A key takeaway from the 6th Annual Pharma IPR Indian 2017 was the need for concerted action among Indian pharma peers on domestic IP and legal issues, even as they explore how recent amendments from the US FDA, EPO will impact them.
Experts on global pharmaceutical patent laws from five important geographies — the US, Europe, the UAE, Japan and China — as well as IP experts from India, gave an overview of recent and upcoming patent litigation and regulatory trends at the recently held 6th Annual Pharma IPR Indian 2017.
The audience, comprising representatives mostly from the IP cells of pharma companies, took the opportunity to clarify grey areas of recently amended guidelines as well as to compare the regulatory systems across these geographies, which are important export destinations. The first day of the three-day event, organised by the CPhI Conferences, division of UBM, was devoted to a review of the scenario in the US, followed by the rest of the countries on the next day while the last day was reserved for new developments in India.
Speaking on Indian patent law issues, Saya Choudhary Kapur, Partner, Singh & Singh Lall & Sethi appealed to the industry to come together to counter the rising incidence of quia timet injunctions, of which more than 40 have already been filed. These are injunctions filed to prevent a possible future injury (infringements in the case of pharma industry), and as she explained, could hinder R&D. She also updated the audience on the seriousness of the government on e-filing and other initiatives like the new Intellectual Property Rights policy.
Archana Sahadeva, Associate Partner, Singh & Singh Lall & Sethi spoke about litigation arising out of the ban on FDCs. Like Kapur, she too rued that the Indian pharma industry was not united in countering these legal issues.
The highlight of the conference were two panel discussions. The first one moderated by Taranpreet Singh Lamba, VP intellectual Property and Global Product Portfolio, Glenmark agreed that the Indian pharma industry should look towards to innovation. Dr Eswaran Iyer, Associate VP, IP and Senior Counsel, Sun Pharma, spoke of the steps taken by the sector to move from generics to innovation. Underlining this imperative, Paras Vasanani, Assistant General Manager-Global IP, Amneal Pharmaceuticals quoted the diktat, ‘publish and perish, patent and prosper,’ propagated by Dr RA Mashelkar.
Speaking about the need to balancing innovation and accessibility, Mahalaxmi Andheria, VP IPR, Panacea Biotech, argued that India was currently still at the stage of ensuring accessibility and affordability and there were many challenges to be overcome.
This was followed by a panel discussion on biosimilars. Moderated by Dr Mandar Kodgule, Former Senior VP IP, Wockhardt, the panel examined the potential of biosimilars to be the next big thing for Indian pharma. From a legal point of view, Ranjna Mehta-Dutt, Partner, Remfry & Sagar cautioned that unlike generic copies of chemical drugs which could be made at a much lower cost than innovators, biosimilars, though copies of innovator biologics, were still quite expensive to make. He asked the industry on how it would balance cost with affordability.
Looking at the situation from both the western and Indian point of view, Dr Bhaswat Chakraborty, Senior VP and Chair, R&D core committee, Cadila Pharma, opined that the Indian biosimilar ecosystem was quite robust but admitted that the timelines were long and sometimes regulators needed to be informed and educated about certain developments, like a new test required for a particular biosimilar.
Pointing out the variations between the way biosimilar regulations have evolved in different countries, Dr Ambrish Shrivastava, VP Medical Affairs, Clinical Research, Regulatory, Alkem, said India uses the term ‘similar biogenerics,’ while the US calls them follow on biologics, and the EU refers to them as biosimilars. His opinion was that the Indian biosimilar regulations were rigid and stringent that the US FDA’s. In terms of future biosimilar strategies, Chakraborty applauded the fact that Indian regulations are getting harmonised with the rest of the world. He cautioned that China was a competitor, while innovators too are planning to make biosimilars, adding to the intense competition in the field.
Changes in US laws
The US focussed sessions did a deep dive into the implications of recent changes in laws like the implications of US FDA’s final rule to amend regulations governing 505(b)(2) applications and abbreviated new drug applications (ANDAs) published on November 26 last year and the impact of the Federal Rules of Civil Procedure (FRCP) Amendments and strategies to make their Hatch-Waxman litigation more cost effective.
Speaking on the strategic use of IPRs to challenge pharma patents, Mark Remus, IP attorney, Brinks Gilson & Lione pointed out that while the pharma and biotech sectors tended to have the lowest number of claims compared to other industries, the rate of patentability was better than other sectors. He gave examples of successful strategies as well as a list of IPR mistakes to avoid.
Expanding on the implications of Para IV filings for US markets, John W Bateman and Jeffrey A Wolfson, both partners at Haynes and Boone took many queries from the audience, especially on the implications of US FDA’s final rule to amend regulations governing 505(b)(2) applications and abbreviated new drug applications (ANDAs) published on November 26 last year. The speakers stressed on time frames and ways to reduce cost while filing accurate Para IV for ANDAs.
Derek Duarte, President, Blackstone Discovery advised the audience on the impact of Federal Rules of Civil Procedure (FRCP) Amendments and strategies to make their Hatch-Waxman litigations more cost effective. The FRCP Amendments dealt with replacing the former relevance standard for discoverable information with a new proportionality standard, speeding up the litigation process with earlier initial case deadlines and the potential for more active case management, and consequences for failing to preserve electronically stored information. Companies could explore using the implications of the FRCP Amendments to be more cost effective as it could limit the document preservation requirement. These moves are being seen as attempts by the US FDA to reduce unnecessary litigation that delay availability of generic drugs.
Speaking about recent FDA guidelines on Hatch Waxman Act and its implications, Paul Braier, Partner, Greenblum cautioned companies to understand FDA guidelines on refusal to approve an ANDA.
Dr Alpesh Pathak, Global IP head, Intas Pharmaceuticals, examined the biosimilars scenario from the US perspective, giving an overview of the steps in the ‘patent dance.’ He reviewed pertinent ongoing cases like the Novartis/ Sandoz vs Amgen case, where Sandoz launched a biosimilar version of Amgen’s Neupogen in 2015. The case, which is set for the next hearing in July this year, is being closely watched as the decision will clarify the court’s stance on certain aspects of the Biologics Price Competition and Innovation Act (BPCIA), specifically when biosimilar companies need to notify originators about their biosimilars which would trigger a six-month waiting period. Intas and Apotex are also involved in a patent dispute for their biosimilar version of pegfilgrastim, a biosimilar version of Amgen’s Neulasta.
Srikant Reddy, Partner, Goodwin Procter highlighted the strategies related to settlement of Hatch-Waxman and biosimilars litigation, including recent FDA developments and reverse payments. An interesting session deliberated on the impact of the Trump administration on US patent law. A panel discussion on the Indian IPR scenario, saw patent attorneys and IP heads of pharma companies deliberate on how Indian companies can think beyond patents, as the declining patent cliff will negatively impact the generic market in India. They looked at the challenges posed by trademarks and copyrights and strategies to cope with them.
Impact of Brexit and UPC
Day two started with an update on recent developments in the European Patent Office by Dr Dieter Tzschoppe, Director, European Patent Office followed by a presentation on the impact of Brexit. Dr Jonathan DM Atkinson and Martyn Fish, both partners with HGF, spoke about the implementation of the Unified Patent Court (UPC) and how this would impact IP strategies of pharma companies applying for patents in the EU. As Fish said, the decision to file for a Unified Patent is a choice and an opportunity, but it would be a cost versus coverage consideration that each company would have to analyse on a case to case basis.
Evaluating the recent and upcoming reforms in Supplementary Protection Certificate regime (SPCs) in the EU, Dr Ludwig Englmeier, Head Patents Early Opportunities, Sandoz International reviewed major cases which had defined the court’s treatment of SPCs, which is an extension of patent period, awarded by courts for a lengthy regulatory review period to compensate for extra research.
The biosimilar regulatory pathway is better defined in the EU but as Dr Alexander Wittkopp, Partner – Patent Attorney – US Patent Agent, Hamm & Wittkopp pointed out, there are still areas like secondary biosimilar patents which are uncharted territory.
IP strategies for the Middle East, Japan and China
Comparing the patent filing strategies in the Middle East, Nevin Jacob Koshy, Head, United Trademark & Patent Services reviewed the patenting and patent filing system in each country in the region, and touched upon issues that need to be resolved for an effective patent regime. He highlighted that besides the usual three principles for deciding patentability, (novelty, non-obviousness, and industrial application) a fourth principle required in the Middle East was that the underlying principle of the patent has to be in line with Sharia law. According to him, many companies like Pfizer are setting up plants in this region as many of their brands were being infringed upon by generics.
Kuzuwa Kiyoshi, President, Kuzuwa & Partners gave an overview on pharma IP and regulatory issues in Japan while a comparison of the IP practices in China and the rest of the world, particularly the US, was presented by Dr Toby Mak, patent attorney, Tee & Howe, who pointed out that the Chinese IP system was relatively hostile to the applicant/ patentee.