Sunday, December 17, 2006

Now you may google patents!

Google 's ever-expanding portfolio of freebies now includes Google Patent Search (Beta). You may generally search more than 7 million patents here. Those with specific needs can search here.

Sunday, November 26, 2006

Reporting patent decisions

Our courts have, by force of tradition, found it habitually convenient to follow their previous decisions rendered on similar grounds. Despite the acquisitions of colour-matching, the practice had made the system predictable, and to an extent, efficient. As a system based on the doctrine of precedent, there is a great degree of trust imposed on reporting decisions of courts. There is a fairly trustworthy means of reporting decisions of the High Courts and the Supreme Court in place now. The decisions of the lower courts, being devoid of any binding effect, were never meant to make it to the reports.

Decisions concerning patents get reported when disputes are brought before the High Courts or the Supreme Court. The patent decision rendered by a Controller has a very rare chance of being reported. Out of the nearly 8000 pharmaceutical applications pending before the Patent Office, more than 150 opposition proceedings have been launched. Of the opposition decisions rendered by the Patent Office, only a few have been reported – Patent and Trademark Cases, a subscription journal has reported the decision on Wockhardt’s Nadoxin and Pharmabiz reporting the decision on Novartis’ Gleevac. You will find a summary report on some opposition proceedings here and here.

Reporting decisions of the Controller will have its own set of problems. First, these decisions can at best have persuasive effect offering guidance and cannot have any binding effect. Hence the primary incentive for reporting them is simply not there. Secondly, the humungous number of patent decisions (of rejection and grant of applications) rendered by Patent Offices the world over make it next to impossible to report them all.

Yet we find decisions of first instance being reported in an ingenious way. It has been the practice in the European Patent Office to include the decision of the first instance (Opposition Board) in its appellate decision. This form of indirect reporting serves the vital need of those who need to refer to the decision of the first instance for additional details and to get the bigger picture where needed. It will indeed be desirable for the development of patent law in this country, if the Appellate Board and the High Courts make it a point to include the decision at the first instance in their decisions.

Thursday, November 09, 2006

Workshop in Delhi on Access to Affordable Medicines

Those who are interested in issues relating to access to medicines, which incidentally involves issues on Patent laws in India, will be pleased to know that Centad in collaboration with others is organizing a workshop on "Access to Affordable Medicines" on 11th November, 2006 (9 am to 12 pm) at S6, India Social Forum, Jawaharlal Nehru Stadium, New Delhi.

Friday, October 27, 2006

Is the opponent a party to the pre-grant opposition proceedings?

I have consistently canvassed a proposition, much to the chagrin of legal puritans, that an opponent in a pre-grant opposition is not a party to the proceeding. In strict legalese it means that a pre-grant opposition proceeding before the Controller is not a proceeding inter partes. Though a bare reading of section 25(1) of the Patents Act, 1970 gives an impression that pre-grant opposition proceeding is between the applicant and the opponent, the details in the Act and the Rules point to the contrary. For starters, pre-grant opposition proceedings are entertained in the application stage where third parties cannot, and need not, be regarded as essential parties to the proceeding. For the reasons stated below, pre-grant opposition procedure can at best be regarded as a procedure to take into account the case presented by an opponent who is not a party to the proceeding and nothing more.

Firstly, a pre-grant opposition, though initiated by a third party, will be regarded as an extension of the application procedure as the opposition takes place before the grant of the application. For this reason, pre-grant opposition will be treated as a proceeding involving the Controller and the applicant. The role of the opponent is merely to supply information to the Controller. In fact, the power of the Controller to revoke and amend the patent is conferred under section 15 which may be exercised even without a pre-grant opposition. In other words, the outcome of the application can be the same even without an opposition.

Secondly, a brief comparison between the procedures of pre-grant and pos-grant opposition gives an unmistakable impression the pre-grant opposition proceedings are not intended to be a proceeding between parties. Unlike post-grant opposition where an opponent becomes a party by filing his notice of opposition in Form 7, pre-grant opposition requires only a written representation and as such there is no procedure by which the opponent can officially enter into the proceedings. In a country where things become 'official' on the payment of fees to the Government, the status of an opponent remains obscure as there is no fee for filing a pre-grant opposition. Furthermore, there is no specific provision similar to rule 63 by which an opponent can be eligible for costs of opposition.

Thirdly, the mere fact that a representation is made by the opponent in pre-grant opposition will not oblige the Controller to act upon it. The opposition will be entertained only 'if the Controller is of the opinion that application for patent shall be refused or the complete specification requires amendment'. The applicant will be informed about the opposition only if the Controller, in his opinion, is satisfied about the merits of the opposition.

Fourthly, the opponent will not be entitled to know the defence of the applicant in pre-grant proceedings. Unlike the procedure for post-grant opposition, the Act and the Rules do not detail the manner in which an opponent can get information about the applicant's defence.

Finally, as argued earlier, though an applicant can prefer an appeal from the order of the Controller in pre-grant opposition proceedings, there is no corresponding right of appeal for the opponent.

Friday, October 06, 2006

Delhi workshop on pre-grant opposition

The third and final workshop in the series of sensitisation workshops on pre-grant opposition will be held in Delhi on October 19, 2006 at the Jacaranda Hall II, India Habitat Centre. The earlier workshops organised by Centad in Mumbai and Hyderabad were well represented by the experts and professionals from the pharmaceutical industry.

Once again, I have been slotted in the dreaded post-lunch session. I will speak (and try to keep every one awake till the Tea break) on “Patent Pre-grant Opposition in India” (essentially the legal aspects of pre-grant opposition under the Patents Act, 1970) in session III (14:00 hrs – 15:00).

I hope to see you there.

Monday, September 25, 2006

Can there be an appeal to the Appellate Board from the order of the Controller in pre-grant opposition proceedings?

Surprisingly, the answer is yes!

In the Seminar on Pre-grant Opposition, I heard a unanimous voice that the only remedy from the order of the Controller in pre-grant opposition proceedings is to file a writ petition as there was no provision of appeal under the Act or the Rules. Few weeks back, I had taken a different view before the Madras High Court in writ petition filed against an order of the Controller (Chennai) rejecting the patent application. In response to the writ filed challenging the order of the Controller, we had taken a plea that the writ petition cannot be maintained as the Act provided for a system of appeal against the Controller’s order in pre-grant opposition.

So, is there an appeal to the Appellate Board? The first thing that strikes you on reading section 117A of the Patents Act, 1970 is the conspicuous absence of section 25(1) – the section that deals with the grounds of pre-grant opposition. [I was also surprised by the absence of section 92A]

Sub-section (2) of section 117A reads thus –

(2) An appeal shall lie to the Appellate Board from any decision, order or direction of the Controller or Central Government under section 15, section 16, section 17, section 18, section 19, section 20, sub-sections (4) of section 25, section 28, section 51, section 54, section 57, section 60, section 61, section 63, section 66, sub-section (3) of section 69, section 78, sub-sections (1) to (5) of section 84, section 85, section 88, section 91, section 92 and section 94.

In fact, section 25(1) is not supposed to be in the above section. Section 25(1) is the counterpart of section 25(2), both of which deal with the grounds of opposition before and after the grant. As you will see, section 25(2) is not mentioned expressly in section 117A. The section that finds mention in section 117A is section 25(4). This perfectly fits into the scheme of things as the order of the Controller in post-grant opposition, pursuant to the opposition under the grounds mentioned in section 25(2), is passed under section 25(4).

Section 25 does not contain details of the order that may be passed by the Controller consequent to a pre-grant opposition. The details of that are contained in section 15. Read section 15 carefully and you will find the two things that a Controller may do with respect to an application before him. He may “refuse the application or may require the application… to be amended.” Luckily, these two options coincide with what a Controller can do consequent to a pre-grant opposition which are detailed in rule 55(5). And therein lies your right to approach the Appellate Board from an order passed in pre-grant opposition proceedings. An order passed by the Controller pursuant to pre-grant opposition is an order passed under section 15 which is a subject matter of appeal under section 117A.

Thursday, September 21, 2006

Workshop on Pre-Grant Opposition Proceedings

Centad (Centre for Trade And Development in collaboration with National Academy of Legal Studies and Research (NALSAR) University of Law is organising a Workshop on Patent Pre-grant Opposition on 22 September 2006 in Hyederabad at NALSAR Law University.

I have been invited to make a presentation on Pre-grant opposition.

My session details is as follows:

1400-1500 Session III
Patent Pre-grant Opposition in India

Feroz Ali, Advocate, Chennai
Tahir Amin, Initiative for Medicines, Access and Knowledge (I-MAK), Bangalore

My Article published in The Hindu Business Line, also available in this blog, serves as the background paper for this seminar.

Wednesday, July 19, 2006

Patent for nimesulide preparation refused on Panacea's pre-grant objection

This article was published in Pharmabiz on Wednesday, July 19, 2006.

Stoplik Services India Pvt Ltd filed an application for Patent No. 183458 (454/BOM/1998 dated 14.07.1998) for "A process for the preparation of a therapeutic anti-inflammatory and analgesic composition containing nimesulide for use transdermally". The said application was opposed by Panacea Biotec Ltd which filed a notice of opposition on Feb 1, 2000 against the grant of patent.

The case involves opposition proceeding under the Patents Act, 1970 before the recent amendments which introduced a two-stage opposition, i.e., pre-grant opposition and post-grant opposition. The reference to section 25 in the proceeding is to the provisions of the section as it was before the Patents (Amendment) Act, 2002.

The invention is defined in the claim of the specification as follows:

1. A process for the preparation of a therapeutic anti-inflammatory and analgesic composition for tropical use which comprises the following steps:
(a) forming a mixture of 0.5% w/w to 30% w/w of a percutaneous enhancer and 2.5% w/w to 30% w/w of one or more vehicle/base as herein described;
(b) adding to the said mixture of step (a) 0.1% w/w to 10%w/w of nimesulide following by stirring the mixture until completely dissolved;
(c) forming homogenous mixture of 0.5% w/w to 12% of a surfactant, 0.2% w/w to 50% w/w of a Gelling agent/thickening agent of the kind herein described and 2.5% w/w to 30% w/w of one or more the said vehicle/base in a homogeniser to obtain a homogenized mixture;
(d) adding the said mixture obtained in step (b) to the said homogenized mixture obtained in step (c) under stirring to obtain the desired composition for analgesic use and wherein up to 2.0% w/w of a neutralising agent/pH adjusting agent as herein described is added to the composition to neutralize or adjust the pH of the mixture.

The application was opposed on the following grounds

Wrongfully obtained: Section 25(1)(a)

The opponent produced proof to show that the business of the applicant dealt with compression packing, yarn packing and zero compression packing and that the applicant was not a pharmaceutical company. The opponent alleged that the patent was wrongfully obtained from different specifications and documents. The present patent was also identical with Patent Application No. 1389/Del/1995 filed on July 25, 1995. The opponent pointed out that all the figures, the way of presentation and even the grammatical mistakes were common to both the applications. The applicant denied that above allegations. The Controller observed that the Application No. 1389/Del/1995 was not published or accepted before the date of filing of the Application No. 454/BOM/1998. Hence the earlier application was not in the public domain at the time of filing of the alleged invention. The Controller held that no clear case of wrongful obtainment was made as there was no sufficient evidence to prove this ground.

Reference cited by the opponent that the applicant was involved in a different trade (not in pharmaceutical business) will not in itself be a ground to conclude that the invention was wrongfully obtained. The order of the Controller did not throw any light on this issue.

Prior Publication: Section 25(1)(b)

The opponent had also pleaded that the invention as described in the specification and claims of the Patent Application No. 183458 has been defined and described in several patents granted and published - a detailed list of which was given by the opponent. It was alleged that these patents anticipate the subject matter of the present application.

Despite citing many patents, the stress of the opponent case was based on the Patent Application filed in Sri Lanka having Patent No. 11012, granted on September 20, 1996. The opponent compared the said document with the present application. In defence, the applicants stated that all the cited applications were not open to public on the date on April 4, 1997, the filing date of the parent application to which the present application is antedated. The applicant prayed for the dismissal of this ground as being baseless and vague. Moreover, they pointed out that the opponents have not furnished English translated copy of many patent of foreign countries on which they had relied upon and hence the same could not be taken on record as evidence. The applicant also distinguished the US Patent No.5688829 as being one for product where as the present application was for a process.

With regard to anticipation, the Controller relied on Canadian General Electric Company v Fada Radio AIR 1950 PC 1 to show that to amount to anticipation, the latter invention must be described in the earlier publication that is held to anticipate it. It is not sufficient to show that the earlier invention described in an early specification could have been used to produce a particular result. It must be shown that the specifications contain clear and unmistakable directions on how to use it. It must be shown that the public have been so presented with the invention that it is out of the power of any subsequent person to claim the invention as his own.

The test of anticipation is that the antecedent statement must be such that a person of ordinary knowledge of the subject would at once perceive and understand and be able to practically apply the discovery without the necessity of making further experiments. Only such disclosure can invalidate a subsequent patent. To establish anticipation, the publication relied upon should satisfy the following conditions.

1. it must have been effected before the priority date of the claim which is the subject of attack by the opponent, and
2. such publication may include any specification filed in pursuance of an application for a patent made in Indian on or after Jan 1, 1912 or any other document published anywhere, and
3. the claim attacked must be contained in any of the said publication.

The Controller held that non-production of translated copies of the document containing prior disclosure would be detrimental to the case of the opponent. However, the Sri Lankan and Nigerian Patent application relied upon by the opponent were granted on 20/09/1996 and 03/03/1997 respectively. The Controller after making a comparative table on the impugned patent and the Sri Lankan and Nigerian patents concluded that two questions should be answered in determining whether an invention is novel.
1. Does a particular document or action disclose the invention in such a way as to make it part of the state of the art?
2. Does the document or action make available the necessary information to destroy the novelty of the invention?

While compared to the Sri Lankan and Nigerian patents, the Controller held that the impugned application did not pass the test of novelty. A comparison of claim 1 of the impugned application and claims 20, 21 and 22 of the Sri Lankan or Nigerian Patents show that the principal claim lacks novelty. Claims 2 and 3 of the impugned application also lacks novelty in view of the claims 5 and 7 of the above said foreign patents.

Prior public knowledge or prior public use in India: Section 25(1)(d)

In the light of the several patents relied upon by the opponent, it was canvassed that the invention was publicly known and used in India. It was brought to the notice of the Controller that the product relating to Nimesulide gel/tropical and transdermal composition was present in the Indian market in July 1996. The Controller held that the opponent would succeed on this ground too for the reasons given for the earlier ground of prior publication.

Obviousness and lack of inventive step: Section 25(1)(e)

The opponent had alleged that the impugned application was substantially identical as the invention disclosed and claimed in prior published and granted in Sri Lanka and Nigeria. For the reasons stated by the Controller under the ground of prior publication, it was held that it is very obvious that a man in the art could have done the same thing as claimed by the applicants. The above ground was also granted in favour of the opponents.

Novelty: Section 25(1)(f)

The Controller held that the opponents would succeed even on this ground for the reasons given above.

The Controller ordered that the grant of the Patent on the application for Patent No. 183458 shall be refused and ordered cost of Rs 17,100 to be paid by the applicants.

The above case amply illustrates the effectiveness of opposition procedure. Unlike the examination conducted by the Patent Office which could be plagued with information-scarcity, the opponents have a distinct advantage with regard to knowledge of the invention. Being active participants in the pharmaceutical trade, the competitors can provide for vital information with regard to prior publication and prior user.

Order on costs

Under section 77(1)(e), the Controller has the power to award costs in an opposition proceeding. The matters in respect of which cost can be awarded and the limit of such costs are detailed in the Fourth Schedule. As per section 77(2), the order for costs awarded by the Controller shall be executable as a decree of a civil court.

Saturday, July 01, 2006

Exclusive Marketing Rights — The importance of opposition proceedings

This article was published in The Hindu Business Line on Friday, Jun 30, 2006.

No Patent Office, howsoever well-equipped, can keep pace with the rapid strides at which science grows and technology proliferates. The knowledge should essentially come from the competitors who have expertise in that particular field of technology. The grant of EMR, the proceedings for infringement and rejection of patent application have raised uncomfortable issues.

A string of infringement actions and two contradicting High Court decisions later, the Controller of Patents has rejected the application for the grant of patent to Gleevac, a life-saving anti-cancer drug manufactured by Novartis.

It was pointed out in these columns (`Exclusive Marketing Rights — a monopoly without a right', Business Line, March 20, 2004) that the EMR (Exclusive Marketing Rights) holder, pending the processing of its patent application, would get a free hand to exclusively market the product without any competition .

On January 25, 2006, the Controller of Patents refused to proceed with the patent application for the above drug pursuant to opposition proceedings initiated by the competitors.

As apprehended, with the rejection of patent application, the foundation on which the EMR was granted stands demolished, leaving questions on what happens when the law provides for a monopoly in the present, anticipating a right that may or may not be granted in the future.

The grant of EMR, the interim proceedings for infringement before the High Courts and the eventual rejection of patent application have raised uncomfortable issues with disconcerting regularity.

Even before the cries against granting a patent-like right without following a patent-like procedure could die down, the incongruity of differing interim reliefs, one by the Madras High Court and the other by the Bombay High Court, on the same set of facts, fuelled a further furore.

The rejection of the patent application was no less tumultuous. Consider the following three issues to understand how the first-ever contested case on pharmaceutical patents in the post-WTO era has been handled.

Why did not the preliminary examination before the grant of EMR reveal what the Controller had determined later with regard to patentability of the invention?

One of the grounds for rejecting the patent application was that the drug was not an invention under Section 3(d) of the Patents Act, 1970. Section 24A of the Act (now omitted) empowered the Controller to refer the patent application to an examiner for making a report on whether the said invention came under the excluded category of inventions detailed in Sections 3 and 4 of the Act.

Ideally, the examination under Section 24A should have revealed that the drug was not a patentable invention under Section 3(d) and it was only a new form of a known substance as held later by the Controller. This lapse could be directly attributed to the lack of opposition procedure before the grant of EMR.

Why did not the courts look into the arguments with regard to validity of the invention, raised by the defendants in the infringement suits? True, the courts are not obliged to look into the validity of a grant at the interim stage. But where the grant was based on a summary procedure devoid of any opposition mechanism and where the courts have been urged with details of invalidity, the courts could have considered the issue of validity as a preliminary issue (the Bombay High Court did consider the issue of validity is some detail).

Ironically, the patent application has now been rejected by the Controller on the same ground on which a revocation was prayed for before the High Courts.

Why did not the Patent Office determine, in the first instance, that the conditions for the grant of EMR were not satisfied?

No EMR would have been granted if the basic conditions for the grant were not satisfied. In the opposition proceedings before the Controller it was alleged that the application filed in India on July 17, 1998, as a convention application, claimed Swiss priority, when Switzerland was not a convention country on that date.

The Controller agreed with the merit in the above contention. This raises critical questions about the information supplied at the time of application. More so, the allegation that the EMR holder had misled the Patent Office was specifically raised before the Bombay High Court.

Every patent discloses information about the area in which the invention is claimed. The patent system — a term that signifies the conglomeration of all the patents granted, pending applications and information disclosed through patents or otherwise amounting to prior art — can itself be considered as an information bureau providing scientific and technological information to the world at large. Opponents to a patent play the crucial role of supplying information that is not available to the Patent Office.

The summary nature of the grant of EMR appears to be the root cause for the above anomalies. To begin with, the nature of grant of the EMR was summary, discreet, discretionary and without any redress mechanism for opposition of such a grant. The summary nature ensured that the entire process was accomplished quickly without the fanfare of publication and the opposition that usually followed it.

Patent Offices are often criticised for incompetence and blamed for granting patents for things that ought not to be granted. No Patent Office, howsoever well-equipped, can keep pace with the rapid strides at which science grows and technology proliferates. The knowledge about an earlier invention or a disclosure should essentially come from the competitors who have expertise in that particular field of technology.

The procedure of opposition by peers is a process devised to overcome the information-scarcity that may affect the Patent Office.

As the EMR episode illustrates, taking away the process of opposition and advocating summary procedure for rights that confer a monopoly (like patents and EMRs) can create an imbalance in patent information and affect competition.

Saturday, February 11, 2006

`Breaking' patents — Effective use of compulsory licensing

This article was published in The Hindu Business Line on Wednesday, Dec 15, 2004.

In the light of the Doha Declaration and the bold Brazilian initiative to break the patent of several HIV/AIDS medications, the Government should provide for effective compulsory licensing which, exercised cautiously, has the power to remedy most of the problems relating to access and pricing of drugs. Doing so would be a great show of political will in implementing the legitimate flexibilities available under the WTO.

THE Brazilian Government's World AIDS Day message came as a shocker to many pharmaceutical majors. The Government announced that, to prevent the financial collapse of its successful public health programme providing free antiretroviral drugs to HIV/AIDS infected persons, it would break the patent of several medications.

As the Brazilian law permits the government to disregard patents in case of health emergencies such as the HIV/AIDS epidemic, antiretroviral drugs will no longer enjoy patent.

By this, the Brazilian Government has given a new dimension to compulsory licensing. Ordinarily, the TRIPS (Trade Related Intellectual Property Rights) Agreement does not allow countries to provide for compulsory licences for drugs which are patented elsewhere.

In its new avatar, compulsory licensing will be extended to permit domestic production of the drugs covered by foreign patents with the permission of the Brazilian Government.

Technically, the term "breaking" patents means that the patented drugs enjoying monopolistic protection will be allowed to be manufactured domestically.

Thus, a patented drug could be used without the authorisation of the patent holder. In economic terms, it would mean national production of patented drugs from start to finish without having to depend on outside support for essential materials.

Article 31 of the TRIPS Agreement provides for such use without the authorisation of the right holder.

Though the TRIPS Agreement emphasises on obtaining authorisation from the right holder on reasonable commercial terms, it, nevertheless, does allow this requirement to be waived in the case of a national emergency or other circumstances of extreme emergency or in cases of public non-commercial use.

This exception is embodied in Section 92 of the Indian Patents Act, 1970 which empowers the Central government to grant compulsory licences in special circumstances.

Compulsory licensing in India

As the Indian experience shows, the grant of compulsory licences is riddled with technical absurdities. Under Section 84 of the Patents Act, an application for the grant of compulsory licence can be made to the Controller of Patents only after the expiration of three years from the date of the grant of a patent.

In a world where diseases spread in epidemic proportions, a monopoly to manufacture and market a life-saving drug for three years can result in certain havoc.

The Section also requires the person making the application to set out the nature of interest and provides an opportunity for the patent holder to oppose the application.

All this may sound fine in the interest of natural justice, but as compulsory licensing would be resorted to in emergency situations, any difficulty in seeking a grant would unnecessarily delay the process. Delay in getting access to life saving drugs would literally be a matter of life and death.

Chapter XVI of the Patents Act deals with compulsory licences. This chapter is drafted along the lines of Article 31 of the TRIPS Agreement. It is pertinent to note that the Article deals only with "use" and not with "manufacture" of patented articles.

So far, compulsory licensing has been generally understood to include a right covered by the patent. Currently, only process patent is available for drugs and medicines. Accordingly, a compulsory licence so granted will be to the extent of the preceding process patent.

Come 2005, the patents laws in India will be amended to introduce product patents for drugs and medicines for a period of 20 years. When product patents are granted, the corresponding licences would normally include all the rights covered by the product patent. The final say, however, is with the Controller of Patents who shall decide the terms of the grant of compulsory licence.

Moreover, under the Indian Patents Act, the grant of compulsory licence is available only for drugs patented under the Act. It does not provide for compulsory licensing of drugs patented elsewhere.

This loophole has been exploited by many pharmaceutical majors which prefer to export their drugs into India and have chosen not to apply for a patent in India.

Proposed Amendment

The controversial Patents (Amendment) Bill, 2003 attempts to remedy this situation partially. It proposes to introduce Section 92A, which will empower the Controller to grant compulsory licence for the manufacture and export of patented pharmaceutical products to any needy country if a compulsory licence has been granted in that country.

The hue and cry over the proposed Patent Bill is predominantly premised on the availability and pricing of drugs.

Unless the new amendment, which will have the effect of fully complying the Indian patent laws with the WTO standards, takes care of access to live saving drugs and the related pricing issues, the hard work done at every World Trade Organisation meeting will be rendered futile.

Doha Declaration

The Declaration on TRIPS Agreement and Public Health (Doha Declaration) gives member-countries the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.

It also states that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of the WTO members' right to protect public health and to promote access to medicines for all.

The Government, the courts and the patent offices should uniformly recognise the problem at hand and work together to interpret and implement the TRIPS Agreement keeping public health as the priority.

In the light of the Doha Declaration and the bold Brazilian initiative, the Government should provide for effective compulsory licensing, which exercised cautiously has the power to remedy most of the problems relating to access and pricing of drugs.

To do so will be a great show of political will in implementing the legitimate flexibilities available under the WTO.

See my previous post Breaking patents.

Thursday, January 19, 2006

Patents Ordinance: Surviving the Winds of Change

This article was published in Pharmabiz on Wednesday, January 12, 2005.

The apprehensions of the pharmaceutical industry voiced by various associations seem more like a knee-jerk reaction to the recent Patents Ordinance than a studied response. The Ordinance contains, by and large, the very same provisions as the Patents (Amendment) Bill, 2003 which was introduced in the Rajya Sabha on December 22, 2003. The industry had sufficient time to react to these new provisions. The amendment in the law was inevitable as India had to comply with the obligation of fully conforming the Patents Act, 1970 (Act) to the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement under the WTO. Everybody knew that the transitional period of 10 years granted to developing countries under Article 65 of the TRIPS would come to a definitive end on December 31, 2004.

The Ordinance has put an end to the era of reverse engineering. Expectedly, the pharmaceutical industry has raised some fears about the Ordinance mainly with regard to patentability, pre-grant opposition and compulsory licensing.


As the patents law in India developed differently keeping in view the needs of the local consumers and the domestic producers, the exclusions on patentability are more than those found in patent legislations of other countries. The Act defines "invention" as a new product or process involving an inventive step and capable of industrial application. Section 3 of the Act provides for the inventions that are not patentable. The section enumerates 15 such non-patentable inventions which can be used as a ground in opposing a patent before its grant or in revocations proceedings after the grant. Contrary to the popular belief, the Ordinance has made only cosmetic changes and has left the existing provisions intact.

The issue of patentability assumes importance as it limits the scope of inventions for which a patent can be claimed. The Ordinance provides for challenge of an invention at various levels.

Multi-level challenge mechanism

The Ordinance has introduced a multi-level patent challenge mechanism. First, it provides for a preliminary challenge even before the patent is granted. Section 25 contains a mechanism by which any person can represent by way of opposition to the Patent Controller against the grant on the ground of patentability. This is known as the pre-grant opposition. Some sections of the Industry have raised their dissatisfaction that only a "representation" is permitted and that the opposition of the person is not "heard". The objections at this stage are of a preliminary nature and any failure at this stage can be remedied at the next level.

Secondly, the Ordinance provides for post-grant opposition at any time after the grant of patent but before the expiry of a period of one year from the date of publication of the grant of patent. Any interested person can do this. Again the Ordinance does not prevent a person who had raised a failing opposition at the pre-grant stage to oppose the patent after its grant. There are 11 comprehensive grounds enumerated for post-grant opposition including patentability.

Thirdly, even if all efforts to oppose the grant of patent, either before or soon after the grant, fails, there exists the option of approaching the IPAB (Intellectual Property Appellate Board) under section 64 of the Act as amended by the Ordinance. Here again, any interested person may prefer a petition to the Appellate Board for revoking a patent on any of the 17 grounds enumerated therein. Needless to say, patentability is one of the grounds on which the patent may be revoked.

Finally, if a competitor is found to manufacture a patented drug and the patent holder had filed a suit for infringement against the competitor, all the grounds available under section 64 for revoking a patent may be raised as a counter-claim in a suit for infringement before the High Court and the High Court, if it deems necessary, has the power to revoke a granted patent.

Compulsory licensing

Chapter XVI of the Patents Act, 1970 deals with compulsory licences. Except for the inclusion of a new section 92A, the provisions on compulsory licensing under the Act have remained untouched. The grant of compulsory licenses, even before the Ordinance came into force, was riddled with technical absurdities. Under section 84 of the Act, an application for the grant of compulsory licence can be made to the Controller of Patents only after the expiration of three years from the date of the grant of a patent. In a world where diseases spread freely beyond all geographic barriers, a monopoly to manufacture and market a life saving drug for three years can result in colossal loss of human lives. The section also requires the person making the application to set out the nature of interest and provides an opportunity for the patent holder to oppose the application. These provisions impose unwarranted difficulties in seeking a grant of a life saving drug and unnecessarily delays the process. The final say, however, remains with the Controller of Patents who shall decide the terms of the grant of compulsory licence.

The grant of compulsory licence is available only for drugs that are patented under the Act. It does not provide for compulsory licensing of drugs patented elsewhere. This loophole has been exploited by many pharmaceutical majors who now prefer to export their drugs into India and have chosen not to apply for a patent in India.

Moving ahead

The Ordinance has only brought into effect an inevitable change that India, as a founding member of the WTO, had agreed to 10 years ago. Due to India's international obligations and the possible threat of sanctions, the industry stands very little to gain in seeking for changes in the Ordinance. The industry should look at the flexibilities provided within the patent system and the WTO and devise ingenious ways to apply and interpret them. By doing so, it would be conforming its practices with the Doha Declaration on Pubic Health which allows a Member Country to interpret and implement TRIPS Agreement in a manner supportive of its right to protect public health and to promote access to medicines for all.