Regulatory Pathway for Biosimilar Products in Nigeria

In December 2012, the National Agency for Food and Drug Administration and Control (NAFDAC), which is Nigeria’s equivalent of the U.S. Food and Drug Administration (FDA), released a guidance document and guidelines for the registration of biosimilars in Nigeria.  These documents were created in recognition of the need to ensure a pathway for biosimilars in Nigeria as patents continue to expire on many of the leading biologics owned by some of the world’s largest pharmaceutical companies.

What do the NAFDAC’s guidelines state?

According to NAFDAC, a biosimilar is a product that demonstrates similarity in terms of quality, safety and efficacy to a named Reference Biotherapeutic Product (RBP).  The RBP must be licensed on the basis of a full registration dossier in Nigeria and/or by national drug regulatory authorities of countries who are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) [such as the European Medicines Agency for Europe, the Pharmaceuticals and Medical Devices Agency for Japan and the Food and Drug Administration for the United States (US)].  What this means is that on the basis of proven similarity, the registration of a biosimilar will rely, in part, on non-clinical and clinical data generated with a previously licensed RBP.

Quick Facts:

  • Biosimilars are not generic medicines.
  • The manufacturer must provide the rationale for the choice of the RBP.
  • The RBP should have been registered on the basis of a full registration dossier in Nigeria and/or by national drug regulatory authorities of countries who are members, observers or associates of the ICH.
  • The NAFDAC’s guidelines also state that RBP’s that are not licensed in Nigeria must be from jurisdictions that have established relationships with Nigeria. However, the guidelines do not provide any details of what would be considered to be an “established relationship”.
  • Only one reference product is allowed throughout the development of the biosimilar and the manufacturer needs to demonstrate that the chosen RBP is suitable to support the application for registration or marketing authorization of a biosimilar.
  • The drug substance of the RBP and the biosimilar product must be shown to be similar and the dosage form and route of administration of the biosimilar product should be the same as that of the RBP.
  • A biosimilar product cannot be used as a reference product by another manufacturer because a reference product has to be approved on the basis of a complete/full quality and clinical data package.
  • Any biosimilar product whose name, package or label bears close resemblance to an already registered product or is likely to be mistaken for such registered product will not be considered for registration.
  • Approval of a product through the biosimilar pathway is not an indication that the biosimilar may be automatically substituted with its reference product or other biosimilar.
  • Pharmacists are not permitted to substitute biosimilars without first consulting with physicians. 
  • NAFDAC’s pathway for biosimilars includes the need for quality, pre-clinical and clinical data.
  • The quality data includes detailed analytical characterization of the biosimilar product and RMP, a comparison of the physicochemical and biological activity and properties of the biosimilar product and RBP as well as data on the purity, impurities, contaminants and stability of the biosimilar product.  
  • Comparative pre-clinical studies which focus on issues regarding biological activity, pharmacokinetics, comparability, efficacy, safety and immunogenicity should also be conducted.
  • The clinical studies required will depend on the existing knowledge about the RBP and the intended indication but will include at least pharmacokinetic and pharmacodynamic studies as well as efficacy studies. 
  • The minimum labeling requirements on the primary and secondary package labels are:  name of the product-INN/scientific name and brand name (where applicable), manufacturer’s name and factory location address, the NAFDAC Registration Number, batch number/lot number, manufacturing and expiration dates, quantitative listing of all active ingredients per unit dose, and the defined storage conditions.
  • Although Nigeria does not have any specific legislation focusing on data exclusivity or protection of undisclosed information, Section 3 of the Food, Drugs and Regulated Products, etc. Act prohibits the disclosure of information supplied to the NAFDAC to assist the agency in reaching a decision on subsequently filed application.

What does the registration process entail?

A manufacturer seeking to register biosimilar products in Nigeria is required to submit a separate application form for each product (the manufacturer must be represented by an applicant, namely, a duly registered pharmaceutical company, who must be in possession of a notarized Power of Attorney from the manufacturer authorizing him to speak for the manufacturer on all matters relating to the product).

The applicant will obtain an application form from NAFDAC’s Regulatory and Registration Directorate following submission of an application letter and the payment of prescribed fees.  The application form requires the manufacturer’s name, the International Non-proprietary Name (INN)/scientific name, brand name, strength, pack size and indication of the biosimilar product.  In addition, the following documents must be submitted:

  1. Manufacturer’s license or a certificate issued by the competent health authority of the country of manufacture:  This document shows that the company is licensed to manufacture biotechnological products which may be used in the country of origin and/or exported.
  2. Product license or certificate of registration:  This document serves as documentary evidence of registration of such product by the competent Health Authority of the country of manufacture.
  3. Certificate of Pharmaceutical Product (COPP) in conformity with the WHO format:  This document serves as documentary evidence by the competent Health Authority that the sale of the product does not constitute a contravention of the drug laws of the country of manufacture.
  4. Valid WHO GMP Certificate.

All documents are required to be authenticated by the Nigerian Mission in the country of manufacture.  In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate the documents.

After licensing, the manufacturer will be responsible for ensuring that products imported after licensing comply with the approved label, quality and other conditions of approval.  The manufacturer will also be responsible for importation, good distribution, storage of the product, submission of a detailed Risk Management Plan (RMP) as well as providing Periodic Safety Update Reports (PSUR) in line with the Guidelines for Post Marketing Surveillance (PMS).

What costs are involved in registering a biosimilar in Nigeria?

The official cost for registering a biosimilar in Nigeria is N350,000 (approximately US $2,190) plus 5% VAT.  The guidelines provide a breakdown of the costs as follows:

 a.  N10,000 for Import Permit;

b.  N240,000 for Processing Fee; and

c.  N100,000 for Product License.

Every fee is subject to review and attracts 5% VAT. 

How long is a biosimilar certificate valid?

The Certificate of Registration for a biosimilar is valid for a period of five (5) years; however, NAFDAC may suspend, withdraw or cancel the certificate of registration of a biosimilar product if the data or documents with which the product was registered are found to be false or falsified.

This post was written by Ufuoma Akpotaire of Nigerian Law Intellectual Property Watch and Lisa Mueller.

This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.

Nigeria Patent Protection: The Basics – Part 2 of a 2-Part Series

This is Part 2 of a two-part posting examining patent procurement and enforcement in Nigeria. You can view Part 1 by clicking here. This post examines working requirements, revocation proceedings, compulsory licenses and infringement.

Working Requirements

The invention described in a patent must be worked within four years of the date of filing of a patent application in Nigeria or three years from the issue date of the patent, whichever occurs later. Failure to work a patent in Nigeria may lead to the granting of a compulsory license (discussed in more detail below).

Revocation Proceedings

Any interested person or party can request the Federal High Court invalidate a patent based on any of the grounds listed in the Patents and Designs Act No. 60 {which is now the Patents and Designs Act (Act)}.  Specifically, a patent can be invalidated if:

1.  The subject matter is not patentable (for example, the subject matter lacks novelty and/or inventive activity);

2.  The description does not sufficiently describe the invention and/or the claims do not define the scope of protection or exceed the limits of the description; and/or

3.  A patent for the same invention has already been granted in Nigeria based on a prior application or an application entitled to an earlier filing date.

Compulsory Licenses

A compulsory license may be granted if:

1.  The patented invention is not being worked in Nigeria;

2.  The extent of the working does not meet the demand for the patented invention on reasonable terms;

3.  Working in Nigeria is being hampered by importation of the patented invention; and/or

4.  The establishment or development of industrial or commercial activities in Nigeria is being hampered by a lack of working of the patented invention.

A compulsory license can also be granted where a later patent cannot be worked without infringing an earlier issued patent (provided that the later patent constitutes technical progress or serves a different industrial purpose than the earlier patent).

Infringement and Enforcement

According to the Act, a patent confers on the patentee the right to prevent any other person from conducting the following acts:

1.  The making, importing, selling or using of the patented product;

2.  Stocking the patented product for sale or use;

3.  For process patents, the using or applying of the patented process; and/or

4.  Performing any of one or two with respect to a product obtained directly from a patented process.

However, exceptions to the above include:

1.  Acts not done for industrial or commercial purposes;

2.  Acts done with respect to products covered by a patent that are lawfully sold in Nigeria; and/or

3.  Acts done in Nigeria in good faith from a date prior to the filing of the patent application or the foreign priority date of the patent application (or if “serious preparations” have been made with a view of manufacturing a product or applying a process).

In Nigeria, the claims are used to determine infringement and the description (the specification and drawings) is used to interpret the claims.

The Federal High Court has exclusive jurisdiction for all patent infringement actions, and the remedies available to a successful patentee in an infringement action include:

1.  An injunction;

2.  Damages; and/or

3.  An accounts of profits.

Intellectual Property Jurisprudence & A Growing Legal Fraternity

During the last several years, a number of patent infringement lawsuits have been decided by the Federal High Court, giving credence to the fact that intellectual property jurisprudence is developing fairly well in Nigeria.

There is a growing legal fraternity of very well educated practitioners, most of whom have had overseas training.

An example of a patent infringement lawsuit in which a patent was found to be valid and infringed is Pfizer Limited v. Tyonex Nigeria Limited and Ebamic Pharmacy Limited (Federal High Court, January 23, 2007).

This case involved a Pfizer patent claiming amlodipine besylate, which was being sold in Nigeria under the brand name “NORVASC.” The defendants imported a generic version of this drug from Turkey and marketed it as “AMLOVAS.” Pfizer lodged a complaint with the appropriate regulatory authority in Nigeria, which moved swiftly to de-register the generic product, arrest the Managing Director of the first defendant company, and seal the premises of both defendants for one week.

In addition, the Federal High Court considered the validity and infringement of Pfizer’s patent and decided in favor of Pfizer, granting an injunction and damages accordingly.

Please watch the BRIC Wall for future updates on any patent litigation in Nigeria.

This post was written by Lisa Mueller and Nicky Garnett of Adams & Adams.

To read Part 1 of this two part blog, please click here.

Nigeria Patent Protection: The Basics – Part 1 of a 2-Part Series

Recently, some of us at the BRIC Wall have had several clients file patent applications in Nigeria. As this was our first experience filing and prosecuting patent applications in this country, we thought it would be helpful to share what we have learned about patent procurement and enforcement in Nigeria.

This is Part 1 of a two-part posting examining patent procurement and enforcement in Nigeria. This post examines the basics for filing and prosecuting a patent application in Nigeria. Part 2 will examine revocation proceedings, infringement, enforcement and compulsory licenses.

Nigeria is a federal constitutional republic comprising 36 states and is located on the west coast of Africa on the Gulf of Guinea. Nigeria is known as the “Giant of Africa” and is the most populous country in Africa. Specifically, its population is roughly 152.2 million people. The official language of Nigeria is English and its currency is the Naira (1 Naira is approximately 0.0062 U.S. dollars).

In 1970, Nigeria enacted the Patents and Designs Act No. 60 {which is now the Patents and Designs Act (Act)}. The Act created the Nigerian patent system and is presently in force today and was published as the Patents and Designs Act, Chapter 344 Laws of the Federation of Nigeria 1990. Additionally, Nigeria has been a member of the Paris Convention since 1963, a member of the World Trade Organization (WTO) in 1995 and a member of the Patent Cooperation Treaty (PCT) since 2005. Patent and design applications are filed, examined and granted by the Trademarks, Patents and Designs Registry (Registry). Applications can be filed with the Registry either manually (namely, a paper filing) or electronically (using the electronic filing system).

When filing a patent application in Nigeria, the below documents must be filed in order to satisfy the requisite formal requirements:

1.  Detailed information on the Applicant (this can be the inventor or a successor in interest). If the inventor is not the Applicant, then an assignment must be filed (assignments and voluntary licenses must be recorded at the Registry in order to be effective against third parties in Nigeria);

2.  Power of Attorney;

3.  An assignment from the inventor(s) or a statement by the Applicant justifying the right to the invention (if applicable);

4.  A copy of the specification, including the claims, drawings and abstract (all in English);

5.  A certified copy of the priority document, if necessary; and

6.  The prescribed fee.

A patent application can be filed in Nigeria as a: (1) “non-convention” filing (namely, directly in Nigeria without claiming priority to any other patent application); (2) as a “convention” filing (namely, the application claims priority to an application filed within the last 12 months under the Paris Convention); or (3) National phase patent application off of a PCT application. It is important for Applicants to understand that although Nigeria is a member of the PCT, it has not yet amended its laws to implement the PCT. Despite this, the Registry is accepting timely filed National phase applications, examining these applications, and granting patents off of such applications. This raises the question of whether any such patents granted off a National phase application in Nigeria are valid; however, as of yet, we are not aware of this issue being raised in any litigation.

Under the Act, any invention that is new, possesses inventive activity and is capable of industrial application constitutes patentable subject matter. The following is not considered to constitute patentable subject matter: (1) plants or animal varieties or essentially biological processes (although microbiological processes and products produced by such processes are considered to be patentable subject matter); (2) inventions that are contrary to the public order or morality; and (3) scientific principles or discoveries.

Under the Act, absolute novelty is required. In other words, an invention is considered to be “new” provided that it does not form part of the state of the art (“state of the art” is defined as referring to “everything concerning that art or field of knowledge which has been made available to the public anywhere and at any time whatever (by means of a written or oral description, by use or in any other way) before the date of the filing of the patent application relating to the invention or the foreign priority date validly claimed in respect thereof, so however that an invention shall not be deemed to have been made available to the public merely by reason of the fact that, within the period of six months preceding the filing of a patent application in respect of the invention, the inventor or his successor in title has exhibited it in an official or officially recognized international exhibition.”) As mentioned in the definition of the “state of the art, a six-month grace period is available for the inventor or legal successor if the invention is displayed at an official or officially recognized international exhibition.

According to the Act, an invention results from inventive activity if it does not “obviously” follow from the state of the art. Additionally, an invention is capable of industrial application if it can be manufactured or used in any kind of industry (such as agriculture).

In Nigeria, applications are subject only to formal examination. Thus, there is no examination for either novelty or inventive activity. Thereupon, if the formal requirements for filing the application are satisfied, a patent will be granted (while the Act and patent regulations do not provide a provision to delay acceptance (such as in South Africa), it may be possible to file an informal request for the Registry to delay acceptance but only if the application is filed manually as the electronic filing system does not make any provision for “special requests” such as this). Therefore, Applicants filing and prosecuting patent applications in Nigeria need to be vigilant that the claims filed possess novelty and inventive activity. With respect to making any amendments during prosecution, the Act is silent regarding an Applicant’s right to amend the specification, drawings and/or claims during prosecution. However, the patent regulations give the Registry discretion in allowing entry of any document (including a change to a drawing) it sees fit. These regulations are broadly interpreted to provide the Applicant the right to make amendments to a pending application or even to an issued patent.

The Act requires that the details of all granted patents are published in the official Journal after grant (although such publication is not routinely followed). Any patent granted will have a term of 20 years from its filing date {provided that the annual renewal fees are paid (for which there is a six-month grace period)}.

The Act does not provide for an opposition procedure. Rather, any interested person can request the Federal Court to invalidate a patent based on any grounds listed in the Act, such as:

1.  The subject matter of the patent is not patentable (namely, it lacks novelty, inventive activity and/or industrial applicability);

2.  The description of the invention does not sufficiently describe the invention and/or the claims do not define the scope of protection or exceed the limits of the description; and/or

3.  A patent for the same invention has already been granted in Nigeria based on a prior application or an application entitled to an earlier filing date.

This post was written by Lisa Mueller and Nicky Garnett of Adams & Adams.

To read part two of this post, please click here.