Divisional Practice in the BRICs and other Countries – Part 2 of a 9-Part Series

This is Part 2 of a nine-part series examining divisional practice in the BRIC as well as several non-BRIC countries. Click here to view Part 1.

Divisional Practice in Brazil

Time Period for Filing a Divisional 

A divisional application can be filed at any time up until the end of examination.  The “end of examination” occurs when:

1.  An Examiner issues a conclusive (“final”) Office Action rejecting the claims as not patentable; or

2.  Thirty days prior to the publication of the conclusive Office Action, such as a rejection decision or the allowance of the application (each conclusive Office Action is published in the Official Gazette (the time period for when such publication will occur cannot be predicted)),

Whichever occurs last.

Because determining the exact date of the “end of examination” is somewhat complex, 2 examples will be given.

Example 1:  An Examiner issues a conclusive Office Action on January 9, 2013.  The conclusive Office Action is published in the Official Gazette on January 31, 2013 (30 days prior to the publication of the conclusive Office Action is January 1, 2013).  Under these facts, the end of examination is January 9, 2013 (the date the Examiner issued the conclusive Office Action since this occurred last).  Therefore, the time period for filing a divisional application expired on January 8, 2013, well before the Applicant even knew that it’s application had been finally rejected.
Example 1

Example 2:  An Examiner issues a conclusive Office Action on January 9, 2013.  The conclusive Office Action is published in the Official Gazette on February 11, 2013 (30 days prior to the publication of the conclusive Office Action is January 11, 2013).  Under these facts, the end of examination is January 11, 2013 (the date 30 days prior to the publication of the conclusive Office Action in the Official Gazette).  Therefore, the time period for filing a divisional application expired on January 11, 2013, again, likely well before the Applicant even knew that it’s application had been finally rejected.

Example 2

Furthermore, once an application is allowed by an Examiner, it is no longer possible to file a divisional application.  Therefore, because it is not possible to predict when an Examiner will allow an application or issue a conclusive Office Action, Applicants should consider filing one or more divisional applications when requesting examination or when responding to a first Office Action or shortly thereafter.

Claims of a Divisional Application and Double Patenting

The claims of a parent and divisional application cannot be identical as this creates an issue of double protection or double patenting.  Additionally, the subject matter of the claims in a divisional application is restricted to the subject matter of the claims contained in a parent application pending up until the time that a request for examination is filed in the parent application.  In other words, new categories of claims or embodiments not included in the claims of a parent application before a request for examination is filed will not be accepted by National Institute of Industrial Property (INPI) in a divisional application.  For example, if a parent application contained claims for a first embodiment at the time a request for examination is made, a divisional application cannot contain claims to a second embodiment.  Alternatively, if a parent application contained process claims at the time a request for examination is made, a divisional application cannot contain claims to a composition or product.

As alluded to above, INPI is currently objecting to divisional applications that contain new categories of claims and/or new embodiments that were not included in the claims of a parent application before the filing of the request for examination in the parent application.  It is INPI’s position that the set of claims in a divisional application must be restricted to the subject matter of the claims pending in the parent application up until the time that a request for examination is filed in accordance with the provisions of Article 32 of the Brazilian Industrial Property Law (Article 32 allows an applicant to make claim amendments and add additional claims up until the date that a request for examination is filed provided that any amendments or new claims do not exceed the subject matter originally disclosed in the application).  Therefore, it is very important for Applicants to include at least one claim for each embodiment in a parent application before filing a request for examination in order to enable the filing of a future divisional application.

Requirements for Filing a Divisional

According to Article 26 of the Brazilian Industrial Property Law, a patent application can be divided into two or more applications:

1.   Ex officio by INPI when technical examination reveals that the claims are complex or contain a group of inventions that comprise more than one inventive concept (namely, the claims lack unity of invention); or

2.  At the request of the Applicant up until the end of the examination.

When filing a divisional, a copy of the specification, abstract, drawings, a new set of claims and a power of attorney must be submitted.  The title of the application and the abstract can be amended to better define the subject matter being protected.  In addition, a divisional application must include a specific reference to the parent (original) application and cannot contain subject matter that exceeds that disclosed in the parent application.  The reference to the parent application can be included in the specification after the title and should include the application number and filing date of the parent application.  For example, the specification of the divisional application can be amended to include the following cross-reference: “Divided from BR ___              filed on ____ / ____ / ____;”

All official fees (namely, filing fees, examination fees, annuities and the fee(s) for claiming priority, if any) must be paid at the time of filing of a divisional application in order to place the divisional application on the same administrative prosecution level as the parent application.

The filing fees for a divisional application are the same as the fees for an originally filed patent application.  Moreover, the examination fee for a divisional application depends on the total number of claims and increases substantially if an application contains a large number of claims.   Specifically, after the first 10 claims, there are three ranges of fees for claims (namely, for claims 11-15, claims 16-30 and claims 31 and on).  The claim fees increase with each range until claim 31.  After claim 31, the price per claim remains the same.

Examination of Divisional Applications

According to Article 27 of the Brazilian Industrial Property Law, a divisional application will receive the same filing date as well as the benefit of any priority claim made in a parent application.

Divisional applications are not given any priority status in terms of examination by INPI.  Typically, in many instances, what occurs is that the Examiner will examine both the parent and divisional applications simultaneously and publish Office Actions in both applications since it is necessary for the Examiner to analyze whether the set of claims in the divisional application are in accordance to the provisions of Article 32 of the Brazilian Industrial property Law.

This post was written by Lisa Mueller and Silvia Moreira Taketsuma Costa of Dannemann Siemsen.

Divisional Practice in the BRICs and other Countries – Part 1 of a 9-Part Series

This is Part 1 of a nine-part series examining divisional practice in the BRIC as well as several non-BRIC countries.  Specifically, we will examine divisional practice in Brazil, Canada, China, Europe, India, Mexico, Russia, and the United States (in no particular order).  The last post in this series will summarize the similarities and differences in divisional practice in each of these countries in chart form.  We look forward to receiving your comments on these postings.

Divisional Practice in Mexico

Time Periods for Filing Divisional Applications
A divisional application can be filed in Mexico at one or both of the below time periods:

1.  When responding to an Office Action raising a lack of unity rejection; and/or

2.  Any time prior to the grant of a Mexican patent application (such a divisional application is referred to as a “voluntary” divisional application).

Divisional Applications filed in Response to a Lack of Unity Rejection
The Industrial Property Law (“Law”) provides that if an application fails to comply with the unity of invention requirement, an Applicant must be notified of such in an Office Action.  In addition, the Applicant is allowed to divide the application into one or more divisional applications depending on the number of inventions identified by the Mexican Institute of Industrial Property (“IMPI”).  An Applicant must file one or more divisional applications when responding to an Office Action containing a lack of unity rejection.

However, a question arises as to when such divisional applications must actually be filed.  For example, assume that an Applicant receives an Office Action containing a lack of unity rejection.  Specifically, in the Office Action, the Examiner argues that the claims are directed to 5 different inventions and requires the Applicant to elect a single invention for prosecution (or present arguments as to why the claims relate to a single inventive concept (If such arguments are not sufficient to convince the Examiner to remove the lack of unity rejection, then a further Office Action will be issued requiring the Applicant to elect a single invention and file one or more divisional applications)).   If the Applicant elects to pursue claims to the first invention in the originally filed (parent) application, is the Applicant required to file 1, 2, 3 or 4 divisional applications for any non-elected inventions when responding to the Office Action containing the lack of unity rejection (depending on whether the Applicant wanted to pursue some or all of the non-elected inventions)?

Strictly speaking, under the Law, an Applicant is required to file one or more divisional applications for all non-elected inventions when responding to an Office Action containing a lack of unity rejection.  Because no guidelines exist regarding such a scenario, IMPI allows Applicants to file a first (single) divisional application containing claims to all non-elected inventions when responding to an Office Action containing a lack of unity rejection.   What will ultimately occur, however, is that the Applicant will receive an Office Action in the first divisional application raising a lack of unity rejection.  At that time, the Applicant will be required to file a further (second) divisional at the time of responding to the Office Action for any non-elected inventions.

Claims of a Divisional Application and Double Patenting
A divisional application can be filed with one or more claims as originally filed.  However, if an Applicant files a divisional application containing one or more claims that are identical to claims that have previously undergone substantive examination by IMPI (such as in a previous parent or divisional application), then the Applicant should amend the claims in question so as not to be identical with any such previously examined claims.  The reason is IMPI will not conduct substantive examination twice for identically claimed subject matter in a pending divisional application when the same claimed subject matter has already been examined in a previous parent or divisional application.  However, an Applicant can pursue any claimed subject matter (including any claims that have been previously deleted in a parent or divisional application) in a divisional application that has not previously been substantively examined in another parent or divisional application by IMPI.  Therefore, when filing a divisional application in Mexico, Applicants should carefully consider the claims to be filed with the divisional application taking into account any claimed subject matter substantively examined by IMPI in a previous parent or divisional application.

Requirements for Filing a Divisional Application
When filing a divisional application, the following documents must be submitted:

1.  A copy of the description and drawings;

2.  A set of claims to be pursued; and

3.  If appropriate (namely, if the Applicant has assigned its rights in the parent application to a third party), an assignment and Power of Attorney.

Documentation relating to the priority claim and translation do not need to be submitted.

The current government fee for filing a divisional application is approximately $800.00 U.S. dollars.  An additional $110.00 U.S. dollars is required for each priority claim made. 

Examination and Publication of Divisional Applications
Like an original (parent) application, a divisional application is examined in chronological order.  However, this rule is not strictly applied in all substantive examination groups and in some groups, divisional applications are examined more quickly then non-divisional applications.

Additionally, divisional applications are not published until granted.  Therefore, it is not possible to know whether a divisional application corresponding to a parent application has been filed unless mention of the filing of a divisional application is made in the file wrapper of the parent application.

This post was written by Lisa Mueller and Pedro Herrera of Olivares.

Is the Patent Term “Guarantee” in Brazil Unconstitutional?

Article 40 of Brazil’s Industrial Property Law (Law) guarantees a minimum patent term of 10 years from the date of grant. This article is an especially important provision in the Law due to the fact that it typically takes 10 to 13 years for patent applications in the pharmaceutical and high technology areas to be granted by the National Institute of Industrial Property (INPI). The problem is further exacerbated for pharmaceutical applications which are required to receive “prior consent” from the National Sanitary Vigilance Agency (ANVISA) before such applications can be granted.

During the last few months in Brazil, Article 40 has been the subject of significant debate. In fact, proposed bill PL 5402/2013 would remove the “guaranteed” 10 year patent term and replace it with a maximum term of 20 years, as authorized by Article 33 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

Additionally, as discussed in a previous BRIC Wall post, on September 6, 2013, attorneys for INPI issued a binding opinion that the term of mailbox patents (patent applications filed between January 1, 1995 and May 14, 1997) was 20 years from their filing date and that the provision in the sole paragraph of Article 40 did not apply to these patents. Because the opinion was not self-executing, on September 12, 2013, 33 lawsuits were filed by INPI in the Federal Court in Rio de Janerio. 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.

Now comes word that on Monday November 4, 2013, the Associação Brasileira das Indústrias de Química Fina, Biotecnologia e Suas Especialidades (Abifina), a Brazilian organization representing national companies with chemicals interests, brought a constitutional challenge before the Brazilian Supreme Court requesting that Article 40 be declared unconstitutional. This case has been assigned to Judge Luiz Fux, appointed to the Supreme Court by the Workers’ Party – PT. It should be very interesting to see how Judge Fux rules with respect to this constitutional challenge.

Please watch the BRIC Wall for future updates on this constitutional challenge to Article 40 in Brazil.

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

Request for Public Comments by ANVISA on the Interchangeability of Branded Generic Drugs with Reference Drugs in Brazil

The National Sanitary Vigilance Agency (ANVISA) is currently accepting public comments on the issue of whether branded generic drugs should be considered to be interchangeable with reference (innovator) drugs (reference drugs). According to the current regulations in Brazil, only non-branded generic drugs are considered to be interchangeable with reference drugs. However, ANVISA is now considering changing its regulations to allow branded generic drugs to be interchangeable with reference drugs. Such a change could have a significant impact on how drugs are prescribed and ultimately distributed to patients in Brazil. Moreover, this change would provide a boost to the Brazilian generic drug industry.

Currently, because non-branded generic drugs are considered to be interchangeable with reference drugs, pharmacists in Brazil may, at their own discretion, substitute a doctor’s prescription for a reference drug with a non-branded generic drug. The reason such substitution is permitted is because both Brazilian law and ANVISA allow for this interchangeability. If ANVISA were to change its regulations to allow branded generic drugs to also be interchangeable, a pharmacist would be able to substitute a reference drug with either a branded or non-branded generic drug. Therefore, this potential change would make it significantly easier for pharmacists to sell generic drugs because they would have a choice of providing a patient not only the reference drug but also branded and non-branded generic drugs. Previously, a patient could only purchase a branded generic drug if the prescribing doctor wrote a prescription for the branded-generic drug.

The Request for Public Comments #4 of October 18, 2013 (published on October 21, 2013) may be found by clicking here. Comments can be submitted up until November 27, 2013 by clicking here.

Please watch the BRIC Wall for further updates on whether ANVISA changes its regulations to allow branded generic drugs to be interchangeable with reference drugs.

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