The Privacy Of The Patent System

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02 Nov 2017

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2.1 Introduction

According to the TRIPS Agreement, developing counties which are member states of the Towered required to provide patent protection on medicines by 1 January 2000 (World Trade Organization 2002). A patent aims to promote innovation by rewarding inventors with the exclusive right to produce and sell a good, for a limited time, to prevent others from making, using, selling, or distributing the patented invention without permission. Social benefit is derived not only from being able to access a new technology as it comes to market, but also from access to the information disclosed within the patent system, which is a source of valuable technical knowledge that can be reproducible without unnecessary burden. These aims coincide with the objectives of the TRIPS Agreement to promote technological innovation and to transfer and disseminate technology; a balance of rights and obligations.

Patent information, whether it has been filed, granted, is pending or has expired, is important to public health in a number of ways. Local health authorities and procurement bodies need to have patent information to help them choose cheaper medicines from alternative sources without the risk of patent infringement (World Health Organization 2004). Research institutions and originator and generic pharmaceutical firms, need to know about the patent information information of specific products in specific countries in order to determine their freedom to operate in research and development, manufacturing and procurement without infringing upon patents, and to understand which licenses might have to be negotiated (Yancey and Stewart 2007). In addition, this information enables an overview of trends over time in terms of medical research and development, the changing directions of established players, and the growing role of new players in medical research and development (Liu and Shyu 1997; Ernst 2003).

However, given the critical nature of this information, identifying the patent for each medicine is surprisingly difficult, even in countries with a high level of technology (World Health Organization 2008). First, a single medicine can be protected by a large number of separate patents. Each patent can be related to an invention concerning the product (e.g. a specific molecule), a process (e.g. the process to manufacture this molecule), a medical indication (e.g. the effect of this molecule on a human body), or a combination of products (e.g. a fixed dose combination of two molecules). This is because patents protect the invention, not the medicine as such. Second, patents on medical products commonly involve very technical claims that are comprehensible only to those with substantial scientific training. Third, the fact that searching for a patent by the active ingredient name yields no results does not mean there is no patent related to that medicine, since patent specifications typically do not reference end products, in significant part because the invention was discovered before the product name was known.

In developing countries the problem is worse as there are substantial capacity and resource constraints in national patent offices, a lack of communication between the relevant authorities, and language barriers (World Health Organization 2011). As a result, developing countries usually buy patented products instead of seeking a generic equivalent version, since they assume that a medicine patented in the USA is also patented in their country. The avian flu pandemic in late 2005 is a good example which shows that the governments in developing countries could have provided this medicine for their population faster and more cheaply if the patent information of oseltamivir [1] was prepared and known. After the Philippines government planned to implement CL, the owner of the medicine declared that there was actually no patent covering oseltamivir filed in the Philippines (Requejo 2005). Also, Thailand had been purchasing the original of sertraline, a depressive disorder treatment, and risperidone, a schizophrenia treatment, for many years until the use of CL for these medicines was considered and it was found that there were no patents for these medicines in Thailand (Thaipost 2009).

In light of this, the proposal of a global pharmaceutical patent database was considered by the World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) at the 2008 World Health Assembly. The proposal was to create a user-friendly, public, global database on the status of health-related patents in all countries which could meaningfully advance public health objectives, including efficient pharmaceutical procurement, in developing countries. However, at the time of writing, the progress of this database cannot be found.

With regard to patent information related to medicines for specific diseases, some patent landscape reports on various topics have been published by different international organizations (World Health Organization 2004; World Intellectual Property Organization 2007). For example, the Médecins Sans Frontières initiated a project collaborating with selected national or regional patent offices to undertake the verification of the patent information of 18 ARV treatment products in 29 countries (Boulet, Perriens et al. 2000). Covering other diseases, a project determining the patent of the medicines on the WHO Model Lists of Essential Medicines is on-going (World Health Organization 2010). These projects aim to help developing countries obtain patent information, as undertaking a patent search is costly and time-consuming.

The patent landscapes mentioned are specific to communicable diseases. However, the burden of disease in low- and middle-income countries is now turning to non-communicable diseases, especially cancer (World Health Organization 2011). Cancer has been an important health problem in Thailand with more than 100,000 new cases diagnosed and more than 30,000 deaths each year (Wibulpolprasert 2007). Medicines treating cancer are generally expensive. The prices of new-to-market treatments, targeted therapies and those with limited toxicity are set very high. It is claimed that most of the high price chemotherapy agents are patented and it is further argued that patents lead to unaffordable prices (Ministry of Public Health 2008). Surprisingly, this claim was made without knowing exactly which medicines are under patent protection.

At present, there is no literature determining the patent of oncology medicines in developing countries generally, or in specific countries like Thailand. Numerous considerations come into play when discussing the impact of patents on public health. A fundamental part of assessing the impacts of patents is to first discover which medicines are actually covered by patents. Only then it is possible to estimate the impact of patenting on access to those medicines. Identifying which medicines are patented in one country, like Thailand, and then estimating patent impact on access may seem simple. However, it requires many processes. The number of patented medicines may be less than one expected due to the misapprehension that monopoly medicines or those medicines patented in the US are also patented in the considered country. Patent information helps to inform procurement agencies in Thailand about whether to purchase or manufacture generic versions, or whether they must obtain voluntary or CLs to legally purchase or manufacture generic versions. As mentioned previously, Thailand has been slow to seek generic versions of some products because of the misunderstanding that they were patented in Thailand. This chapter aims to shed light on the processes to identify the patent of oncology medicines in order to be able to estimate the likely impact of patents.

Following this introduction, the next section describes the pharmaceutical patent system, including medicine patent databases in USA, Canada and Thailand. This is followed by the method of patent search employed in this study. Part 4 presents the results and Part 5 concludes and discusses the patent information system in Thailand with lessons also for other developing countries.

2.2. Pharmaceutical patent and patent search guideline

A patent is an exclusive right granted to individuals who invest in the creation and dissemination of knowledge, providing them with an incentive to produce a new and useful product or a new way of doing something or of solving a problem (World Intellectual Property Organization 2011). A patent for a specific invention is national and the application for a patent is filed in the country where protection is desired; there is no worldwide protection. When a company invents a new product or process, the Paris Convention allows this company one year to file patent applications in any other Member State of the Paris Convention (World Intellectual Property Organization). This one-year period is to preserve the novelty of the invention during the time the company decides in which countries it wants to seek patent protection. A pharmaceutical company which owns an invention, either through its own R&D or in-licensing of patents from other inventors (i.e. other companies, public institutions, etc.), will file or enforce patent protection in countries where there is a market for such an invention or where potential competitors could use the invention for their own product development (Bhat 2005).

As mentioned in the introduction chapter, the pharmaceutical industry is inherently risky and costly since it faces a rapidly evolving science of discovery, as well as changing economic, legal and regulatory environments. Hundreds of millions of dollars invested in a new drug can take a decade or more to pay back, as scientific and technical barriers produce a high failure rate (DiMasi, Hansen et al. 2003). It is said that patents for the pharmaceutical industry are especially important compared with other industries, given that the actual manufacturing process is relatively easy to replicate and can be imitated with a fraction of investment of that required for the research and clinical testing (Scherer 1993). Moreover, the pharmaceutical industry is heavily regulated by government agencies to assure the safety and efficacy of products which will be sold to consumers. Without the degree of financial protection patenting secures, many argue that the innovative good or process would never be created (Nogués 1993).

Since identifying patent information on each pharmaceutical product is very complicated, there are some manuals published by WHO and World Intellectual Property Organization (WIPO) which provide a guide on how to identify if relevant patents relating to a medicine exist in the country of interest (World Intellectual Property Organization 2007; World Health Organization 2010). The manuals suggest using the US FDA Orange Book and the Health Canada Patent Register as a starting point, given the difficulties in identifying and matching patents to relevant products, since US FDA and Health Canada also provide patent information for ‘approved for sale’ medicines. However, locating patents in developing countries through the extended searches described in Box 2.1, is not a straightforward process. One reason is that the patent family and national phase data available in esp@cenet and Patentscope do not cover all countries where the patent may have been filed (World Health Organization 2010). Also, even where developing country patent offices offer an online searchable database key data may be omitted, incorrectly inputted or out of date, all of which can lead to an unsuccessful search (Limpananont, Kuanpotch et al. 2004). Finally, as complete specifications and claims for patents filed or granted in developing countries are rarely available online, in many cases they will have to be requested directly from the concerned national or regional patent office.

Box 2.1: Summary of steps to search for patents on medicines

Step 1

The first step is to identify patents that relate to marketed medicines. One efficient way of obtaining this information is through public databases made available online by the US FDA (the Orange Book) and Health Canada (Patent Register). These databases match some key US and Canadian patent numbers to medicines that are marketed in these countries, but that may also be sold in other countries.

Step 2

Once US and/or Canadian patent(s) number(s) relating to a medicine have been identified, the next step is to obtain the bibliographic details of the patent(s). It is also recommended to obtain the specification(s) of the US and/or Canadian patent(s) found. Having access to the bibliographic data and full details of the identified patents is not only useful for identifying priority data relevant to equivalent patents filed in other countries, but also for finding keywords that may be used to expand the search to other related patents. The EPO’s esp@cenet database is a source to obtain bibliographic data.

Step 3

As the Orange Book and Health Canada Patent Register do not provide information on all relevant patents relating to a particular medicine, further searches are necessary. It is recommended to expand patent searches using various techniques including keywords, applicant/assignee name, patent classification, citations and date range information. The WIPO public database and Patentscope offer more search fields than other public databases and provide information on international patent applications, as well as national phase data.

Step 4

Taking the techniques and information obtained through steps 1 to 3, the next step is to apply them to finding patents in the country of interest.

Source: WHO (2010)

2.3 Thai patent database

Although this thesis aims to assess patent implications, the first important task is to know which medicines are actually patented in Thailand. The possible approach to obtaining information on patents in Thailand is to locate the date of application for the first patent, usually protecting the basic substance of the patented medicine found from the US and Canada databases, then add one year to this date, since those patents for the same invention should have been filed within the one-year priority period referred to earlier. This allows one to get an approximate idea of when the same patent granted for the same drug in other countries will likely start and expire. However, this applies only to countries where a patent has been granted and where the patentee regularly pays the maintenance fees to keep the patent "alive". Moreover, it depends on the specific patent and country, since patent owners themselves may not file or maintain all patents. In addition, one medicine is likely to be covered by more than one patent. It is possible that the patent owner will choose to file one of the patent families. This then leads to an incorrect assumption of patent information and leads to risk of infringement. Patent analysis therefore should be done on a country specific basis.

In Thailand, there is no legal link between medicine registration and patent information. The patent database in Thailand is maintained by the Department of Intellectual Property (DIP), under the Ministry of Commerce. DIP provides an open-access database to search for patent applications and documents that patent holders in all fields, including pharmaceuticals, may have filed. The patent documents are provided in the Thai language; with terms stemming from foreign languages translated into Thai, including technical terms and the names of persons and organizations. However, searching for pharmaceutical patents with this database is not straightforward, since it is linked with name of the medicine, and often patents are filed under chemical name. Thus, searching for patents by active ingredient name is likely to yield no results. The inconsistency in translation of patent documents from English to Thai further exacerbates the problem.

In an attempt to resolve these problems, 2002 saw the launch of a Pharmaceutical Product Patent Database Development Project (PPDD) undertaken by the Social Pharmacy Research Unit, [2] Chulalongkorn University. This project examined the patent documents filed in Thailand in the international code of A61K (preparations for medical, dental, or toilet purposes (World Intellectual Property Organization), during the period 1992-2002 in order to develop a more consistent and comprehensive database of patented drugs. This database [3] is user-friendly and may be searched either by active ingredient or trade name. Unfortunately, it has not been updated since the project finished and thus has no record of medicines since 2003. Moreover, in undertaking a patent search for oncology medicines, only two medicines were found to be covered by patents in Thailand compared with 47 medicines found to be patented medicines from the US FDA and Health Canada databases. If this information is correct and up to date, it would be a great opportunity to procure the cheaper generic versions of 45 medicines. However, some of these medicines were introduced in Thailand after 2003 and hence the patent information of these medicines will not be able to be found from this database.

Patent information is often inaccurate and incomplete. All patent databases always indicate that the information may not be complete. It is therefore suggested that patent owners be contacted in order to verify medicine patent . As a result, an innovative method of cooperating with related authorities, patent offices and public health offices, as well as pharmaceutical companies to update patent information related to medicine is needed. In the next section, the process of identifying patented medicines undertaken for this thesis is outlined in more detail.

2.4. Methods

As mentioned in the introduction chapter, this thesis focuses on cancer medicines. All cancer medicines marketed in Thailand in 2008, the year this study was conducted, were obtained from the Thai FDA. This resulted in 88 active ingredients to conduct patent searches for. Mixed methods were used as recommended by the WHO guideline and other sources available in Thailand. Figure 2.1 presents the process to search for medicine patent employed in this study. In short, all active ingredients were initially searched for in the DIP public database and PPDD databases, as mentioned in the previous section. For the medicines with a status of ‘not-found’, the patent status and information (patent number and filing date) of their active ingredients were searched for in the U.S. FDA Orange Book and Health Canada databases. Further searches were conducted to identify the priority and family information for the Thai patent office to verify relevant patents in Thailand. Active ingredients that were found to be patented in USA or Canada, but where patent information was not found in DIP, were then confirmed with the relevant pharmaceutical companies and the NLEM committee. The next section describes each step in details.

Figure 2. Patent search process

2.4.1 Identification of patented medicines by Thai patent office

The critical information required to search for relevant patents of each medicine is identifying the ‘priority data’. The priority data are the application numbers and dates provided when the first patent application claiming an invention is filed (World Health Organization 2010). These numbers are referred to when subsequent patents or related subject matter patents are filed. This ‘priority data’ can therefore be used to connect related patent documents across national or regional patent offices, through databases and computerized search systems. Hence, the priority application number functions as an identifying code in the world intellectual property system. WIPO considers the availability of correct priority application numbers to be extremely important and has requested that "the standard be implemented by industrial property offices as soon as possible" (World Intellectual Property Organization 2007). The Thai patent office is compliant with this standard and requests applicants to provide priority data of every patent filing at DIP. Therefore, by providing the priority number(s) for a patent relating to each medicine, a patent office may be able to match it to a patent filed in Thailand.

In theory, the priority application numbers can be used on their own to request applications and granted patents from the Thai patent office. However, in practice, a ‘patent family’ searching step, which includes all related patents, can help make the patent search more comprehensive. A ‘patent family’ is a list of similar patent documents linked by priority application numbers from throughout the world that derive their origin from the priority patent (Hingley and Park 2003). Identifying the patent family generates a group of hundreds of patents all originating to a specific priority application number. For this thesis, patent family information was retrieved through the European Patent Office’s (EPO) Esp@ceNet. [4] As a result, a family of patent numbers and filing dates of each patent is recored and used as another source of information to search for patents filed in Thailand.

In short, the first step is to identify patented medicines from the Orange book and/or Health Canada databases (Generic Pharmaceutical Industry and Intellectual Property Section 2008; World Health Organization 2010). These two databases also provide the patent(s) listed by the proprietor in relation to the market product. All patent numbers for each product were recorded. For each patent number, the priority data were retrieved from US and Canadian patent information through the online patent office databases: the United States Patent and Trademark Office (USPTO) [5] and Canadian Intellectual Property Office (CIPO) [6] for US and Canadian patents respectively. A search for the relevant patent families for each patent was then conducted.

Table 2. Example information used to search for patents of amifostine

1

2

3

4

5

6

Patent number

Application number

Filing date

Priority data

Patent family

(filing number and date)

Priority date of patent famiy

5424471

08/099,298

July 29, 1993

US19930099298 19930729; US19920922929 19920731

EP0655917 (A1) - 1995-06-07

EP0655917 (A4) - 1995-08-02

EP0655917 (B1) - 2004-03-17 EP1243272 (A2) - 2002-09-25

EP1243272 (A3) - 2003-01-22

EP1764103 (A2) - 2007-03-21

US5424471 (A) - 1995-06-13 US5591731 (A) - 1997-01-07

1992-07-31

5591731

08/389,386

February 16, 1995

US19950389386 19950216; US19930099298 19930729; US19920922929 19920731

EP0655917 (A1) - 1995-06-07

EP0655917 (A4) - 1995-08-02

EP0655917 (B1) - 2004-03-17 EP1243272 (A2) - 2002-09-25

EP1243272 (A3) - 2003-01-22 EP1764103 (A2) - 2007-03-21

US5424471 (A) - 1995-06-13 US5591731 (A) - 1997-01-07

1992-07-31

5994409

08/987,550

December 9, 1997

US19970987550 19971209

EP1039887 (A1) - 2000-10-04 EP1039887 (A4) - 2003-01-15

EP1039887 (B1) - 2006-05-24 EP1537861 (A2) - 2005-06-08

EP1537861 (A3) - 2005-06-15 US5994409 (A) - 1999-11-30

US6586476 (B1) - 2003-07-01 US2002132795 (A1) - 2002-09-19

US7105575 (B2) - 2006-09-12

1997-12-09

2120133

66440

July 30, 1993

US19930099298 19930729; US19920922929 19920731

EP0655917 (A1) - 1995-06-07

EP0655917 (A4) - 1995-08-02

EP0655917 (B1) - 2004-03-17

EP1243272 (A2) - 2002-09-25

EP1243272 (A3) - 2003-01-22 EP1764103 (A2) - 2007-03-21 US5424471 (A) - 1995-06-13 US5591731 (A) - 1997-01-07

US2006040903 (A1) - 2006-02-23

1992-07-31

An example of patent data retrival for one medicine, amifostine, is illustrated in Table 2.1. From Orange book and Health Canada databases, there are four patents reported. Each patent, application number and date and priority data were recorded as shown in column 2 to 4. Each patent number was then used to search for patent family in Esp@ceNet to get the information in column 5. Thai patent database [7] allows users to search with flexible fields such as by patent number, application date, priority patent number, priority patent date. Data in column 4, priority data, were used as priority to search in the DIP internal database. If no patent information was found, the data from column 1 to 3 was used. The search was then finalised by searching by patent family data, column 5 and 6, respectively. To sum up, for one medicine, it could reach to a hundred of search terms.

In conclusion, verification was provided by the Thai patent offices by using key sets of information to identify if the medicine is patented ,, which are:

US and/or Canadian patent number, application number and date;

the priority application data of each patent; and

patent application numbers and dates identified through the patent family search.

2.4.2 Identification of patented medicines by other authorities

For those medicines found to have patent(s) in the US and/or Canada but not found by the Thai patent office, confirmation was sought directly from the relevant pharmaceutical companies on their patent status: examination process, adverstisement process, granted patent or others.The names of companies selling suspected patented medicines (from Orange Book and/or from the monopoly medicine status from the FDA drug registration database) are listed in Appendix 1. A questionnaire was developed to survey medicine patent information from these companies, including application number, types of patents (product, process, or petty patent), date of the application, patent status (filing, examination, advertisement or granted) and patent expiry date. An example is shown in Appendix 2. Since the time available to collect information was limited, 14 weeks, the survey was done via the Association of Pharmaceutical Research & Manufacturers (PReMA) who cooperated and distributed the questionnaire from October 2010 to January 2011.

Pharmaceutical patent information may also be obtained from the NLEM committee. The NLEM is a list of medicines, vaccines, radioactive substances, and disinfection agents that are necessary for the prevention and control of major health problems in Thailand. The NLEM is referred to by the three public health schemes as the ‘pharmaceutical reimbursement list’ (Teerawattananon, Tantivess et al. 2009). Applicants for pharmaceutical patents have to submit the "Por.Tor.Yor. 14 Form" to the NLEM committee. There is one section with regard to patent information. It requests product owners to provide patent information for the medicine concerned. However, submitting patent information is requested, not required, since there is no law or regulation to force the applicants to provide the patent information. Therefore, there is much missing patent data and some information is incorrect.

In parallel to questionnaires being administered to pharmaceutical companies, as outlined, a request was made to the NLEM committee to access the forms to retrieve the patent information part of the form submitted by pharmaceutical companies. Data were then cross-checked with the data provided by the pharmaceutical companies.

2.5. Results

Figure 2.2 shows the results from the patent verification process. From 88 active ingredients selling in Thailand in 2008, four patented medicines were found from PPDD and DIP. It was found that 47 medicines have been filed for patent protection in USA or Canada. All relevant data, including priority patent data and patent family data of each patented medicine were sent to the patent office in Thailand to search for the patent application or patent granted to those 47 medicines. Twenty-one medicines were found to have patent protection from the DIP internal database and through verification by a patent officer. For the rest of the medicines, the Por.Tor.Yor. form was requested from the NLEM, in parallel with a survey of pharmaceutical companies. Another six medicines were confirmed to have been subject to filed patents in Thailand; three of which were retrieved from the NLEM. A number of pharmaceutical companies refused to complete the questionnaire survey, claiming that they did not have the information or that it was company policy to keep the information requested confidential. Therefore, for eight medicines (Appendix 3) there is no information concerning patent status. Appendix 3 also shows non-patented medicines, of which twelve were confirmed as such by pharmaceutical companies.

Figure 2. Step by step results of patent status verification

Table 2.2 shows patent information for 31 active ingredients that the patent owner filed for patent protection, either for product, process or new use protection, in Thailand over the period 1993-2008. It also provides their patent number, application number, filing date and expiry date. As can be seen from the table, most medicines are protected by product patents. Only two process patented medicines, docetaxel and gemcitabine, and one new use patented medicine, ondansetron, were found. There are some medicines that are still under the examination process. 14 medicines that have a patent status of ‘examination’ still have to await the examination process to be finished.

Patents of four medicines are under the ‘filing’ status. The patent details of medicines that currently remain in the filing process are not known. DIP regulations state that applications for patents which are not published or issued are not generally open to the public, and no information concerning them is released. Therefore, the details of patents filed for four medicines (dasatinib, etoposide, oxaliplatin and trastuzumab) cannot be obtained. For granisetron, ibandronic acid and sorafenib, there is no patent information available through the Por.Tor.Yor. 14 Form of NLEM or through information obtained from pharmaceutical companies.

Table 2. List of patented medicines

No.

Active ingredients

 

Patent information

Patent number

Application No.

Type

Filing date

Expiry date

1

Aprepitant

17690

9801002488

Product

1-Jul-1998

1-Jul-2018

Examination

0201004524

Product

3-Dec-2002

-

2

Bevacizumab

Examination

0501004920

Product

20-Oct-2005

-

3

Bortezomib

Examination

0501001443

Process

29-Mar-2005

-

4

Capecitabine

9441

9301002157

Product

26-Nov-1993

26-Nov-2013

5

Cetuximab

Examination

0201004785

Product

20-Dec-2002

-

Examination

0401004678

Product

25-Nov-2004

-

Examination

0401004701

Product

26-Nov-2004

-

6

Dasatinib

Examination

0501005150

New use

2-Nov-2005

 

Filing process

7

Docetaxel

12332

9501001641

Process

7-Jul-1995

7-Jul-2015

8

Doxorubicin

Filing process

9

Epoetin beta***

Examination

101001782

10-May-2001

10

Erlotinib HCl

Examination

9601000814

Product

19-Mar-1996

-

11

Etoposide

Filing process

12

Fludarabine phosphate

Examination

0201004766

Product

19-Dec-2002

 

13

Gefitinib

27686

9601001252

Product

24-Apr-1996

24-Apr-2016

14

Gemcitabine*

Examination

19307

Process

21-Jun- 1993

-

10145

19308

Process

21-Jun- 1993

21-Jun- 2013

15

Goserelin

Examination

0101000493

Product

14-Feb-2001

- 

16

Granisetron**

No patent information disclosure

17

Ibandronic acid**

No patent information disclosure

18

Ibritumomab

9595

9301002057

Product

12-Nov-1993

12-Nov-2013

19

Imatinib

Examination

9801002650

Product

13-Jul-1998

 

20

Irinotecan

Examination

0501002510

Product

31-May-2005

-

21

Lapatinib

Examination

9901000064

Product

11-Jan-1999

-

22

Letrozole

Examination

0801000497

Process

31-Jan-2008

-

23

Medroxyprogesterone

9157

9501003476

Product

26-Dec-1995

26-Dec-2015

24

Nilotinib

Examination

0301002355

Product

25-Jun-2003

 

25

Ondansetron *

9938

9401001016

New formula, New use

23-May-1994

23-May-2014

Examination

0501000228

Product

20/01/2005

-

26

Oxaliplatin

Filing process

27

Paclitaxel*

Examination

030658

Product

27-Mar-1996

-

Examination

034883

Product

20-Dec-1996

-

Examination

063343

Product

31-Jan-2001

-

Examination

072446

Product

20-Jan-2002

28

Rituximab

9595

9301002057

Product

12-Nov-1993

12-Nov-2013

29

Sorafenib***

No patent information disclosure

30

Trastuzumab**

Filing process

31

Tretinoin

Examination

1003953

New use

16-Oct-00

16-Oct-20

* from FDA patent database ,** from pharmaceutical companies, *** from NLEM

Figure 2. Patent status and sources of patent information

In conclusion, in figure 2.3, 35% of oncology medicines in Thailand in 2008 were patented, 57% were unpatented, and 8%were unknown. The list of unknown patent status and non-patented medicines are shown in Appendix 3. The pie chart below shows that DIP is the main source of patent information. Pharmaceutical companies are also an important source to confirm that the medicines are not patented in local markets.

Table 2.2 presents the list of 13 active ingredients that were found to be unpatented in the USA or Canada. Each medicine has only one seller marketing it in Thai market. The sales value of these medicines in the year 2008 was approximately 262 million baht (8.7 million $US).

Table 2. List of monopoly status medicines found to have no patent in US or Canada drug patent database

No.

Active ingredients

No.

Active ingredients

No.

Active ingredients

1

altretamine

6

Dactinomycin

11

ramosetron hydrochloride

2

asparaginase

7

hydroxycarbamide

12

tegafur + uracil

3

azacitidine

8

Idarubicin

13

thioguanine

4

buserelin

9

Lenograstim

5

chlorambucil

10

Melphalan

Three main sources of patent information have revealed that there are 31 medicines that product owners requested patent protection for in the Thai market. The number could be higher if the medicines with unknown patent status are included, which yields 39 medicines out of 88 medicines, but this is still well under half of medicines in the Thai market. When comparing this number with the figure of patented medicines either in the US or Canada, 49 of these 88 medicines were found to have patent protection in the USA or Canada.

2.5. Conclusion and discussion

This chapter provides information on the patent status for each oncology medicine marketed in Thailand in 2008. Given that there is no good system to identify whether a medicine is patented or not in Thailand, this chapter shows how patent information can be searched for in Thailand. By tracing the medicine’s origin from the US, Canada and Espacenet patent databases, and continuing to investigate with the Thai patent office, the FDA and pharmaceutical companies, 31 medicines were found to have patent protection.

The national patent office is the most obvious source to identify patents. However, the process takes considerable time since their capacity to deal with requests is limited. Although the guidelines for assessing patents are very useful, patent information for some medicines were not able to be found using this process. There are three possible reasons for this. First, product owners may decide that the patent filed in Thailand will not be shown in the patent family as it may have subsequent patents granted later on to protect; for instance, an improved manufacturing process or improved formulation with fewer side-effects, which have not yet been linked together. Second, the applicant might submit the wrong priority data, for example instead of 630.224, writing 630,224, which would mean that the electronic database would not be able to identify it. Third, it may be the case that pharmaceutical companies might choose not to file a patent in Thailand if they think the capability to produce that medicine is limited.

Aso, the decision to choose which patent will be filed in any country depends on its owner assessing the cost, scope of protection, law enforcement or any potential negative consequesnces (Borrell and Watal 2003; Pavento, Greene et al. 2003). Four medicines, bortezomib, docetaxel, gemcitabine and letrozole, were found to have process patent protection instead of product patent protection. Process patent means that local manufacturers or other suppliers can produce or find similar products that have a technically different production process without incurring patent infringement. This might be because a patent is typically filed when the invention is found and it takes considerable time to bring that product into the market. Since Thailand changed its patent law in 1992, the first product patent of a medicine filed elsewhere may already have expired by 1992, or it may not be possible to file a patent in Thailand, i.e. it cannot be counted as ‘novelty’. Therefore, relatively important patents, that still have patent life, maybe considered filing in Thailand.

The USA and Canada account for a significant market share of world pharmaceutical sales (International Union Against Cancer 2008). Product owners will try to seek patent protection in these countries. There is an assumption that if a medicine is patented in the US, it is likely to be patented in a developing country as well. This might not be the case since it depends on company’s decision to file a patent application in the country. This study confirms this argument since the results show that 15 active ingredients patented in the USA do not have a patent in Thailand. With lower technology capability and performance, pharmaceutical companies may not consider it worthwhile to protect their products with patents in some developing countries. Developing countries may therefore find that they pay more than they need to for some medicines simply due to this misinterpretation.

Identifying patented medicines is very simple in developed countries like the US and Canada since there is a direct linkage between the FDA and patent office. Patent linkage refers to the communication process between the Health Ministry and the Patent Office to prevent marketing approval of generic drugs until after the expiration of patents covering the drug product or approved use. This system requires product owners to file patent information related to medicine within 30 days of approval. Despite the fact that it helps in identifying patented medicines and opens the door to access to technical knowledge related to those medicines, it causes problems since it could delay entry of generic medicines to the market since the manufacturer of the generics must provide notice to the original manufacturer of its submission of an application, thereby allowing the patent owner the opportunity to seek enforcement of its patent rights (MERCK 2011; Knowledge Ecology International 2011 ).

In many developing countries, however, this option is not available, and pharmaceutical patent information is effectively secret from all but the patent holder. Private services may not cover these countries, or may be prohibitively expensive for public organizations. As a result, many guidelines concerning how to conduct a pharmaceutical patent search have been published, although often systems cannot be navigated easily to work out precisely what is patented. Thus, international organizations have tried to provide examples of how to find a patented medicine in some countries (World Health Organization 2004; World Intellectual Property Organization 2011). These efforts have demonstrated the appropriate means to identify patent landscapes in developing countries.

Establishing a user friendly health related patent database for developing countries was proposed by the WHO's IGWG (World Health Organization 2008). However, although it is feasible, this establishment could consume huge effort and considerable time, expertise and funding to overcome the barriers. Some patent mapping in developing countries has been done but this can only focus on specific medicines, as this study focuses on oncology medicines. In addition, the patent review reports always state clearly that the patent information in the report may not be considered as a complete and official source of patent information. It is recommended to confirm with the patent office or pharmaceutical companies directly before medicine procurement is made.

This makes an obvious imbalance in the patent system visible. A government grants a monopoly right to exclude others from making, using or importing the invention throughout that country, in exchange for the disclosure of the invention to the public to meet the objective of the patent system to encourage inventive activity, as well as technology transfer. Yet the exclusive right protection is reached while the disclosure is still confidential in developing countries, impeding strategic procurement. This chapter reveals that a lack of patent information could lead to missed opportunities in the cost-effective procurement of generic medicines, since not every monopoly medicine is patented. The difficulties in obtaining such information make it very difficult to establish what price should be paid, and what the implication of a patent on price is. It is impossible to estimate the impact of patenting on price or other factors if the patent status itself is not known. Indeed, ironically, patenting might actually not hinder public health if, as is the case in Amir’sstudy, only 2% of essential medicines listed on the WHO Essential Medicine List are patented (Amir 2004).

This study reveals the oncology medicine patent landscape in Thailand with the verification of patent statuses at the national level. The next level of inquiry is whether granted patents cover inventions that affect the use of and access to some medicines. In this case, analysis of national patents is needed to determine the scope of the patent with respect to a commercial product made, used, sold or imported into Thailand. Further studies need to be done to answer this question.



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