Monthly Archives: January 2017

India: Do we need Patent Term Extension and Non-Patent Exclusivities for Pharmaceuticals?

India, though in a phase of rapid economic development, still has the bane of poverty. In this country, around 22% of the population is Below the Poverty Line [1], and hence most of the nation’s policies are oriented towards the poor. India’s IP Policy is no different, as the IP legislature in India is mostly oriented towards giving the general public an easy and inexpensive access to medicines. Indian IP policy drafters have used every flexibility in the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS), to which India is a signatory, for this purpose.

The curious case of drug development

The process of development of the drugs to treat the diseases and ailments is pretty much painstaking. A drug regulatory authority, (e.g. The US Food and Drug Administration-US FDA; Central Drugs Standard Control Organization-CDSCO in India) monitors and governs the testing of the New Chemical Entities (NCEs) through pre-clinical and clinical trials to prove their safety and efficacy to treat an ailment. Several NCEs fail at some or the other stage, rendering all the money and efforts in vain. The amount of money invested in each NCE is of the order of billions of dollars. [2] The time period it takes for the development of the NCEs as approved ‘Drugs’ typically ranges from 10-15 years [2]. The chances of a candidate making it through this whole of the process, to the desk of the pharmacy, are merely 2% [2]. So, in this precarious situation, the 20 years of patent protection granted to the drug products is not sufficient to recover the huge investment made in the R&D of the product. So, the pharma companies usually demand the extension of the protection of their monopoly over the drug product. This Patent Term Extension (PTE) is granted by the Patent Office of the region or country.

Now, these clinical trials generate data regarding the therapeutic activity and safety of the drug. So, if a generic player wants to launch the same drug, it will need this data to prove that its generic version of the drug is ‘equivalent’ to the innovator’s product. Since the innovator companies invest huge amounts of time, money and efforts into generating this data, they demand exclusivity of this data. This Clinical Trial Data Exclusivity is under the discretion of the drug regulatory authority and regardless of the existence of a valid patent on the subject matter. If granted, it gives an additional layer of protection to the innovator drug product.

In the following paragraphs, we will discuss the Patent Term Extension and Clinical Trial Data Exclusivity provisions present in the US and European, legislature, in comparison with the Indian scenario. Several other countries also provide these provisions, but we will limit our discussion to these three jurisdictions.

 

Patent Term Extension

In the US, according to the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, 1984 [3], the patent term can be extended up to 5 years, however, the total patent term (including extension) should not be more than 14 years after the date of approval of the product by FDA. This period may be extended by a period of another six months of Pediatric Exclusivity.

The European Patent Office similarly provides an extension of protection in this regards, by giving the Supplementary Protection Certificate (SPC). [4] The SPC allows extending the Patent term by 5 years. however, the total patent term (including extension) should not be more than 15 years after the date of approval of the product by the European Medicines Agency. Additional 6 months’ protection is given to medicinal preparation to treat children (Pediatric Formulations). This extension is not applicable to orphan drugs [11]

Non-Patent Exclusivities:

The US FDA grants different types of Non-Patent Exclusivities [5] [6]

  1. 5 years for a New Chemical Exclusivity (NCE) for the Active Ingredient approved for the first time
  2. 180 days exclusivity for the generic player who first files and maintain an ANDA (Abbreviated New Drug Application) with Paragraph IV certification, which requires the applicant to prove either that he will not be infringing the innovator’s patent or that the innovator’s patent is invalid/not enforceable.
  • 3 years of New Clinical Study Exclusivity for submission of “reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application [or the supplemental application] and conducted or sponsored by the applicant”. For example, in case of preparation of a drug previously approved, which differs in the route of administration, drug delivery system, dosing regimen, modification of the drug such as salt or ester, which won’t affect the pharmacological actions of the drug. The exclusivity period would start from the date of NDA approval of the same drug. This is for the Active Ingredient has been approved before in another application.
  1. 5 additional years in case of antibiotics that treat some serious condition, for products that have obtained Qualified Infectious Disease Products (QIDP) designation under the Generating Antibiotics Incentives Now (GAIN) Act.
  2. 7 years for an orphan drug, i.e. the drug for the treatment of the rare diseases
  3. 6 months of Pediatric Exclusivity which gets added to the existing Patents and exclusivities.

The table below summarizes these exclusivities in relation to whether innovator and/or generic players can avail them.

Table 1. Scheme of Exclusivities granted by the US FDA

Sr. No. Description  NDA Applicant  ANDA Applicants
1 New Chemical Entity (NCE) 5 years NA
2 New Clinical Investigation (NCI) (Same drug, different route of administration or another form of the same drug, e.g. salt form) 3 years NA
3 First Abbreviated New Drug Application, under Para (IV), with applicant successfully proving the innovators patent invalid, or not infringing, or in case the infringement suit is not filed within 45 days of application NA 6 months
4 Antibiotics with Qualified Infectious Disease Product (QIDP) designation to treat serious conditions 5 additional years NA
5 Drugs to treat rare disease (Orphan Drugs) 7 years NA
6 Pediatric preparation 6 additional months NA

The European Medicines Agency, after 2005,started the 8+2(+1) formula which dictates that the innovator will be getting 8 years’ data exclusivity, and 2 years of market protection, during which no generic can be placed on the market, and an additional 1 year exclusivity for the new indication which shows significant clinical benefit (same as NCI in the US). Prior to this rule, there was a distinction for nationalized procedure and centralized procedure. The following table indicates the exclusivity period based on the application date and type.

Date of submission of application For Centralized Procedure For Nationalized Procedure
Before

20.11.2005 (CP)

30.10.2005 (NP)

10 years’ data exclusivity 6a or 10b years’ data exclusivity
After

20.11.2005 (CP)

30.10.2005 (NP)

8 years data exclusivity

+2 years market protection

(+1 year market protection for the new indication showing significant clinical benefit)

a – Austria, Denmark, Finland, Ireland, Portugal, Spain, Greece, Poland, Czech Republic, Hungary, Lithuania, Latvia, Sweden, Slovakia, Malta, Estonia, Cyprus, Bulgaria, Romania, Norway, Iceland, and Liechtenstein. (‘6-year countries’)

b – Belgium, Germany, France, Italy, Netherlands, Sweden, United Kingdom, Luxembourg. (’10 year countries’)

In addition to this, the orphan drugs get 2 more years of exclusivity. [7], [11]

India

India has not, as of yet, implemented such provisions, because-

  1. Granting of the PTE and Non-Patent Exclusivities would require the establishment of the Patent Linkage system in effect, which is not there at present, and India is not planning to do it in the near future, because India has not, as of yet, entered into any trade agreement which requires such provisions.
  2. The TRIPS agreement also does not require members to grant such benefits to the innovators, this means that India is in no obligations to grant PTE and Non-Patent Exclusivities. [8] Whatever pressure is there on Indian policymakers to implement such benefits, are there due to the Trade Agreements like the Trans-Pacific Partnership (TPP), Regional Comprehensive Economic Partnership (RCEP). These agreements constitute to a new regime called as TRIPS Plus, which is lobbied by the big pharma companies of the developed countries. Currently, India is not signatory to any of such agreements.
  3. If at all these provisions are implemented, they would severely delay the entry of generic versions of the drugs into the market. India, being a developing country, simply cannot afford granting PTE and DE to every request, at the expense of access to the poor.
  4. On the same lines, the Indian Pharma sector is largely thriving on the generic players, so the industry is hardly affected by the absence of provisions for PTE and DE.

These provisions have long been sought by the Big Pharma lobby of the developed nations, by criticizing India’s ‘weak’ IP policies. Companies like Bayer, Novartis have tried to tweak with the legislature for the same purpose. [9] Several generic pharma companies and access-to-medicines activists like Médecins Sans Frontières (Doctors without Borders) have constantly warned India about the effects of such provisions, saying that India will no longer remain the ‘Pharmacy of the world’. [10]

Implementing these would be advantageous only to the innovator companies, and millions will be stripped off their right to live a healthy life. This is being sugarcoated to say that these provisions will boost the trade and innovation in India. On the other hand, if these provisions are not introduced, India will be under constant pressure to do so at the earliest, but it won’t kill anyone. Now it is up to the policy makers whom they are going to put first.

About the Author: Mr. Swapnil Chandwade intern at Khurana and Khurana, Advocates and IP Attorneys. In case of any queries, feel free to reach on swapnil@khuranaandkhurana.com.

References:

  1. http://data.worldbank.org/country/india
  2. http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html
  3. http://www.fda.gov/newsevents/testimony/ucm115033.htm
  4. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31992R1768
  5. http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf
  6. http://www.orangebookblog.com/files/nonpatent_exclusivity.pdf
  7. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf
  8. https://indiankanoon.org/doc/1123372/
  9. https://iiprd.wordpress.com/2010/05/17/bayer-vs-cipla/
  10. http://www.thehindu.com/sci-tech/health/If-India-signs-RCEP-it-will-not-be-the-pharmacy-of-the-world-MSF/article14422200.ece
  11. Chakrabarti, G., 2014. Need of data exclusivity: Impact on access to medicine. Journal of Intellectual Property Rights, 19(5), pp.325-336.
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First Symposium of IIPRD in 2017

After successfully conducting several symposiums in 2016, IIPRD is coming up with one-day seminar on software and electronics patent portfolio with focus on preliminary preparation, prosecution, and litigation in India and US.  While the programme is being organized in Pune on February 23, the one in Bengaluru will be hosted February 24.

The seminar is being arranged by IIPRD along with Khurana and Khurana, Advocates and IP Attorneys and Sughrue Mion.

With speakers like Chid Iyer-partner of International Law Firm of Sughrue Mion, Anubhav Kapoor-Tata Technologies’ General Counsel and Company Secretary, Vinod Khurana-Senior Partner at IIPRD and Khurana & Khurana, IP Attorneys, Irfan Modi-Senior IP Law Attorney at IBM India, Subhadip Sarkar- Senior Director and manages Intellectual Property at Cognizant Technology Solutions, Mr. R. Lakshminarayanan- Head of Intellectual Property Rights (IPR) Management in Samsung R&D India, Mr. Ajay Panwar- having 11 years of experience in the field of IP with domain expertise in software and electronics, Tarun Khurana- having over 14 years of experience in a broad range of IP subject matters, and Co-Founding Partner and Patent Attorney of Khurana & Khurana, Abhishek Pandurangi- partner at Khurana & Khurana, having over a stretch of 7 years as an IP practitioner, entrepreneur, legal expert and a trainer, one cannot afford to miss same. This event turns out to be great opportunity for IP Groups, R&D experts, In-House IP/Legal Counsels, Patent Agents & Attorneys in the field of Practice, Patent Litigators, and Professionals in Legal Domain related to Software,Information Technology, Instrumentation, Electronics, Electrical, Embedded, Mobile Technology, IoT, and Telecom Domains.

Fee per delegate is INR 5,000 for Indians and is INR 10,000 for foreign applicants.

For more details about profiles of partners, programme outline, speakers, why and how to apply, please see http://www.iiprd.com/iiprd-symposium-23rd-february-2017-24th-february-2017/.

Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year.

Here is our take:

Details of the Patent Application and important dates:

Patent application number in India 2056/KOLNP/2010
Title of the invention SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID
Applicant VERTEX PHARMACEUTICALS INCORPORATED
International application number/ International filing date PCT/US2008/08545/

 

04/12/2008

Priority Application Number/ Priority date US61/012,162

 

07/12/2007

National phase Filing date 04/12/2008
Publication date 03/09/2010
Request for examination date 25/11/2010
Pre-Grant Opposition under section 25 (1) 19/02/2011
First examination report Date 20/08/2014
Date of communication of outstanding objections 01/03/2016
Date of hearing after failure to put the application in condition of allowance 18/03/2016
Date of decision of rejection 31/03/2016

Application Area:

Lumacaftor is given with another active ingredient Ivacaftor in the treatment of cystic fibrosis which is caused by F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Facts of the case:

First Examination Report (FER) was issued on 20/08/2014 which not only objected claims based on the prior arts cited in International Preliminary Report on Patentability (IPRP) corresponding to PCT application but also used section 3 (d), 3 (i), 3 (n) of the Patents Act, 1970, and procedural grounds for objection.

As the FER was issued on 20/08/2014 (before 16/05/2016), period of twelve months was allowed to put the application in condition of allowance. Controller found the application not to be in condition of allowance even after 12 months and communicated the objections on 01/03/2016. Finally, hearing was held on 18/03/2016.

As reported in the decision of controller dated 31/03/2016, “There were nine (09) objections mentioned in the hearing letter including major technical objections on the grounds of novelty, inventive step and non-patentability of the claimed subject matter u/s 3(d) of the ‘Act’.”

Section 3 (d) has been reproduced below for the reference:

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 of 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;

Analysis of the rejection decision:

Dr. I. S. Bhattacharya, attorney of the applicant, who attended the hearing, relied on the technical data filed as affidavit along with reply statement in respect of pre-grant opposition already filed under section 25(1) for the instant application to argue that form 1 of Lumacaftor ought to be considered be Novel and Inventive. She asserted that better pharmacokinetic properties / superior bioavailability of the formulation of claimed polymorphic Form I compared to the hydrochloride salt of the compound were enough to win the Patent.

Controller in response declined to accept the arguments on the ground ‘Anything beyond the disclosure of complete specification is not acceptable’ as the technical data was not part of the complete specification yet. The technical details were also rebuffed on the ground that different pharmacokinetic properties / superior bioavailability results were natural results of comparison of Form I (free solid) with hydrochloride salt of the same compound. He further opined that better bioavailability does not necessarily lead to better efficacy.

Based on these grounds, controller went on to reject the Patent Application under section 15.

Controller also took into consideration the pre-grant opposition that had also been filed under section 25(1) by Indian Pharmaceuticals Alliance, Mumbai for the instant application. Controller did not conduct a separate hearing under section 25 (1) as the grounds and prior arts were incorporated in the hearing letter and were heard on 18/03/2016. Controller accepted the petition under section 25 (1) while refusing the grant of the patent application no. 2056/KOLNP/2010.

Reference:

http://ipindiaservices.gov.in/decision/2056-KOLNP-2010-16971/2056-KOLNP-2010.pdf

A Primer to Patent Application Drafting with special emphasis on standard practise(s) before the Indian Patent Office

An enforceable Patent being the key to effective Commercialization/Out-Licensing of any technology needs to be drafted well. No matter how good a technology is, if the description of the technical subject matter of a Patent is not enabling or fails to disclose all necessary embodiments, and in case the claims are narrowly drafted and do not gain support from the specification, the worth of the technology is insignificant.

Patent application (whether provisional or complete specification), being a complex techno-legal document and difficult to prepare, mostly requires inventors to seek professional assistance from a patent practitioner. Nevertheless, many inventors facing the economic crunch decide to proceed on their own. This is a perfectly fine choice, but it needs to be done with eyes wide open. It also requires the do-it-yourself inventor to become as knowledgeable and familiar with the process of describing an invention and drafting a patent application as possible before he/she decides to embark on the path of preparing his/her own patent application. Patent claims, particularly, are enormously difficult to draft due to the peculiar format/rules prescribed by the Patent Offices of different jurisdictions. The claim set section defines the boundaries (i.e., scope) of patent protection afforded under the patent. The claim set must particularly point out and distinctly claim the subject matter which the inventor regards as his/her invention. There is much to be learned with respect to drafting claims, which is why inventors are at a substantial disadvantage if they are to represent themselves. However, avoiding pitfalls, an inventor can still strive to conclude a complete and descriptive patent application successfully. Further, as a do-it-yourself inventor develops his style of patent drafting, it is useful for him/her to occasionally look back to the rules of practice to ensure that they are still being followed.

Considering this need of several inventors, this document (http://www.khuranaandkhurana.com/wp-content/uploads/2017/01/ANATOMY-OF-PATENT-SPECIFICATION.pdf) is prepared, which may serve the purpose of a primer delineating some standard practices which can be followed to pen down the invention in the best possible manner. The information provided as part of the document explains and elaborates on the following important elements/parts/aspects of the patent application to be filed before the Indian Patent Office:

1) Title of Invention
2) Field of Invention
3) State of the art in the field (Background & Prior Art)
4) Object of invention
5) Brief description of drawings
6) Preamble to description
7) Detailed description of Invention
8) Sequence Listing (if any)
9) Claims; and
10) Abstract