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1681

LEGAL PROTECTION ON PHARMACEUTICAL PRODUCT

PATENTS BY THE GOVERNMENT ON COVID-19’S REMDEVISIR

AND FAVIPIRAVIR

Bernadete Nurmawati

, Dewi Iryani

, Puguh Aji Hari Setiawan

, KMS Herman

Faculty of Law, Bung Karno University, Indonesia

2,3

Master of Law, Bung Karno University, Indonesia

Master of Law, Borobudur University, Indonesia

benurmawati@gmail.com

iryani.dewi@yahoo.co.id

ubkpuguhaji@gmail.com

kemas_herman@yahoo.com

PAPER INFO ABSTRACT

Received:

November 2022

Revised:

November 2022

Approved:

November 2022

Background: The implementation of patents by the Government for

pharmaceutical products can be carried out in terms of very urgent needs for

the benefit of the community, such as medicines that are still protected by

patents to overcome Coronavirus Disease 2019 (Covid-19) in Indonesia.

Aim: To analyze the implementation of Patents by the Government

according to Law Number 13 of 2016 concerning Patents and legal protection

for pharmaceutical product patent holders for the Implementation of Patents

by the Government against remdevisir drugs and favipiravir.

Method: Research method based on normative juridical approach from

various legal materials through literature studies.

Findings: To overcome the Covid-19 disease in Indonesia, the government

needs to establish an access policy for pharmaceutical products as stated in

Presidential Regulation Number 100 of 2021 concerning the Implementation

of Patents by the Government against Remdesivir Drugs and Presidential

Regulation Number 101 of 2021 concerning the Implementation of Patents

by the Government against the Favipiravir Drug, on November 10, 2021.

Patent holders of Remdevisir and Favipiravir medicinal pharmaceutical

products are entitled to legal protection for the exercise of exclusive rights

and payment of compensation during the Implementation of Patents by the

Government in the amount of 1% of the net selling value of Remdesivir and

Favipiravir drugs.

KEYWORDS

patents, pharmaceutical products, compensation

Commons Attribution-ShareAlike 4.0 International License (CC BY-SA 4.0)

INTRODUCTION

A patent is an exclusive right granted by the state to the inventor for the results of his

invention in the field of technology for a certain period to carry out the invention himself or

give consent to other parties to carry it out (van Apeldoorn, 1993). From this understanding,

the important element of patents are patent rights, which means the rights granted by the

government to carry out inventions and are exclusive (Sitorus, 2014). In Patents, there are

exclusive rights that make the Patent Holder can grant permission or license to other parties or

third parties (Hanoraga & Prasetyawati, 2015).

Law No. 13 of 2016 concerning Patent, Article 19 Paragraph (1) letter a states the Patent

Holder has the exclusive right to exercise the Patent in his possession and to prohibit other

parties who without his consent in terms of product-patents: Making, using, selling, importing,

renting, handing over, or providing for sale or rent or surrendering products that are granted a

Patent. Article 19 Paragraph (2), the prohibition on using the production process granted a

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1682 Interdisciplinary Social Studies, 2(2), Nov 2022

Patent as referred to in paragraph (1) point b, only applies to the import of products that are

solely generated from the use of the process that is protected by patents.

In this pandemic condition, many innovations in the field of pharmaceutical technology

can be requested for patents to the state or can also be released not to be asked for patents to

the state (Liu et al., 2021). Law No. 13 of 2016 concerning Patents, does not stipulate that

requesting patents to the state is a legal obligation for innovators but instead is seated as a right

for innovators (Atmaja et al., 2021).

However, with this pandemic condition, there are many innovations in the field of health

technology that is useful for preventing the Coronavirus Disease 2019 (Covid-19) from being

produced, so basically, innovations in the field of health technology can be requested for

patents to the state or can also be released not to be asked for patents to the state. These two

actions are justified because Law No. 13 of 2016 concerning Patents in reality never stipulates

that asking the state for patents is a legal obligation for innovators but instead is seated as a

right for innovators.

When innovations in the field of health technology are requested for patents to the state by

innovators, innovations in the field of health technology that is useful for preventing the Covid

19 virus should be able to be granted patents if they meet the requirements outlined in Law No.

13 of 2016 concerning Patents (Masnun & Roszana, 2019). When the patent was granted by

the state, it was at that time that innovations in the field of health technology that was useful

for preventing the Covid-19 virus contained exclusive rights (Yuan & Li, 2022).

In attaching patents as an exclusive right to innovations in the field of health technology

that is useful for preventing the Covid-19 virus, using them to prevent the Covid-19 will not be

hindered (Wimmer & Keestra, 2022). There are three arguments regarding that matter. First,

with patents attached to innovations in the field of health technology that is useful for

preventing the Covid-19, the patent holder can permit several health technology companies to

produce innovations in the field of health technology that is useful for preventing the Covid-

19 virus without having to apply commercially, such as releasing royalty rights from patents

for innovations in the field of health technology that useful for preventing the Covid-19 virus.

It will happen if the patent holder has a high sense of humanity over the Covid-19 pandemic.

It has happened regarding the use of the Astra Zeneca Vaccine patent, in which the patent

holder waives royalty rights (Purwaningsih, 2020).

Second, if the patent holder does not have a high sense of humanity over the Covid-19

pandemic and tends to want to take high economic benefits from the Covid-19 pandemic

situation, then the use of this patent will still be able to be done by applying the leeway

(flexibility) contained in Law No. 13 of 2016 concerning Patents, through compulsory

licensing and the implementation of patents by the government. It is usually done because of

the urgent interests of society or the use of patents by holders that can harm the interests of

society at large. In this context, the state intervenes through Law No. 13 of 2016 concerning

Patents related to the use of patents where the interests of the community are the things that

must take precedence over the interests of the patent holders themselves (Indonesia’s Agency

of Drug and Food Control & Indonesia’s Ministry of Health, 1986). Third, with the existence

of patents as an exclusive right to innovations in the field of health technology that is useful

for preventing the Covid-19 virus. This, on the one hand, can guarantee the presence of genuine

products that will be effective in preventing the spread of the Covid-19 virus, and on the other

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hand, can minimize the spread of counterfeit products that may worsen the spread of the Covid-

19 virus.

Based on the description above, it can be argued that when an innovator produces

innovations in the field of health technology that is useful for preventing the Covid-19 virus

and then the innovator registers a patent with the state, and the patent is obtained, it can be

ascertained that the patent obtained will not hinder the efforts of the government or the public

in preventing the Covid-19 virus. Obtaining patents for innovations in the field of health

technology can be used as an effective means to prevent the Covid-19 virus.

To overcome the Covid-19 disease in Indonesia, it is necessary to establish the

Implementation of Patents by the Government as stipulated in Article 109 (1) which reads "The

Government can implement its Patents in Indonesia based on considerations related to the

defense and security of the State or very urgent needs for the benefit of the community."

The World Trade Organization (WTO) calls for the Implementation of Patents by the

Government with the term government use contained in the glossary term of the WTO (Esmail

& Kohler, 2012). The definition of government use describes that the Implementation of

Patents by the Government is intended when the government uses or permits other parties to

use the rights to product patents or process patents for the benefit of the government without

having to obtain permission from the holder. The implementation of Patents by the Government

is also allowed in the TRIPs agreement through the rules in Article 31. Following the terms of

the TRIPs agreement, the application of government use must take into account 3 conditions,

namely in the condition of a national emergency, other conditions of an urgent nature, or use

for the benefit of the community and its non-commercial nature.

The provisions of Article 31 (b) of the TRIPs Agreement explain that in its implementation

the use of a patent by the government or a third party on behalf of the government first needs

to make efforts to obtain permission from the patent holder, but on the one hand, the provisions

of the patent holder's permit in question can be set aside for matters relating to national

emergencies or other very urgent circumstances or non-commercial use.

Patent Law No. 13 of 2016 is a patent application for the Indonesian government. The

government can conduct patents without the permission of the patent holder in an emergency.

Such as in making pharmaceutical and/or biotechnology products at high prices and/or needed

in dealing with diseases that can cause sudden death in large quantities, causing meaningful

disabilities, and as a Public Health Emergency that Disturbs the World.

Pharmaceutical products that are still under patent protection tend to be sold at high prices

due to the exclusive rights of the patent holder. The patent holder has the right to use his patent

by prohibiting anyone from using his patent without his permission. However, a country may

set limited exceptions to exclusive rights covered by patents. Provided that such exceptions are

not without valid reason contrary to the normal exploitation of patents and do not prejudice the

reasonable interests of the patent holder. In terms of public health, the state must provide

comprehensive medical services including the provision of patented pharmaceutical products

in urgent need.

Pharmaceutical products needed by the community in very urgent needs, the government

has determined the Covid-19 pandemic which is a Global Pandemic according to the statement

of the World Health Organization (WHO) and the Government has also determined non-natural

disasters for the spread of Covid-19 as a national disaster (Kuznetsova, 2020; Singh et al.,

Legal Protection on Pharmaceutical Product Patents by the Government on Covid-19’S Remdevisir and

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2020). Amid the current pandemic, the government must take quick action to overcome the

Covid-19 disease. It is considering that by fulfilling the very urgent needs for the benefit of

public health in efforts to overcome the Covid-19 disease in Indonesia, it is necessary to

implement a patent implementation policy by the government for access to Covid-19 drugs.

The government sets policies to meet the needs of pharmaceutical and biotechnology

products through the Implementation of Patents by the Government, namely, the Government

issues a policy of Patent Implementation by the Government with the enactment of Presidential

Regulation Number 100 of 2021 concerning the Implementation of Patents by the Government

on Rendemsivir Drugs and Presidential Regulation Number 101 of 2021 concerning The

Implementation of Patents by the Government on Favipiravir Drugs. The implementation of

patents by the Government on the drugs Rendemsivir and Favipiravir aims to meet the

availability and very urgent need for the treatment of Covid-19.

Based on the description above, the formulation of the problem is how the Implementation

of Patents by the Government according to Law Number 13 of 2016 concerning Patents and

how is the legal protection for pharmaceutical product patent holders for the Implementation

of Patents by the Government against remdevisir drugs and favipiravir.

METHOD

The approach method used in this study was normative juridical. Normative legal research

is a process to find a rule of law, legal principles, and legal doctrines to answer legal problems

faced using a statute approach (Christiani, 2016). This statutory approach was carried out by

studying the consistency or conformity between one law and another, as well as between laws

and other regulations (Soekanto & Mamudji, 2006).

Based on the type of research approach used, the data search was carried out using

secondary data collection methods. Secondary data are data obtained from the results of a

literature review of various literature or library materials related to problems or research

materials that are often referred to as legal materials. Meanwhile, the data analysis technique

used in this study was qualitative, which is an analytical descriptive data analysis method that

refers to a certain problem that is then associated with the literature or opinions of legal experts

or based on applicable laws and regulations.

RESULTS AND DISCUSSION

Implementation of Patents by the Government According to Law Number 13 of 2016

concerning Patents

Meeting domestic needs is closely related to the public interest, and the participation of

the government is urgently needed. The measure of the public interest is so flexible that it is

too broad and difficult to explain the meaning of the public interest. Concerning patent

protection arrangements must be carried out fairly, that is, arrangements that ensure a balance

between human interests and protected society (Cullet, 2003).

If the public interest desires or even requires it, the patent holder's exclusive right may be

revoked following the provisions of the law so that it can be said that the exclusive right to use

it is limited by the public interest. With proper public interest criteria, the public interest in

protecting patents does not cause the state to act arbitrarily against patent holders, and instead,

the interests of the other party are protected.

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The government has the authority to take the patent policies necessary to realize balance

and fairness between patent holders and the public interest. The state may intervene to provide

restrictive arrangements even if exclusive patent rights are granted by the state indefinitely to

the patent holder. Patent protection provisions in the form of exclusive rights must strike a

balance between the patent recipient and the public interest to achieve fairness. Patent was

formed to reward and stimulate innovations by granting exclusive rights to patent holders. In

addition, patents have a negative impact because they can prevent people from accessing health

services and medicines. Therefore, in connection, the implementation of patents by the

government may be carried out to protect the public interest and for other reasons prescribed

by law.

If the government thinks that a patent in Indonesia is very important for the defense of

state security and a very urgent need for the benefit of society, then the government can

implement the patent itself. However, if the government does not or has not intended to

implement the patent itself, then the government can appoint a third party to carry it out by

providing reasonable compensation to the Patent Holder as compensation for the Government's

Implementation of the Patent and the government notifies in writing about the matter to the

patent holder. If the patent holder does not agree to the amount of compensation provided by

the government, the patent holder can take legal action by filing a lawsuit in commercial court.

The suit is filed within 90 days, commencing from the date of delivery of the Copy of the

Presidential Regulation. The process of examining the lawsuit does not stop the Government's

Implementation of the Patent. When the patent holder does not file a lawsuit, it is considered

to agree to receive the amount of compensation that has been determined by the government.

Patent holders in the field of defense and security of the state whose patents are exercised by

the government, it is exempt from the obligation to pay annual fees. Meanwhile, patent holders

related to urgent needs for the benefit of the community are required to pay an annual fee for

patents implemented by the government. The overall cost of Patent Implementation by the

Government is charged by the state budget.

The implementation of patents carried out by the government in the field of defense and

security includes firearms, ammunition, military explosives, interception, wiretapping,

reconnaissance, device interception, and password analysis, even the process of funds or

equipment of defense and security of the state. The implementation of patents includes urgent

needs including pharmaceutical and biotechnology products that have high prices but are

needed in tackling diseases that can result in sudden death in large numbers or cause significant

disability. In other words, it is become a public health emergency that shakes the world. In

addition, chemical or biotechnological products related to agriculture are necessary and

intended for food security. Not only that, veterinary drugs are aimed at treating the widespread

pest and or disease of infected animals. Furthermore, products are intended to overcome natural

disasters and environmental disasters.

The Patent Act appears that the exercise of patents cannot be carried out by private parties

or individuals. The government can implement patents independently in Indonesia based on

several considerations. Starting from defense and security considerations and considering

urgent needs for the benefit of the wider community. However, the implementation of patents

by the government related to defense and security and urgent needs are carried out on a limited

basis, namely to meet domestic needs, and are noncommercial. The implementation of patents

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by the Government is regulated by a Presidential Regulation, then the implementation is carried

out within a certain period. However, it can be extended after hearing consideration from the

relevant minister or the head of the agency responsible for the relevant field. Ministers or heads

of agencies related to the patent authority exercised by the government. For example, patents

in the field of pharmacy, the relevant minister is a minister whose duties and authorities are in

the field of health.

Procedures for Patent Implementation by the Government in Indonesia are regulated in

Presidential Regulation Number 77 of 2020. Based on Articles 16 to 18 of Presidential

Regulation Number 77 of 2020, regulate the mechanism for submitting applications for Patent

Implementation by the Government. The application for the implementation of pharmaceutical

product invention patents is submitted by the minister of health to the Minister who organizes

government affairs in the field of law (Minister of Law and Human Rights) in writing by

fulfilling the application requirements listed in Article 16 paragraph (2) of Presidential

Regulation Number 77 of 2020. Then, the Minister conducts an administrative examination in

the form of completeness of the application and examination of the legal status of patent

protection of pharmaceutical products according to the application that has been submitted.

If the application is declared incomplete, the minister of health is given not more than 14

(fourteen) days from the date of return to complete the application. If it turns out that the

application is incomplete, the Minister of Health has a maximum of 14 days from the date of

return to complete the application. If the pharmaceutical product submitted is not protected by

Patents in Indonesia and/or the completeness of the application is not completed by the

applicant, then the application is rejected. The Minister then notifies the holder of the

Pharmaceutical Product Patent on the application for patent implementation by the Government

within no more than 5 days from the time the application is declared to meet the administrative

requirements and legal status of patent protection.

Furthermore, following Article 19 and Article 20 of Presidential Regulation Number 77 of

2020, the Minister establishes a team of various elements, including the ministry that organizes

government affairs in the field of law, the ministry of health, the ministry that organizes

government affairs in the field of finance, the ministry that organizes government affairs in the

field of the state secretariat, and experts through a Ministerial Decree to give consideration and

determine the amount of compensation within not more than 90 days from the establishment

of the Ministerial Decree. Then, the results of the implementation of the tasks carried out by

the Team are submitted to the Minister and if the Minister approves, the Minister submits the

results of the implementation of the task to the president within no more than 15 days from the

time the Minister approves to be determined by Presidential Regulation.

The enforcement of pharmaceutical product patents by the government is the same as the

enforcement of pharmaceutical product patents, the government remains responsible for

notifying writing pharmaceutical patent holders that the government is implementing patents

following the provisions of Article 114 paragraph (1) of Law Number 13 of 2016. Article 114

paragraph (2) of Law Number 13 of 2016 and Article 20 of Presidential Regulation Number

77 of 2020, the Minister submits a copy of the Presidential Regulation stipulating the

implementation of pharmaceutical product patents to patent holders in the form of written

notice. With this notification, the patent holder of a pharmaceutical product can know the

process of Patent Implementation by the Government filed by the minister of health and the

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provisions of the Presidential Regulation on the determination of Patent Implementation by the

Government.

Based on Article 116 of Law Number 13 of 2016 and Article 14 of Presidential Regulation

Number 77 of 2020 regulating the Patent Executor by the Government, the ministry of health

represented by the minister of health acts as the executor of pharmaceutical product patents.

The health minister may appoint a third party to execute a patent on behalf of the government

if the government is unable to exercise the patent on its own. In determining third parties, the

minister of health shall pay attention to the requirements of third parties, including (a) having

facilities and being able to execute patents; (b) not transferring the execution of the patent to

another party; (c) have a good way of production, circulation, and supervision following the

provisions of laws and regulations. In this case, the ministry of health is obliged to periodically

supervise and control the implementation of pharmaceutical product patents by third parties on

behalf of the government.

Legal Protection for Pharmaceutical Product Patent Holders for the Implementation of

Patents by the Government Against the Remdevisir and Favipiravir

The implementation of Patents by the Government is very important for a country in terms

of urgent needs for the benefit of society. Urgent needs for the national interest include, among

others, the health sector such as medicines that are still protected by patents in Indonesia that

are needed to overcome widespread diseases. As is known, one of the functions of a Patent is

to ensure the continuity of the country's economy and strive to improve the welfare of the

people in the country concerned.

The execution of a Patent by the Government cannot be carried out exclusively as is the

case with a patent holder who can continue to use the patent right for the duration of the patent

protection granted. The right of the government to implement pharmaceutical product patents

must be limited only based on the purpose of their implementation, namely to meet the urgent

needs for the benefit of public health while still complying with applicable laws and

regulations. When the government decides to exercise its rights, the government also has the

responsibility to ensure that the implementation of patents carried out by itself can be carried

out effectively and on target by looking at the scope and period of Patent Implementation by

the Government. Therefore, the government must be able to make maximum efforts in the

implementation of patents to ensure the availability of easier and more affordable access to

pharmaceutical products for the public within a predetermined period.

If the government declares a very urgent need, the right depends on the consideration of

the relevant ministry or agency that will implement the patent. The Ministry of Health regulates

the implementation of patents on drugs for very urgent needs in the prevention of widespread

diseases on a national scale, this can be seen from the data owned by the ministry regarding

the level of disease spread in each region of Indonesia. In addition, there are 3 important things

that need to be considered in the Implementation of Patents by the Government as referred to

in Article 109 paragraph (2) of Law Number 13 of 2016, namely: (1) limited patent

implementation; (2) the implementation of patents for domestic needs; and (3) the execution

of patents is non-commercial or not profit-oriented or in no way profit-focused.

Based on Presidential Regulation Number 77 of 2020 concerning Procedures for Patent

Implementation by the Government, if the government cannot implement the Patent itself, the

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Favipiravir

1688 Interdisciplinary Social Studies, 2(2), Nov 2022

government can appoint a third party to execute the Patent with the obligation to fulfill several

requirements. Article 116 of Law Number 13 of 2016 and Article 14 of Presidential Regulation

Number 77 of 2020 regulate the implementing party of patents by the government, the ministry

of health represented by the minister of health acts as the executor of pharmaceutical product

patents (Sari, 2015). The health minister may appoint a third party to execute a patent on behalf

of the government if the government is unable to exercise the patent on its own. In determining

third parties, the minister of health must pay attention to the requirements of third parties,

including having facilities and being able to carry out patents, not transferring patent

implementation to other parties, and having good production methods, circulation, and

supervision following the provisions of laws and regulations.

The implementation of the Patent by the Government, Menteri, who organizes government

affairs in the health sector, appointed the pharmaceutical industry as the executor of the

Remdesivir and Favipiravir drug patents. Then the government appointed, First the license of

the drug Favipiravir was given to the Pharmaceutical Industry PT. Beta Pharmacon (Dexa

Group) under the Avigan® trademark since September 2020 and PT. Kimia Farma Tbk

manufactures generic products Favipiravir in Indonesia. Both Remdesivir drugs are given to

the Pharmaceutical Industry of PT. Amarox Pharma Global, PT. Indofarma, and PT. Dexa

Medica. Both drugs proven through clinical trials show their usefulness in curing Covid-19

patients.

The implementation of patents by the Government on Remdesivir and Favipiravir drugs is

carried out for 3 (three) years from the time this Presidential Regulation comes into force. If

after 3 (three) years as referred to in paragraph (3) the pandemic has not ended, the Patent

Implementation by the Government is extended until the Coronavirus Disease 2019 (Covid-l9)

pandemic is determined to end by the Government.

Patent holders are entitled to legal protection during the Implementation of Patents by the

Government and have been guaranteed in applicable laws and regulations. The existence of

this legal protection can be said to be a concrete manifestation that the Implementation of

Patents by the Government does not limit or hinder the interests of patent holders related to the

fulfillment of exclusive rights that have been granted by the state during the patent protection

period. Exclusive rights are property rights of economic value (Economic rights) in exchange

for the sacrifice of time, energy, thoughts, and costs incurred to produce an invention. Patent

holders not only have exclusive rights but also to their patents implemented by the government

have also given rise to special rights for patent holders implied in Law Number 13 of 2016 and

Presidential Regulation Number 77 of 2020.

Patent holders not only have exclusive rights but also to their patents carried out by the

government have also given rise to special rights for patent holders following Article 112

paragraph (2) of Law Number 13 of 2016 and Article 15 paragraph (2) of Presidential

Regulation Number 77 of 2020 that pharmaceutical product patent holders can still exercise

exclusive rights to their patents in full, that is, carrying out patents in its possession and

prohibiting other parties who without their consent in terms of making, using, selling,

importing, renting, handing over or providing for sale or lease or surrendering patented

pharmaceutical products. In other words, the patent holder does not lose the economic benefits

of his pharmaceutical product patents.

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The government in this case the ministry of health or a third party appointed by the minister

of health to implement pharmaceutical product patents is obliged to provide reasonable rewards

to the patent holders of pharmaceutical products. The provision of reasonable compensation as

a form of compensation and a balance between the economic benefits obtained by the patent

holder and the state's financial ability to pay according to the terms of the reward and the

amount of compensation stipulated in the Presidential Regulation on the determination of the

implementation of pharmaceutical product patents by the government. The provision of

reasonable rewards is carried out in the implementation of patents on the drug Remdesivir and

Favipiravir by the government. Based on article 3 of Presidential Regulation Number 100 and

101 of 20211 concerning the Implementation of Patents by the Government, provides

compensation to patent holders of 1% of the net selling value of Remdesivir and Favipiravir

drugs. Article 5, the provision of compensation as referred to in article 4 is carried out annually,

and the provision of compensation as referred to in paragraph (1) is carried out according to

the period as referred to in Article 1 paragraph (3) and paragraph (4).

CONCLUSION

Based on the results of research and discussion as previously outlined, the government can

implement its patents in Indonesia based on considerations related to state defense and security

or very urgent needs for the benefit of the community. However, if the government does not or

has not intended to implement the patent itself, then the government can appoint a third party

to carry it out by providing reasonable compensation to the Patent Holder as compensation for

the Government's Implementation of the Patent and the government notifies in writing about

the matter to the patent holder. The implementation of patents by the Government is carried

out on a limited basis, to meet domestic needs, is non-commercial, and is stipulated by

Government Regulations and Presidential Regulations.

Patent holders of pharmaceutical products Remdevisir And Favipiravir Drugs For The

Treatment of Covid-19 are entitled to legal protection for the implementation of exclusive

rights and payment of compensation during the Implementation of Patents by the Government

following Presidential Regulation Number 100 and 101 of 2021, reasonable compensation to

patent holders amounting to 1% of the net selling value of Remdesivir and Favipiravir drugs.

The granting of rewards to the patent holder is carried out annually.

Patent Implementation Arrangements by the Government, if the government does not or

has not intended to implement its patents to meet the urgent needs for the benefit of public

health, then it requires legal certainty through making agreements with third parties recognized

by the government. In the implementation of patents by third parties, effective supervision by

the government is needed so that pharmaceutical product patents can protect patent holders

from counterfeit products.

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