With a pinch of “salt” –The origin of Section 3(d) controversy

Two separate pre-grant oppositions under Section 25(1) of the Patents Act, 1999(“Act”) were filed before the Opposition Board, Chennai (“Board”) respectively by Natco Pharmaceuticals and Ranbaxy Laboratories Limited both on May 26, 2005 to the patent application No. 1602/MAS/1998 of M/s. Novartis AG for an invention titled “Crystal Modification of A.N.-Phenyt-2-Pyrimidineamine derivative, processes for its manufacture and its use”. Novartis’s application filed in India on July 17, 1998 claimed priority 18th July, 1997 from the corresponding application in Switzerland.

The issues involved in both the pre-grant opposition were more or less identical. In the opposition filed by Ranbaxy the issues involved were of (1) priority claims, (2) anticipation and (3) prohibition of grant of patent under Section 3(d) of the Act. Natco’s opposition, in addition to, priority claims, anticipation and prohibition of grant of patent under Section 3(d), also involved the fourth question obviousness of Novartis’s invention. On January 25, 2006, the Board decided in favour of the opponents on all counts and refused the patent application of Novartis.

Briefly and simply put, the patent application of Novartis claimed the beta-crystal form of the imatinib mesylate. Interestingly, the Invention of the base compound imatinib had already been disclosed in the European Patent in 1993 and its equivalent United States Patent (US Patent).

On anticipation by prior publication, the Board held that the opponents, Ranbaxy and Natco, were correct that the invention of the Novartis has been anticipated by prior art. The opponents succeeded in proving that the salt imatinib mesylate is already known from the prior art publications and that the salt normally exists in the β-form which is the most thermodynamically stable product. To prove this the opponents put on record the following –

(a) The prior US Patent of 1993 and its equivalents that specifically mention imatinib mesylate as the product. Though Novartis argued that the US Patent just disclosed the free base and not the salt, the Board observed and held otherwise stating that claims in the US Patent specifically mentioned the salt prepared from the free base;

(b) Publications such as Nature Medicine (5th May, 1996), Cancer Research (Vol. 56, Issue I, 1996) and Blood (1st November, 1997) wherein imatinib mesylate has been disclosed. Hence, there was no human intervention or ingenuinity in the preparation of beta-crystalline form of the salt imatinib mesylate

Similarly the Board decided in favour of the opponents who were successfully able to prove that the salt imatinib mesylate inherently existed in the β-crystalline form and that it is obvious for a person skilled in the art to prepare corresponding pharmaceutically acceptable salts especially in view of the disclosure provided US Patent of 1993 and its equivalents. To support its claims, the opponents had submitted reports of two reputed government institutions -Indian Institute of Chemical Technology, Hyderabad and Indian Institute of Technology, Delhi. Both IICT and IIT found the salt exists in the β-crystalline form, which is thermodynamically most stable form. These institutes performed the experiments at least ten times and at all times the crystals were found to exist in the β-form. Hence, it was held that the product claims by Novartis were obvious to a person skilled in the relevant art especially as the teaching to prepare the salt already existed in the US Patent and equivalents.

The Board also decided that the priority as claimed by Novartis for its patent application in India from its corresponding Swiss application filed on July 18, 1997 was incorrect and the said priority cannot be claimed. The reason for this is that up till the filing of the patent application by Novartis in India i.e. July 17, 1998, Switzerland was not a convention country. Switzerland became a convention country in September 1998. Interestingly, Novartis despite knowing this position chose to remain quiet and did not amend its application accordingly.

The last issue that was dealt by the Board was the issue of section 3(d) of the Indian Patents Act, 1999. This is a unique Section which appears only in the Indian patent law. Simply put Section 3(d) provides that polymorphs, metabolites, pure forms, salts, esters, derivatives etc cannot be regarded as inventions that are patentable unless these show an “enhanced efficacy”. Further simplifying, a new form a known substance cannot be granted patent in India. In this case, the Board held that the invention of Novartis is “only a new form of known substance”. It was also held that there is no enhancement of the known efficacy of the β-crystal form over the known substances. Hence the Board concluded that the subject matter of this application is not patentable under Section 3(d) of the Patents Act.

Therefore, the Board refused the patent No. 1602/MAS/1998 of Novartis holding it to be contrary to section 3(d), prior anticipated, obvious and incorrect priority claimed. Novartis has appealed against the order as well as challenged the constitutional validity of Section 3(d) in the High Court of Chennai. The matter is sub judice.

The lessons that can be learnt from the above situating are-

Patent attorneys must ensure while claiming priority from a country in India, ensure that such country is in fact a convention country.

Corollary of lesson 1 is that the applicant/ patentee should have a patent strategy in place to avoid running into such situations regarding priority. Do not forget, priorities may make or break a patent.

Every country has different domestic laws. Therefore, while filing or after filing (if there is no time) and before the issuance of first Patent Office action, it is imperative for the patent attorneys in the domestic country must revisit the claims to see if the claims are in conformity with domestic laws rather the leave it for the last minute.

If there are any amendments/changes/corrections that require to be carried out, then such changes must be immediately carried out to avoid any third party alleging that fraud has been committed by the applicant/patentee.

Before filing an application the patent attorney should honestly inform the applicant the problems that the application may face in India.

Nibbling on Nimbus is DD??

The Nimbus Prasar Bharathi controversy continues. I cannot help but feel bad for Nimbus. To fight against the government is not the easiest of things. The Government after listensing to the cries from Prasar Bharati that seven minutes delay will not work for them, promptly promulgated the ordinance that makes it mandatory for private sports channels to share live feed of any international sports event with Prasar Bharti

Nimbus is sticking by its earlier position and says that it would follow the court’s order to the fullest. They say that they have done nothing wrong by giving a seven minute delayed feed of the Kolkatta match to Doordarshan. Nimbus’s essential problem is still regarding the ordinance requiring them to share live feed with Doordarshan for their DTH (Direct To Home) service as well as cable homes with Doordarshan.

It is interesting to know the opinion of the Delhi High Court on February 8, 2007. Justice B.D. Ahmed remarked-'Why was the government so swift in bringing an ordinance. The rule of law should not have been subverted. It brings bad taste in mouth, when there is subversion of judicial process,'

Clearly it seems that on the face of record, the court does realize that this is a subversion of rule of law and contrary to the legitimate interests of Nimbus. The hearing is appointed for February 12, 2007 and hopefully this issue would be settled for once and for all. I also hope that the court holds the ordinance as subversiuon of rule of law and justice is met.

IPO – an electronic revelation!

There is good news for patent attorneys in India- the Indian Patent Office (IPO) is going electronic!

Sounds good right! There have been series of meeting that have been talking place between patent agents and attorneys in the Delhi Patent Office. There must be such meetings in other three Patent Offices at Chennai, Kolkata and Mumbai as well, but I am not sure so I will not commit or comment.The meetings involve discussions about substantive law and as well as things such as the stereotypical objections raised by the IPO in the first examination reports (FER). But this is topic for another day and for the present I shall restrict myself to reporting the electronic revelation.

The Controller Mr. BP Singh in the meeting on February 2, 2007 unveiled the prototype of the electronic filing system for patent application filing as well as updating other information and documents pertaining to the patent application. Some of the salient points are-

(a) The online filing by the patent agents and attorney, which obviously saves the time to gruelling travel to Dwarka;

(b) Immediate generation of fee receipt. Thus there is no longer the “conventional” paper letters requesting for the fee receipt;

(c) Immediate issuance of application number to the patent application;

(d) Creation of account for the patent attorneys and agents to pay the fee online;

(e) Issuance of FER by electronic means and no more hand written paper FER;

(f) Replies and responses to FER can be electronically uploaded or sent to the Examiner / Controller

These are few of the features which are apparent and have been communicated. There are drawbacks also such as what happens if the sever of the IPO is down and it is a last date case or a priority application filing. Another concern for patent attorneys and agents is the time limit to submit the fees. The Controller did not give a clear answer if the fee has to be paid by six in the evening or till midnight. After all if the system is electronic then the priority would be for the “day”, not fixed for a particular “time”. A solution would be the bringing back of the provision of filing fee within a month after submitting the documents. The popular reason given is that this provision of one month is being misused as people are filing divisional applications without fee and if the parent application is accepted, then they do not pay the fee. There is a remedy to this; for divisional applications make it mandatory that the fee has to be given to IPOP and if it is not given then the parent can be revoked.

Another aspect is the amount of data that can be stored which has direct impact on the speed and connectivity to the IPO server. These are probably being address within the IPO, but I am always sceptical about how things work beyond the red tape.

In any case, without being overly pessimistic, we must look at the bright side that this is a big advance for the IPO to be going electronic and genuine efforts of the IPO should be commended. After all half the battle is won when the intentions are good.

“Mashelkar” the “New Chemical Entity”

My first reaction on reading the Mashelkar Committee’s “Report of the Technical Expert Group on Patent Law Issues, December 2006” was –“WOW!!”

The report is extremely concise, to the point and more importantly an honest report on the issues of patentability of New Chemical Entities (NCE) and micro organism.

Briefly, the reason for the Report was that when the Patents (Amendment) Bill, 2005 was introduced in the Parliament in March, 2005 for debate to make the Patents Act compatible with India’s international obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement), issues regarding patentability of micro-organisms and the definition of 'pharmaceutical substance' to mean “a new chemical entity (NCE)” or “new medical entity (NME)” were raised. It was then decided that a Technical Expert Group on Patent Law Issues should be set up to discuss and come out with findings.

The issues referred, therefore, were two i.e. to quote verbatim from the Report-

1. whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; and

2. whether it would be TRIPS compatible to exclude micro-organisms from patenting.

Amongst other things, I liked the approach which the Committee took i.e. “consultative approach” which included industry associations, non-governmental organizations, intellectual property attorneys, etc. The Group studied the inputs received and also took into account other relevant literature to arrive at their assessment.

The Report concludes that it would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only and excluding micro-organisms per se from patent protection would be violative of TRIPS Agreement.

The Report very succinctly states that it is important that “incremental innovation” of NCE should be allowed and “evergreening” should be discouraged. To this extent the Report distinguishes between “incremental innovation” of NCE should be allowed and “evergreening” by stating what IP Institute, London has stated:

"It is important to distinguish 'ever-greening' from what is commonly referred to as 'incremental innovation'. While 'ever-greening' refers to an extension of a patent monopoly, achieved by executing trivial and insignificant changes to an already existing patented product, 'incremental innovations' are sequential developments that build on the original patented product and may be of tremendous value in a country like India. Therefore, such incremental developments ought to be encouraged by the Indian patent regime.”

The Report is futuristic and highly progress oriented for India and would be welcomed with open arms by Indian pharmaceutical companies that are in constant battle with foreign pharmaceutical company. The only way Indian pharmaceutical companies have managed to stay in the race is by innovation. The Committee’s Report emphasising on “incremental innovation” puts forth the message that Indian Patent Office has to open its mindset and has to understand the distinction between “evergreening” and “incremental innovation”

More importantly, Section 3(d) of the Indian Patent Act, 1970 has to be interpreted with an open mind. The minute the Patent Office sees that there the patent application involves an advancement of a NCE, it immediately applies that Section 3(d) of the Act applies and the invention s not patentable. Section 3(d) of the Act reads as –

" The following are not inventions within the meaning of this Act, -
….
….

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;".

This section is a negative Section which states that certain things are not patentable. The Section clearly means “certain things”, not everything. This is where the problem starts. The Indian Patent Office (IPO) considers that the Section excludes everything from patentability especially if it is in regard to pharmaceuticals. The attorneys are at continuous logger head with the IPO that if the new pharmaceutical substance satisfies the three criteria for patentability, the bar under Section 3(d) cannot apply. Of course, the onus is on the patent attorneys to ensure that they should advice the clients if there is a clear case of “evergreening” rather then criticising the IPO. To be fair on the IPO, it is finding its feet in this rapidly evolving IP world.

I would say that the Examiners should be trained and the IPO library should be stacked with patent law books from around the world that would help the Examiners to understand the subject better and also help immensely to examine the patent applications at a world class level. To this extent in a meeting between the patent agents, patent attorneys and Controller of Patents yesterday, the Controller said that Examiners are being sent abroad to understand patent practices better and subsequently apply the same in India.

Coming back to the topic of NCE, it is interesting that the grant of patents only to NCE would severely hamper the pharmaceutical industry which is finding its feet. If reports are to be believed that only 32% of some 1200 pharmaceutical substances were declared by US FDA (unsubstantiated report) as NCE goes to show to research ad develop NCE is not easy. It takes millions of Rupees to develop NCE and at the moment no Indian company has such financial strength. The strength of Indians has always been in their ability to innovate and it is in national interest that this ability should be protected and encouraged. By just allowing patents for NCE therefore is definitely not the solution or the way to grow

I would love to see the report being implemented in the IPO. According to me while the report is extremely good, its implementation is what will decide the future of the Indian patent law and Indian pharmaceutical companies. The onus is now on the government to bring this report either into an amendment format or as guidelines for IPO.