Source: https://www.bskb.com/ip-update-vol-13-no-6/
Timestamp: 2019-04-18 11:20:48+00:00

Document:
The July 30, 2015 Federal Register issued a statement that after receiving over sixty (60) comments from the public on on the 2014 Interim Patent Eligibility Guidance, the USPTO has produced a July 2015 Update: Subject Matter Eligibility.
explanation of the role of preemption in the eligibility analysis, including a discussion of the streamlined analysis.
Appendix 1: provides new examples that are illustrative of major themes from the comments.
Appendix 2: is a comprehensive index of examples for use with the 2014 Interim Patent Eligibility Guidance, including new and previously issued examples.
Appendix 3: lists and discusses selected eligibility cases from the Supreme Court and the U.S. Court of Appeals for the Federal Circuit.
The update is intended to assist examiners in applying the 2014 Interim Patent Eligibility Guidance during the patent examination process.
The July 2015 Update, which includes the appendices, is available to the public here.
The USPTO is now seeking public comment on the July 2015 Update: Subject Matter Eligibility.
Comment Deadline Date: Written comments must be received on or before October 28, 2015.
Addresses: Comments must be sent by electronic mail over the Internet addressed to 2014_interim_guidance@uspto.gov. The comments will be available for viewing via the Office’s Internet Web site (http://www.uspto.gov). Because comments will be made available for public inspection, information that the submitter does not desire to make public, such as an address or phone number, should not be included in the comments.
On July 21, 2015, the Court of Appeals for the Federal Circuit issued their decision for Amgen Inc. v. Sandoz, Inc. (App. No. 15-1499). The divided panel considered two important issues regarding the interpretation of provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).
This action by the aBLA applicant initiates the “patent dance”, which is an exchange of information regarding the product and manufacturing process used for the aBLA and patents, which the Reference Product Sponsor (“RPS”) believes may be infringed by the aBLA product and processes.
On October 14, 2014, Amgen sued Sandoz alleging, among other things, that Sandoz had violated the requirements of the BPCIA by failing to provide the required information under §262 (l)(2)(A), i.e. by failing to engage in the patent dance. Sandoz argued in response that despite the language in the statute that “the subsection (k) applicant shall provide to the reference product sponsor a copy of the application” the patent dance was an optional action by the aBLA applicant.
The second issue considered by the court pertains to the 180-day commercial marketing notice required by the BPCIA. 42 U.S.C. § 262(l)(8)(A) requires that the aBLA applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” (emphasis added) In this case, Sandoz first provided notice to Amgen on July 8, 2014, that Sandoz had filed aBLA, for which approval was expected in “Q1/2 of 2015” and that a product would be launched upon approval. The FDA approved the aBLA of Sandoz on March 6, 2015, upon which Sandoz gave a second notice of commercial marketing to Amgen.
When a sub-section (k) applicant files its aBLA, it likely does not know for certain when, or if, it will obtain FDA licensure. The FDA could request changes to the product during the review process, or it could approve some but not all sought-for uses. Giving notice after FDA licensure, once the scope of the approved license is known and the marketing of the proposed biosimilar product is imminent, allows the RPS to effectively determine whether, and on which patents, to seek a preliminary injunction from the court.
Requiring that a product be licensed before notice of commercial marketing ensures the existence of a fully crystallized controversy regarding the need for injunctive relief.
Furthermore, requiring FDA licensure before notice of commercial marketing does not necessarily conflict with the twelve-year exclusivity period of § 262(k)(7)(A). It is true that in this case, as we decide infra, Amgen will have an additional 180 days of market exclusion after Sandoz’s effective notice date; that is because Sandoz only filed its aBLA 23 years after Amgen obtained FDA approval of its Neupogen product. Amgen had more than an “extra” 180 days, but that is apparently the way the law, business, and the science evolved. That extra 180 days will not likely be the usual case, as aBLAs will often be filed during the 12-year exclusivity period for other products. A statute must be interpreted as it is enacted, not especially in light of particular, untypical facts of a given case. Finally, it is counterintuitive to provide that notice of commercial marketing be given at a time before one knows when, or if, the product will be approved, or licensed.
With regard to the question as to whether the 180-day notice requirement is optional or required, the court found that unlike the disclosure requirement of the patent dance under 42 U.S.C.§262(l)(2)(A), the notice requirement is required. The court distinguished the finding of “shall” in §262(l)(2)(A) as being optional from the finding that “shall” in §262(l)(8)(A) as being mandatory on the basis that the statute provides explicit remedies for failure to comply with the disclosure requirements of §262(l)(2)(A), whereas there are no corresponding remedies for failure to comply with the 180-day notice requirement under §262(l)(8)(A).
It is worth noting that following the reasoning of the court, because the statue provides for remedies for failure to comply with the disclosure requirements under paragraph (l)(2)(A) (i.e. the patent dance), the disclosure is not, in fact, required. However, because the statute does not provide for a remedy for failure to comply with the 180-day notice requirement, the notice is required. This then leaves the question, as to what would be the remedy for the RPS if no notice is given, noting that Sandoz did comply with the notice requirement with the second notice? Could the RPS request an injunction against marketing by the aBLA applicant until proper notice is received?
Summary provided by MaryAnne Armstrong, Ph.D.
There is a category with the USPTO called “walking corpses” (a patent that everybody thought was a normal patent and it turns out that there is some defect that means it was never actually a patent at all) for the USPTO.
For many years, there has been a requirement under 35 USC § 132 that states if you are going to file an RCE in a case that is the US National Phase of a PCT application, you need to have filed the Declaration prior to the day that you file the RCE. However, the USPTO has not been enforcing this requirement.
The above revision has created a new category for the “walking corpses”.
An applicant enters the US National Phase from a PCT Application.
Taking advantage of the rule changes effective September 16, 2012, that permit submitting the Declaration late, Applicant plans on submitting the Declaration shortly before paying the Issue Fee.
During pendency of the application, an RCE was filed.
If you did not file the Declaration until after you filed the RCE, you have an RCE application that is a “walking corpse”.
The USPTO has recently decided to start checking for this issue in any National Phase Application (based on an international application filed on or after September 16, 2012) and is now issuing deficiency notices.
The Federal Register announced that the U.S. Patent and Trademark Office (USPTO) and Korean Intellectual Property Office (KIPO) are initiating a joint Work Sharing Pilot Program to study whether the exchange of search reports between offices for corresponding counterpart applications improves patent quality and facilitates the examination of patent applications in both offices.
Petitions will be accepted for two (2) years.
Each office will be limited to granting 400 petitions.
The office may extend the program.
Both offices reserve the right to terminate the program.
Each office will concurrently conduct a prior art search for its corresponding counterpart application.
The search report from each office will then be exchanged between offices before either office issues a communication concerning patentability to the applicant.
As a result of the exchange, the Examiners may have a more comprehensive set of references before them when making an initial patentability determination.
Each office will accord special status to its counterpart application to first action.
First Action Interview pilot program procedures will be applied during the examination of the U.S. application and make the Korean search report of record concurrently with the issuance of a Pre-Interview Communication.
An application must meet all of the requirements to be accepted in the pilot program (see below Requirements).
New patent applications are normally taken up for examination in the order of their U.S. filing date.
Applications accepted into the program will receive expedited processing by being granted special status and taken out of turn until issuance of a Pre-Interview Communication, or first action allowance, but will not maintain special status thereafter.
While KIPO and USPTO will be sharing search reports, the possibility exists that there may be differences in the listing of references made of record by the USPTO versus those made of record in the corresponding KIPO counterpart application.
Participants in the program should review the references cited in each respective office’s search reports.
copies of the newly cited.
The application must be a non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage in compliance with 35 U.S.C. 371(c), with an effective filing date of no earlier than March 16, 2013.
a. The U.S. application and the corresponding KIPO counterpart application must have a common earliest priority date that is no earlier than March 16, 2013.
A completed petition form PTO/SB/437KR must be filed in the application via EFS-Web. No governmental fee is required.
The petition submission must include an express written consent under 35 U.S.C. 122(c) for the USPTO to accept and consider prior art references and comments from KIPO, during the examination of the U.S. application participating in the pilot program.
a. The petition also must provide written authorization for the USPTO to provide KIPO access to the participating U.S. application’s bibliographic data and search reports in accordance with 35 U.S.C. 122(a) and 37 CFR 1.14(c).
b. Form PTO/SB/437KR includes language compliant with the consent requirements for this pilot program.
The petition must be filed at least one day before a first Office action on the merits of the application appears in the PAIR system.
a. Applicant should check the status of the application in PAIR prior to submitting the petition to ensure that this requirement is met.
The petition for participation filed in the corresponding KIPO counterpart application for the program must grant or have been granted by KIPO.
a. The KIPO and the USPTO petitions should be filed within fifteen days of each other.
b. Both the KIPO and the USPTO petitions must be granted for the applications to be treated under the program.
c. The requirements of each office’s pilot program may differ. Applicants should review the requirements for both pilot programs when considering participation, ensuring that the respective corresponding counterpart applications comply with both office’s requirements.
The petition submission must include a claims correspondence table that notes which claims between the pending U.S. and KIPO applications have a substantially corresponding scope to each other.
a. Applicants may file a preliminary amendment to amend the claims of the corresponding U.S. counterpart application to satisfy this requirement when attempting to make the U.S. application eligible for the program.
c. Not contain any multiple dependent claims.
The claims must be directed to a single invention.
a. If the Office determines that the claims are directed to multiple inventions (e.g., in a restriction requirement), the applicant must make a telephonic election without traverse.
b. An applicant is responsible for ensuring that the same invention is elected in both the U.S. and KIPO corresponding counterpart applications for concurrent treatment in the program.
All submissions for the participating application while being treated under the program’s procedure must be filed via EFS.
The petition must include a statement that the applicant agrees not to file a request for a refund of the search fee and any excess claim fees paid in the application after the mailing or notification date of the Pre-Interview Communication. See form PTO/SB/413C (Request for First Action Interview).
a. Any petition for express abandonment under 37 CFR 1.138(d) to obtain a refund of the search fee and excess claim fee filed after the mailing or notification date of a Pre-Interview Communication will not be granted.
The Federal Register announced that the U.S. Patent and Trademark Office (USPTO) and Japanese Patent Office (JPO) are initiating a joint Work Sharing Pilot Program to study whether the exchange of search reports between offices for corresponding counterpart applications improve patent quality and facilitates the examination of patent applications in both offices.
There may be applications eligible to participate in both the JPO and KIPO Pilot Programs, however, such applications will not not be permitted to participate in both programs. The main difference between the KIPO and JPO programs is that to qualify for the JPO program, the U.S. Application must be published.
200 granted petitions where JPO performs the first search and USPTO performs the second search.
First Action Interview pilot program procedures will be applied during the examination of the U.S. application and make the Japanese search report of record concurrently with the issuance of a Pre-Interview Communication.
The offices will search the corresponding counterpart applications participating in the pilot program sequentially.
The office of first search will be set based upon which participating counterpart application, the JPO or the U.S. application, has the earlier filing date.
In the event that the corresponding counterpart applications were filed on the same day, then the office of first search will be determined as agreed to by the offices.
While JPO and USPTO will be sharing search reports, the possibility exists that there may be differences in the listing of references made of record by the USPTO versus those made of record in the corresponding JPO counterpart application.
The application must be a published non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage in compliance with 35 U.S.C. 371(c), with an effective filing date of no earlier than March 16, 2013.
a. The U.S. application and the corresponding JPO counterpart application must have a common earliest priority date that is no earlier than March 16, 2013.
A completed petition form PTO/SB/437JP must be filed in the application via EFS-Web after the U.S. application has published. No governmental fee is required.
a. Applicant may request early publication to expedite the filing of the petition.
The petition submission must include an express written consent under 35 U.S.C. 122(c) for the USPTO to accept and consider prior art references and comments from JPO, that will be considered during the examination of the U.S. application participating in the pilot program.
a. Form PTO/SB/437JP includes language compliant with the consent requirements for this pilot program.
The petition for participation filed in the corresponding JPO counterpart application for the program must be granted or have been granted by JPO.
a. The JPO and the USPTO petitions should be filed within fifteen days of each other.
b. Both the JPO and the USPTO petitions must be granted before either application can be treated under the program.
c. The requirements for each pilot program may differ. Applicants should review the requirements for both pilot programs when considering participation, ensuring that the respective corresponding counterpart applications comply with both office’s requirements.
The petition submission must include a claims correspondence table that notes which claims between the pending U.S. and JPO applications have a substantially corresponding scope to each other.
a. Contain three or fewer independent claims.
b. Contain twenty or fewer total claims.
b. An applicant is responsible for ensuring that the same invention is elected in both the U.S. and JPO corresponding counterpart applications for concurrent treatment in the program.
Under the U.S.-Brazil Commercial Dialogue IPR working group, the U.S. Patent and Trademark Office (USPTO) and the Brazilian National Institute of Industrial Property (INPI) have been working together to exchange best practices aimed at trying to reduce each country’s patent backlogs.
On June 30, a Joint Statement on Patent Work Sharing was signed. This agreement is part of broader government-wide efforts to expand trade and investment with Brazil and is something the private sector has been urging both governments to adopt for some time.
The Joint Statement emphasizes the importance and value of work sharing to improve efficiency in the patent application process-a benefit to patent applicants as well as patent offices.
Reduces the cost of obtaining patent protection in multiple jurisdictions.
Mechanisms are effective in grappling with increased workload demands, leading to improved efficiencies in patent examination practice.
More broadly, patent work sharing will help boost the economic growth and development of both the United States and Brazil.
President Obama and Brazilian President Rousseff issued a Joint Communique which specifically referenced the Joint Statement, and recognized each country’s work sharing potential. The Joint Communique is an important milestone for the USPTO. It emphasizes the importance of intellectual property in bilateral discussions with partner nations, while highlighting the central role OPIA serves in providing expert IP advice to the various branches of the U.S. government, as well as the patent offices of foreign governments.
Pursuant to the goals outlined in the Joint Statement, OPIA is now working closely with counterpart officials in the Brazilian patent office — the National Institute of Intellectual Property (INPI) — to establish a technical framework for a future patent work-sharing program between the two offices. The agreement on the work-sharing program is expected to be finalized by the end of summer.
Further to the Expedited Patent Appeal Program announcement from IP Update Vol 13, No. 5, the USPTO has announced that they are working on other initiatives to reduce the ex parte backlog, which they will release in the near future.
In addition, they are starting a law clerk fellowship pilot program to identify further ways to provide more support to the judges to increase efficiency.

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