Brazil’s Ministry of Health Issues New List of “Strategic” Drugs

On December 13, 2013, the Brazilian Ministry of Health published Ordinance 3089/2013 (Ordinance) which revoked previous Ordinances 978/2008 and 1284/2010.  This new Ordinance redefines the list of drugs considered to be of strategic interest to the Brazilian Universal Healthcare System (SUS).  Specifically, the Ordinance creates new categories of therapeutic designations considered to be strategic (such as antihypertensives and sickle-cell disease).  Additionally, it almost doubles the number of active pharmaceutical ingredients considered to be of strategic interest to the SUS.

The Ordinance clearly stipulates that the drugs listed may be part of future Productive Development Policy (PDP) projects as well as other projects and initiatives aimed towards transferring technology, innovation and local production of drugs to Brazil in an effort to strengthen the local industry sector.  However, the Ordinance fails to mention that the National Sanitary Vigilance Agency (ANVISA), pursuant to Resolution 21/2013, now has a larger bucket of strategically important compounds to potentially justify its analysis of patent applications under the guise of protecting public health.  Accordingly, we expect there to be an increase in the number of patent applications that ANVISA examines as being of strategic interest to the SUS.

Interestingly, the Ministry of Health did not, as it has done previously, attach a list of strategically important drugs and therapeutic destinations to the Ordinance.  Rather, Article 6 of the Ordinance states that:  “The products of strategic interest to the SUS may be found at the Ministry of Health’s homepage – http://www.saude.gov.br”.

It is rather surprising that a list of strategically important drugs and therapeutic destinations was not attached to the Ordinance.  Because a specific list was not attached to the Ordinance, it is possible that the Ministry of Health may, without publication of any notice, alter the list on its webpage by its own volition.  Additionally, it is even more surprising that the link provided is not directed to a specific page of the Ministry of Health’s web portal, but instead, to its home page.  One significant problem is that it is difficult to find any information as to which drugs are considered strategic on the home page of the Ministry of Health.  In fact, at this time, navigation to the list of strategic drugs is contained in a link (which is not highlighted as being a hyperlink) at the bottom of an article published on the Ministry of Health’s website that refers to a news story that does not relate to the new Ordinance.  The link to the news story can be found at: http://portalsaude.saude.gov.br/index.php/cidadao/principal/agencia-saude/7470-sus-tera-medicamento-para-transplantados-produzido-no-pais.  A link to the new list of strategic drugs can be found at the bottom of this news story: http://portalsaude.saude.gov.br/images/pdf/2013/dezembro/16/ANEXO-DA-PORTARIA-3089-11DEZ13.pdf.  The list is also attached (ANEXO-DA-PORTARIA-3089-11DEZ13).

The above actions clearly demonstrate that the Ministry of Health has not made available to the public a list of the drugs considered to be strategic to the SUS.  We believe that an argument can be made that the actions by the Ministry of Health, namely, failing to include the list of strategically important drugs and therapeutic destinations as an attachment to the Ordinance, as well as providing a link in the Ordinance that directs the public to the home page of the Ministry of Health instead of the list itself violates the Principle of Legality in which administrative rules are to be clearly communicated and ascertainable to the public.  Additionally, this lack of clarity creates legal uncertainty regarding the content of the list of strategic drugs given the possibility (at least theoretically) that the Ministry of Health may revise a page on its website on its own volition.

Please watch the BRIC Wall for further updates on the issuance by the Ministry of Health of updated lists containing additional drugs considered to be of strategic interest to the SUS.

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

Divisional Practice in the BRICs and other Countries – Part 5 of a 9-Part Series: Russia

This is Part 5 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.

Divisional Practice in Russia

In Russia, a divisional patent application can be filed voluntarily without any connection to any rejection contained in an Office Action (such as a lack of unity rejection).  In other words, a  divisional application can be filed for any reason.

Time Period for Filing a Divisional Application

A divisional application can be filed at any time:

1.  Up until the date of issuance of a patent in a parent application (which typically occurs within 2-3 months following payment of the Grant fee); or

2.  Within 6 months from the date of receipt of a Final Rejection in a parent application.

Requirements for Filing a Divisional Application

According to Articles 1374 and 1375 of the Russian Civil Code Part IV (“Code”), the requirements for filing a divisional application are as follows:  

1.  Submission of a copy of the specification (including the abstract), claims and drawings of the divisional application as well as an entry form indicating the name and address of the Applicant and the inventor(s);

2.  The divisional application cannot include any subject matter not disclosed in the parent application; and

3.  The parent application and the divisional application cannot claim identical subject matter.  

More than one divisional application can arise from a parent application.  

Additionally, in accordance with current patent practice in Russia, a divisional application can be filed from a divisional application (meaning “cascading” divisionals are permitted).  The priority and filing dates of each cascading divisional application will be identical to the priority and filing date of the very first (original) parent application.   

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the parent application or PCT application.  However, the claims of a divisional application filed containing the claims of a parent or PCT application will need to be amended at some point prior to issuance to ensure that neither the parent or divisional application claim identical subject matter.  In other words, there should be no overlapping of claimed subject matter in the parent and the divisional application. 

Double Patenting

Any patent issuing from a parent and a divisional application cannot claim the identical subject matter as this would present a double patenting problem.  In order to determine whether or not double patenting exists, the claims as allowed are examined to determine whether or not identical subject matter is being claimed.  Specifically, claimed subject matter will be recognized as being identical if:

1.   The independent claims in the parent and divisional application are completely (100%) identical with one another; or 

2.   One or more independent claims in the parent or divisional application recite one or more alternatives and the one or more alternatives are identical with one or more alternatives claimed in the parent or (another) divisional application.  

If two applications claim identical subject matter, an Examiner is likely to raise the issue of double patenting during the first stage of prosecution in both applications.  In the situation where two applications claiming identical subject matter have the same priority date and are filed by the same Applicant, an Examiner will issue an Office Action setting a period of 12 months for the Applicant to decide which of the two applications should be allowed to proceed to grant (assuming there are no other rejections).  If the Applicant does not respond to the Office Action, both applications will become abandoned.   

If two applications claiming identical subject matter are owned by different Applicants, a patent may be issued with respect to only one of these applications provided that the Applicants agree to such an arrangement and execute an agreement to that effect.  The agreement must be concluded within 12 months from issuance of an Office Action raising the issue of the identity of the subject matter being claimed in the two applications.  The term for executing the agreement and submitting it to the Patent Office can be extended for an additional 10 months.  In the absence of an agreement between the Applicants, both applications will be abandoned.  

Unfortunately, there are no specific regulations that address the situation where identical subject matter is claimed in an issued patent and a pending divisional application owned by different Applicants.  However, the Code contains regulations that address a situation where identical subject matter is claimed in an issued patent and pending divisional application owned by the same Applicant.  In this situation, no Decision of Grant will be issued for the divisional application until the time the issued patent is revoked by the Applicant (owner).  

Unfortunately, Examiners generally do not check to see whether or not identical subject matter is being claimed in a pending parent and divisional application or an issued patent and pending divisional application, especially if the identical subject matter is being claimed as one or more alternatives.  Therefore, it is possible that multiple patents may issue to the same Applicant (or different Applicants) claiming identical subject matter.  Thereupon, it is important for Applicants to be diligent when prosecuting divisional applications in Russia to ensure that the claims being pursued in any divisional application are not identical to any parent or other divisional application owned by the Applicant (or others). 

The issuance of two patents claiming identical subject matter can be challenged in the revocation tribunal known as the “Chamber for Patent Disputes”.  A revocation action can be filed by a third party at any time during the term of the patent.  We are not aware of any revocation actions that have been filed on the ground that two patents claim identical subject matter.  In the absence of such case law, we cannot predict the approach the tribunal might take to resolve such an action.

Examination of Divisional Applications

A divisional application is accorded the same filing date as the first parent application.   However, a divisional application is treated as a new patent application filing and thus: 

1.   Is allotted its own (new) application number; 

2.  Requires payment of certain fees (separate from the fees paid in the parent application); 

3.  Requires the filing of a request for examination (separate from the filing of a request for examination in the parent application); 

4.  Is prosecuted separately from the parent application; and

5.  Results in a patent that is independent from the parent application. 

The fees for a divisional patent application are the same as for any parent application.  Additionally, the term of a patent issuing off of a divisional application is twenty years from the filing date of the first (original) parent application. 

A divisional application is examined only when a Request for Examination (“Request”) is filed within the prescribed period (namely, thirty six months from the date of filing of the application). If a Request is not filed within time, the application will be considered withdrawn.

This post was written by Lisa Mueller and Vladislav Ugryumov and Tatiana Lyu from Gowlings.

Divisional Practice in the BRICs and other Countries – Part 4 of a 9-Part Series

This is Part 4 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.

Divisional Practice in India

In India, a divisional patent application can only be filed if a plurality of inventions is being claimed in an original (parent) application.

Specifically, according to Section 16 (1) of the Indian Patents Act, 1970 (“Act”), a divisional application can only be filed under the following circumstances:

1.  The original (parent) patent application claims subject matter directed to more than one invention and the Applicant, after filing of the original (parent) patent application but before grant, voluntarily decides to divide the original (parent) application into one or more divisional applications; and

2.  An objection is raised in an Office Action that the claims of the original (parent) patent application relate to more than one invention (namely, the claims lack unity), and hence are not allowable under the Act.   In this case, the Applicant can file a divisional application to overcome such an objection.

It is important to note that an Applicant cannot file multiple patent applications claiming the same invention and refer to each such application as a “divisional” application.

Time Period for Filing a Divisional Application

A divisional application can be filed any time up until the grant of the original (parent) application.

Requirements for Filing a Divisional Application

According to Section 16 of the Act, the requirements for filing a divisional application are as follows:

a) Submission of a copy of the specification, claims and drawings of the divisional application;

b) The divisional application cannot include any subject matter not disclosed in the original (parent) application; and

c) The original application and the divisional application cannot claim identical subject matter.

More than one divisional application can arise from an original (parent) application.  However, a divisional application cannot be filed from a divisional application (namely, no “cascading” divisionals are permitted).  In other words, any and all divisional applications must be divided out of the originally filed (parent) application.

In a recent decision, two divisional applications (specifically, applications 3272/KOLNP/2008 and 3273/KOLNP/2008 owned by Roche AG directed to the breast cancer drug Herceptin) were rejected because a divisional application of a divisional application was found not to be permissible under the Act.  Click here to learn more about this decision.  

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the original (parent) application or PCT application.  However, the claims of a divisional application filed containing the claims of an original (parent) or PCT application will need to be amended at some point prior to issuance to ensure that neither the original (parent) or divisional application claim identical subject matter.  In other words, there should be no overlapping of claimed subject matter in the original (parent) and the divisional application.

Double Patenting

In India, an Applicant is entitled only to a single patent per invention as per section 46 of the Act.  In other words, double patenting is not permitted.  Pursuant to section 16(3) of the Act, an Examiner may require amendment of the claims of either the original (parent) or divisional application as necessary to ensure that neither application includes a claim for any identical matter claimed in the other application.

If a double patenting problem arises, the Examiner will raise an objection and the identical subject matter must be deleted from the claims of either the original (parent) application or the divisional application.

Examination of Divisional Applications

A divisional application is accorded the same filing date as the original (parent) application.   However, 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 original (parent) application, and will result in an independent patent from the original (parent) application.  The fees for a divisional patent application are the same as for any original (parent) application.  The term of patent for a divisional application is twenty years from the filing date of the original (parent) application.

A divisional application is examined in relation to the original (parent) application so as to avoid claim overlap resulting in double patenting.

A divisional application is examined only when a Request for Examination (“Request”) is filed within the prescribed period (namely, forty-eight months from the date of filing of the application or from the date of priority of the original (parent) application or within six months from the date of filing of the divisional application, whichever is later).  If a Request is not filed within time, the application will be considered as withdrawn.

As an illustration, an original (parent) application was filed on October 11, 2000 (and later issued as a patent) in the Indian Patent Office.  The grant of the patent was published on April 6, 2007.  A divisional application was filed on August 16, 2005, and a Request for Examination was made on March 17, 2006.  In this case, the Examiner held that the Request for Examination filed for the divisional application on March 17, 2006, was beyond the prescribed period (namely, a Request for Examination was due by February 16, 2006, six months from the date of filing of the divisional application since this was the latest date).  Therefore, the divisional application was treated as withdrawn.

This post was written by Julia Cox, Lisa Mueller and the attorneys at Chadha & Chadha.

Divisional Practice in the BRICs and other Countries – Part 3 of a 9-Part Series

This is Part 3 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

Divisional Practice in the United States (U.S.)

Continuing Applications

In the U.S., a pending application may serve as the basis for a continuing application.  Three types of continuing applications exist under U.S. practice, namely divisional, continuation, and continuation-in-part applications.  A continuing application may itself serve as the basis for another continuing application. 

Time Period for Filing a Continuing Application 

One or more divisional, continuation, and/or continuation-in-part applications may be filed any time prior to grant of a U.S. patent application. 

Requirements for Filing a Continuing Application 

When filing a continuing application, the following documents must be submitted: 

1.  A copy of the specification, drawings, and abstract;

2.  A set of claims to be pursued;

3.  An oath or declaration; and

4.  Filing, search, examination, publication, and processing fees.

Additional fees will be required for more than three independent claims, more than 20 total claims, and more than 100 sheets.  

Claims of a Continuing Application 

Divisional Application U.S. law provides that if an application contains claims directed to two or more independent and distinct inventions, an Applicant may be required to elect a single invention for examination on the merits.  Each non-elected invention may be pursued in what is referred to as a “divisional” application(s).  Because restriction was required in the parent (original) application, the parent application cannot serve as the basis of a double patenting rejection as long as the claims of the divisional application are directed to a non-elected invention.  In another words, in a properly filed divisional application, a double patenting rejection cannot be made.   

Continuation Application A continuation application contains the originally disclosed subject matter.  A continuation application may be filed with the originally filed claims and/or new claims (provided that there is support for the claims in the specification as originally filed).  The parent application (or another continuation application that claims priority back to the parent application) may serve as the basis of a double patenting rejection during examination of any continuation application. 

Continuation-in-part Application A continuation-in-part application contains the originally disclosed subject matter, plus additional, new subject matter.  Accordingly, the claims of a continuation-in-part may be directed to the originally disclosed subject matter, the newly disclosed subject matter, or a combination thereof.  The parent application (or a continuation application that claims priority back to the parent application) may serve as the basis of a double patenting rejection during examination of a continuation-in-part application. 

Double Patenting 

Under U.S. practice, the doctrine of double patenting prevents an Applicant from extending patent exclusivity beyond the term of a patent.  This doctrine assumes that the public will be free to use the claimed invention, plus modifications and variants that would have been obvious to one of ordinary skill in the art upon expiration of a patent.  Double patenting may be raised when an issued patent and one or more pending applications (referred to as “non-provisional” double patenting) or two or more pending applications (referred to as “provisional” double patenting because neither application has yet issued as a patent) meet one of the following requirements: (1) have the same inventors; (2) have at least one common inventor; (3) are commonly assigned or owned; or (4) are non-commonly owned or assigned, but subject to a joint research agreement. 

Generally, two types of double patenting exist in U.S. practice: 

1.  Statutory Double Patenting:  Based on 35 U.S.C. § 101, refers to the fact that an Applicant may obtain only a single patent per invention.  Accordingly, if the claims of an application being examined and an issued patent or pending application are directed to the same invention, a statutory double patenting rejection will be issued by the United States Patent and Trademark Office (USPTO).  The phrase “same invention” means identical subject matter.  The test of whether or not the same invention is being claimed twice is whether the claim in an application being examined can be infringed without literally infringing a corresponding claim in a patent or pending application.  An example is provided below. 

            Example: 

      a.  Claim in a pending application undergoing examination:  A compound of Formula I wherein X is chlorine.

            b.  Claim in issued patent:  A compound of Formula I wherein X is chlorine.

            c.  Test:  Can the claim in the examined application be infringed without literally infringing the claim in the issued patent?  Answer:  No.  The claim in the application being examined will be rejected by the Examiner for statutory double patenting.

2.  Non-statutory Obviousness-type Double Patenting:  This type of double patenting is the result of a judicially created doctrine.  Non-statutory obviousness-type double patenting intends to prevent an Applicant from extending patent exclusivity by obtaining claims in a second patent that are patentably indistinguishable (in other words, not patentably distinct) from the claims in another patent or pending application.  Accordingly, if the claimed invention in an application that is being examined (such as in a continuation or continuation-in-part application) is an obvious variant or modification of a claimed invention in an issued patent or pending application, a non-statutory obviousness-type double patenting rejection will be issued by the USPTO.  Essentially, a non-statutory obviousness-type double patenting rejection is considered to be “analogous” to a failure to meet the obviousness requirement of 35 U.S.C. Section 103 except the patent or pending application underlining the double patenting rejection does not have to be prior art.  

The key inquiry in a non-statutory obviousness-type double patenting rejection is the differences between the inventions defined by the conflicting claims.  The specification can only be used to construe the meaning of the claims (namely, as a dictionary to learn the meaning of the term in the claims).   

Overcoming a Double Patenting Rejection 

Statutory Double Patenting:  A statutory double patenting rejection may be overcome by:  (1) amending the claims in the application being examined so as not to be coextensive in scope with the claims of the issued patent or pending application that form the basis of the rejection; (2) arguing the rejection; (3) canceling the conflicting claims in the application being examined; (4) if a “provisional” statutory double patenting rejection is the only rejection remaining in both applications, asking the Examiner to withdraw the rejection in the application with the earlier filing date and permitting that application to issue as a patent (if both applications were filed on the same date, Applicant will need to elect which of the two applications is to be allowed); or (5) abandoning the application in which the rejection is raised.  Neither a terminal disclaimer nor a declaration under 37 C.F.R. Section 1.131 can be used to overcome a statutory double patenting rejection. 

Non-statutory Obviousness-type Double Patenting:  A non-statutory obviousness-type double patenting rejection may be overcome by:  (1) amending the claims in the application being examined to be patentably distinct over the claims of the issued patent or pending application that form the basis of the rejection; (2) arguing the rejection; (3) canceling the claims at issue in the pending application being examined; (4) if a “provisional” non-statutory obviousness-type double patenting rejection is the only rejection remaining in both applications, asking the Examiner to withdraw the rejection in the application with the earlier filing date and permitting that application to issue as a patent (if both applications were filed on the same date, Applicant will need to elect which of the two applications is to be allowed); (6) if the rejection is a “provisional” rejection abandoning one of the pending applications; or (7) filing a terminal disclaimer.  A declaration under 37 C.F.R. Section 1.131 cannot be used to overcome a statutory double patenting rejection. 

Terminal Disclaimers 

A terminal disclaimer is a legal document that ensures that the term of a patent granted on an examined application will not extend past the expiration of the term of the conflicting patent or a patent granted on a conflicting application.  A terminal disclaimer is effective only if there is common ownership between the conflicting claims at issue.  If there is no common ownership, a terminal disclaimer cannot be filed.  Additionally, it is important to remember when conducting due diligence that a patent granted in which a terminal disclaimer is filed is enforceable only as long as the patent issuing and the prior patent that formed the basis of the non-statutory obviousness-type double patenting rejection are commonly owned. 

A terminal disclaimer must:  (1) specify the portion of the term of the patent being disclaimed; (2) state the present extent of Applicant’s or Assignee’s ownership interest in the patent to be granted; and (3) indicate that the terminal disclaimer fee is enclosed (Presently, $160.00 per terminal disclaimer filed).  The terminal disclaimer may be signed by the attorney or agent of record, by the applicant, by the combination of the applicant and an assignee of part interest, or an assignee of entire interest. 

A terminal disclaimer operates with respect to all claims in a patent.  A terminal disclaimer is only effective with respect to the application identified in the disclaimer, unless an Applicant specifically recites that the disclaimer applies to one or more continuation applications.   

A certificate of correction cannot be used to remove a terminal disclaimer mistakenly filed during prosecution or which is no longer believed to be necessary.  However, an Applicant can file a petition to withdraw a terminal disclaimer during prosecution before an application issues provided that grounds are provided as to why the terminal disclaimer(s) is believed to no longer be necessary.  A reissue proceeding cannot be used to withdraw a terminal disclaimer that is in effect at the time a patent issues.

This post was written by Laura Opperman and Lisa Mueller.