Approval of the First Biosimilar Monoclonal Antibody in Brazil

Today, the National Sanitary Vigilance Agency (ANVISA) granted marketing authorization to Celltrion Healthcare Distribuidora de Produtos Farmaceuticos dos Brasil Ltda’s (the Brazilian subsidiary of Celltrion, Inc. (a Korean company)) for the monoclonal antibody Remsima, a copy of Janssen’s Remicade (infliximab). The approved indications include rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult and pediatric Crohn’s Disease, fistulizing Crohn’s disease and adult and pediatric ulcerative colitis or retocolitis.

Today’s approval is the first granted by ANVISA for a biosimilar monoclonal antibody. Celltrion’s approval followed the abbreviated pathway as set forth in ANVISA’s Rule #55/2010, which does not use the terms “biosimilar” or “biogeneric”, but instead refers to a “new biologic product” for an innovator product and a “biologic product” for a biosimilar.

Anvisa’s Rule #55/2010, establishes two pathways for the abbreviated approval of copies of biological products: (1) development by comparability (Article 22, XXV); and (2) individual development (Article 22, XXVI). The individual development pathway requires the submission of a full dossier of data relating to the development, manufacturing and quality of the biosimilar version of the biological product as well as the results of non-clinical and clinical studies performed with the product. In contrast, the comparative pathway requires the submission of a comparative dossier containing data from non-clinical and clinical studies used to demonstrate the comparability between the biological comparator product (a reference product) and the follow-on the biological product for which approval is sought. Remsina was approved under the comparability pathway.

This post was written by Lisa Mueller of Michael Best and the Licks Attorneys.

Pre-Grant Submissions and Post-Grant Review Proceedings in Brazil – Part 6 of an 8 Part Series

This is Part 6 of an 8-part series examining post-grant review proceedings, oppositions, and third party observations in the U.S., BRIC and several non-BRIC countries.  To see Part 1, Post-Grant Oppositions in Japan, click here.  To see Part 2, Third Party Submissions in Russia, click here.  To see Part 3, Pre- and Post-Grant Oppositions in India, click here; To see Part 4, Third Party Submissions in the U.S., click here; To see Part 5, Third Party Observations in Europe, click here.

Pre-Grant Submissions

Article 31 of the Brazilian Patent Statute (Statute #9,279/96) allows a third party to file a petition containing arguments and other documents relating to the patentability of an invention.  Any such submission may contain information and arguments relating to novelty, obviousness, clarity, sufficiency, industrial applicability, added subject matter and subject matter excluded from patentability.

A pre-grant submission must be filed during the pendency of an application (namely, between the publication of the application and the termination of examination). The petition must be filed in Portuguese and must include a statement of the grounds upon which it is based.  Specifically, the petition should highlight any information provided as evidence (such as any documents that raise issues of novelty or obviousness).  The Brazilian Patent Office does not charge any fees for the filing of a pre-grant submission.

Documentary evidence, such as patents, published applications and non-patent literature or evidence of prior use (such as affidavits, drawings, brochures) submitted in support of the arguments, may be filed in any language (the Brazilian Patent Office (INPI) may require a translation into Portuguese within a specified time period). The petition may be filed by paper or electronically but cannot be filed anonymously (such as by using a “straw man”).

Because INPI will not inform the Applicant about the filing of a pre-grant submission, it is advisable that an Applicant  routinely monitor its applications on  INPI’s website for such submissions in the event the Applicant wishes to file a reply (although the filing of a reply is not mandatory).  Additionally, there is no specified period during which an Applicant must file a reply.

The Brazilian Patent Office must analyze any pre-grant petition submitted during examination.  However, an Examiner is not obligated to rely on any of the documents and/or arguments presented in the submission.

Additionally, according to INPI’s Normative Instruction #30/2013, any documents submitted by an interested third party through a pre-grant review petition will be considered to be a prior art document identified during a search carried out by the Examiner. In the event any such documents are deemed relevant in the assessment of patentability, these documents will be attached to an examination report.

Post-Grant Review Proceedings

Post-grant review proceedings are regulated by Articles 50 to 55 of the Brazilian Patent Statute (Statute #9,279/96). Article 51 of the Statute provides that once a patent has granted, any third party having a legitimate interest, or INPI itself, has a period of six months to file a post-grant review petition.  The Brazilian Patent Office charges a fee for filing a post-grant review petition.  The fee is approximately US$ 300.00 if the petition is filed electronically and approximately US$ 500.00 if the petition is filed non-electronically (such as by paper or fax).

As with a pre-grant submission, a post-grant review petition must be filed in Portuguese and must include a statement of the grounds upon which it is based.  The petition should also discuss any information provided as evidence (such as any documents that raise issues of novelty or obviousness).

When a post-grant review is requested, INPI publishes a notification in the Brazilian Industrial Property Gazette. This publication triggers a 60-day period for the Patentee to submit a response to the post-grant review petition. In its reply, the Patentee is allowed to submit counter arguments, affidavits, test results and, if necessary, amend the claims.

After receipt of the Patentee’s reply, INPI analyzes the arguments submitted and publishes a preliminary opinion regarding whether or not the post-grant review petition is accepted.  The Patentee and third party petitioner have 60 days to file comments to the preliminary opinion.  Each party can submit counter arguments, affidavits, test results, etc.

Additionally, this is the last opportunity for the Patentee to make any claim amendments. Although there is no oral proceeding, the parties can request a meeting with INPI.  Interestingly, INPI has changed its conclusions in the preliminary opinion in only five percent of the cases.

A post-grant review is finally decided by the Director of INPI. The decision is not appealable and can only be challenged before Federal Courts.

The entire proceeding, from the publication of the notification of a post-grant review request in the Brazilian Industrial Property Gazette to the publication of the decision of the Director of INPI takes approximately one year.

Currently, a total of only 562 post-grant reviews have been requested.  Approximately 30 post-grant reviews are requested each year. As shown below, in the majority of the post-grant review requests, INPI decides for the Patentee and maintains the patent.

LMUeller Blog Image

Typically, Brazilian companies are responsible for filing the majority of the post-grant review petitions. In the pharmaceutical sector, for example, Brazilian Gx companies Libbs Ltd. and Eurofarma S.A are the most active in challenging patents through post-grant review proceedings.

Regarding the technology fields receiving post-grant review petitions, the majority of petitions are filed against patents directed to agricultural technologies. Other affected fields are the electrical and telecommunication, mechanical and chemical.

This post was written by Lisa Mueller of Michael Best and Roberto Rodrigues and Luiza Cotia of Licks Attorneys.


 

 

Third Party Observations in Europe – Part 5 of an 8 Part Series

This is Part 5 of an 8-part series examining post-grant review proceedings, oppositions, and third party observations in the U.S., BRIC and several non-BRIC countries. To see Part 1, Post-Grant Oppositions in Japan, click here. To see Part 2, Third Party Submissions in Russia, click here. To see Part 3, Pre- and Post-Grant Oppositions in India, click here; To see Part 4, Third Party Submissions in the U.S., click here.

Third Party Observations

Article 115 of the European Patent Code (EPC) allows any third party, following the publication of an European patent application, to present observations concerning the patentability of the invention to which the application relates. Specifically, observations can be directed to novelty, inventive step, clarity (which cannot be asserted as a ground during an opposition), sufficiency, industrial applicability, added subject matter and subject matter excluded from patentability. Third party observations (TPO) can be submitted after a pending European patent application publishes, including after an Applicant receives a Rule 71(3) communication (indicating the European Patent Office’s (EPO) intent to grant a patent) up until the date the decision to grant is handed over to the EPO’s internal post service for dispatch (observations submitted after this date will simply be added to the non-public part of the file), as well as during an appeal proceeding.

Observations must be filed in writing in English, French or German and must include a statement of the grounds on which they are based. Documentary evidence, such as patents, published applications and non-patent literature or evidence of prior use (such as affidavits, drawings, brochures) submitted in support of the arguments, may be filed in any language (the EPO may require a translation into one of its official languages within a specified time period). Observations may be filed by paper (such as by mail or fax), electronically or by using the “submit observations” tool from the EPO register which can be found here. There is no fee for filing a TPO.

Although the EPO will acknowledge receipt of a TPO, it will not specifically inform the third party of any further action it takes in connection with the TPO. After filing, the EPO will forward the TPO the Applicant who has the option of commenting if it so chooses. Examiners are required to take a TPO into account during examination and are obligated to provide an opinion on any TPOs filed in the next examination report.

While a TPO can be filed anonymously (such as through a “straw man”), certain advantages are available for third parties who reveal their identity. Specifically, any TPO submitted by a third party that identifies itself will be given priority by the EPO during examination (as part of its “Early Certainty from Search” initiative) and may be admitted during an opposition.

Comparison of TPOs with Third Party Submissions in the U.S.

The below provides a comparison between TPOs in the EPO and third party submissions in the U.S. Patent and Trademark Office (USPTO).

TPO1

TPO2

TPO3

Please note that our final post in this series will compare Inter Partes and Post-Grant review in the USPTO with oppositions in the EPO.

This post was written by Lisa Mueller.

 

 

 

Third Party Submissions in the U.S. – Part 4 of an 8 Part Series

This is Part 4 of an 8-part series examining post-grant review proceedings, oppositions, and third party observations in the U.S., BRIC and several non-BRIC countries. To see Part 1, Post-Grant Oppositions in Japan, click here. To see Part 2, Third Party Submissions in Russia, click here. To see Part 3, Pre- and Post-Grant Oppositions in India, click here.

Third Party Submissions

The Leahy-Smith America Invents Act (AIA), enacted on September 16, 2011, modified the rules concerning third party submission of certain documents during the pendency of a patent application. Specifically, the new rules (1) expanded the time period during which a third party can submit documents; and (2) allows a third party to comment on each document submitted. The main objective of the third party or pre-issuance submissions program is to provide relevant information to Examiners early in the examination process and, as a result, improve the quality of granted patents.

The new rules became effective on September 16, 2012 and apply to any patent application filed before, on or after this date. Any third party (who can remain anonymous) who is not the patent owner, can submit patents, published patent applications or other printed publications of potential relevance during examination along with a concise description of the relevance of each document to the U.S. Patent and Trademark Office (USPTO). Potentially relevant documents submitted may be those raising questions of novelty, inventive step, written description enablement, indefiniteness, improper propriety claim, prior use, etc.

The time period for making such submissions is prior to the earlier of:

  1. The mailing date of a Notice of Allowance; or
  2. The later of:
    1. Six months after the date of first publication of the application by the USPTO (publication of a PCT application or re-publication of a U.S. patent application does not count); or
    2. The mailing date of a first Office Action on the merits rejecting the claims (a restriction requirement does not constitute a first Office Action on the merits).

The documents submitted must be filed prior to, not on, any of the above dates. Also, the filing a request for continued examination (RCE), does not reset the time period for making any such submissions.

There is no limit on the number of submissions that can be made, provided that each submission is made prior to the above dates. However, each submission must contain the following:

  1. A document list identifying the patents, published patent applications or other printed publication being submitted;
  2. A legible copy of all publications or portions of publications submitted (other than U.S. patents and patent applications);
  3. A concise description of the asserted relevance of each document;
  4. An English language translation of any non-English language documents;
  5. A statement by the submitting party stating that it is not an individual having a duty to disclose information to the USPTO and that the submission complies with the requirements of 35 U.S.C. §122(e) and 37 C.F.R. §1.290; and
  6. The required fee, if necessary (A $180.00 fee is required for every ten items or a fraction thereof submitted. However, if the submission is the first submission by a third party and three or fewer documents are being submitted, then no fee is required. Additionally, a small entity discount is available).

There is no requirement that the documents submitted be prior art. In fact, a third party can submit patents, published applications or other printed publications that are already of record (in other words, cumulative submissions are permitted). However, such documents cannot be submitted in provisional applications, issued patents or in a post-issuance proceeding (such as a reissue application or reexamination proceeding).

The description of relevance is a statement of facts regarding the patents, published patent applications or publications submitted. The description can be submitted as a narrative or as a claim chart and must explain how each item listed is of potential relevance to the examination of the application. The description must be more than a bare statement that one or more documents are “relevant”. Specifically, the description should draw the Examiner’s attention to the potential relevant pages or lines of the each document submitted and how it relates to the claims.  While there are no page limits, no arguments or conclusions regarding patentability are permitted. For example, statements such as the below should be avoided:

It would have been obvious to one of ordinary skill in the art to combine the teachings of publication X and publication Y to obtain Z as recited in claim 1; or

The composition of claim 1 is unpatentable in view of publication X and publication Y.

How useful are these third-party submissions in influencing Examiners at the USPTO?  Apparently, not very useful so far.  As shown below, the number of applications at the USPTO that received Office Actions after receipt of a proper third-party submission as of September 2014 was approximately 13%.

PIECHART

Source: USPTO – September 26, 2014 data available at: http://www.uspto.gov/sites/default/files/patents/init_events/preissuance_submission_statistics1.pdf)

It will be interesting to see whether over time third-party submissions become more effective in influencing Examiners during the examination process.

This post was written by Lisa Mueller.

 

 

 

Pre- and Post-Grant Oppositions in India – Part 3 of an 8 Part Series

This is Part 3 of an 8-part series examining post-grant review proceedings, oppositions, and third party observations in the U.S., BRIC and several non-BRIC countries. To see Part 1, Post-Grant Oppositions in Japan, click here. To see Part 2, Third Party Submissions in Russia, click here.

Pre-Grant Oppositions

Any third party (Opponent) may file a pre-grant opposition during the pendency of a patent application. Such an opposition may be filed at any time after publication of the application but prior to grant provided that a request for examination has been filed. The grounds available for a pre-grant opposition are provided in Section 25(1) of the Indian Patents Act, 1970 (Act) and Rule 55 of the Indian Patent Rules, 2003 (Rules) and include:

  • Applicant wrongfully obtained the whole or any part of the invention (Section 25(1)(a)).
  • Prior publication (Section 25(1)(b)).
  • Prior claiming (namely, double patenting, Section 25(1)(c)).
  • The invention was publicly known or publicly used in India. Under this ground, an invention claiming a process is deemed to have been publicly known or publicly used in India if, before the priority date, a product made by the process has been imported into India (except if such importation was for the purpose of a reasonable trial or experiment) (Section 25(1)(d)).
  • The invention is obvious/lacks inventive step (Section 25(1)(e)).
  • The subject matter claimed does not constitute an invention or is directed to non-patentable subject matter (Section 25(1)(f)).
  • The specification does not sufficiently and clearly describe the invention or a method by which it is to be performed (Section 25(1)(g)).
  • Failure to disclose information to the Controller as required by Section 8 or some or all of the information furnished by the Applicant as required by Section 8 was known by the Applicant to be false (Section 25(1)(h)).
  • With respect to a convention application, failure to file the application within twelve months from the date of the first application in a convention country by the Applicant or a person from whom the Applicant derives title (Section 25(1)(i)).
  • The specification does not disclose or wrongly mentions the source or geographical origin of biological material used in the invention (Section 25(1)(j)).
  • The invention claims traditional knowledge (Section 25(1)(k)).

The initial step of a pre-grant opposition proceeding involves an Opponent submitting a “written representation” to the Indian Patent Office (IPO). The written representation must provide a written statement setting forth the grounds for the opposition and evidence in support thereof. At the same time, the Opponent can request an oral hearing.

Next, the Controller considers the written representation submitted by the Opponent. If the Controller believes that the pre-grant opposition lacks merit, the Opponent (but not the Applicant) is given an opportunity for a hearing (if requested at the time the written representation was filed). After the hearing, if the Controller is still of the opinion that the opposition should be refused, a speaking order (namely, an order in which the Controller provides his reason or explanation for why the order was passed) is issued rejecting the pre-grant opposition (which typically occurs within one month).

If the Controller is of the opinion that the pre-grant opposition has merit (meaning that the application should be refused or that the claims require amendment), the Applicant is notified and provided with a copy of the written representation. Additionally, the Applicant is given a period of three months from the date of the notice to file statement and evidence in response. The Controller considers the submissions made by the Opponent and Applicant and decides whether to refuse or grant the patent. Specifically, a written decision is provided within one month from the date of completion of the pre-grant opposition proceeding. Unfortunately, this decision cannot be appealed. Nonetheless, the losing party may invoke the writ jurisdiction of the High Court or file a post-grant opposition or revocation as a remedy at a later date.

Neither the presence of the Opponent nor Applicant is required during a pre-grant opposition proceeding. In fact, legal representatives for both can submit the written representation, statement and evidence on behalf of each party and may also participate in the opposition proceedings. Additionally, pre-grant oppositions are less intense and require less involvement by the Opponent and Applicant as compared to the more trial-like procedure adopted in post-grant oppositions (discussed below).

Post-Grant Oppositions

A post-grant opposition can be filed by any interested person by serving a Notice of Opposition (Notice) on the Controller. According to the Act, any “person” refers to “any person engaged in, or in promoting, research in the same field as that to which the invention relates”. The time period for filing a post-grant opposition is twelve months from the date of publication of grant of a patent. The grounds available for a post-grant opposition are provided in Section 25(2) of the Act and include:

  • Patentee wrongfully obtained the whole or any part of the invention (Section 25(2)(a)).
  • Prior publication (Section 25(2)(b)).
  • Prior claiming (namely, double patenting, Section 25(2)(c)).
  • The invention was publicly known or publicly used in India. Under this ground, an invention claiming a process is deemed to have been publicly known or publicly used in India if, before the priority date, a product made by the process has been imported into India (except if such importation was for the purpose of a reasonable trial or experiment) (Section 25(2)(d)).
  • The invention is obvious/lacks inventive step (Section 25(2)(e)).
  • The subject matter claimed does not constitute an invention or is directed to non-patentable subject matter (Section 25(2)(f)).
  • The specification does not sufficiently and clearly describe the invention or a method by which it is to be performed (Section 25(2)(g)).
  • Failure to disclose information to the Controller as required by Section 8 or some or all of the information furnished by the Applicant as required by Section 8 was known by the Applicant to be false (Section 25(2)(h)).
  • With respect to a convention application, failure to file the application within twelve months from the date of the first application in a convention country by the Applicant or a person from whom the Applicant derives title (Section 25(2)(i)).
  • The specification does not disclose or wrongly mentions the source and geographical origin of biological material used for the invention (Section 25(2)(j)).
  • The claimed invention was anticipated by knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere (Section 25(2)(k)).

In addition to filing the Notice in the IPO, the Opponent is required to serve a copy of the Notice and evidence on the Patentee. Upon receipt of a Notice, the Controller is required under Rule 56 of the Rules to set up an Opposition Board (Board). The Board consists of three members, one of whom is required to be an Examiner (however, the Examiner cannot be the Examiner that examined the application). If the Patentee decides not to contest the opposition, the patent is per se revoked.

If the Patentee contests the opposition, within two months from the date of receipt of a copy of the Notice from the Opponent, Patentee is required to file a reply statement. The reply statement must set out the grounds upon which the opposition is contested as well as provide any evidence in support thereof. The Patentee must serve a copy of its reply statement and any supporting evidence on the Opponent.

Within one month from the date of receipt of the Patentee’s reply statement (and any supporting evidence), the Opponent may file further evidence in response to the evidence submitted by the Patentee in connection with its reply statement. In a post-grant proceeding, evidence may be submitted in the form of affidavits or exhibits. Additionally, prior art patents and publications are generally submitted as evidence.  The Opponent must serve a copy of any such further evidence submitted to the Patentee. Once the Opponent files any such further evidence, no further evidence can be submitted by either party without prior approval from the Controller. If such approval is received, any such further evidence must be submitted before receipt of notification by the Controller of the date of oral hearing.

Within three months from the date on which all documents (written statements, replies and evidence) are forwarded to the Board, the Board reviews and considers the submissions made by both parties, including the grounds of opposition, the Patentee’s reply statement as well as all the evidence submitted, and submits a joint recommendation report to the Controller with respect to each ground of opposition. A notice is issued providing not less than ten days for the parties to present their oral arguments. Once oral arguments are completed, a written decision is ordinarily provided within one month, although a specific time period is not prescribed in the Act. Further, an aggrieved party may appeal the Controller’s decision at the Intellectual Property Appellate Board (IPAB) under Section 117 (A) of the Act. 

This post was written by Lisa Mueller and Nidhi Anand ‎of Chadha & Chadha.