Monthly Archives: July 2016

Update On Pune Office: Change of Address

Kind Attention..!

This is to update our Patrons that in the wake of our growing client demand, we have changed our Pune office address to a new one which is more centrally located in the heart of city facilitating our patrons, existing and future ones in Pune, Maharashtra and surrounding region to reach us easily and in a hassle free manner.

Kindly note our new Address for PUNE Office as below:

Khurana & Khurana, Advocates and IP Attorneys
Office No. 206, 2nd Floor, Citymall,
University Road, Ganesh Khind,
Shivaji Nagar, Pune – 411007, Maharashtra, India
Tel: +91-(020) 65223365
E-Mail id: info@khuranaandkhurana.com

REQUEST ALL OUR PATRONS TO KINDLY UPDATE THE CONTACT DETAILS FOR OUR PUNE OFFICE AS MENTIONED ABOVE AND ALL FURTHER COMMUNICATIONS FOR PUNE OFFICE TO BE MADE THERETO

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Post Prosecution Pilot Program (P3): A Commendable Decision by USPTO

On Monday 11 July, USPTO announced a new pilot program (P3), intended to boost the prosecution efficiency. Under the P3 program, an applicant can file a request for consideration after final rejection, statement that he is willing and available to participate in the event, along with copy of response to a final rejection, and optionally proposed non-broadening amendment to the one or more claims. The program provides an opportunity to the applicant to make an oral prosecution to a panel of examiners, and then receive a written decision from the panel.

Duration of the initiative:

The P3 pilot is scheduled to start from 11 July 2016 and will continue till earlier of 12 January 2017 or receipt of 1,600 compliant requests by USPTO. There are multiple technology centres involved in this initiative and one or more of them shall stop accepting further requests as soon as their counter reaches 200.

Eligibility:

To participate in the P3 pilot program, applicant has to file a request within 2 months from the mailing date of final rejection, and before applying a notice of appeal. USPTO is providing facility to the applicant, to present an oral presentation to a panel of 3 examiners, during the conference. To apply for P3 Pilot program the requirements are as follows:

  • A request form to apply under P3 pilot program;
  • A statement within the Request Form that the applicant is willing and available to participate in a P3 conference with the panel of examiners;
  • A response under 37 C.F.R. 1.116 comprising no more than 5 pages of arguments (exclusive of amendments) to final rejection; and
  • Optionally a proposed non-broadening amendment to one or more claims.

There is no fee required to participant in the program. The goal of the P3 pilot program is to reduce the number of appeals take to patent trial and appeal board. It will also hopefully reduce the request for continued examination (RCE) filing after final rejection.

The USPTO is also requesting comments from the public, and suggestion to improve the prosecution process. The patent office plans to evaluate the public feedback to the pilot program so as to achieve its goals. Comments and suggestion can be sent by email on: afterfinalpractice@USPTO.gov, or by post to: USPTO, mail stop comments patents, office of commissioner for patents, P.O. Box 1450, Alexandria, VA 22313 – 1450. View the USPTO Notice for more details.

About the Author: Saurabh Kumar Jain, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Saurabh@khuranaandkhurana.com.

Patent Cooperation Treaty National Phase Entry in India: 31 months Period: Effect of Patent (Amendment) Rules, 2016

Under Patent Cooperation Treaty (PCT), applicant gets varying period of 30-34 months to enter different states with National Phase applications. In the case of India, this period is 31 months. Decisions have been given by Hon’ble High Courts of India regarding extendible or non-extendible nature of this period of 31 months.

In the case of NOKIA CORPORATION VS DEPUTY CONTROLLER OF PATENTS AND DESIGNS decided by Hon’ble MADRAS HC, Indian application was filed as National Phase Entry on August 18, 2009 claiming a priority from an earlier US application 11/622, 147 dated January 11, 2007. Indian Patent Office rejected to accept the patent application by resorting to rule 20 (3) of the Patents Rules, 2003 which mandates to file Indian National Phase Application within 31 months from the priority date which in the current case was August 11, 2009. After returning the documents to attorneys on August 21, 2009, online application was filed on September 10, 2009, which was accorded application No. 5322/CHENP/2009. Along with patent application, petitions under Rule 137 and 138 for condoning the delay in filing National Phase application were also filed, and also request for personal hearing was made. According to the petitioner, National Phase application could be filed within 31 months, along with the request for one month extension of time, under Rule 138, if necessary petition under Rule 137 for Condonation of irregularity was filed before expiry of prescribed period of one month. Patent office rejected to condone the delay by holding that it will be detrimental to public at large. Madras HC held that in case, an application is moved for extension of time by one month or shorter period, it is required to be decided on merit by taking into consideration facts and circumstances of each case. Court went on to stay that it is the discretion of the Controller to extend the period on facts and circumstances of the case, but it was not correct on the part of the Deputy Controller to have rejected the application, by treating it to be not maintainable, as having been filed after expiry of prescribed time under rule 20 of the Patents Rules 2003. In short, court declared that that if applicant shows sufficient cause for the delay, national phase application could be filed within 32 months from the priority date.

After this decision, two different cases related to 31 months were decided by Hon’ble Delhi HC.

In the case of 5402/DELNP/2011, reason for missing timeline of 31 months was mentioned by agents as the non-receipt of the instructing emails due to limitations of the agent’s IT systems in place at that time. Petitions under rule 137 and rule 138 were filed for condoning the delay, obviating the irregularity and extending the deadlines to complete the procedures.

 The petitions were rejected by controller for below reasons:

Reasons for rejecting petition under rule 137:

  1. Condonation can’t be allowed to result in detriment to the interest of any person.
  2. Provisions were applicable to amendments only and not for condoning the delay in filing National Phase application.

Reason for rejecting petition under rule 138:

  1. Application for extension was not made before expiry of prescribed period of time.

Controller decided that condoning the delay would be to the detriment of the public and by resorting to rule 22, Patent Rules, 2003, held that subject matter of the patent application had fallen in the public domain.

Controller also held that the delay in the current case was unintentional, hence articles 48 of the PCT was not attracted as it allows condonation of delay in the case of unavoidable loss or delay in mail and not in the case of unintentional delay.

In the case of 1494/DELNP/2010, reason for not meeting deadline of 31 months was mentioned as docketing error on the part of US Attorney. Petitions under rule 137 and 138 were filed even in this case. In this case also, controller rejected to accept the patent application after the expiry of 31 months and held that subject matter had fallen in the public domain. Controller cited similar grounds as that of the 5402/DELNP/2011 case.

In both cases i.e. 5402/DELNP/2011 and 1494/DELNP/2010, Hon’ble Delhi High Court chose not to rely on the earlier Madras High Court decision and instead relied on Nippon case decided by Delhi HC which had strictly interpreted provisions related to 48 months period during which request for examination is to be filed. Delhi high court declared that in case of the application for which this deadline is missed, application is to be treated as withdrawn and not existent in the law and no amendment of priority date should be allowed in case of such application. Though Nokia case was specific to 31 months period, case was not relied upon in these two cases as it was older than Nippon case, and was decided by Madras court against the latter which was decided by Delhi High Court within jurisdiction of Delhi IPO falls.

Before introduction of the 2016 amendment rules, the picture was unclear as practices of different high courts were different and much was dependent on the discretion of the controller.  Now with the 2016 amendment of rule 138 of the Patent Rules, 2016, possible of extension of 31 months time period has been expressly barred. Rule 138 gives list of timelines in case which, extension cannot be sought. Before amendment, this section was not listing period of 31 months time period as one the non-extendible timelines but now includes the same.

With this change, applicant and their agents are required to docket the applications with more care.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com.

Choosing India as International Search Authority (ISA) and International Preliminary Examining Authority (IPEA): Who Can and Who Cannot

It is long since October 15th, 2013, that India started to work as International Search Authority (ISA) and International Preliminary Examining Authority (IPEA).  Agreement between the Indian Patent Office (IPO) and the International Bureau (IB) of the World Intellectual Property Organization (WIPO) in respect of the same can be accessed here. With the introduction of Patent (Amendment) Rules, 2016, that took effect from May 16, 2016, India has brought in provision for Expedited Examination of Patent applications for which request may be made on any of the following grounds, namely:-

 (a) that India has been indicated as the competent ISA or elected as an IPEA in the corresponding international application; or

(b) that the applicant is a startup.

So as to better understand the eligibility to request for expedited examination, it is important to understand which states can choose India as competent ISA and IPEA. In the above referred agreement, article 3 that deals with Competence of Authority makes it clear that the India shall act as ISA and IPEA for any international application filed with the receiving Office of, or acting for, any Contracting State specified in Annex A provided other requirements are fulfilled. Annex A states that India; and any State that the India will specify can choose India as competent ISA and IPEA. As India has not specified any other state than India that can choose India as ISA and IPEA, as on now India is the only state with the receiving Office of, or acting for which international application may be filed in order to select India as competent ISA and IPEA.

So as per the existing scenario, for Indian Applicants, any of the Austrian Patent Office (AT), Australian Patent Office (AU), European Patent Office (EP), China Intellectual Property Office (CN), United States Patent & Trademark Office (US), Swedish Patent Office (SE) and India (IN) can be chosen as competent ISAs and IPEAs but India can be chosen as ISA and IPEA only for international applications filed with the receiving Office of, or acting for India.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:swapnil@khuranaandkhurana.com.

Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation

In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § 262(l)(2)(A) notice of USFDA review.

            In Amgen v. Apotex, the Federal Circuit rejected Apotex’s contention that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” procedure of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that the 180 days notice provision under § 262(l)(8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.

Background:

            The biologic product at issue is Amgen’s Neulasta® (pegfilgrastim). Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. Pegfilgrastim treatment that can help patients make white blood cells after receiving cancer treatment. After Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Neulasta® (pegfilgrastim), the parties began the BPCIA’s patent information exchange process, known as the “patent dance”, and as a result, Amgen concluded that two patents U.S. Patent Nos. 8,952,138 and 5,824,784 will be infringed by Apotex’s biosimilar version of Neulasta®. Those infringement claims are being litigated in the U.S. District Court for the Southern District of Florida, although the ‘784 patent has been dropped since it expired.

            Apotex sent Amgen a letter on April 17, 2015, stating that it was “providing notice of future commercial marketing pursuant to § 262(l)(8)(A), though Apotex lacked an FDA license.” Amgen sought a preliminary injunction to “require Apotex to provide … notice if and when it receives a marketing license from FDA and to delay any commercial marketing for 180 days from that notice.” The district court granted that motion, citing the Federal Circuit’s decision in Amgen v. Sandoz that notice cannot be given before the biosimilar product is approved. Apotex appealed.

What is Biosimilar Patent Dance:

            The US Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information for resolving any patent disputes before a biosimilar product can enter the US market.  This procedure has strict timing and sequencing requirements and involves several rounds of information exchanges between the reference product sponsor and the biosimilar applicant. Some of the key steps of this process include:

  • Within 20 days after the FDA has accepted its abbreviated application, the biosimilar applicant must provide the reference product sponsor with confidential access to the biosimilar application and relevant manufacturing information for the proposed biologic.
  • Within 60 days of receiving these materials, the reference product sponsor must provide to the biosimilar applicant: (1) a list of patents it believes are infringed, and (2) identify which, if any, of these patents it would be willing to license to the biosimilar applicant.
  • Within 60 days of receipt of the patent list, the biosimilar applicant must provide the reference product sponsor a statement describing, on a claim-by-claim basis, the factual and legal basis as to why each patent is invalid, unenforceable, and/or not infringed. Within this same 60 day period, the biosimilar applicant may provide to the reference product sponsor a counter list of patents that the biosimilar applicant believes could be subject to a claim of patent infringement.
  • Within 60 days of receiving these materials, the reference product sponsor must provide a reciprocal statement describing, on a claim-by-claim basis, the factual and legal basis that each patent will be infringed, as well as a response to any statement regarding validity and enforceability.
  • The parties then have up to 15 days to negotiate in good faith to arrive at a list of patents, if any, that should be subject to a patent infringement action.

– If the parties reach agreement, then the reference product sponsor must bring an infringement action within 30 days for each patent on the negotiated list.

– If the parties do not reach agreement, the biosimilar applicant must notify the reference product sponsor of the number of patents it will provide in a second list, and the parties then simultaneously exchange within 5 days of this notice a list of patents that each party believes should be the subject of the infringement litigation. Within 30 days after this exchange, the reference product sponsor must bring an infringement action on all the patents on the simultaneously exchanged lists.

The Federal Circuit’s decision in the Amgen v. Apotex case:

            Two provisions of the BPCIA were at play in the Federal Circuit’s decision.  First, under § 262(l)(2)(A), the biosimilar applicant initiates the statutory “patent dance” by providing a copy of its biosimilar application and information about how its product is manufactured.  Second, under § 262(l)(8)(A), the applicant must provide a notice to the innovator 180 days before the first commercial marketing of the biosimilar product.

            In Amgen v. Apotex, Apotex argued that it had followed the patent dance procedure and made its (2)(A) disclosures to Amgen, and that the (8)(A) notice of commercial marketing is only mandatory if the applicant failed to provide the information required by (2)(A).

            The Federal Circuit rejected this argument and upheld the district court’s grant of an injunction to Amgen.  The court held that (8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.

            The Federal Circuit looked to the text of the law, finding that the “language of (8)(A) is categorical”, and there is “no other statutory language that effectively compels a treatment of (8)(A) as non-mandatory.”  The court further noted that § 262(l)(8)(A) “contains no words that make the applicability of its notice rule turn on whether the applicant took the earlier step of giving the § 262(l)](2)(A) notice that begins the patent dance (i.e. information-exchange) process,” and stood by its holding in Amgen v. Sandoz that the statute is “‘a standalone notice provision’ not dependent on the information-exchange processes that begin with (2)(A).” The court held that “the (8)(A) notice must be a notice given after FDA licensure of the biosimilar product, not before, and that pre-licensure notices are of no legal effect for purposes of (8)(A)”. The court explained that the 180 days period gives the reference product sponsor a period of time to assess and act upon its patent rights.

            In sum, the Federal Circuit concluded that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.

The Federal Circuit’s order can be found at the following link:

http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1308.Opinion.6-30-2016.1.PDF

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com.