Third Party Submissions in Russia – Part 2 of an 8 Part Series

This is Part 2 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.

Third Party Submissions in Russia

One of the most fundamental amendments to Russia’s Civil Code (Code) part IV “Rights to the Results of Intellectual Activities and Means of Individualization” relates to Article 1386.5 concerning third party observations of the patentability of an invention. This amendment, signed into law on March 12th, 2014 by Russian President Vladimir Putin, provides formal acceptance of observations to be submitted to the Russian Patent Office effective October 1st, 2014.

Under Article 1386.5, after publication of a patent application in Russia, any third party (who may use a straw man) may submit to the Russian Patent Office arguments regarding the compliance of the claimed invention with respect to the patentability requirements provided in Article 1350 of the Code.  The patentability requirements provided in this article are novelty, inventive step and that the invention be industrial exploitable.  There is no limit on the number of type or kinds of references that can be submitted (only that the references must be prior art). Such third party observations can be submitted up until the day the application is allowed by the Examiner. Finally, there is no official government fee for filing such observations.

Although third party observations were not previously prohibited and thus submissions were made to the Russian Patent Office, the enactment of this amendment means observations will at the least be considered during the examination of the challenged application.  Similar to other countries, a third party has neither the right to participate in the examination of the invention for patentability nor the right to communicate with the Examiner.

The primary obstacle that remains for Russia’s allowance of third party observations is the lack of public access to prosecution files, which renders it difficult to ascertain which challenged claims are on file.  The submission of such observations has played a significant role in opposition trials worldwide and it is yet to be seen what effect the legal acceptance of third party observations will have in Russia.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Vladislav Ugryumov of Gowlings (Moscow).

Brazil mailbox litigation update: First case to be heard by the Federal Court of Appeals on March 24, 2015

Finally, the Federal Court of Appeals for the 2nd Circuit (Federal Court) will have an opportunity to rule on mailbox cases in Brazil. On March 24th, the Federal Court will hear an appeal filed by the Brazilian Patent Office (INPI) against the decision rendered by Judge Brandão of the 25th Federal District Court who rejected the lawsuits arising from the cases stating that the suits were a violation of the “legitimate expectation” principle.  The panel will comprise Reporting Appellate Judge, the Honorable Messod Azulay from the 2nd Panel of the Court of Appeals and the Honorable Simone Schreiber.

The potential good news for the patent owners is that the Honorable Andre Fontes (who is known to be anti-patent) will not be present during the hearing as he is away on holiday. A member of the First Panel, probably the Honorable Abel Gomes, will be third Appellate Judge in the hearing. Therefore, the composition of the panel appears to be favorable for the patent owners.  Reporting Appellate Judge Azulay is expected to reject INPI’s appeal and maintain the trial court decision.

Currently, fourteen appeals are pending before the Federal Court (eight in the first specialized panel and six in the second specialized panel).

Please watch the BRIC Wall Blog for further updates on mailbox litigation in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues and Mario Reis of Licks Attorneys

U.S. FDA Approves the First Biosimilar Product

On March 6, 2015, the U.S. Food and Drug Administration (FDA) approved Sandoz Inc.’s (Sandoz) Zarxio as the first biosimilar product for use in the U.S.  Specifically, the FDA found Zarxio biosimilar to Amgen Inc.’s Neupogen® (filgrastim), which was originally licensed in 1991.  Zarxio is approved for the same indications as Neupogen® and can be prescribed by a health care professional for:

  1. Patients with cancer receiving myelosuppressive chemotherapy;
  2. Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
  3. Patients with cancer undergoing bone marrow transplantation;
  4. Patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
  5. Patients with severe chronic neutropenia.

The FDA’s approval of Zarxio was based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrated Zarxio to be biosimilar to Neupogen®.  Zarxio has been approved as biosimilar and not as an interchangeable product.

Interestingly, because the FDA has not yet issued a guidance on how current and future biological products marketed in the U.S. should be named, the FDA designated a placeholder nonproprietary name for Zarxio as “filgrastim-sndz.”  According to the FDA, this “placeholder” nonproprietary name should “not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products”.

Express Scripts Holding Co., the largest pharmacy benefit manager in the U.S., estimates that Zarxio will save the U.S. health-care system approximately $5.7 billion in the next 10 years assuming the product will be 30 percent cheaper than Neupogen®.

The approval of Zarxio was received with a great deal of enthusiasm in the U.S.  For example, Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association stated:

Today’s FDA approval of Zarxio (filgrastim-sndz), the first biosimilar medicine in the United States, heralds a new era for cancer patients and the American health care system, one where access to safe, affordable versions of lifesaving biologics will finally be a reality.  Consumers, employers, private insurers, taxpayers, state governments and federal programs all will benefit from the advent of biosimilars, as intended by the Biologics Price Competition and Innovation Act (BPCIA) that was enacted as part of the Affordable Care Act.

However, despite the excitement generated by this approval, it is likely going to be some time until Zarxio is commercially available.  Specifically, Amgen has asked a federal judge in California for an injunction to block the launch of Zarxio, claiming Novartis did not follow the rules in seeking regulatory approval of the product.  A hearing is set for March 13, 2015 to consider the request.  Additionally, Novartis has agreed to delay the launch of Zarxio in the U.S. until the court issues a decision or until April 10, 2015, whichever is earlier.

Please watch the BRIC Wall for further updates on biosimilars in the U.S.

Post-Grant Oppositions in Japan – Part 1 of an 8 Part Series

This is Part 1 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.

Post-Grant Oppositions in Japan

As a result of amendments made in 2014 to the Japanese Patent Law, post-grant oppositions will once again become available in Japan effective April 1, 2015.  The new opposition system is very similar to the previous post-grant opposition system which was introduced in 1994 and terminated in 2004.  A summary of the opposition system is provided below:

  1. Timing for filing an Opposition: An opposition can be filed within six months from the date of issuance of a patent grant publication.  An opposition can be filed by any person.
  2. Grounds available for an opposition: Lack of novelty, inventive step and/or failure to satisfy the enablement, support, or clarity requirement.
  3. Oral Hearing:  No oral hearing will be available.  Instead, the opposition will be carried out solely on the written documents submitted by the parties.  Specifically, when an opposition brief is filed, the Opposition Division (which will consist of at least three Examiners) will review the brief and issue an Office Action if it finds that at least one of the grounds for the opposition is reasonable and that the patent should be revoked.  The Examiners can raise grounds not put forward by the opponent, but cannot attack any claims not challenged by the opponent.  In response, the patentee is permitted to file an argument and an amendment (which is referred to as a correction) within the prescribed period.  If the patentee files an amendment, the opponent may file an argument against the submitted correction. If the Opposition Division renders a decision revoking the patent, the patentee may file an appeal to the Intellectual Property High Court.  Interestingly, if the Opposition Division renders a decision maintaining the patent, the opponent is not permitted to appeal, but must instead has the option to attack the validity in an invalidation trial.

This post was written by Lisa Mueller.


Post-Grant Review Proceedings, Oppositions and Third-Party Observations in the U.S., BRIC and other Non-BRIC Countries: An Introduction

The Leahy-Smith America Invents Act introduced post-grant review proceedings before the U.S. Patent Trial and Appeal Board and the United States Patent and Trademark Office.  As a result, two new types of proceedings were introduced:  post-grant review (PGR) and inter parties review (IPR).

PGR is available for patents issued from applications having an effective filing date on or after March 16, 2013.  A PGR must be filed within nine months after the date of the grant of the patent or of the issuance of a reissue patent.  The grounds that can be raised in a PGR are broad and include:  ineligible subjection matter (§101), written description, enablement and indefiniteness (but not best mode; §112), novelty (§102) and obviousness (§103).

In contrast, an IPR can be filed on any issued patent regardless of its filing date.  The timing for filing an IPR is:

  1. For patents issued under the first-to-invent system (namely, filed prior to March 16, 2013), at any time;
  2. For patents issued under the first-to-file system (namely on or after March 16, 2013), after the later of either:
    1. A date that is nine months after the grant of a patent; or
    2. If a post-grant review is instituted, the date of the termination of such post-grant review

The grounds that can be raised in an IPR are limited to lack of novelty and obviousness and only on the basis of prior art consisting of patents or printed publications.

We at the BRIC Wall thought it would be informative to compare and examine the administrative processes available at various patent offices to dispute or challenge the patentability or validity of a patent application.  Specifically, in an upcoming series of posts, we will review post-grant review proceedings, oppositions and third party observations in the U.S., but also in Australia, Brazil, China, Europe, Japan, India, Russia.

We are excited about these upcoming posts and look forward to comments from our readers.

This post was written by Lisa Mueller.