BRIC-a-BRAC: January 31, 2014

1.  An interesting article in Pharmaexec.com discusses Russia’s focus on developing a “world class” biopharmaceutical sector.  The article states that IMS Health predicts that Russia’s $16.6 billion in annual prescription drug sales (11th in market size) will rise to $26.6 billion by 2017 (8th in market size).  Specifically, the article discusses ChemRar, a consortia of biotech startups and R & D venture companies funded through a mix of private capital and public funds dedicated to the goal of developing and commercializing innovative medicines with therapeutic potential for Russia (and hopefully the world).  Also discussed is Skolkovo, a publicly funded institution and incubator home to 200 companies that has a broad range of business and policy objectives.  

Finally, the article interviewed key players in Russia’s biopharmaceutical industry and identified four strategic questions it believes will prove critical to Russia’s success.  These questions are: 

a.  “Will government efforts to advance the ‘front end’ of innovation – through new infrastructure, financing of basic research, and tax incentives – be accompanied by the far more essential ‘back end’ of a fair and transparent investment, regulatory and pricing regime based on international standards?

b.  Is there political will to ensure that public health gains a higher profile as a strategic driver of Russia’s future, where medicines — both patent and generic — are recognized as a key part of service delivery within an adequately financed national health care system?

c.  Are the market opportunities in Russia sufficient for the top 10 foreign players to establish world-class R&D operations in the country, effectively transferring to Russia the expertise required to access global knowledge networks and fill the local gaps in financial and human capital?

d.  Can domestic pharma producers build the size and scale to surpass the foreign-based multinationals in Russia and extend that success to international markets, making the transition from copying, distribution and manufacture to an originator of world class innovations?”

2.  On Tuesday, January 28, 2014, the Nigerian government launched the country’s first Intellectual Property Automated Systems (IPAS).  The government believes that the IPAS will make patent registration easier in Nigeria.  The system was launched by Olusegun Aganga, Minister of Industry, Trade and Investment and is considered to be a major milestone in the effort to transform the Nigerian industrial landscape.  According to Mr. Aganga:  

“The introduction of the IPAS will further improve and uplift the integrity and standards of all applications that emanate from Nigeria. 

It will enhance the confidence of both the local and international communities and further encourage local and foreign direct investment in the country.  This is about consumer and investment protection and it is a very good development for the country.”  

To learn more, click here

3.  This week the question was asked whether or not Indian companies have a “chronic data falsification problem” after the United States (US) Food and Drug Administration (FDA) accused Ranbaxy of failing to ensure the integrity of its data.  Specifically, FDA inspectors reportedly found evidence that the company was “over-writing electronic raw data files for ongoing sample sequences until acceptable results were achieved.”

This is the second “offense” for Ranbaxy.  In May 2013, Ranbaxy pleaded guilty to falsifying data.  In fact, in 2013, the US FDA (in warning letters) raised questions regarding the integrity and reliability of data generated by 7 companies.  These companies were Ranbaxy, Wockhardt Limited, Agila Specialties Private Limited, Posh Chemicals Private Limited, Aarti Drugs Limited, Fresenius Kabi Oncology Ltd. and RPG Life Sciences Limited.  To learn more, click here.

Divisional Practice in the BRICs and other Countries – Part 6 of a 9-Part Series: China

This is Part 6 of a nine-part series examining divisional practice in the BRIC as well as several non-BRIC countries.  To view Part 1 (Divisional Practice in Mexico), click here.  To view Part 2 (Divisional Practice in Brazil), click here.  To view Part 3 (Divisional Practice in the United States), click here.  To view Part 4 (Divisional Practice in India), click here.  To view Part 5 (Divisional Practice in Russia), click here.

Divisional Practice in China

Time Periods for filing a Divisional Application 

In China, an Applicant can file a divisional application:

1.  At any time while a parent application is pending but no later than the expiration of 2 months from the date of receipt of the Notification to Grant Patent Right from the Chinese Patent Office (SIPO) [the 2 month period is the time during which the application proceeds through the formalities of registration].  An Applicant can file a divisional application during this 2 month period regardless of whether or not the Applicant proceeds with the formalities of registration (namely, paying the issue fee).  However, see the important note below. 

2.  Within 3 months from the date the Applicant receives a Notification of Rejection in a parent application (regardless of whether or not the Applicant requests reexamination of the Examiner’s decision).  A Notification of Rejection notifies the Applicant that the application is rejected and that prosecution has been “closed” by the Examiner.  An Applicant can file a request to the Board of Patent Reexamination (a Reexamination Request) to re-examine the application in view of the Examiner’s decision. 

3.  At any time after filing a Reexamination Request. 

4.  If the Board of Patent Reexamination (Board) overturns the Examiner’s rejection, the application is returned to the Examiner for further examination.  During this further examination, an Applicant can file a divisional application (but a divisional application can be filed no later than the expiration of 2 months from the date of receiving the Notification to Grant Patent Right). 

5.  If the Board maintains the Examiner’s Rejection, an Applicant may appeal to court (namely, a first instance court) within 3 months of receipt of the reexamination decision from the Board (Reexamination Decision).  An Applicant can file a divisional application during this 3 month period regardless of whether or not the Applicant files an appeal. 

6.  If an Applicant appeals to a first instance court after receipt of the Reexamination Decision. 

7.  If the first instance court maintains the Reexamination Decision, an Applicant may further appeal to the second instance court within 15 days from receipt of the first instance court’s decision.  Regardless of whether or not the Applicant files an appeal with the second instance court, the Applicant can file a divisional application within 15 days of receipt of the decision from the first instance court.  

8.  After appealing a decision from a first instance court to a second instance court.  

9.  If the first instance court overturns the Reexamination Decision, an Applicant can file a divisional application. 

Important Note:  An Applicant cannot file a divisional application after the expiration of the 2 month period from the date of receipt of the Notification to Grant Patent Right of the parent application, if the parent application has been withdrawn, or is deemed to have been withdrawn and the application has not been restored (namely, reinstated).  Additionally, in accordance with current patent practice in China, a divisional application can be filed from a previously filed divisional application (meaning “cascading” divisionals are permitted).  

In China, a divisional application has the same filing date as the very first parent application.  This date is referred to as the “divisional submission date” (rather than the filing date).  After a divisional application is filed, an Examiner reviews the divisional submission date to confirm that the divisional filing is correct and is not after the (1) expiration of the 2 month period from the date of receipt of the Notification to Grant Patent Right in the very first parent application; (2) withdrawal of the very first parent application; or (3) withdrawal of the very first patent application which has not been reinstated.  In addition, the Examiner will determine whether the divisional application satisfies any of items 1-9 above.  

The divisional submission date is particularly important with respect to “cascading divisionals” (such as, for example, a second divisional application (divisional application 2) filed from first divisional application (divisional application 1)).  A cascading divisional can be filed voluntarily (meaning the divisional application can be filed for any reason) or in response to a lack of unity rejection raised in a prior filed divisional application.  

If a further filed divisional application (such as divisional application 2) is a voluntary divisional filed from a previously filed divisional application (such as divisional application 1), an Examiner will review the divisional submission date of divisional application 2 with the status of the very first (original) parent application.  Specifically, the Examiner will review the divisional submission date (of divisional application 2) to confirm that the divisional filing is correct and is not after the (1) expiration of the 2 month period from the date of receipt of the Notification to Grant Patent Right in the very first parent application; (2) withdrawal of the very first parent application; or (3) withdrawal of the very first patent application which has not been reinstated.  In addition, the Examiner will determine whether the divisional application satisfies any of items 1-9 above (but as it relates to the status of the very first parent application).  

If a further filed divisional application (such as divisional application 2) is filed in response to a lack of unity rejection raised by an Examiner in a previously filed divisional application (such as divisional application 1), an Examiner will review the divisional submission date of divisional application 2 with the status of divisional application 1.  Specifically, the Examiner will review the divisional submission date (of divisional application 2) to confirm that the divisional filing is correct and is not after the (1) expiration of the 2 month period from the date of receipt of the Notification to Grant Patent Right in divisional application 1; (2) withdrawal of divisional application 1; or (3) withdrawal of divisional application 1 which has not been reinstated.  In addition, the Examiner will determine whether divisional application 2 satisfies any of items 1-9 above (but as it relates to the status of divisional application 1).  

Practically speaking, the filing a further divisional application based on a previously filed divisional application is many times not possible because the very first parent application is granted, rejected or withdrawn (meaning it is “closed”).  However, if a previously filed divisional application (such as divisional application 1) was filed in response to a lack of unity rejection, the filing of a further divisional application (such as divisional application 2) in response to the lack of unity rejection is considered to be an “EXCEPTION”.  In addition, as discussed below, in order to receive the benefit of this “EXCEPTION”, an Applicant must submit a copy of the Office Action where the lack of unity rejection was raised when filing the further divisional application (divisional application 2).  If a copy of the Office Action is not submitted, the Examiner will examine the divisional submission date (of divisional application 2) according to the status of the very first parent application and will reject the divisional application (divisional application 2) if the very first parent application is closed.

Requirements for Filing a Divisional Application

When filing a divisional application, a copy of the specification, abstract and drawings from the parent application must be filed.  A set of claims (either the original claims from the parent application or a new claim set) must also be included.  In addition, the following are also required:

1.  Payment of all the necessary filing fees;

2.  A Power of Attorney;

3.  Priority document of the parent application;

4.  An assignment; and

5.  If the divisional application is being filed in response to a lack of unity raised in a previously filed divisional application, a copy of the Office Action where the lack of unity rejection was raised.

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the parent or PCT application.  However, the claims of a divisional application filed using the claims of a parent or PCT application will need to be amended at some point during prosecution to ensure that neither the parent or divisional application claim the exact same subject matter.  However, partial overlap of the subject matter between a parent and a divisional application is permitted (for example, if claim 1 of a parent application claims a plate having a length of 5 to 10 meters, claim 1 of a divisional application can recite a plate having a length of 1 to 20 meters). 

Double Patenting

In China, an Applicant is entitled only to a single patent per invention (meaning that the claims of 2 patents cannot protect the same invention; thereupon, the claims cannot have the exact same scope).  In other words, what is considered to be “statutory” double patenting in the United States is not permitted.  Thus, an Examiner may require amendment of the claims of either the parent or divisional application as necessary to ensure that neither application includes a claim for any identical matter claimed in the other application.  Moreover, there is no obviousness-type double patenting in China.

Examination of Divisional Applications

A divisional application is treated as a substantive application and is accorded a separate application number, requires separate fees, requires a separate request for examination, will be prosecuted separately from the parent application, and will result in an independent patent from the parent application.  The fees for a divisional application are the same as for any parent application.  The term of patent for a divisional application is twenty years (for an invention) or ten years (for a utility Model or design) from the filing date of the very first parent application. 

Special or Unique Requirements for Filing a Divisional Application in China 

The time periods applicable for a divisional application, such as the time limit for requesting substantive examination or paying the fee for requesting substantive examination, are calculated from the initial filing date (or priority date) of the very first parent application.  If a time limit has expired or is less than two months from the divisional submission date, the Applicant is permitted to complete any formalities or pay any required fees within 2 months from the divisional submission date or within 15 days from receipt of the Notification of Acceptance of the divisional application.   

A divisional application cannot be used to change the application type (such as an invention, utility model or design) of the parent application.  In other words, if the parent application is for a utility model, a divisional application cannot be filed directed to a design. 

The inventor(s) of a divisional application must be the same as or be included in the list of the inventors contained in the parent application. 

The Applicant of a divisional application must be the same as the parent application.  If the Applicant for the parent and divisional application are different, an assignment must be submitted. 

Function of Divisional Applications in China 

The legislative intent behind the filing of one or more divisional applications in China has its origin in the unity of invention requirement, namely, providing an Applicant with the opportunity to protect those inventions described and claimed in a parent application that do not form a single inventive concept.  However, despite this intent, divisional applications are used in China to achieve a variety of purposes.  

For example, a divisional application can be filed to incorporate an amendment that would not be entered by an Examiner during prosecution of a parent application.  In general, when responding to an Office Action, an Applicant must amend the claims according to the comments provided by the Examiner in Office Action and cannot enlarge the scope of the claims (in contrast, when making voluntary amendments, an Applicant is permitted to enlarge the scope of the claims).  Therefore, if an Applicant wishes to include new claims or claim amendments that were not accepted during prosecution of a parent application (such as enlarging the scope of the claims, adding one or more claims directed to embodiments not present in the original claims, or making other amendments that would not have been in accordance with the Examiner’s comments), an Applicant can file a divisional application with the new claims. 

Additionally, if during prosecution an Examiner indicates that certain claims are allowable but other claims are not patentable, an Applicant can cancel the claims deemed not to be patentable in order to place the application in condition for allowance.  The Applicant can pursue the canceled claims in a divisional application.   

Moreover, an Applicant can file a divisional application with the same claims as in a parent  application for the purposes of having different Examiner examine its application.  

This post was written by Lisa Mueller and Ivan Shen of Shen IP.

 

 

BRIC-a-BRAC: January 24, 2014

1.  Brazilian President Rousseff has appointed Arthur Chioro, a member of the Worker’s Party, as Brazil’s new Minister of Health.  The departing Minister of Health, Alexandre Padilha, is leaving his post to run for governor of the State of São Paulo.  The Ministry of Health has the largest budget of any of the ministries in Brazil at approximately R$106 (approximately U.S. $44.9) billion. 

Until his appointment, Mr. Chioro served as the Secretary of Health in São Bernardo do Campo, the 4th largest city in São Paulo state.  Mr. Chioro has strong ties to the Workers’ Party and to former President Lula, who is also a resident of São Bernardo do Campo.  During his time as Secretary of Health, Mr. Chioro successfully instituted several important health programs and obtained millions of reais in investments from the federal government.  Specifically, he established new Public Health Emergency Services Units, inaugurated a new public hospital that will increase (to about 18,000) the number of patients that can be interned under the Brazilian Universal Healthcare System, and supported the “Mais Médico” (More Doctors) program in São Bernardo do Campo by offering positions to Cuban doctors to work in the poorer areas of the city.

Interestingly, Mr. Chioro is being targeted by the São Paulo State Prosecutor for administrative improbity (lack of integrity or dishonesty).  Specifically, in September 2013, a civil investigation was initiated to determine the degree to which Chioro violated principles of public administration while serving as Secretary of Health of São Bernardo do Campo.  During his tenure as Secretary of Health, Mr. Chioro was the majority owner of a health consulting company that provided services to other municipalities, particularly those municipalities in which Workers’ Party members controlled the municipal governments. 

Many thanks to Gustavo de Freitas Morais ‎of Dannemann Siemsen for sharing this information.

2.  In a further follow-up to last Friday’s and this Monday’s BRIC-a-BRAC post, Novo Nordisk announced that last week it resigned from the Innovative Pharmaceutical Industry Association South Africa (IPASA) in view of a disagreement with the organization regarding its alleged campaign to delay South Africa’s proposed changes to its patent laws.  IPASA is hoping that Novo Nordisk will reconsider its position and remain a part of the organization.  To learn more, click here.

3.  Section 7(2) of the Indian Patent Act, 1970 requires an Applicant to establish proof of the right to make a patent application.  Such a proof of right can be established by submitting “Form-1” (which is executed by the inventors; a copy of which can be found here:  Form-1) or a certified/notarized copy of an assignment between the Applicant and inventors.  If an application is made by virtue of an assignment of the right to apply for the patent for the invention, an Applicant has 6 months from the date of filing of the application to provide such proof of the right. 

In a recent case, NTT DoCoMo Inc. v. The Controller of Patents and Designs, the Intellectual Property Appellate Board held that a proof of right “must be filed for all the applications, ordinary and convention applications, alike”.  In view of this decision, it is important that Applicants filing ordinary, convention and National Phase Patent Cooperation Treaty (PCT) applications in India file a proof of right in order to avoid their applications being refused.

 

 

 

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.

BRIC-a-BRAC

1.  In a follow up to Friday’s BRIC-a-BRAC post, South Africa has slammed the global pharmaceutical companies involved in the so-called campaign to delay the proposed changes to its patent laws accusing them of a “satanic” plot to commit “genocide”.  Specifically, Minister of Health Aaron Motsoaledi stated that the campaign was aimed at turning South Africans against the government.  “It’s a conspiracy of satanic magnitude,” he said.  “This document can sentence many South Africans to death.  This is a plan for genocide.”

The new patent law will prevent “ever-greening” (which allows for patent protection for minor changes to an existing drug or for the discovery of a new use for an existing drug) and is expected to reduce prices and facilitate the growth of South Africa’s struggling generic drug industry (which is now dominated by Aspen Pharmacare and Adcock Ingram).

As mentioned in Friday’s post, the trade organization, Innovative Pharmaceutical Industry Association South Africa (IPASA), was coordinating the campaign.  Some members of IPASA include Sanofi, Baxter, Novartis and Pfizer.  A document prepared for IPASA by the U.S. consulting firm Public Affairs Engagement outlines the plan to delay the patent reforms until at least after South Africa’s elections in early May by suggesting that the new law would be “politically damaging”.  The document also states that “The world cares that South Africa is proposing to take a wrong turn in economic policy by weakening IP protections.  And by cares, we mean both expresses compassionate concern and will take action by reducing investment.”  This last sentence has many wondering whether global pharmaceutical companies will reduce their investment if and when the proposed patent reforms are enacted.  Time will tell.  To learn more, click here.

2.  It is nice to see more and more conferences being offered on US and global biosimilar protection.  On Thursday and Friday of this week, I will be attending Momentum’s “The IP Counsel Exchange for Biosimilar Applicants and Innovator Biologic Sponsors” at the W Union Square in New York (Conference agenda is posted here132W14-NYC_Biosimilar_122013_v10[2]).  During the conference, I will share any interesting information.  If you are attending, please look me up.

BRIC-a-BRAC

1. On December 16, 2013, Columbia’s National Institute of Food and Drug Monitoring (INVIMA) announced the approval of Remsima (infliximab) for the indications of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.  Remsima is the first “similar” biotherapeutic product to be approved in Columbia and was developed by Celltrion in collaboration with Hospira.  To learn more, click here.

2. According to an article published on January 14, 2014 in Brazil Pharma News, Sindusfarma, (the Pharmaceutical Products Industry Union in the State of San Paulo) expects the sales of pharmaceutical drugs in Brazil to continue to be strong in 2014; however, profit margins are expected to decrease.  Specifically, the article notes that the expectation in 2014 is for industry growth to be around approximately 13% with revenues of approximately 24 billion (US dollars).  The highest growth is expected in the generic drug market.

3. In Brazil, “similar medicines” (drugs having a trade or brand name) will be afforded the same status as generic drugs (drugs having only the generic name of the active ingredient). In other words, pharmacists in Brazil will be allowed to substitute a branded product with a similar drug. Given this new status, the price of similar drugs will be required to be priced 35% lower than the referenced products.  To learn more, click here

4. An interesting article in the Guardian reports that several drug companies in South Africa have been accused of participating in a well-funded campaign to delay the introduction of changes to the patent law that would enable patents on new medicines to be bypassed in the interest of public health.  The trade body Innovative Pharmaceutical Industry Association South Africa (IPASA) was coordinating the campaign. IPASA reports that it is no longer going ahead with the campaign although it believes that it was legitimate for drug companies to promote their views in this manner.  To learn more, click here.

Time Period and Burden of Proof Requirements when Requesting Revocation of a Patent in Kenya

 

Since patent decisions are relatively infrequent in Africa, we at the BRIC Wall have decided to report when new decisions are issued.  Specifically, near the end of 2013, the Industrial Property Tribunal (Tribunal) in Kenya decided Chemserve Cleaning Services Limited (Chemserve; the Requester) v. Sanitam Services (East Africa) Limited (Sanitam; the Respondent).  This case involved Sanitam’s ARIPO (AP) Patent No. 773 claiming a foot operated sanitary bin registered on October 15, 1999.  Chemserve learned of the patent in August 2006 (when it received a letter from Sanitam’s lawyers alleging infringement); however, it waited until April 2008 to file a request for revocation.  Specifically, Chemserve alleged that the patent was invalid because the claimed products:

1.  Lacked novelty and inventive step; and

2.  Existed in the marketplace before the filing date of the patent thus forming part of the prior art.

The only evidence submitted by Chemserve in support of its request was an affidavit and statement by the company’s General Manager in which he averred that:

“Company had been importing the said litter/sanitary disposal binds before the patent was granted by ARIPO and I am advised by my advocates on record and which information I verily believe to be true that under s. 23(2) of the Industrial Property Act, 2001, everything made available to the public anywhere in the world by means of written disclosure (including drawings and other illustrations) or, by oral disclosure, use, exhibition or other non-written means shall be considered prior art.

 By virtue of the Company’s having been importing the said litter/sanitary disposal bin that constituted prior art and Patent No. AP 777 was wrongly granted to Sanitam Services (EA) Limited’s alleged invention.”

In response, Sanitam argued:

1.  The request for revocation was not timely filed pursuant to Section 103 of The Industrial Property Act, 2001 (Act); and

2.  The unique foot operated system patented under AP Patent No. 773 was new, possessed inventive step and did not form part of the prior art.

Revocation under Section 103 of the Act

In Kenya, revocation of a patent is governed by Section 103 of the Act.  Specifically, section 103 provides:

(1)  Any interested party may in the proceedings instituted by him against the owner of a patent, or a registered utility model or industrial design or in proceedings instituted against him by the owner, request the Tribunal to revoke or invalidate the patent, utility model or industrial design registration.

(2)  An interested party may within a period of 9 months from the date of publication of the grant of a patent, utility model or industrial design request the Tribunal to revoke or invalidate the patent, utility model or industrial design registration.

Chemserve argued that the request for revocation was timely filed because the patent was registered under the Industrial Property Act of 1989 which did not provide for publication of the grant of a patent.  Thereupon, it argued that the “time bar” of 9 months as recited in Section 103(2) did not apply.  The Tribunal disagreed.

In its analysis, the Tribunal recognized that Section 103(1) provided no time limit as to when a request for revocation should be made and that the only inference regarding time could be drawn from the phrase “in the proceedings” which, in the Tribunal’s opinion, extended the time for filing a revocation until a final determination was made in such proceedings.  However, the Tribunal concluded that when reading the two sections of Section 103 together, it was likely that the legislative intent was to “prevent a situation where a party becomes aware of a patent, industrial design or utility model and then literally sits on the right to revoke it until a later date for commercial convenience in the form of damages and accounts for profits.” 

Thus, according to the Tribunal, the proviso or time bar in Section 103(2) was a clear qualification of the right to seek revocation of a patent under this section.  Specifically, the Tribunal stated:

“Parliament in its wisdom placed that caveat to the said right and unless a contrary intention or provision exists such provision should and must be given its place in enforcing the law. 

…Indeed the law in our view being alive to the possibility that party may for bonafide reasons not be aware of the existence of the patent within the limited time has provided a leeway under Rule 33 by allowing for extension of time for the challenge.  Such extension of time is naturally discretionary and will afford the Tribunal an opportunity to examine the bonafides of the party and the reasons for the delay before exercising it judiciously.

The law should and in our view cannot come to the aid of an indolent party and it must be demonstrated that they were diligent and proactive in presenting their case.”

Applying the above principles, the Tribunal held that even if Chemserve had not been aware of the grant of the patent, it learned of the patent in 2006 but chose not to take any action while continuing to trade in similar products until 2 years later when it filed the request for revocation.  According to the Tribunal, “The Requester chose to selectively invoke Section 103(1) on the issue of revocation without complying with its proviso on time under 103(2) and now urges the Tribunal to wish it away.  To do so would in our view be discriminatory and amount to a miscarriage of justice on the part of the Respondent who deserves equal protection of the law as the Requester.”  The Tribunal also noted that Chemserve failed to file for an extension of time under Rule 33 at the time it filed the request for revocation or even belatedly. 

Invalidity

The Tribunal further held that even if the request for revocation had been timely filed, Chemserve failed to meet the burden of proof required to establish that the patent was invalid.  Specifically, the Tribunal stated that the burden (of proof) was on Chemserve to demonstrate that the claimed products (1) lacked novelty and inventive step; and (2) existed in the marketplace before the filing date of the patent and thus formed part of the prior art.  The Tribunal noted that both parties chose not to produce any evidence other than the affidavit and statement by Chemserve’s General Manager.  The Tribunal found the affidavit not helpful because it related to transactions of similar products manufactured by third parties who were not called as witnesses.  Additionally, the “similar products” were not provided to the Tribunal nor was any attempt made to demonstrate the similarity between these products and the claimed products.  In the end, the Tribunal appeared frustrated by the lack of evidence stating:

“In the end the Tribunal was denied an opportunity to make any substantive findings on the allegations of prior art and inventiveness so as to review the decision of the registrar in granting the patent.  Such a finding in our view requires substantive proof and more diligence than has been exercised by the Requester.  It may very well be possible that the Requester’s assertions are true but in the absence of testimony to the extent and in light of the certificate of registration granted to the Respondent and their counter argument that the products met the legal requirements the balance of probabilities tilts in favor of the Respondents which we so find.”

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