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.

Recent Brazilian Jurisprudence Concerning the Scope of ANVISA’s Prior Consent

Article 229 of the Brazilian Industrial Property Law #9.279/96 was amended with the publication of Brazilian Law 10.196 on February 14, 2001, to add Section 229-C which provides that “The grant of patents for pharmaceutical products and processes shall depend upon the prior consent from the National Sanitary Vigilance Agency.” Thus, as a result of the addition of this provision, any patent application related to a pharmaceutical product or process became subject to the “prior consent” of the National Sanitary Vigilance Agency (ANVISA), whose mandate is to protect the public by preventing “the production and commercialization of products and services that are potentially harmful to human health.” Therefore, in effect, Section 229-C provides for a two-tier examination process for pharmaceutical products and processes in Brazil.

In view of the inherent conflict between ANVISA and the Brazilian Patent Office {the National Institute of Industrial Property (INPI)} regarding the review of the patentability requirements (namely, novelty, inventive step, enablement of the claims, clarity, etc.) of patent applications directed to pharmaceutical products and processes, an administrative proceeding was conducted before the Attorney General’s Office (AGU) on July 22, 2008. The result of the proceeding was the issuance of Opinion No. 210/PGF/AE/2009 on October 16, 2009 (Federal Opinion), which was subsequently approved by the Attorney General. The Federal Opinion held that ANVISA’s statutory duty to review pharmaceutical patent applications for prior consent should be limited to the examination of issues closely related to its institutional purposes, namely, issues related to public health. Unhappy with the Federal Opinion, ANVISA filed a request for reconsideration with the AGU. On July 1, 2011, the AGU issued Opinion No. 337/PGF/EA/2010 (Second Opinion), which was subsequently approved by the Attorney General, reaffirming the conclusions stated in the Federal Opinion. Specifically, the Second Opinion ratified that ANVISA was required to limit its examination of patent applications only to issues of public health for purposes of granting or denying prior consent.

On August 19, 2013, a civil pro-ANVISA action was brought by a Federal Public Prosecutor in Brazil seeking to:

(1) declare null and void the Federal Opinion;

(2) declare and recognize the legal authority of ANVISA to analyze the patentability requirements for pharmaceutical product and process patent applications; and

(3) declare the full applicability of the provisions of Article 229-C concerning ANVISA’s granting of prior consent.

A preliminary injunction request was also sought to immediately declare null and void the Federal Opinion until a decision on the merits was issued. The trial judge denied this request and an appeal was made to the Federal Circuit. The Circuit court decided not to rule on this appeal until a final decision on the merits was issued by the lower court.

A decision by the trial judge was issued on September 12, 2013, summarily dismissing the claims of the Federal Public Prosecutor. Essentially, the judge held that it did not make sense to assign to ANVISA, the institutional purpose of which is to protect the health of the population, the additional role of reviewing the patentability requirements of pharmaceutical product and process applications for which INPI was charged with the same responsibility. The judge concluded that a fair interpretation of the law was to avoid this sort of “double” patentability analysis.

It is expected that ANVISA will appeal the trial judge’s decision to the Federal Court of Appeals. Please watch the BRIC Wall for future updates on any such appeal.

This post was written by Lisa Mueller and Gustavo de Freitas Morais of Danneman Siemsen.

The Problem of Mailbox Patents and Patent Term in Brazil

The World Trade Organization (WTO) is an international organization that deals with the rules of trade between nations. When the WTO was created on January 1, 1995, one of the agreements that came into effect was the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. To date, the TRIPS Agreement is considered one of the most comprehensive multilateral agreements on intellectual property.

Most member countries agreed to apply the TRIPS Agreement immediately upon joining the WTO. However, developing countries were permitted certain transitional periods in order to have sufficient time to enact new laws that were TRIPS compliant. One such transitional period allowed developing countries up to ten years (specifically, until January 1, 2005) to introduce patent protection for pharmaceutical and agrochemical products. However, Article 70.8 of the TRIPS Agreement provided that developing countries that utilized this transitional period were required to allow inventors to file patent applications on pharmaceutical and agrochemical products beginning on January 1, 1995, even though a decision to grant a patent on such applications could be delayed up until January 1, 2005. This provision of the TRIPS Agreement is often referred to as the “mailbox” provision (meaning that a “mailbox” is created to receive and store such applications) and patents issuing from applications filed pursuant to this provision are frequently referred to as “mailbox” patents. According to the TRIPS Agreement, the term of any “mailbox” patent is 20 years from its filing date.

At the time Brazil became a member of the WTO, patents on pharmaceutical and agrochemical products were prohibited. Thus, Brazil utilized the transitional period in order to have sufficient time to become TRIPS compliant and established a mailbox for any pharmaceutical and agrochemical product applications filed between January 1, 1995, and May 14, 1997 (“filed” refers to any application having a convention filing date or having a PCT International filing date (and for which the National Phase was entered in Brazil) between January 1, 1995, and May 14, 1997). Applications filed in the mailbox were also referred to as “pipeline” applications. Brazil enacted a new, TRIPS-compliant patent law on May 15, 1996, the full provisions of which went into effect on May 14, 1997. Effective on May 15, 1997, “mailbox” or “pipeline” applications ceased to exist.

The term of a mailbox patent is set forth in the sole paragraph of Article 229 of the Industrial Property Law (Law) which reads as follows:

“Article 229…Sole Paragraph – The patenting criteria of this Law shall apply on the effective filing date of the application in Brazil, or on the priority date, if any, to applications relating to pharmaceutical products and to chemical products for agriculture filed between January 1, 1995 and May 14, 1997, and protection is assured as from the date of grant of the patent for the remaining term, counted from the date of filing in Brazil, such term being limited to the one prescribed in the heading of Article 40.”

Article 40 provides that the term of a patent is 20 years from its filing date but not less than 10 years from the date of grant. Specifically, Article 40 states:

“Article 40 – The term of a patent for an invention shall be 20 (twenty) years and for a utility model 15 (fifteen) years as from the filing date.

Sole Paragraph – The term shall not be less than 10 (ten) years for inventions and 7 (seven) years for utility models, as from the date of grant, except where INPI is prevented from carrying out the substantive examination of the application due to pending litigation or for reasons beyond its control.”

Additionally, Article 229-B of the Law provides that the National Institute of Industrial Property (INPI) will grant or deny a patent for any mailbox application by December 31, 2004.  Specifically, Article 229-B states:

“Article 229-B – Product patent applications filed between January 1, 1995 and May 14, 1997, which were not granted protection under Article 9 letters “b” and “c” of Law No. 5.772 of [December 21,] 1971, whose applicants failed to exercise the right specified in Articles 230 and 231, shall be decided until December 31, 2004 in conformity with this Law.”

For many years, INPI has been examining and issuing mailbox patents well beyond December 31, 2004. These patents have been receiving a term of 10 years from grant.

On September 5, 2013, the federal attorneys of INPI submitted a brief to the President of INPI regarding the term of mailbox patents. Specifically, the attorneys argued that the term of mailbox patents was 20 years from their filing date and that the provision in the sole paragraph of Article 40 did not apply to these patents (namely, these patents were entitled to a patent term of 10 years from grant) because mailbox patents were given specific treatment under the sole paragraph of Article 229. In addition, the federal attorneys argued that the Brazilian Association of Intellectual Property had “expressly acknowledged” that mailbox patents did not benefit from this minimum patent term. Therefore, according to the brief, a nullification action under Article 46 of the Law was appropriate for any mailbox patent granted having a patent term of 10 years from grant.  Interestingly, the brief is completely silent regarding Article 229-B and the fact that INPI was required to grant or deny mailbox applications by December 31, 2004. In fact, had INPI examined such applications as it was required to do so by December 31, 2004, the issue regarding the term of mailbox patents discussed in the brief would not exist.

On September 6, 2013, the brief was signed by Jorge de Paula Costa Avila, the President of INPI (who was subsequently removed as President). The brief was very quickly published in the Patent Gazette on September 10, 2013, which was highly unusual. On September 12, 2013, 33 lawsuits were filed by INPI in the Federal Court in Rio de Janerio (Federal Court). Examples of the some of the companies named in the lawsuits include:  Astellas, Merck, Monsanto, Boehringer Ingelheim, Sanofi, Pfizer, AbbVie, Bayer, Bayer Crop Science, Bayer Animal Health GmBH, Siemens Healthcare, Diagnostics GmBH, Novartis, AstraZeneca, Johnson & Johnson, Gilead and Eli Lilly. Each of the lawsuits reads very much like the brief and seeks: (1) correction of the term of the recited mailbox patents; (2) nullification of the patents (according to Article 56 of the Law, a nullity action can be brought by INPI or any party with a legitimate interest); and (3) a preliminary request to suspend the rights of the mailbox patents while the lawsuit is pending. The lawsuits were filed in front of one judge in the Federal Court who has subsequently reassigned three of the lawsuits to other judges. All of the judges denied the preliminary requests in each of the lawsuits.

We recommend that any company receiving one of these lawsuits carefully consider the value of each of its mailbox patents recited in the lawsuit. If the patents have value, we recommend that a company fully participate in the lawsuit. However, if one or more of the patents have little to no value, we recommend that a company renounce its interest in such patents (namely, abandon the patent). The reason is that according to Brazilian Civil Procedure, the losing party in a lawsuit must pay the other party’s attorney fees {which are fixed at 10-20% of the amount assigned to the lawsuit (likely to be about U.S $1,000, however, by the time this fee is collected, with interest, could be about U.S. $10,000)}. Therefore, if a company simply ignores the lawsuit and loses, there is a risk that the company may be liable to pay INPI’s attorney fees. Certain inconveniences can result if a company is unaware and fails to pay these attorney fees. Specifically, the attorney fee debt may be listed in the Brazilian government’s debtor list. If this listing occurs, a debtor company may be restricted from participating in public biddings as a potential supplier of a product or service (for example, oncology drugs or medical supplies) to the government or public agencies. Some companies sell their products primarily through such a bidding process, so the consequences could be substantial.

Please watch the BRIC Wall for future updates on these mailbox patent lawsuits in Brazil.

This post was written by Lisa Mueller and Gustavo de Freitas Morais and Justin Duarte Piné of Danneman Siemsen.