Monday, March 30, 2009

Ghost Post on IP (Software) Raids: Court Sponsored Extortion?


In a first of its kind for SpicyIP, we bring you a "ghost-post", a term that we use to refer to a post by someone who wishes to remain anonymous.

Interestingly, I met this certain someone ("X") during my years in active IP practice. We had raided a small firm accused of software piracy and X was the defendant's counsel. It was perhaps one of the last software piracy raids that I ever did--as it left a bad taste in my mouth and I figured that aggressive IP enforcement against small traders was often inequitable and really not my cup of tea. Part of the reason was also a heart to heart discussion I had with X during the course of that case. X strongly castigated me for representing a team that used highly extortionist tactics for getting their way against small defendants.

I met X again recently and we resurrected our old discussion on the inequity of IP raids. I asked him to write a piece on this for us, given his vast experience with these sort of cases. And here is what he has penned: very heartfelt, and yet very persuasive.


SOFTWARE RAIDS: COURT SPONSORED EXTORTION ?

Picture this.

You are working in your office one day, when all of a sudden, a group of people arrive unannounced brandishing a court order. The order allows them to walk into your office and conduct an audit of all your office computers to collect evidence of the use of unlicensed software in your office.

This group consists of a court-appointed commissioner, lawyers representing the plaintiff, and technical persons who will carry out the actual software audit.

Knowing that to disobey the order will amount to a contempt of court, you allow the group to carry out the audit.

The audit lasts several hours and continues well into the night. Needless to say, it is physically and emotionally draining on you as your work has come to a stand-still. Everyone around you knows there is some court proceeding going on. You have already lost face with your employees, and possibly even clients who have visited your office during the audit.

As you have several dozen computers purchased over a period of time, and the audit is conducted unannounced, you may not have the time to gather documentation and invoices demonstrating the purchase of licensed software.

While the court order allows you to back up your valuable client and business data, the plaintiff’s lawyers don’t allow you to do so, stating that documents/ data found on machines that contain any unlicensed software may not be backed up.

As everything is happening so fast and your whole world has been turned upside down, you do not have the time, presence of mind or legal representation to argue that (a) the court order does not make any such distinction; (b) such data may have been created on licensed software or (c) that such a backup of DATA does not infringe the copyright of the software company in its PROGRAMS.

All computers found with copies of what the plaintiff’s lawyers are calling unlicensed software are seized and sealed. You do not have the time, presence of mind or legal representation to argue that such copies may be backup copies allowed under the law, or that therefore several, or all of the seized machines are not liable to be seized, or that such copies are actually allowed under the software license.

The plaintiff’s lawyers conveniently do not inform you that the law allows back-up copies to be maintained or what constitutes a back-up copy permissible under law.

Even more importantly, your licensed servers are seized because they are found to contain back-up copies of software, allowed under the law, but deemed infringing by the plaintiff’s lawyers.

At the end of the audit, you are informed that your computers contain copies of unlicensed software to varying degrees. You are made to sign a report prepared by the commissioner, along with sheets that represent the software audit of each computer in your office.

Most of your computers and servers are seized and sealed. You are told that you cannot touch them till the court allows you to. You are not even allowed to separate the hard drives of those machines that contain the alleged unlicensed software, for the purpose of seizure, so as to enable you to continue using the rest of the machine, even though the court order clearly states that only storage media containing the unlicensed software is to be seized.

Again, you do not have the wherewithal to argue that the scope of the order has been exceeded.
The group leave your office in complete disarray, but not before the plaintiff’s lawyers tell you to meet them at their hotel later that night to discuss “settlement”, and vague references to press publicity.

You suddenly realise that you do not have access to any of your data and cannot service your clients.

You promptly rush over to the hotel in an attempt to save your business, reputation and sanity and make this go away at any cost.

The plaintiff’s lawyers play good-cop bad-cop. But they tell you that it is in the best interest of your business and reputation to settle immediately. There are threats about going to the press, about shutting your business down forever of you don’t play ball. They provide you with an exorbitant settlement figure that will effectively bankrupt you.

You beg and plead that you cannot afford the figure, that there are defences and mitigating circumstances, that maybe some software was installed in an unauthorised manner by employees and that you did not know, that you certainly do not need all that software for your business and therefore why must you be forced to purchase it; that you undertake that you will not use that software, and even if you do, in future, you will buy licenses, or that you will make use of open-source free alternatives (that last bit doesn’t go down too well).

You find yourself agreeing to all this even before you have seen the allegations made against you in the lawsuit. You agree to settle even before you know the merits of your case.

Your main concern is how to have your office up and running tomorrow, and save your reputation. You cannot be concerned about legal niceties! You cannot be concerned about defences available to you under the law.

You cannot be concerned about whether you in turn have a right to sue the plaintiff for wrongfully seizing your machines or overreaching the orders of the court.

You cannot be concerned with the fact that the court issuing the order to have you raided, did not have jurisdiction to do so in the first place, and that therefore the order itself is bad in law.

You don’t have the time to be concerned about all these nuances!

Even if these points are brought to your attention by your lawyer, you are keenly aware of the delays that are endemic to the legal system.

You are also keenly aware of the fact that the plaintiff will try and delay the hearing of the matter as much as possible to cripple your business to gain an forceful hand in the settlement negotiation.

The plaintiff also delays entering into a mutually agreeable settlement with you, knowing that you are in an extremely weak bargaining position (considering your office is virtually shut down), and that you won’t have any choice but to meet its exorbitant demands.

To top it off, the plaintiff’s PR agency puts out an article in the leading newspapers stating that your company was raided and found to be running on unlicensed software, thereby ruining your reputation beyond all measure.

Fighting on the merits would invite further unwanted media attention, not to mention a delay in the resumption of your business.

You are genuinely unable to meet the plaintiff’s monetary demands but execute a wholly one-sided settlement agreement anyway as you are left with no choice.

The suit papers arrive a few days later and you finally know what the lawsuit against you was all about.

More importantly, you realize that if the cards weren’t all stacked against you, you may have had a chance to successfully defend yourself.

It is too late, as you now have a court decree against you.

Does this not strike anyone as an extreme method of enforcement ? Does it not strike anyone that the courts are an unwitting tool in this extortion ?

Does it not strike anyone that even if the court had jurisdiction, certain safeguards must be incorporated in order to allow for the backup of data, and other methods so that the business of the defendant is not brought to a standstill.

Must not such orders safeguard against heavy-handed actions of the plaintiff during the execution of the commission, and provide for penalties against the plaintiff for overreaching the scope of such orders ?

Must the court not appoint independent technical experts to conduct such commissions ?

Must not the court provide the commissioner with some amount of discretion in the execution of the commission, for instance, to allow the use of computers after taking an undertaking from that the unlicensed software on such computers will not be used ?

After all, the purpose of executing a commission is to collect evidence, not stop a business. What purpose is served by not allowing a defendant to back up data, or be denied the use of an entire computer, when it is really only the hard disk that matters ?

Does this not strike anyone as an abuse of the law and court process with a view to committing extortion ? Does this not strike anyone as UNFAIR ?

作者 GHOST POSTER

Is it Unconstitutional for the Patent Office to be the Adjudicatory Authority deciding Oppositions & CL proceedings?

In an ideal world the patent office's role should be limited to administrative activities i.e. the examination and grant of patents. We don't live in an ideal world. The Indian Patent Office not only decides on patent applications but has also found itself burdened with the additional functions of deciding both pre-grant & post-grant patent oppositions apart from granting compulsory licences targeted at remedying anti-competitive activities of patentees. The fundamental question that we must ask ourselves at this stage is whether the patent office, operating under the aegis of the Ministry of Commerce, should even be adjudicating such disputes which are of a judicial nature. One of the underlying principles of the Constitution of India is that there must be a separation of powers between the three arms of the State i.e. the Executive, the Legislature and the Judiciary must each operate in their own spheres i.e. the Legislature must legislate and lay down the policy in the form of a law, the Executive must execute this policy keeping with the law and the Judiciary must decide the disputes that arise from any violation of the law. While each arm operates independently they are accountable to each other through a system of checks and balances. Such separation of powers is the cornerstone of most democracies and is one of the principle reasons that a democratic form of government is one of the most stable models for governance. 

Although the Doctrine of Separation of Powers is not as clearly enunciated in the Indian Constitution as it is in the American Constitution, the Supreme Court of India has held in a series of judgments (the epic case of Keshavnanda Bharti included) that the doctrine of separation of powers forms a part of the basic structure of the Indian Constitution which cannot be amended by the Parliament. The most recent judicial exposition of this doctrine was in the case of Madras Bar Association v. Union of India where the Madras High Court in an excellent judgment concluded that the National Company Law Tribunal as also a National Company Law Appellate Tribunal were unconstitutional because they violated the doctrine of separation of powers. The case was appealed to the Supreme Court and arguments were concluded only recently. Please do read Mihir's excellent post on this case on the India Corporate Law blog. The main objection raised in this case was that the Parliament through the impugned legislation was transferring “intrinsic judicial functions” away from the High Courts and to a tribunal lacking the degree of independence that was required of a body discharging a judicial function. The objection was not that the High Court were being outsed from hearing company law matters but the fact that the new tribunal was virtually an extension of the executive especially since the tribunal was lacking in both institutional independence and individual independence. This lack of independence was attributed to the system of appointments as also the qualifications for the appointments which sometimes bore no rational nexus to the post that was sought to be filled. (For e.g. How does a person armed with science degree useful in deciding a company law dispute?)

The question is whether we can extend this logic to the adjudicatory role of the patent office while deciding opposition proceedings as also compulsory licences for anti-competitive activities. The essential distinction that we must draw here is whether these functions can be characterized as an “administrative function” or as a “judicial function”? In his judgment in the case of Shankarlal Aggarwala v. Shankarlal Poddar AIR 1965 SC 507 Justice Ayyangar (of the Ayyangar Report on Patent Law fame) held that “It is perhaps not possible to formulate a definition which would satisfactorily distinguish, in this context, between an administrative and a judicial order. That the power is entrusted to or wielded by a person who functions as a Court is not decisive of the question whether the act or decision is administrative or judicial. But we conceive that an administrative order would be one which is directed to the regulation or supervision of matters as distinguished from an order which decided the rights of parties or confers or refuses to confer rights to property which are the subject of adjudication before the Court. One of the test would be whether a matter which involves the exercise of discretion is left for the decision of the authority, particularly if that authority were a Court and if the discretion has to be exercised on objective, as distinguished from a purely subjective, consideration, it would be a judicial decision. It has sometimes been said that the essence of a judicial proceeding or of a judicial order is that there should be two parties and a lis between them which is the subject of adjudication, as a result of that order or a decision on an issue between a proposal and an opposition.” (para 9)

Both Opposition proceedings and Compulsory Licensing proceedings are essentially adversarial proceedings where the Patent Office is deciding a lis between two parties. In fact as per Sec. 77 of the Patent Act the Controller is empowered to function as a Civil Court and his powers under this section extends to issuing summons, administering an oath, requiring the discovery and production of any document, issuing commissions for the examination of witnesses or documents, and even awarding costs. In opposition proceedings the Patent Office hears arguments from two opposite parties and decides as to whether or not a patent should be granted or whether a granted patent should be revoked. In a compulsory licensing proceeding the Patent Office decides whether or not the patentee is fulfilling the reasonable requirements of the public. This power extends to deciding whether or not the patentee is selling the product at a 'reasonable price'. Clearly these proceedings are deciding the rights of the citizens. There can be no dispute over the fact that both these proceedings are “intrinsic judicial functions”. 

Both of these proceedings are conducted under the direct supervision of the Controller. Under Section 25 the Opposition Board is constituted by the Controller. Under Chapter XVI all CL applications are made to the Controller. And who is the Controller? Usually a patent specialist from within the ranks was appointed as the Controller but for the first time the Government of India has appointed a career IAS officer as the Controller of Patents. In effect we have the Government of India deciding the rights of its citizens. To what level of executive interference are these proceedings open to? Can the Government of India influence an opposition proceeding as also the grant of a Compulsory Licence? Under the present structure, the Executive arm of the Government can definitely influence these proceedings because it is their representative who is heading the patent office. The essential question over here is not whether such interference is taking place but whether there is even the theoretical possibility for such interference to take place.

Coming to the qualifications of the officials of the Patent Office I'm not quite sure where exactly to research this aspect because the Act lays down absolutely no statutory requirements in this regards. This is a matter that I'll deal with in a later post. Please do write in with any information that you may have in this regards.

 For now let it suffice to say that the adjudicatory function of the Patent Office is patently unconstitutional because of the lack of insitutional and individual independence of the entire statutory mechanism prescribed under the Patents Act. The question is whether the IP Bar is ready to tackle this problem in the same manner that the Madras Bar Association dealt with the National Company Law Tribunal?


Copyright in Chess: IP going a bit too far?

Duncan Bucknell (IP ThinkTank)’s Global Week in Review recently highlighted this post on the IP Factor blog which raises some rather entertaining questions pertaining to copyrights. Apparently, the Bulgarian Chess Federation banned ChessBase, among the world’s best chess websites, from broadcasting a game live, citing copyright infringement...


Essentially, as games from top tournaments are played, several websites broadcast the moves – either on an online chessboard, or in written form (for instance, 1. e4 e5. 2. Nf3 Nc6 – the “algebraic” notation widely used for noting chess games). The Bulgarian Chess Federation sought to stop other websites from broadcasting moves live. This raises several issues:


  • Are the moves of a chess game the subject-matter of copyright?
  • In case they are, who does this copyright belong to? The players of the game or the organizers?
  • Would “live” broadcasts of chess games impair any intellectual property of the organizers?
  • Often, professional chess players prepare “novelties” (moves not played before) in their home preparation. Do they have copyright over the “novelties”? For instance, in chess openings analysed deeply, players will know the “theory” several moves deep. They will deviate from “theory” with a deeply-prepared “novelty” – can they claim copyright over their novelty?
  • If they do have copyright over the moves, would the use of those novelties in other games by other players be fair use?


The reputed chess historian, Edward Winter, has written this piece on the history of copyright in chess. The Toronto Star carried a report on the specific controversy here, and another report is available and here. All in all, this seems at first glance to be an instance of intellectual property taken way too far… What do our readers think?


Foreign Intellectual Property: Narrowing the effect of Tyburn's case

A previous post discussed the issue of whether (as a matter of private international law) a domestic Court could hear matters connected to the protection of foreign intellectual property rights. A recent decision of Mann J. in the High Court (Chancery Division) – Lucasfilm v. Ainsworth, [2009] F.S.R. 2 – appears to have held that it can.


I had mentioned that the decision in Tyburn’s case held that domestic Courts do not have jurisdiction over claims related to foreign intellectual property. Tyburn was based on the extension of the so-called “Mocambique” principle of private international law, which states that domestic Courts have no jurisdiction over suits pertaining to foreign land. The previous post described Tyburn in the following words:


A case which highlights the problems posed in this area is Tyburn Productions v. Conan Doyle [1991] Ch 75. The plaintiff was a British company which wished to distribute a Sherlock Holmes movie in the United States. The defendant was the only surviving child of Sir Arthur Conan Doyle. The plaintiff was concerned that the defendant would make allegations that he was the sole copyright-holder in relation to Sherlock Holmes. Therefore, a declaration was sought from the British Courts that the defendant had no such copyright. It was held that the British Courts had no jurisdiction in the matter, as questions relating to the validity of intellectual property rights were local actions which could only be adjudicated in the place in respect of which the relief was sought.


In Lucasfilm, the Court distinguished Tyburn on the ground that there was a distinction between actions going to the validity of a foreign right and actions which assume validity and are merely for appropriate relief. The rule in Tyburn was confined to the former category. The following principles were said to emerge from the cases after Tyburn:


  • There is a tendency to move away from a strict and absolute application of the Moçambique rule to all intellectual property cases, and in particular copyright cases.
  • There is a distinction between title and validity on the one hand and trespass/infringement on the other, which would justify the conclusion that infringement of foreign copyright should be justiciable in domestic Courts.
  • The private international law rule (if any) which underpins the extent to which a domestic Court should not embark on a consideration of aspects of intellectual property rights is a policy rule which depends on the specific facts of each case, and is not a rule which takes away jurisdiction as such.


The Court therefore concluded:


I am therefore prepared to conclude that an English court can, and in an appropriate case should, determine at least questions of infringement of foreign copyright cases. Those cases will include cases where subsistence is not in issue. I would not, however, hold that questions of subsistence can never be decided here. In land cases incidental questions of title can apparently now be considered. I can see no reason why the same should not apply to copyright.


It would therefore seem that the rule of Tyburn is confined to its specific facts and is not being extended to other areas.

Wednesday, March 25, 2009

PHARMA LOBBY WANTS A PROBE INTO DELAYED ORDERS

Mint recently reported that the Indian Pharmaceutical Alliance (IPA) sent a letter [on 17 March 2009] to P.H. Kurian [Controller General of Patents, Designs and Trademarks], T.C. James [Director, Department of Industrial Policies and Promotion] and the Union Government Body that oversees the country’s patent enforcement regulations, asking for a probe be conducted to examine the delay in deciding patent opposition cases.


The alliance, which represents India’s top pharmaceutical companies, including Ranbaxy Laboratories Ltd, Dr Reddys Laboratories Ltd and Sun Pharmaceutical Industries Ltd., alleges corruption on behalf of the patent officials and claims that [pre–grant] patent opposition proceedings and the related law is being misused by department officials and that the guilty officials should be penalized.


It is interesting to note the in the article the author states that the delay in pre-grant opposition proceedings, heard by the Patent Office officials, benefits the opposing party as they can either keep the genuine patent applicants from commercializing their products or they can sell their own generic versions till a final decision is made. On the contrary, a delay in deciding on a post-grant opposition case results in a patent holder enjoying a continued monopoly in the market even if its patent rights are under question. Since the opposing party cannot exploit the market in the latter case, the pre-grant opposition proceedings are more lucrative from a commercial standpoint. Thus, as alleged, eyeing this benefit, several companies are taking undue advantage of the pre-grant opposition proceedings. If this were the logic behind companies causing and supporting delay in pre-grant opposition cases then IPA’s demand for a probe into the delay is quite interesting and surprising, since they themselves are opposing parties in several proceedings before the Patent Offices.


The letter closely follows the dicta of P. H. Kurian, who after taking charge in January, had issued an internal circular urging the heads of the four regional patent offices in Kolkata, New Delhi, Mumbai and Chennai to issue final orders by 31 March in some 600 patent and trademark opposition cases. Some of these cases have been pending for three years.


As per the report, Kurian and James could not be reached for comment.


It is pertinent to note that apart from the above-mentioned demand for a probe examining the delay, earlier this month, the IPA had asked the Union government to re-examine 86 drug patents granted between 2006 and 2008, the first three years of India’s new product patent regime for the drugs and agriculture sector. The body said 67 of these 86 patents were in violation of section 3(D) of the 2005 amended Indian patent law, and the remaining 19 were against section 3(E) of the new law.


Section 3(D) of the Indian patent law doesn’t permit patent grants for mere modifications of known drugs unless they can claim a significant enhancement of therapeutic efficacy compared with the previously known base product. And as per section 3(E), mere combinations of two or more known drugs don’t qualify for patent rights in India.


One has to wait and watch as to where this leads.


Tuesday, March 24, 2009

The Ramkumar Dual SIM Patent Case: A Declaratory Suit?

Pursuant to our last post on this theme, SpicyIP just heard that Micromax, a dual SIM cell phone importer filed a declaratory suit for non infringement before a court in Gurgaon (very close to New Delhi and part of the NCR region). This suit asks the court to declare that Micromax's imports of dual SIM phones do not infringe Ramkumar's patent, since they are outside the scope of the claims in his patent. Do any of our readers have more news on this?

I believe the court has not passed a final order here yet, but restrained Ramkumar from preventing the export or import of dual SIM phones by Micromax. This may perhaps explain why Ramkumar desisted from impleading Micromax as a party in the suit before the Madras High Court. I'm also guessing that once the defendants' appear in the Madras High Court in response to the ex parte order, they will likely challenge of the validity of Ramkumar's patent.

The Growing Promiscuity of Indian Courts in Granting "Ex Parte" Injunctions

In several earlier posts, I lamented the fact that some Indian courts are beginning to demonstrate a rather promiscuous propensity to grant "ex-parte" restraining orders (i.e. orders without even hearing the other side) at the drop of a hat in highly technical patent cases.

The latest example is the case of Ramkumar, an overzealous patentee who's claimed much more than what he legitimately invented and squeezed illegitimate royalties out of many dual sim phone importers in the process. Our earlier post focussed on a writ petition filed by Samsung claiming that the customs rules sought to be invoked by Ramkumar are constitutionally flawed, as they vest Indian customs authorities with the discretion to label even legitimate imports as "prohibited goods" without even hearing the importer. This writ petition was heard last Tuesday (March 17th), and was withdrawn by Samsung with the liberty to refile, since Samsung's goods were allegedly seized by the Delhi customs authorities as well and Samsung wished to add this key jurisdictional component to the writ. As far as my understanding goes, the writ has not been refiled as yet.

Today, the Economic Times reports that Ramkumar obtained an ex parte restraining order against several defendants that allegedly manufacture and sell dual SIM phones in India. It states:

"The Madras High Court on Monday restrained mobile phone manufacturers Samsung, Mirc Electronics and Spice Mobile and several retailers from manufacturing and selling multiple SIM holding mobile phones.

"On a petition filed by our client Somasundaram Ramkumar, Justice Jaypaul has issued an injunction whereby Samsung Electronics, Mirc Electronics and Spice Mobile were restrained from manufacturing multiple SIM holding mobile phones," D Ferdinand, Ramkumar's lawyer and a partner at legal firm BFS Legal, said.

Several retailers, including online retailers Ebay India and Rediff.com and importers were also restrained from selling such phones, he added.

Earlier, Ramkumar had accused the companies and retailers of infringing his patent for multiple SIM mobile phones.

The case will be taken for hearing April 13."

Brevity is no doubt the soul of wit. But the judge in this case (Hon Justice Jeyapaul) takes this a bit too far when he deems it fit to dispense with the matter by merely stating that:

"Heard the submissions made by the learned counsel appearing for the applicant....

The applicant has produced Patent Certificate granted on 11.2.2008 for the invention of Mobile Phones with plurality of Sim Cards allocated to different communication networks:

...Therefore, there shall be an order against respondents 1, 4, 6, 7, 8, 10 and 11 that they shall not engage in manufacturing dual or plural sim card phone India till 13.4.2009."

(please note that these are reproductions of the key parts of the order, a certified copy of which is still not available).

Given that this was an ex parte restraining order against several defendants, shouldn't his Lordship have given us some inkling of how his brain worked in assessing the scope of the patentee's claim and the fact that the defendants products' necessarily fell within such claims? And more importantly, as to how he assessed the case, keeping in mind the 3 factor test for grant of injunctions: prima facie case, balance of convenience and irreparable injury. Or did his Lordship assume that like him, all of us are blessed with an innate "patent" sense and sensibility. Or perhaps, this is but a manifestation of Justice Stewart's "I know it when I see it" approach...

In a previous post, I had highlighted the fact that Ramkumar's patent scope is rather narrow:

"In fact, in the case at hand, it would appear that the patent does not cover all "Dual SIM phones" (as Dual SIM technology itself has been around and is part of the prior art), but only those Dual SIM phones that also provide for more than one headphone/earphone jack, so that two people can be on two calls at the same time via the same handset. However, most of the goods seized by customs (consisting of both Samsung's products and a number of other imports belonging to several Indian importers) appear to be generic Dual SIM phones with just one headphone/earphone jack. In other words, the patentee is attempting to claim rights over technology that is part of the prior art and clearly outside the scope of his patent."

Later in the comment section, I added:

"...the essential element of the patent is the fact that you could have multiple jacks on a Dual Sim phone. And the patentee has been wrongly instigating customs to seize all dual SIM phones and not just ones with multiple jacks. Interestingly the first international search report in relation to Ramkumar's alleged invention states:

"The search has revealed that the concept of a mobile phone having provisions for utilizing at least two SIM cards allocated to different communication networks in order to simultaneously operate said mobile phone in said different communication networks according to the subject of independent claim 1 is NOT NOVEL since a mobile phone providing the same features as claims 1 to 6 of the present application are directed to is at least disclosed in German Offenlegungsschrift DE 199 19 389 A1 (SIEMENS AG) 2 November 2000."

Perhaps after the parties are heard, the judge may come to realise the folly of his "innate" patent sense!

On a broader note, one hopes that our judiciary will refrain from readily assuming that an ex parte philosophy that evolved in the context of trademark counterfeiting and copyright piracy cases could just as easily be transposed to patent cases, where issues of validity and non infringement are often raised.

Religion and IP: The tales of Tirupati, Attukal and Osho

This blog has been the forum for considerable debate surrounding the protection of religious and spiritual symbols, including those related to Yoga, and the Tirupati laddu GI.

The latter, for instance, most recently re-appeared on the scene with the Hindu reporting that "The Tirupati laddu ... may soon get intellectual property rights (IPR) as the managing trust of the temple is seeking geographical exclusivity for the delicacy. The Tirumala Tirupati Devasthanams (TTD), a trust which manages the world’s richest temple — Tirumala Venkateswara Temple — at Tirumala in Andhra Pradesh, has submitted an application before the Geographical Indication Registry seeking the GI tag."

This is probably the first time that a product of spiritual connotation will be acquiring GI status, and has its fair share of critics, who question the necessity of appropriating such symbols, as well as the economic motives behind such moves.

Tirupati laddus may have set some sort of precedent, whether desirable or not is a moot point, but there is another religious symbol that has been added to the list -
the pictorial representation of the deity of Attukal in Kerala.

A short unobtrusive report appeared in the Hindu some days ago, with a dateline from Trivandrum, Kerala, stating that
"The Attukal Bhagawathy Temple here has secured trademark protection for the picture of the deity and its claim to the title ‘Sabarimala of Women.’ Office-bearers of the trust said... that the certificates issued by the trademarks registry under the Union government would help to prevent unauthorised use of the picture and title."

This story was flagged by R Praveen Raj, a regular SpicyIP commentator, who has raised the issue with leading policymakers of the state and the country already, highlighting several points relating to the grant of the mark that warrant attention.


For instance, a fundamental question that emerges is whether the pictoral representation of the deity ought to be regarded as a subject of trademark at all or not. A literal reading of the Act would suggest that there is nothing preventing such an application, although there have been raised questions about
Section 9(2)(b) of the Trade Marks Act 1999, which deals with Absolute grounds for refusal of registration. This section says that a mark shall not be registered as a trade mark if it contains or comprises of any matter likely to hurt the religious susceptibilities of any class or section of the citizens of India. It would be interesting to know how the examiners evaluated the trade mark under this section.

A secondary question relates to the status of the Trust - According to the Indian Trademark Journal (large PDF file), the Attukal Bhagavathy Temple Trust has claimed the mark under Class 42 of the Fourth Schedule of the Trademark Rules 2002 (which deals with Classification of Goods and Services - Name of the Classes), classified as 'Temple Services, Social Services, Welfare Services and Cultural Activities'. In doing so, the Registry appears to have chosen to interpret "Temple services, etc" under S. 2(1)(z) as a "service of any description which is made available to potential users and includes the provision of services in connection with business of any industrial or commercial matters...".
By extension, the question that one is tempted to ask is - can the Trust's operations, referred to here as "Temple Services etc" qualify to be services in connection with business of any industrial or commercial activities?

Yet another issue is of deceptive similarity. The Attukal temple is dedicated to Kannagi, a legendary figure from the Tamil epic the Silappathikaram, and the trademarked picture is a graphic visualisation of Kannagi. Hindu polytheism is not my forte, but I am aware that Kannagi is the resident/guardian deity of the city of Madurai, and that she is also worshipped at the Kodungallur temple , also in Kerala. I am not aware of the representations of these idols/deities, but its is very possible that they bear a resemblance to the trade marked image.


Is there ominous similarity with the GI for Tirupati Laddoos story? Is this going to get mainstreamed in India in the years to come? Open for your thoughts.


The last word ought to go, perhaps, to a decision of the National Arbitration Forum (NAF) in a domain name dispute containing references to the spiritual leader Osho. The complaint was instituted by an organisation that claimed exclusive trademark rights to the name 'Osho', believing the respondent (a spiritual organisation that also followed Osho's precepts) to be violating its rights. The 2000 decision, which is available here, was extremely critical of the complainant, and said:


"To grant Complainant’s request for relief would be to permit virtual monopolization on the Internet by Complainant of any domain name which includes the name of a great spiritual teacher and leader. While making no judgment on the relative merits or validity of the world’s religions or spiritual movements or any leader thereof, this Arbitrator finds that permitting this would be as improper as doing the same with Christianity, Judaism, Islam, Zorastrianism, Hinduism, Buddhism, Taoism, Confucianism, Shintoism or any of the several hundred other of the world’s religions and/or spiritual movements."

Sunday, March 22, 2009

Delhi HC restores PPL's right to sue for copyright infringement

In July last year we had carried a post on a Delhi High Court judgment which held that Copyright Societies had no right to sue on behalf of their members. It just came to our knowledge that this judgment was over-ruled by a Division Bench of the Delhi High Court on 3rd November, 2008. Strangely though this judgment has not been reported either by Manupatra or PTC. The good news however is that the Delhi High Court website has started hosting copies of all its judgments in a PDF format and unlike the bad old days these judgments have absolutely no typographical errors. The judgment of the appellate court in the case of PPL v. Hotel Gold Regency & Ors. (RFA(OS) No. 57 & 58 of 2008) can be accessed over here.

In July the Single Judge had returned a plaint filed by PPL, a copyright society, on the grounds that (i) Only a copyright owner or an exclusive licencee could institute a suit for copyright infringement under the Copyright Act & (ii) A copyright society could only administer the rights of its members and the Copyright Act did not allow for a copyright society to sue on behalf of its members.

In coming to these conclusions the Single Judge has interpreted the Copyright Act to hold that a copyright society can never be an exclusive licensee because of the proviso to Section 33(1) which states that “an owner of copyright shall, in his individual capacity, continue to have the right to grant licenses in respect of his own works consistent with his obligation as a member of the registered copyright society”. Therefore as per the Single Judge since the Copyright Act did not allow for any Copyright Society to be an exclusive licencee there was no question of any Copyright Society instituting a suit for copyright infringment since as per the Act only an exclusive licencee or the owner of the Copyright Act could insitute such a proceeding.

The Division Bench comprising of Justice Kaul & Justice Garg have given the Copyright Act a wonderfully purposive interpretation so as to come to the conclusion that Copyright Societies did indeed have a right to sue on behalf of their member. The judgment starts of by reasoning that one of the reasons the Single Judge had come to the conclusions in question was for the simple reason that neither of the counsels had brought to the attention of the Single Judge the judgment of the Supreme Court in the case of M/s Entertainment Network (India) Ltd. v. M/s Super Cassette Industries Ltd. 2008 (9) SCALE 69, which had been delivered by the SC after the arguments had been concluded before the Single Judge. In the Entertainment Network (India) Ltd. case the Supreme Court held that Section 34 creates a virtual agency so as to enable the society to act on behalf of the owner and this power to act on behalf of the owner extended to being able to sue infringers on behalf of the copyright owner. In addition to borrowing extensively from the Supreme Court the Division Bench also considered the Statement & Objects of the amendment which stated that one object of the amendment is “to deal more effectively with the infringement of Copyright and related rights”. In light of the Supreme Court judgment in the Entertainment Network case and the Statement of Objects and Reasons, the Division Bench held that the Copyright Societies would have a right to sue on behalf of its members and to state the contrary would mean to give a go-bye to the principles of agency under the Indian Contract Act, 1872.

So far the judgment of the Division Bench was spot on. However in my opinon they have not dealt with the primary point in detail i.e. can a copyright society sue even if they are not an exclusive licencee? There is a reason that the Copyright Act vests the right to sue in only the owner and hte exclusive licencee. The reason for not extending this right to mere licencees is that it would vest in multiple parties the right to sue for the same copyright. If the right to sue is extended to even mere licnecees then in that case there would be total chaos because there would be a multiplicity of proceedings. It is therefore important to vest the right to sue in only one person and not more. This in my opinion is the logic behind Section 55 of the Copyright Act. In the case at hand the Single Judge had noted that PPL had admitted that they were not exclusive licencees. The Division Bench however has not touched on this matter and instead dodged it by holding that it could be decided at trial and not at the preliminary stage.    

Friday, March 20, 2009

SpicyIP Tidbit: US Court Rules in Favour of DRL on Prilosec

Last week brought good tidings for DRL which, these days, finds itself regularly in the news. A district court in Southern New York summarily ruled that DRL’s ANDA filing on Omeprazole Mg Over-The-Counter (OTC) version did not infringe Astra Zeneca’s patents on heartburn drug Prilosec.

SpicyIP has dealt with this case in fair detail earlier with a comprehensive discussion of the issues involved by Mr.Chris Ohly. The suit was a typical Hatch-Waxman patent infringement case where Astra claimed that DRL’s omeprazole magnesium having less than 1% crytallinity detectable and manufactured using a different process infringed its US patents 5,900,424 and U.S. Patent No. 5,690,960, both of which cover Prilosec OTC, an over-the-counter version of the original Prilosec product which was earlier available only with a prescription. The Court held otherwise.

Post verdict, DRL said that it would continue with the regulatory approval process and work towards commercialization of the OTC version. Goldman Sachs estimates that DRL is likely to earn $20-35 million in the next financial year from this drug. The Business Standard reported thus:

The OTC brand product clocked sales of over $360 million in the US in 2008. The OTC version of the drug was granted approval by the FDA in 2003, with a three-year marketing exclusivity. Perrigo Pharmaceutical is the only other player to have launched a generic version of OTC Prilosec following its patent litigation settlement with Astra Zeneca in December 2007, according to sources.”

Public Sector IP and Socially Responsible Licensing


Today, we bring you a guest post from Harry Thangaraj, who does some very interesting work around intellectual property and developing economies.

I've had the pleasure of discussing some of these issues with him and find him to be extremely insightful. I'm therefore very happy to introduce him to our readers, who will no doubt benefit significantly from his perspective. Particularly since his work is not limited to just to the theory of IP and Development, but he is one of the few who has tremendous hands on experience with some of these issues.

Listed below is his brief profile:

"Harry Thangaraj is an IP researcher based at St. George's University, London. He is also part of the EU-funded Pharma-Planta Consortium consisting of 39 academic and industrial partners deveoping processes to manufacture recombinant biopharmaceuticals in plants. Harry is responsible for their IP access strategies aimed at delivering specific biopharmaceuticals at affordable cost to resource-poor countries, and establishing freedom to operate in the field. He is a part qualified patent attorney, holds a PhD in the biosciences with several years of experience in tuberculosis research, and is also a graduate of Christian Medical College India where he completed his MBBS."

Public Sector IP and Socially Responsible Licensing
Harry Thangaraj
IP Research Manager
Pharma-Planta Consortium (www.pharma-planta.org)

The public sector including universities and research councils are crucial sources of innovation and national economic development. The Bayh Dole Act in the USA has undoubtedly facilitated and catalytically incentivized the translation of research into essential goods and services, and elsewhere similar legislative instruments and/or university policy and practice modeled along Bayh Dole is likely to have major transformative effects on local economies. While largely beneficial, in some cases this may come at a cost.

Over zealous enforcement of patent rights by commercial entities who are licensees of public sector IP (PSIP) may hamper the availability of essential technologies which have potential to address the health and nutritional needs of impoverished populations who are disproportionately affected by particular diseases and agricultural failures. This may be contrary to the mission of public sector institutions which is to harness the outcomes of research for the benefit of the public. Arguably, “benefit of the public” extends beyond own country borders. There is a perceived moral and humanitarian imperative to deliver technologies at affordable cost to least developed countries (LDC) which are both financially and technologically challenged, and poorer populations within innovative developing countries (IDC).

Putting this in a historical perspective, initiatives amongst universities to put into place policies and practices related to humanitarian access to their PSIP appeared to have begun with the Zerit® controversy [1]. This fuelled a drive for a number of universities, mainly US, to take up the issue of humanitarian access to PSIP and to be seen as pioneering stakeholders in this important matter of public policy. Zerit® a drug that eventually became a critical part of antiretroviral (HIV) combination therapy had its research origin in Yale University, and a US patent was issued in 1990. Bristol-Myers Squibb (BMS), under a sponsored research agreement, had received an exclusive option to a license towards patents that were likely to emerge from the work, and also included the right to file externally. BMS included some developing countries in their filings including South Africa. This led to a highly visible public controversy with the world’s attention drawn to the potential enforcement of patent rights to block any future moves to import or manufacture locally, affordable generic substitutes. Even so, since this case, other pharmaceuticals essential for developing countries have been exclusively licensed out to industry by academic entities without any Socially Responsible Licensing (SRL) provisions in place [2].

It is tricky to balance the financial incentives provided by Bayh Dole type instruments that allow universities to gain from IP protection and licensing, with humanitarian objectives. SRL policy and practice is one way to achieve this. SRL should be distinguished from other initiatives practiced for many years even before the Zerit® case by large agricultural research institutions. Examples include open source innovation, defensive publishing, patent pooling and royalty free licensing, with the intention of making technologies easily accessible to farmers and the farming industry and establishing freedom to operate in the agricultural field. The major challenge for SRL on the other hand is balancing the positive impacts of exclusivity, chiefly the expensive rapid development and regulatory clearance of critical technologies against the negative impacts of IP barriers through such exclusivity.

I notice on this blog that there was concern amongst some about “exclusive” versus “non exclusive” licensing models in relation to India’s future implementation of its own “Bayh Dole Act” namely The Protection and Utilization of Public Funded Intellectual Property Bill, 2008. I believe the issue is not that simple. Most licensing professionals I have spoken to believe that universities (I use the word “universities” interchangeably with all public sector research institutions) rarely have a great deal of negotiating power when it comes to commercializing technologies, with the rare exception of blockbuster products with significant value. Even so, potential value often cannot be predicted in advance because of numerous risk variables involved in bringing an invention to market. Besides there is a compelling case to reach agreement in a deal, rather than let PSIP sit on a shelf gathering dust and thus placed out of reach of consumers. Put simply the buyer is generally at an advantage over the PSIP seller. I am reliably informed that organizations such as MIT place more reliance upon numbers of deals made rather than quantity of revenue in their metrics of success.

Stevens and Effort [1] compellingly argue that, if universities adopt humanitarian-driven SRL into their policy, and therefore are able to demonstrate to commercial entities that there is a top-level requirement to do so, it would be far easier to persuade industry to conclude deals. More important, they argue that SRL provisions need not kill the potential to make a profit when balanced against the humanitarian objective. Let me illustrate this. With the benefit of hindsight, in the Zerit® deal, the issue would – for example – not revolve around “exclusive” versus “non-exclusive” licensing deals. Rather a provision in the license agreement and/or the preceding sponsored research agreement for not patenting in a developing country with a high HIV burden, or not asserting patent rights there might have been negotiated in advance. A number of similar or alternative provisions might involve concepts of market segmentation (geographically limited exclusivity), tiered pricing, mandatory sublicenses to developing countries to meet specific humanitarian objectives, milestone requirements for product availability (at affordable cost) in developing countries and march in rights if these are unmet, or retention of certain rights to make available the technology via additional sublicenses to other parties for humanitarian objectives.

Stevens and Effort [1] have developed and advocate a number of flexible licensing strategies including licensing language and clauses and how to approach definitions – example – how to define a “Developing Country”. This is a crucial issue since countries such as India and China are not unequivocally developing.

There is now a growing list of universities that are adopting SRL policy and best practices. In some cases these are not explicitly labelled as SRL, but the general concepts and objectives are similar. A 2007 White paper [3] organized/facilitated by Stanford University was the first initiative by the US technology transfer community to draw up a list of principles of best practices in PSIP for the public good. 11 universities and the Association of American Medical Colleges were signatories to the paper. It is generally believed that U.C. Berkley was the first to develop policy and best practices in SRL in 2003 [4]. In many cases, universities that have not incorporated SRL considerations into their general policies are forced to do so in a project-specific manner. This is because of donor-driven (example Bill and Melinda Gates Foundation) requirements for access strategies to be developed while carrying out large collaborative research projects in health technologies important to the developing world. One of the many reasons that the research consortium I work for (Pharma-Planta) successfully attracted funding from the EU was the intent to develop and apply an access strategy for pharmaceuticals developed for HIV.

India is at a crucial point in its history with the forthcoming establishment of its own “Bayh Dole” Act. It is critical that the implementation should be in harmony with the social objectives of its own public funded research base. India’s food and health security should be amongst prime considerations. The explanatory part of section 18 of the draft Act defines “interest of security of India” too narrowly. In my opinion there is also a moral imperative to consider the needs of LDCs. In the new and evolving global economic and IP ecosystems it is likely that LDCs will be increasingly looking at IDCs, rather than the developed world, as sources of technology to address food and health security.

The Centre for the Management of IP in Health R&D (MIHR) and the Public Intellectual Property Resource for Agriculture (PIPRA) through a joint initiative sponsored by the Rockefeller Foundation and the Ewing Marion Kauffman Foundation had made available, some time ago, a Handbook of IP Management in Health and Agriculture Innovation. Although available both in print form and online for a while, I am posting this with the intention of further raising awareness of the online version. The book’s intent was to inform policymakers, technology managers, IP practitioners and scientists of comprehensive strategies to efficiently translate, transfer and disseminate technology related to innovative and essential health and agricultural products and processes. And in doing so, humanitarian access, availability and affordability to technologies that benefit poorer populations in developing countries forms the core of these strategies. IMHO it also serves as the most valuable resource on IP management for ANY IP practitioner or policymaker. I had the privilege of working for MIHR in the past, but I cannot better a review written by the Licensing Executive Society, and will simply point you to the web link [5].

The entire Handbook content, roughly 2000 pages, is available for free here. My personal experience suggests that the navigation will take some getting used to, but your patience will be amply rewarded.

References

[1] Using Academic License Agreements to Promote Global Social Responsibility. Stevens A.J and Effort A.E. Journal of the Licensing Executive Society International. June 2008. 85-101.

[2] Panjabi R., Rajkumar R., and Kim J.Y. (2008) Universities Have a Key Role in Global Access to Medicines. The Chronicle of Higher Education. Available online: www.chronicle.com

[3] In the Public Interest: Nine Points to Consider in Licensing University Technology.

[4] Socially Responsible Licensing at U.C. Berkley. An Intellectual Property Management Strategy to Stimulate Research Support & Maximize Societal Impact.

[5] Book Review: Intellectual Property Management In Health And Agriculture
Innovation: A Handbook Of Best Practices.

Thursday, March 19, 2009

Trade in Generics suffer more Seizures

The latest addition to the rather questionable series of seizures by Dutch officials were a consignment of HIV/AIDS medicines by Aurobindo Pharma Ltd meant for use in Nigeria. The purchase, by the Clinton Foundation through a UN Agency, UNITAID, is the 6th incident of an export by an Indian drug firm being seized in transit in Europe for shipments meant for non-European markets. The grounds on which they were allegedly seized are that they contained counterfeit goods. UNITAID protested sharply against this seizure, proclaiming on its website that the seized goods are in fact not counterfeits and neither do they infringe any intellectual property rights, also raising concerns about the patients whom these drugs had been shipped in for.


They are medicines used in second-line treatment of HIV/AIDS manufactured by Indian company Aurobindo. These medicines have been prequalified by the WHO and have received tentative approval by the United States Food and Drug Administration,” it said.

Why exactly have drugs which have been prequalified by the WHO been seized by the Dutch officials for being counterfeit?


This latest seizure, besides raising several eyebrows, is also raising questions as to the trend that seems to be developing. Several consignments from India as well as Brazil have been stopped over the last few months by EU officials on the basis of infringement of iprs or being counterfeit products – despite the fact that these goods were in transit and not for European markets. In a previous post as per Art. 51 of the TRIPS, it has been pointed out that the TRIPS agreement provides for a certain minimum baseline of standards no doubt, but the EU's action in seizing goods not meant for their market is well above that line, as there is a distinction which has been drawn between actions for imported goods and goods in transit.

The Indian government, aside from taking up the issue bilaterally with the EC and the Dutch authorities, recently made an intervention at the WTO Council for TRIPS meeting on the issue of the public health dimension of the TRIPS Agreement in the context of the Dutch seizures. Here, they pointed out that this was not a case of temporary detention, as some consignments have been held for over months, with procedures initiated for their destruction as well. There has been seizure of goods such as losartan which is perfectly IP legitimate generic drug in both India and the destination country Brazil; and the trade of generic drugs is also perfectly legitimate.

Medecins Sans Frontieres (MSF) has also expressed concerns over these developments as they regularly transport and temporarily store medicines in Europe en route to developing countries.

In addition to this, in the intervention, it has also been pointed out that these actions aren't in line with the 'General Obligations' provided for in Part III (and Art. 41.1 and 41.2 specifically) of the TRIPS Agreement.

“Article 41.1 of TRIPS provides that enforcement procedures “shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse” and Article 41.2 provides that the procedures shall be “fair and equitable.These are ‘General Obligations’ which run through Part III of TRIPS Agreement on Enforcement of IPRs. As I just said, trade of generic drugs is perfectly legitimate. Measures taken by Dutch authorities, clearly, create barriers to such legitimate trade, particularly where there is no risk of diversion to the internal market.


Surprisingly, WHO is reacting quite meekly to the whole incident. Several NGO groups, amongst others, have also been pointing out the public health fallout that this development could lead to and have severely criticised the WHO for maintaining a silence on the seizures. Due to their silence on the issue, 16 civil society groups had contacted WHO's Director-General Dr. Chan for an assessment of the risks that such seizures and 'goods-in-transit' impeding provisions may have on public health programmes.. However, the statement finally issued in mid-March seems to be more of a formality reply without any actually saying anything concrete on the issue. While they do mention that barriers to legitimate trade of generic drugs are undesirable, the action part of their statement reads as:

“In relation to this issue, WHO is continuing to follow developments and consulting with Member States and relevant international intergovernmental organizations. WHO also understands that there is ongoing dialogue among the parties concerned to resolve the matter. Given the public health impact of this issue, WHO remains ready to provide, upon request, technical and policy support to Member States.”

While the WHO seem to be trying to keep a safe distance from the issue, the Mint points out that the Dutch minister for trade, Frank Heemskerk, has admitted to there being a lacunae in their law which has given European custom officials the power of seizing these goods. As reported by Mint,

“Heemskerk added that the Netherlands “supports TRIPS”. He also admitted that the seizure of the consignments “was a technical error on the EU (council) regulations, and we will sort it out”. He added that “patent protection is important but should not be misused to hamper access to generic medicines”.


However, the EU, in their statement is currently maintaining that they are well within their rights and obligations to the international community in seizing these pharma products. While denying any intention to create barriers to legitimate trade in generic medicines, they go on to say that “it is important to allow the customs authorities to control goods in transit suspected to infringe IP rights so that they can stop the traffic of potentially dangerous products, such as fake medicines, even when the shipments are destined for any country”

They also, continue on to say that they are in line with their WTO and TRIPS obligations because 'Article 51 and footnote 13 clearly allow WTO Member(s) to apply border measures to goods under other custom situations including in transit. They also continue to claim that there has been no seizure, but merely 'detention' of goods, stating that the general procedure is to detain where there is a suspicion of infringement. The right-holder is then contacted, who decides whether or not to pursue the case. Interestingly, in the same para, they also go on to say “...should underline that in case of abusive complaints by the right holder, the latter would be liable to damages.” The EU seems to have forgotten about the 2001 Doha declaration wherein members of TRIPS affirmed their determination to promote access to medicines for all. Also, on what authority are the custom officials deciding whether the drugs meet the standards of their destination countries? It's also not clear as to whether it was at the rights-holder's behest or not.

However, to go back to an earlier post , it was pointed out that when Article 51 and footnote 13 are read with Article 52, it is seen that as per Article 52, such transit goods may only be seized when the final 'importation' of the good to a member state would result in a violation of of IPs in that member state – which would mean that seizure of goods in transit, wherein there was neither an infringement in the exporting country nor the importing country, would amount to a violation of Article 52 of TRIPS.

Separately, a group of NGOs had issued a statement to WTO Director General Pascal Lamy. Lamy was more favourable in response, noting that “the issue at stake is certainly very important and sensitive. As such, it deserves to be adequately addressed so that efforts to enhance access to medicines are supported and the creation of barriers to legitimate trade is avoided. . . Your letter rightly points out the strong determination of all WTO Members to promote access to medicines for all which was explicitly confirmed in 2001 when the Doha Declaration on the TRIPS Agreement and Public Health was adopted.” Also, that “it was his understanding that the matter was being handled bilaterally and that WTO dispute settlement procedures might not be relevant at this time, though he would help find a solution if the disagreement persists.”


Brazil has also released a statement on the Losartan seizure specifically after having carried out an analysis of the fact scenario and the legal implications.

In conclusion, the Indian statement goes on to point out that the tendency to promote the IP maximalist agenda has been noticed on other international forae as well, however, in this case, it is threatening to disturb the delicate balance that exists between public policy goals and IP right holders. The recent issue of the confusion of the definition of counterfeit drugs (See Prashant's post on this ) being linked to low-cost generics is also bound to play an important role in the discussions which will come up to decide legality of these seizures and the EU's law on this.


Unless this gets sorted out at the earliest, in addition to the delay these seizures are causing to access to medicine, they will also be causing generics to look for 'safer' alternative routes, which in turn are likely to affect the costs of these medicines. While the bigger companies may be ready to take on the authorities on these arbitrary seizures, many of the smaller generic companies would rather prefer staying clear of trouble and huge legal expenditures.

It would be interesting to see how the EU tries to show how this aligns with their WTO TRIPS obligations of 'avoiding the creation of barriers to trade and providing safeguards against their abuse' , especially in the light of the Doha Declaration wherein all members confirmed their determination to promote access to medicine to all. Hopefully, the relevant parties will realise the folly in sidestepping public health interests while trying to maximise intellectual property right standards to a higher standard than is required.