Tag Archives: CGPDTM

Grant of Compulsory License for Bayer’s Nexavar in India raises more questions than answers

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On March 12, 2012, the Patent Office of India, in its landmark ruling, granted its first ever Compulsory License (CL) for Bayer’s patented kidney and liver cancer drug Nexavar (Sorafenib), to the generic pharma player Natco, broadly citing the following reasons:

  • Reasonable requirements of public under Section 84 have not been satisfied.
  • The Patented Drug was not available to the public at a reasonably affordable price as per Section 84 (1) (b).
  • Patented invention is not worked in the territory of India as per Section 84 (1) (c)

The 62 page order of the Controller General of Patents, Designs and Trade Mark (CGPDTM) granted the CL to Natco for the rest of patent life of sorafenib in India at the high end of the UNDP 2001 royalty guidelines at 6 percent.

Sorafenib:

Sorafenib was co-developed and co-marketed by Bayer and Onyx Pharmaceuticals  for the treatment of advanced  renal cell and hepatocellular carcinoma. The drug got its first regulatory approval from the US FDA for advanced renal cell carcinoma in 2005.

National Institute of Health and Clinical Excellence (NICE) of UK had indicated that the drug extends life of the kidney cancer patients by three months on an average.

As stated earlier, in March 2008, Indian patent for Sorafenib was granted to Bayer by the CGPDTM. Thereafter, in December 2010 Natco had requested for a voluntary license from Bayer, which was rejected by the patentee.

It has been reported that sorafenib was registered as an ‘orphan drug’ in the US. The R&D cost of sorafenib was partly subsidized by the US Orphan Drug tax credit.

Mixed reaction:

Though the research based pharmaceutical industry across the world expressed its disappointment over the judgment, many experts and NGOs from different parts of the globe have opined that CGPDTM has set a right precedence by granting a CL for sorafenib, which will ensure, in the times to come, that patent monopolies are kept limited, especially when the patented products are not “reasonably affordable”.

Many people, therefore, envisage that the grant of the first ever CL by the Indian Patent Office could ultimately open the door for other generics players of India to apply for the same on similar grounds and mainly for ‘non-working of patents’, as many patented medicines are now imported into India by the respective global players.

Granting CL should be the last resort:

While none can deny that all citizens of India should have access to innovative and lifesaving medicines, as will be required for their medical treatment, it appears rather impractical to envisage that routine issue of CL by the Indian Patent Office will be able to resolve this critical issue on a long term basis.  Grant of CL, if any, I reckon, should be taken only after exhausting all other access improvement measures.

Working of a patent:

In this particular case, it has been decided by the CGPDTM that working of a patent will require the concerned company to manufacture the drug in India in a reasonable quantity. The argument of the CGPDTM in this respect, many experts believe, is quite a stretch of an interpretation of the statute.

This is mainly because, as one of the signatories of TRIPS, India has a national commitment for adherence to this important international agreement. It is, therefore, widely believed, if importation is not considered as working of patent, the country could expose itself to the risk of  violation of the Article 27.1 of TRIPS, both in letter and spirit.

The Article 27.1 of TRIPS:

The Article 27.1 of TRIPS on ‘local working of patents’ indicates as follows:

“1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.”

Thus as per Article 27.1 of TRIPS, if commercialization of products patented in India, is done locally either through imports or local manufacturing, should be considered as ‘local working of patents’.

Form 27 vindicates the fact:

Form 27 of the Indian Patents Act, which is a statement regarding the working of patented inventions on commercial scale in India, in its point number 3, under ‘if worked’ states as follows:

“If worked: quantum and value (in Rupees) of the patented product:

  1. Manufactured in India
  2. Imported from other countries (give country-wise details)”

Thus, when Form 27 itself accepts importation as ‘local working of patent’, it is indeed intriguing why was the decision to the contrary taken by the CGPDTM?

Moreover, it is worth noting that the term ‘manufacture in India’ was deleted from the earlier Section 90 (a) of the Patents Act.

A statutory requirement:

CGPDTM through a circular dated December 24, 2009, directed all Patentees and Licensees to furnish information in ‘Form No.27’ on ‘Local Working of Patents’ as prescribed under Section 146 of the Patents Act.

It will be interesting to know, whether CGPDTM in response to Form 27 submissions of Bayer had informed them earlier that the Nexavar Patent has not been worked in India. If not, what is then the sanctity of Form 27 filing?

Delhi High Court Judgment:

Further, it has been well reported that in the legal case of ‘Telemecanique & Controls (I) Limited Vs. Schneider Electric Industries SA 94(2001)DLT865’ on working of patents, the Delhi High Court had concluded that importation would amount to working of Patents.

India specific pricing for innovative drugs is not uncommon:

At this stage, it is worth mentioning that India specific pricing for innovative drugs are not uncommon in the country at all. Following are some good examples:

  • GlaxoSmithKline  Pharmaceuticals has already announced its differential pricing system for India and will sell its innovative drugs at prices 25% to 40% less than what those are in the US.
  • MSD  has already introduced its India specific price for patented products. Their patented cervical cancer drug Gardasil is being sold in India at 75% -80% less than the global prices.
  • Moreover, MSD’s patented anti-diabetic drug Januvia (sitagliptin phosphate) is locally sourced and marketed at one-tenth of the global price.
  • In 2008 Novartis  reportedly tied up with the domestic pharma major USV to market its patented anti-diabetic drug Galvus (Vildagliptin) by pricing it lower than Januvia. According to reports, Novartis markets Galvus in the metros, while USV markets the same brand in tier two and three cities of India.
  • Roche  has recently collaborated with the domestic pharma player Emcure Pharmaceuticals to manufacture its two well-known biologics Herceptin and MabThera not only to cater to the domestic needs, but also for export to other developing markets.

Manufacturing of a small quantity locally – an issue:

As quoted in the order of the CGPDTM there are around 8842 eligible patients for sorafenib in India. All these patients put together will require Nexavar ranging from 27000 (Bayer’s figure) to 70000 boxes (NATCO’s figure) per year.  Thus, the moot question remains: even for such small annual requirements, should global companies set up manufacturing facilities in all the countries like, India.

Another question: if other smaller markets of the world also make local manufacturing mandatory for any pharmaceutical products that will be sold in their respective countries, will the Indian players find those markets attractive enough to expand their business? In that case who will be the net losers?… Patients?

Conclusion:

If the issue of whether importation will be considered as ‘local working of patents’ or not is not answered conclusively under higher judicial scrutiny in conformity of Article 27.1 of TRIPS and CL is granted to local manufacturers for commercial benefits under similar situation, availability of life saving innovative products in the Indian market for the patients of India could be in a real jeopardy.

The objective of improving access to innovative medicines is a very desirable one for any country like ours. However, if India routinely starts granting CL for this purpose before exhausting all other avenues to achieve this goal, it would risk sending a very wrong signal to the outside world that the country is shirking its responsibilities to create an appropriate ecosystem to foster and support pharmaceutical innovation to offer better quality of lives to the citizens of the country in particular.

In the absence of both collaboration and foreign direct investments by the global innovators in the field of pharmaceutical research and development, India may feel handicapped, especially when our neighbor China is surging ahead in this field with longer strides.

Thus, routine grant of CL, as is being envisaged by many in India, on a similar situation could, on the contrary, make the issue of access to innovative medicines by the common man even more challenging, in the longer run.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Indian Patent offices (IPOs) have started showing improvement in their functioning; still lot of grounds to cover.

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Indian Patent offices are located, with four clearly specified jurisdictions, at New Delhi, Mumbai, Kolkata and Chennai.

Since last few years enough efforts have been made towards overall capacity building initiatives, training of personnel and digitalizing the huge databank of these offices, with wide scale application of information technology (IT). As a result the patent offices are now having almost a centralized database to provide online services to the users in various areas of their operations. Users are now having the facilities of not only online patent search, but also for online patent applications.

More extensive IT applications are required to achieve greater system efficiency and transparency:

However, to bring in more efficiency and transparency in the system, there is a need to introduce appropriate IT applications in all the transactional interfaces between the patent office personnel and the patent applicants.

Still there are lots of grounds to cover:

Following are the key areas which should be taken care of by the Controller General of Patents, Design and Trade marks (CGPDTM) to make the IPOs more efficient, transparent and effective:

1. The Patent Manual, which provides essential guidelines to the patent examiners to bring in uniformity in the patent application examination process, is long overdue.

2. Many patent applicants feel that there is a need to include the International Non-proprietary Names (INN) in the title of pharmaceutical patent applications by the IPO.

3. Inadequate bandwidth makes the IT system slow, reducing its operational efficiency.

4. Electronic-filing of patent applications has been introduced, but there is no facility of paying the fees online by credit card. This facility should be introduced to make it more convenient for applicants to file patent applications online, adding more speed to the process.

5. Electronic prosecution of patent applications should be introduced to make the patent prosecution virtually paperless and more efficient.

6. Despite new technological measures most patent officers and also the public in general are still following the traditional method of filing the patent applications due to the ease and authenticity of filing records. To encourage applicants to file applications electronically, incentives such as reduced fees may be offered to those who file their applications electronically.

7. The IPOs should digitize all the physical files lying with them, so that file histories of each application are available online.

8. The Patent offices should have designated centres to provide assistance to applicants for filing or prosecuting applications.

9. Clear guidelines to be issued for conducting pre-grant and post grant opposition proceedings. Presently they are being handled in an arbitrary manner.

10. In order to introduce an efficient system of patent prosecution, it is recommended that the IPOs adjust patent term to compensate patentees for any delay in the grant of the patent that reduces the term of the patent, when such delay is caused solely by the IPOs.

11. Decision making and its communication to all concerned to be made faster at the IPOs. A system to be instituted for issuing the operative part of the decision first, followed by details of the decision taken. These should be advertised immediately in the technical journal to close proceedings at the earliest. Delays are leading to increase in the waiting period for the grant of patents, even if the proceedings have been concluded (opposition or otherwise) attracting serial and frivolous pre-grant oppositions. Such delays are also preventing the patent applicants to get their grants. As a result they are unable to initiate infringement proceedings against infringers quickly, defeating the very purpose of the patent system.

12. The timeline for an application, which will be taken up for examination, needs to be clearly defined. Currently, there is no time-line defined for taking up the applications for examination.

Conclusion:

All concerned will feel happy, if the DIPP in general and the CGPDTM in particular take note of these suggestions and formalize a process within the IPOs to address these important issues.

Growing discontentment of the past, in several areas of operation within the IPOs, is now being effectively addressed. However, the system still warrants more capacity building to enable the IPOs provide world class services to the patent applicants. This process needs to be expedited to further enhance the credibility of the new IPR regime in India.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Simmering discontentment in the functioning of the Indian Patent Office (IPO) – urgent need to tighten the ‘loose knots’ in the system.

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Indian Patent office (IPO) though is headquartered at Kolkata, because of some unknown reason, the office of the Controller General of Patents, Designs and Trade Marks (CGPDTM)is located in Mumbai with other two offices at New Delhi and Chennai. Moreover, the office of the ‘Patent Information System’ is located at Nagpur. Scattered location of the IPO, many believe, could be an impediment in ensuring uniformity in operations between all its units. Such an opinion is debatable though, I shall not deliberate on this issue in this article.The point that I shall argue upon is the crying need in the IPO to tighten 15 identified ‘loose knots’in its operation, which are causing considerable concern within stakeholders, who are casting serious aspersions in its efficiency.There are some areas where our IPO is doing quite well. I shall also dwell upon those areas before highlighting the areas of improvements.

The new IPR regime came into force from January 1, 2005. Even 4 years down the line, the IPO still remains grossly understaffed. Growing dissatisfaction with the current functioning of the IPO is fast sapping initial enthusiasm of the innovators on the new IPR regime in the country. ‘The glass’ now perpetually looks as ‘half empty’, as it were and will continue to do so, if corrective measures are not taken, forthwith.

The information available from the IPO website indicates that all the four centers put together, there are just 134 Examiners, 31 Assistant Controllers, 4 Deputy Controllers and 1 Joint Controller. Staff attrition rate within the IPOs has been reported to be reasonably high, which incidentally appears to be one of the key issues of their inefficiency. These trained IPO personnel are being poached mainly by the private sector enterprises, offering significantly higher remuneration. At the same time, there appears to be 3 times increase in the number of applications filed in the last five years, complicating the situation further.

The silver lining is, despite all these, the performance of IPO quantitatively speaking, is really not as poor. Around 11,000 patents were granted by the IPOs in 2007-08. This number, when translated into average number of patents granted per day, works out to be 50. This figure, when viewed in terms of number of patents granted against the number of applications made, compares reasonably well with the developed nations of the world like, USA and EU. It is worth noting that in those countries the product patent regime is in place, since long.

Indian Patent Act 2005 is believed to be more stringent than the prevailing Patent Acts in the USA or EU. It is good to note that quoting the Department of Industrial Policy and Promotion (DIPP) it has been reported that each Indian Patent Examiner examines about 100 applications per annum against 50 to 80 in the USA and the EU. This is indeed laudable.

Indian Patent Office is currently going through ‘capacity building’ exercises. The efforts being made towards this direction are expected to make the IPOs more efficient, hopefully, in pursuit of excellence.

India has recently been approved as an International Searching and Preliminary Examining Authority under the Patent Cooperation Treaty (PCT). This, in turn, will significantly increase the workload of the IPO.

When we are mentioning about the PCT, perhaps it will not be out of place to say that some section in India argues in favour of the need to include the International Nonproprietary Names (INN) in the title of pharmaceutical patent applications by the IPO. However, as INNs are not required in the title of patent applications under Article 27(1) of the PCT, such a requirement, in my view, could appear to conflict with the PCT.

Thus, it has now become more essential that the Controller General of Patents, Designs and Trade Marks (CGPDTM) tightens the ‘loose knots’ in the IPO system, immediately, to make it efficient and effective.

In this article I shall not go into much debated and discussed, ‘Indian Patent Manual’ issue. I shall only submit the following 15 suggestions towards achieving the above objective:

1. To effectively cope with its growing workload, the Patent office should upgrade its IT facilities and ensure that patent examiners are trained to handle the filing and prosecution of patent applications.

2. Electronic-filing of patent applications has been introduced, but there is no facility of paying the fees online by credit card. This facility should be introduced to make it more convenient for applicants to file patent application online. This will also add speed to the process.

3. Electronic prosecution of patent applications should be introduced to make the patent prosecution paperless and more efficient.

4. To encourage applicants to file applications electronically, incentives such as reduced fees should be offered to applicants who file their applications electronically.

5. The Patent Office has in the past experienced problems in locating and managing physical application files. It is therefore recommended that the Patent Office introduce systems for better management and storage of physical files. Using a system of bar codes on the physical files could be one such system.

6. The Patent Office should digitize all of its physical files so that file histories of each application will be available online.

7. The Indian Patents Database and the Indian Designs Database to be released without further delay.

8. An efficient system to be introduced to ensure timely publication of all patent applications and proceedings that are eligible for publication in the technical journal of the IPO. Currently there is inordinate delay, for example Delhi Patent Office is now publishing applications for 2005

9. Patent applications that are published in the official gazette have minimal information. It is therefore recommended that the official gazette include more details of the applications in order to avoid any frivolous or unnecessary oppositions being filed.

10. The Patent office does not have any centers, which provide assistance to applicants for filing or prosecuting applications. It is therefore recommended that assistance centers should be established to help applicants to file and prosecute applications in India.

11. Clear guidelines to be issued for conducting pre-grant and post grant opposition proceedings. Presently they are being handled in an arbitrary manner

12. In order to avoid any frivolous pre-grant opposition during the prosecution of the application, the Patent Office should introduce a fixed fee that has to be paid to the Patent Office at the time of filing of a pre-grant opposition. This will help to avoid frivolous delays in the grant of the patent.

13. In order to introduce an efficient system of patent prosecution, it is recommended that the Patent Office adjust patent term to compensate patentees for any delay in the grant of the patent that reduces the term of the patent, when such delay is caused solely by the Patent office.

14. Decision making and its communication to all concerned to be made faster at the IPO. A system to be instituted for issuing the operative part of the decision first, followed by details of the decision taken. These should be advertised immediately in the technical journal to close proceedings at the earliest. Delays are leading to extensive delays in the grant of patents even if the proceedings have been concluded (opposition or otherwise) attracting serial and frivolous pre-grant oppositions. Such delays are also preventing the patent applicants to get their grants and are, therefore, unable to initiate infringement proceedings against infringers quickly, defeating the very purpose of the patent and trademark system.

15. The timeline for an application to be taken up for examination to be clearly defined. Currently, there is no time defined for taking up the applications for examination.

It will indeed be great, if the DIPP and the IPO take note of these suggestions and formalize a process within the IPO to address these issues. A growing discontentment in several areas of operation within the IPO is brewing, both in India and abroad. If such discontentment increases further, it may have serious impact on the credibility of the new IPR regime in India.

Will the Government of India want that to happen? I hope not.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.