this file when there was no POA filed in the name of the patent agent? A POA is the most fundamental of instruments establishing that the patent agent is indeed authorized by the patent applicant to prosecute the application in question. If there is no valid POA, the patent office should just reject the entire application.

(iii) Substitution of the applicants under Section 20 of the Patents Act, 1970: The original patent application for Indian patent no: 234753 was filed in the year 1997 by Yamanouchi Europe B.V. On 1st April, 2005 Yamanouchi Pharmaceuticals merged with Fujisawa Pharmaceuticals to create Astellas Pharma Inc. It appears that all subsidiaries were also merged. Section 20 of the Patent Act, 1970 prescribes the procedure to substitute the names of the applicants of an existing patent application which has not yet been granted. On the 31st of July, 2006 the patent agents for the original patent applicants filed a Form 6 (available over here), under Section 20, for the substitution of the patent applicants i.e. the original applicant was going to be replaced by Astellas Pharma Europe B.V. The official reason cited in this Form is the merger and as supporting proof the patent agents enclosed an extract from the trade register along with an English translation. This extract from the trade register in Netherlands has not been put up by the Patent Office on IPAIRS. The following issues arise in this context:

(a) Was Yamanouchi Europe B.V. merely re-named Astellas Pharma Europe B.V. or is the latter a new legal vehicle resulting from the merger of Yamanouchi and Fujisawa?

(b)If it’s a mere name-change then the proof submitted by the patent agent, i.e. an extract of a trade-register, should be enough, although if we want to get technical we need to examine whether it has been authenticated as per Indian law.

(c)However if Astellas Pharma Europe B.V. is a new legal entity then in that case Section 20(3) of the Patents Act, 1970 requires the filing of a specific assignment deed between two parties, with reference to the patent application number etc. which has not been submitted in this case. This would require Yamanouchi to transfer the patent application via an assignment deed to Astellas Pharma Europe B.V.

(iv)The objections raised in the FER: On the 10th of March, 2008 the examiner of patents issued a detailed First Examination Report (FER) (available over here). The following issues arise from this FER:

(a) Objections on the lack of inventive step: The examiner of patents had raised a fundamental objection on the lack of an inventive step in the patent specification. He supported his argument by citing four other patents in the same field. Surprisingly the patentee has been granted this patent without providing any clarification on this point. After all if an objection has been raised in writing, it has to be taken care of in writing. The response to objections has to be in writing so that there is a record of it.

(b)The Section 8 arguments: The examiner of patent has asked the applicant to file the examination/search reports generated by the EPO, JPO and the USPTO for the corresponding patents filed in those countries. The patentee however has gone ahead and filed only Form 4, which contains only cursory details as to the stage of the patent in foreign countries. The patentee seems to have disregarded this very specific request of the patentee.

Conclusion: There are clearly several issues that need to be clarified by the patentee in this case unless of course the patent office has not put up the complete information on the IPAIRS system.

Japanese pharmaceutical company sues for patent infringement in Delhi to protect its French markets

We have recently received information about an interesting patent infringement case filed by Astellas Pharma Europe B.V. (‘Astellas’) a company incorporated in the Netherlands, before the Delhi High Court (C.S. (O.S.) No. 1166 of 2011) against Micro-Labs Ltd., a Bangalore based Indian pharmaceutical company. Despite the distinctly European name of the Plaintiff, it is in reality a subsidiary of a Japanese company, which in itself is the child of a merger between two Japanese companies. For some reason, probably one of convenience, it is this Dutch corporation which holds most of the world-wide patents of the Japanese group companies.

This is an interesting case because the thrust of this patent infringement action is aimed at cutting the supply lines of Mylan’s French subsidiary (Mylan SAS) and it is not really aimed at stopping any marketing activities of the impugned product within India. It must be remembered that until now the patent litigation in India has always been aimed at stopping the marketing activities of generics within India itself. Indian courts are therefore slowing turning into a playground for global litigation. The history of the litigation between the parties, the details of the patent and the lawsuit are explained in greater detail below:

A. History of the Litigation
The litigation before the Delhi High Court can be traced to a commercial agreement between ‘Astellas’ and Mylan SAS for the supply of amoxicillin fast disintegrating tablets along with the sale of the requisite registration data in order for Mylan to be granted, regulatory approval for marketing the drug in France. This commercial arrangement which continued for at least a decade gradually lapsed and Mylan eventually entered into a commercial agreement with Micro-Labs for the supply of the same tablets which were previously being sourced from Astellas. Once Astellas learnt that they had been dumped by Mylan for Micro-Labs, they sued Mylan for patent infringement in France on the grounds that the tablets in question were covered by the claims of a European Patent bearing number 0910344. Mylan counter-sued by initiating legal proceedings for the revocation of the European Patent on grounds of invalidity etc. After several legal threats to Micro-Labs, Astellas filed the present patent infringement suit against Micro-Labs in May of 2011 for violation of the corresponding Indian patent granted by the Chennai Patent Office. However this suit before the Delhi High Court had been pre-empted by both Mylan and Micro-Labs filing separate revocation petitions against Astella’s Indian Patent before the IPAB on the ground of obviousness etc.

B. Indian Patent No: 234753
Astellas has filed the present infringement suit against Micro-Labs on the grounds that its Indian patent number 234753 was infringed. Claim no. 1 of the patent reads as follows:

1. A granulate for the preparation of fast-disintegrating and fast-dissolving compositions, containing an active ingredient, having a solubility in water of 1:>10, in admixture with a water dispersible cellulose, which is a microcrystalline cellulose and sodium carboxymethyl cellulose, characterized in that the water dispersible cellulose is present in an amount of < 15 wt%, the percentage based on the weight of the active ingredient. The remaining 9 claims are dependant claims.

The patent specification explains in the following manner, the problem sought to be solved by the present invention lay in providing a “composition or manufacturing method, which would be generally applicable to all kinds of active ingredients having a solubility in water of less than 10%, in order to obtain fast-disintegrating and fast dissolving compositions, containing a high amount of the active ingredient, while using conventional production equipment”.

The patent specification also explains that the prior art in the field has always contained a lower percentage of active ingredient than the claimed invention which has managed to maintain a higher percentage of active ingredient with the same rate of dissolution thereby not only increasing the bioavailability of the drug but also vastly improving the efficiency of the entire manufacturing process.

C. The defence put up by Micro-Labs in the Delhi law-suit
Since Micro-Labs had already received legal notices from Astellas regarding the alleged infringement, they had filed caveats in all relevant courts and were present in the Delhi High Court on the day Astellas suit came up for the first hearing. Micro-Labs has claimed the following defences in the infringement suit:

(a) Indian patent no. 234753 is anticipated by US Patent No: 5,455,049;
(b) Indian patent no. 234753 lacks inventive step in light of US Patent Nos: 3,539,365; 4,231,802 & 4,199,368 and WO 93/12768;
(c) Indian patent no. 234753 does not sufficiently and fairly describe the invention and the method by which it is to be performed;
(d) Indian patent no. 234753 was obtained on a false suggestion or representation.
(e) That the subject matter of the impugned patent is not patentable under Section 3(d) because it is a combination of known ingredients;
(f) That the claimed composition is not patentable within the meaning of Section 3(e);
(g) That the subject matter of the impugned patent lacks utility;
(h) That the Delhi High Court lacks jurisdiction to hear the matter because the principal office of Micro-Labs is located in Bangalore and not within the jurisdiction of the Delhi High Court.

Conclusion: Most of the above allegations and counter-allegations by both parties can be decided only at the stage of trial. The only issue which can be decided without leading any evidence is the jurisdiction question. If Micro-Labs does file an application under Order 7 Rule 11 of the CPC it is possible that the Delhi High Court will reject the entire plaint for want of jurisdiction. The reason for this being that Astellas has claimed jurisdiction by virtue of Section 20 of the CPC stating that Micro-Labs is residing and carrying out business within the jurisdiction of the Delhi High Court. It must however be noted that Micro-Labs has only a branch office in Delhi, while its registered office is in Bangalore. The ‘explanation’ to Section 20 of the CPC allows for corporations to be sued only at the location of their registered office and not at the location of their branch offices unless the cause of action arises in the location of the branch office. In the present case, Micro-Labs only has a branch office in Delhi, with the registered office located in Bangalore. It is not even the contention of the Plaintiff that Micro-Labs is marketing the impugned product in Delhi and hence there is simply no cause of action in Delhi. If there is no cause of action in Delhi, the suit will necessarily have to be dismissed even before the trial begins.

Novartis Glivec Patent Case: Preliminary Objection

After Justice Bhandari's recusal, the Novartis (Glivec) Patent case came up before a reconstituted bench today comprising of Justice Aftab Alam and Justice Ranjana P Desai. Novartis is appealing to the Supreme Court against an order of the IPAB which rejected its patent application covering Glivec (imatinib mesylate).

Counsels for the respondents, Aryama Sundaram (acting for Natco, to the best of my knowledge) and Abhishek Manu Singh (acting for Ranbaxy and Cipla) forcefully contended that the Supreme Court ought not to be entertaining the matter, since the petitioner (Novartis) should have first approached the High Court.

It bears noting that there is no statutory appeal from the IPAB to the High Court--and this would have to be by way of a writ petition. I am not entirely sure of the law on the point and will look to guidance from our readers who are litigating lawyers. For those interested in an overview of the key legal issues in this case, please see here.

The bench held that this preliminary issue (whether the court ought to entertain the matter) will be taken up on the 17th of October. If this preliminary issue is decided in favour of Novartis, the Supreme Court will begin hearing the case on merits. If not, Novartis would have to take the matter to one of the High Courts. The saga continues....

Guest Post: Delhi HC issues yet another John Doe order to protect Speedy Singhs

Tania Sarcar our now regular guest blogger has sent us another post on a 'John Doe' order passed by the Delhi High Court to protect the Bollywood movie Speedy Singhs.

Delhi HC issues yet another John Doe order to protect Speedy Singhs

By, Tania Sarcar

Yet another John Doe order has been passed by the Delhi High Court, this time for the movie Speedy Singhs, starring Akshay Kumar. The producers of the movie moved the High Court for an injunction in order to pre-empt any copyright infringement.

The film's producers have moved the HC against a few cable operators and against unknown defendants for a temporary and permanent injunction for any copyright infringement; hence the John Doe order.

The producers of the movie were represented before the Delhi HC by Naik & Naik convinced the Court to pass a ‘John Doe’ order passed against all the prospective defendants which includes unknown persons, “restraining them from in any way displaying, releasing, showing, uploading, downloading, exhibiting, playing, defraying the movie Speedy Singhs, without a proper licence from its producers. The order also restrains those who may wish to release or distribute the film without permission through CD, DVD, Blu-ray, VCD, Cable TV, DTH, internet, MMS, tapes, conditional access system or other media. The order is valid till December 19, 2011.”

'John Doe Order', as discussed earlier, is used to describe an injunction sought against a person whose identity is not known at the time of the issuance of the order. It thus enables an IP owner to serve the notice and take action at the same time against anyone who is found to be infringing the copyright of the movie. The order does not specify any one defendant in particular. It is meant for anyone who is likely to infringe the copyrights of a product. The name 'John Doe' is used as a placeholder in a legal action or case for any person whose true identity is unknown. This type of an order is quite rare in Indian courts and are mostly seen in the American and Canadian legal practice. However, recently the Delhi HC passed two other John Doe orders- in July 2011; the movie Singham and in August 2011, for the movie Bodyguard.

Thus, John Doe orders are becoming quite common in the film industry and seem an effective way to curb piracy. It however poses some difficulty for ISPs restricting them from file sharing.

Tracking the litigation around Bayer’s Nexavar patent in India

For the last year or so, Bayer has been defending its Indian Patent No. 215758 for ‘sorafenib’, which is marketed under the brand name Nexavar and is targeted at patients suffering from liver and kidney cancers. (Image from here)

As we had reported in April last year, Bayer had sued Cipla for patent infringement, while Cipla counter-sued for revocation of the patent on grounds of invalidity and suppression of vital Section 8 information.

Earlier this year, Bayer sued NATCO before the Delhi High Court (CS (OS) No. 1090 of 2011) for infringing the same Nexavar patent. I’m not sure whether NATCO is counter-suing for invalidity. NATCO subsequently filed an application for compulsory licencing of the Nexavar patent before the Patent Office and this maybe an indication of the fact that NATCO is convinced of Nexavar’s validity. Rajiv had covered this compulsory licensing application in a post available over here.

The litigation over the Nexavar patent provides an interesting case-study of the duplication and contradictions in the Indian patent litigation system. When Bayer sued Cipla last year, Justice Bhat had managed to convince both parties to drop the proceedings over the interim injunction application and instead accelerate the matter directly to trial. As a part of the speed-tracking, Justice Bhat had appointed two scientific experts under S. 115 of the Patents Act, 1970 to assist the Court in determining the questions of patent validity and patent infringement. As we had reported earlier, Justice Bhat had also framed the issues that were required to be examined by the scientific advisors and as of today the scientific advisors have submitted their reports to the Court which is now presided over by Justice Gita Mittal.

The Bayer-NATCO litigation however has gone on an entirely different track. From the orders available on the website it appears that the Delhi High Court is hearing arguments on the interim injunction application filed by Bayer. Now, two issues arise with respect to this new development:

(i) Why is the litigation over the Nexavar patent being handled by two different judges within the same Court i.e. the Bayer-Cipla matter is being heard by Justice Gita Mittal, while the Bayer-Natco litigation is being heard by Justice Manmohan Singh? Given the inherent complexity of these patent matters, isn’t judicial efficiency better served by both matters being heard by a single judge?

(ii) Why is Bayer even pressing for an interim injunction against NATCO when it is not doing the same with Cipla? Even if the court does grant an interim injunction against NATCO, Bayer will still have to contend with the fact that Cipla will continue to sell in the market. So all that Bayer is actually doing is ensuring that Cipla maintains its market share and profits. How does that make any commercial sense? Am I missing something?

Apart from the litigation in the court, there have also been some interesting developments outside the Court room. Bayer’s counsels Dr. Sanjay Kumar and Arpita Sawhney had made the news last year for leaving Remfry & Sagar taking with them Bayer. They had then joined Lakshmi Kumaran & Sridharan (LKS), a leading IP law firm based out of Delhi and Chennai. Subsequent to their migration, LKS had filed a power of attorney claiming to represent Bayer in the litigation against Cipla. However as Legally India and one of our Anonymous friends’ have reported, Dr. Kumar has left LKS and setup his own shop – Perfexio Legal. It is thus likely that LKS is out of the Bayer litigation for now.

In my opinion, the need of the hour is for greater consolidation amongst various law firms since there are very few law firms in India which actually have the capacity and resources to tackle high-profile patent litigation. The market situation is ripe for best-friend partnerships with foreign law-firms, especially the British law firms, who have the expertise and resources to handle cutting edge patent litigation.

IPAB on a roll - Creates a new logo and slogan!

I'm glad to report that the IPAB appears to have been given a new lease of life by its new Chairperson Justice Prabha Sridevan (retd.). As we had reported earlier, Justice Sridevan is a retired judge of the Madras High Court and was a part of the bench which delivered the historic judgment dismissing Novartis's constitutional challenge against Section 3(d) of the Patents Act, 1970.

The IPAB has been announcing a number of changes to its procedures and rules, in a manner which streamlines and makes more efficient the litigation before the IPAB. Most interestingly, the IPAB has also announced a new new logo and slogan (accompanying image). I extract the following announcement, dated 15th September, 2011 from the IPAB's website explaining the logo and the slogan:

The Intellectual Property Appellate Board has great pleasure in releasing the new Logo and the Slogan. The logo and the slogan express the aim and endeavour of the Board to make it a model Tribunal. The upward slope of the ‘A’ connotes the aim to attain excellence. The national colours have been chosen to show that our adjudication will be rooted in the Constitution and the small balance in the ‘A’ indicates that IPAB will perform its role of balancing the individual interest with the social/public interest. The motto reads as “balancing ip - protection”.

This is a small but a wonderfully symbolic initiative on the part of the IPAB to assure the IP community that it has every intention of shaking off its past lethargy. One only hopes that the Government supports the IPAB in delivering justice because as we all know the IPAB is working with the bare minimum resources.

One of the items on my wishlist is that the IPAB revamp its website to function more like the Gujarat High Court website, which is one of the most superbly efficient website and please don't try to link this to Modi, he has no control over the High Court. As of now it is almost impossible for those of us on the blog to even get the case number of existing petitions before the IPAB.

Creative Commons Licensing Success Stories: Pratham Books

While we have in the past spoken about the dangers of an aggressive and severely restrictive copyright regime, we haven’t focussed enough attention on the use of alternative licensing mechanisms and the social benefit that accrues from such a practice. 

For that reason, I will cover in this post, the efforts of Pratham Books, a non-profit children’s book publishing house and their persistent campaigns for openness and unrestricted access to content suitable for children’s books, by advocating the use of Creative Commons licenses, to achieve the twin objective of creating more reading content for children, and at the same time, ensure that it reaches the desired demographic with maximum penetration. 

Use of Creative Commons Licenses 

For those unfamiliar with the way Creative Commons (CC) licenses work, the experiences of Pratham Books might serve as a useful guide to choosing the perfect license, based on your specific requirements. It is seen that Pratham Books began with a CC Attribution¬-Non commercial¬-Share Alike 2.5 India license but has, over the years, moved towards the more open CC BY and CC BY-SA licenses. While the former license prevents the content from being used for commercial purposes, the CC BY and CC BY-SA have no such restrictions. 

But how does the use of such licenses fit in with their overall objective, one may ask. Given their elementary motivations and simple objectives (ensuring that works published by them are open to the public to distribute, translate and reuse) the CC licenses seem like the perfect choice. While the Attribution license is their preferred default license, the Attribution-Share Alike license guarantees that those who build upon earlier CC licensed works, will have to distribute the resulting work under a similar license, creating a thriving ecosystem of openly accessible derivative works. This is similar to the way the GNU General Public License, written by Richard Stallman, operates, wherein derived works must be distributed under similar copyleft license terms. 

What emerges is simply this – the traditional copyright system just does not fit well with the philosophy nursed by the folks at Pratham books. The publishing industry is famously aggressive for its lobbying against progressive copyright reforms (see our posts on the proposed amendment to S.2(m) of the Copyright Act) and strict enforcement strategies. It comes as no surprise then, that Pratham Books should choose to utilise a licensing model that rests on the doctrine of openness and collaboration. 

Success Story at Pratham Books 

Unsurprisingly, the use of the Creative Commons licenses has allowed Pratham Books to realise most of its objectives. What they are perhaps most proud about though, is the growing community of participants who are willing to collaborate and embrace the philosophy of openness, severely undermining the hitherto unchallenged belief that the traditional copyright model that involves frequent negotiations (mostly on insignificant details) and high transaction costs, is the appropriate way to license content in the publishing industry. 

Given that they have been able to license content to multiple organisations and individuals, their success remains unmatched. The evolution of an entirely different licensing and publishing model is genuinely heartwarming given the underlying purpose of the entire exercise – to place a book in the hands of every child. In fact, they seem to have gone one step further with derivative works being produced in the nature of iPad and iPhone applications, new books with colorful illustrations and books specifically designed for the print impaired. 

There used to be a time when the wisdom in using an open license such as a CC license, was routinely questioned. But if the above results are any indication, their use must certainly be considered a viable alternative in the publishing industry.

SpicyIP Events: IIPRD hosts patent symposiums in Mumbai/Hyderabad in Oct ’11

SpicyIP is informed that the Institute of Intellectual Property Research and Development (IIPRD) will be hosting two symposiums on Advanced Patent Issues in Mumbai and Hyderabad in October 2011. Details of the events are as below. You can also see them in the SpicyIP calendar.

IIPRD (Institute of Intellectual Property Research & Development), a premier IP Consulting Firm in India, is pleased to announce its two Annual Symposiums on Pharma/Biotech and Software/Electronics Patent issues respectively.

SYMPOSIUM 1: One Day International Symposium on Advanced Patent Issues Related To Software, Electronics, Telecommunication Business Methods & Network Computing With Focus on US, EP, and Indian Scenario.

IIPRD is organizing this Symposium in association with US, UK and Indian IP Law Firms, namely Birch Stewart Kolasch & Birch LLP, USA (BSKB), Carpmaels & Ransford, UK, and Khurana & Khurana, Advocates and IP Attorneys (K&K), India. The speakers are a unique gathering of three Patent Attorneys from US, EP and Indian IP Law firms and Head IP&S, Phillips, India.

This One-day International Symposium will be held at two locations in:
Mumbai on 11th Oct ’2011 at Hilton Hotel, and
Hyderabad on 12th Oct’ 2011 at Hotel Taj Banjara

The Symposium is an excellent networking opportunity and promises to be a presentation of all important Patent Issues relating to Prosecution and Enforcement Strategies, Identification of potential inventions, Types of claims allowed in each geography, and their relevance to the broadness of claims, Preparation of set of claims, including an experience sharing session on Drafting of Patent Applications, and Patent Prosecution.

The Symposium will start at 9:00 AM and continue till 5:30 PM. The Registration Fee is Rs. 7, 721/- per delegate and includes high tea and buffet Luncheon (at Mumbai & Hyderabad) and Cocktail and Dinner (at Hyderabad only).

SYMPOSIUM 2: Two Day International Symposium on Strategies for Managing Pharmaceutical, Biotechnology & Chemical Patent Portfolios with focus on US Patent Scenario

This two day international symposium will be held at Hotel Hilton (earlier known as Le Royal Meridian), Mumbai on 10th and 11th Oct 2011.

IIPRD is organizing this in association with US law firm Sughrue Mion PLLC and Khurana & Khurana, IP Attorneys, India. The Symposium is an excellent networking opportunity and promises to be a presentation of all important patent issues such as identification of potential inventions, Biosimilar Legislation, preparation of claim sets, prosecution and examination practices, , ANDA Litigation, and recent case law updates. The speakers are a unique gathering of five US Patent Attorneys from Sughrue Mion, who have extensive years of experience in their professional fields, and will put across to the delegates the real insight of Patent Laws and Practices as prevalent and practiced in United States.

The Registration Fee is Rs. 13,236/- per delegate and includes high tea and buffet luncheon, Cocktail and Dinner.

For the complete brochure and Registration Details of both Symposiums, please see here. Kindly email IIPRD at iiprd@iiprd.com in case of any information.

America Invents Act: an overview

President Obama last Friday signed into law the America Invents Act (“AIA”) at a Virginia school.  The AIA is a serious overhaul of United States patent law in over 60 years.  The recent changes to the US patent law makes it more-in-sync with global patent laws, the changes are intended to bolster innovation and economic development.  There are large number of revisions in the AIA that seek to redress perceived problems with the previous law, reduce administrative and litigation costs, bring patent law more in line with global norms and increase certainty about patent laws.  This post gives a brief overview of the AIA and provides certain implications for inventors globally.    

Notable changes: (1) ownership of inventions to be given to inventors who file their applications first (first inventor to file) rather than those who conceive of their inventions first (changes to section 102 and 103);  (2) infringers of technology for which others later obtain patents may continue to use the technology under significantly more liberal conditions (section 273); (3) Failure to take professional advise may not be used to prove intent or induce or willfulness (section 298); accused infringers better protected from charges of willful infringement when they do not seek advice from counsel; (4) third parties empowered to challenge patents or applications under many conditions (sections 257, 301, 321-329).  (5) There cannot be any more qui tam actions (Section 292) as only the US can sue under section 292; this would put an end to a large number of false marketing cases brought by individuals; (6) There is an increase the fees (15%)across the board-result increased cost of patenting.  

Critics argue that some of the changes, particularly the first to file provision, disadvantage small businesses and/or individual inventors with fewer resources. It is argued that small inventors have a major role in spurring innovation.  With the passage of the AIA, such arguments have been discounted.  A large number of ambiguities remain and only time will tell whether or not they are well founded.  It is most likely that removal of these ambiguities would be left to the courts.

Implications for inventors:  (1) Most practitioners would agree with me that the AIA would result in a comparatively larger number of provisional applications being filed.  The reason is that an inventor needs to show that she was the first to file: and that can be shown by filing a provisional; (2) I should add here that the provisional application should disclose to a person skilled in the art the invention, i.e. the non-provisional application should not contain new material but should be based on the material in the provisional; (3) I expect that the US examination would be more stringent comparatively as examiners are likely to look for support in the provisional application, if any.  This (looking for support in the provisional) would be in conformity to the practice at the European, Chinese and Korean patent offices.

Natco's Compulsory Licence: Professional Negligence?

I've been thoroughly perplexed over the last few days. Why on earth did Natco apply for a compulsory license? Particularly when the process is susceptible to considerable delays and it could be a while before they get a clear signal to go ahead and make generic copies of Bayer's patented Nexavar.

And even when the permission does finally come through, they have to part with some of the moolah in the form of royalties to Bayer. Wouldn't it have been far simpler for them to knock out the patent directly and not pay any royalties at all? But well, you may exclaim: Nexavar is covered by a strong patent, not easily amenable to a validity attack!

So what, I retort? Whoever asked you to challenge the patent on merits? Thanks to some fine jurists at the IPAB, Indian law now permits you to revoke any patented drug on the ground that the price is too high, since such drugs are a potential threats to our public order!

Don't believe me? I suggest you re-examine this IPAB decision that is now in dispute at the Supreme Court.

You and I may disagree with this jurisprudence, but unless it is reversed, it stays as the law of the land. It is for this reason that I argue that Natco's lawyers ought to be held culpable for professional negligence for failing to advocate this far simpler revocation route to their client.

In fact, almost all drug patents held by MNC's could be done to death through this route. Let's make the most of it while it lasts and knock down all these evil pharma patents before some well meaning judge comes along to take the IPAB to task for this flight of legal fancy?

ps: image from here

Patent issues precede UN High level meet on NCDs

For the first time since the General Assembly meet on HIV/AIDs ten years ago, the UN is having a 'high-level' meet to discuss health issues - more specifically the rising public health problem of non-communicable diseases from 19th - 20th September.  Non-Communicable Diseases or NCDs refer to the rising global problem of cancer, cardiovascular diseases, chronic obstructive pulmonary disease, and diabetes. According to the WHO, these account for over 63% of deaths (ie, about 36 million annually) about  in the world today, killing about 9 million people under 60 annually. Earlier, these problems were predominantly in the developed world, however, with rising middle income-d society in the developing world and the increasing consumption of certain types of unhealthy food, NCDs are now also one of the leading causes of death in several developing countries as well. As is mentioned on the WHO site, "The aim is for countries to adopt a concise, action-oriented outcome document that will shape the global agendas for generations to come." 

Given the long term impact of this meeting and the fact that it's a health issue, it goes without saying that IP issues have popped up in right in the center. IP-Watch reports that there has been a set of secret negotiations over the level of influence that IPRs will play in the policy debates - and whether a mention to the Doha Declaration on TRIPS and Public Health should be kept in the draft declaration for ministers at the summit. The Doha declaration emphasizes the right of countries to use TRIPS flexibilities for public health measures. While the context has shifted a bit, the arguments are mostly the same typical ones found in access to medicine debates. NGOs, civil society, etc argue that big pharma companies will cause NCD medicines to be priced too high for poor populations; while the big pharma companies say that there is no real reason to be worried as most of the NCD medicines are already off patent. 

It's quite well known that Big Pharma, and their representatives US and EU, are not in favour of flexibility measures such as compulsory licensing, and have taken steps to show countries their displeasure with bringing up this option. So it's quite expected that they would try to bifurcate these flexibilities from the new declaration on NCDs. The bloc of developing countries, being the most affected by these diseases + drug prices, will naturally want to ensure as many options as possible are present for reducing costs of drugs for their populations. 

Given that this meet will greatly influence the future course of policy for dealing with NCD treatment and prevention, the outcome of the meet is eagerly awaited.  

More detailed analysis here on IP-Watch. 

Issuing interim orders under S. 31 of Copyright Act

The Delhi HC, in its recent judgment in Music Broadcast Pvt Ltd vs Super Cassette Industries Ltd, held that the Copyright Board could issue interim orders under S.31 even in the absence of an express empowering statutory provision. Barring certain lacunae, I must note that it is a fairly reasoned judgment.

Summary of judgment

Considering common law cases dating back to 17^th century, the judgment rightly noted that the power to grant interim orders was firmly grounded in common law. Further, as observed in Polini -vs- Gray ((1879) L.R. 12 Ch. D. 438), refusal or failure to grant interlocutory relief could preclude a “successful party from reaping the fruits of litigation”.

The Court perused the Supreme Court judgment in ManoharLal Chopra v. Seth Hiralal, AIR 1962 SC 527 which held that the courts had the inherent jurisdiction to issue temporary injunction in circumstances which were not covered by the provisions of Order XXXIX CPC. Futher, in Sakiri Vasu v. State of Uttar Pradesh, (2008) 2 SCC 409, the Supreme Court held that “….when any power is expressly granted by the statute, there is impliedly included in the grant, even without special mention, every power and every control the denial of which would render the grant itself ineffective."  In other words, the grant of power included ancillary or incidental powers which were inevitable for the effective delivery of justice.

If the Copyright Board could not issue interim orders under S.31, it might compel a licensee to succumb to the demands of the copyright owner especially when there was a delay.  This would negate the purpose of the enactment. For instance, consider a situation where ‘A’ was granted licence by ‘B’ for an unreasonable fee.  If ‘A’ had approached Copyright Board alleging exorbitant fees, ‘B’ might have cancelled the contract resulting in irreparable loss for ‘A’. Evidently, this possibility would always compel a licensee to succumb to the unreasonable demands of copyright owner - negating the very purpose of the enactment.

In the light of aforesaid case laws and reasoning, it was held that the Copyright Board could issue interim orders under S. 31 of the Act provided all the three factors viz., prima facie case, balance of convenience and irreparable injury were satisfied.

Lacunae in reasoning

Firstly, the judgment did not make any attempt to discern the intention of the statute. It could have done it while negating the argument of petitioner viz., interim order could not be granted unless expressly provided in the statute. Unfortunately, the argument was negated only with the help of aforesaid case laws. In the light of absence of an adverse statutory intention, one might be inclined to dismiss it as a mere academic exercise.  But this reasoning would have made the judgment stronger. A vibrant judgment, or say a write up / article, blunts criticisms or counter arguments which may be raised against it.

Secondly, the judgment rightly referred to Single Bench decision in Music Choice India Pvt. Ltd. - vs- Phonographic Performance Limited where it was held that “There is nothing in the Act to prevent the Copyright Board from passing any interim order of determination of reasonable fee by way of royalty or compensation payable by the Plaintiff, if an application in that behalf is made and a prima facie case is made out.”(para 22). According to the judgment, the aforesaid Single Bench decision was upheld by the Division Bench of Bombay High Court in Music Choice India Pvt. Ltd. -vs- Phonographic Performance Limited. Unfortunately, this is a factually incorrect position since the Division Bench judgment refused to express an opinion on the aforesaid matter  - “Be that as it may, we refrain from expressing any opinion on the issue whether an application for interim relief can be filed and entertained by the Copyright Board.” (para 20).