Pharmaceutical Patent Term Extensions

Agenda

Day 1 - Tuesday, June 25, 2019

8:00	Registration Begins
9:00	Co-Chairs’ Opening Remarks
9:10	HEADLINE The Aftermath of Teva U.K. Decision (C-121/17) – Will We Ever Reach a Convincing Definition of Product Under Article 3(a)?
10:30	Morning Coffee Break
11:00	Examining the Latest SPC Views from European Patent Offices
12:00	Networking Lunch
1:00	Developing a Practical Checklist for Preparing and Prosecuting SPC Applications in Europe
2:00	ARTICLE 3(A) OF THE E.U. SPC REGULATION(S): CJEU C-114/18: Sandoz v Searle
2:30	ARTICLE 3(C) OF THE E.U. SPC REGULATION(S): CJEU C-673/18: Santen v INPI
3:00	Networking Break Interpreting Findings from Recent SPC Referral Cases for Article 3(a) and Article 3(c) of the SPC Regulation
4:00	Interpreting Article 3(d) of The SPC Regulation: In Search of a New Formulation for a Known Active Ingredient
5:00	Chairs’ Closing Remarks and Conclusion of Day One

Day 2 - Wednesday, June 26, 2019

9:00	Co-Chairs’ Opening Remarks
9:10	Analyzing the SPC Manufacturing Waiver Amendment: From Agreement to Implementation
10:30	Networking Break
11:00	Examination into the Availability of the Unitary SPC and its Practical Implementation
12:00	Exploring the Possibility of SPCs through Third Party Marketing Authorization
12:45	Networking Lunch
1:45	RUSSIA SPC in Russia and CIS: Assessing the Landscape and Analysing Developments
2:30	CANADA Understanding how the SPC System Has Changed through the CETA Agreement
3:15	Networking Refreshment Break
3:45	CHINA How Will the Proposed Changes to the Patent Law Benefit Pharmaceutical Companies Through Extended Patent Lifecycle?
4:30	Conference Ends

Day 1 - Tuesday, June 25, 2019

8:00	Registration Begins
9:00	Co-Chairs’ Opening Remarks Dr. Christian Drescher Head of Patent Affairs Midas Pharma Robin Ellis Head Patents – IP Product Strategy Sandoz
9:10	HEADLINE The Aftermath of Teva U.K. Decision (C-121/17) – Will We Ever Reach a Convincing Definition of Product Under Article 3(a)? Henrik Matthiassen Director and Head of IP Department Zealand Pharma Frank Landolt Chief Counsel – IP and Legal Confo Therapeutics Dr. Imre Gonda Head of Intellectual Property Gedeon Richter Plc Kieth Withers Canadian and European Attorney df-mp Examining the latest test for whether a product is protected by the basic patent for SPC purposes Assessing the difference between CJEU’s test and an infringement test Evaluating whether national patent law can still affect the granting of SPC, with regards to equivalents Analyzing the impact of the TEVA UK decision on combination products Debating whether new legislation should be proposed for SPC
10:30	Morning Coffee Break
11:00	Examining the Latest SPC Views from European Patent Offices Dr. Martijn de Lange Patent Examiner Netherlands Patent Office Dr Oliver Werner Head of SPC Working Group German Patent and Trade Mark Office Inês Cristóvão da Silva Head of Patent and Utility Model Department Instituto Nacional da Propriedade Industrial Interpreting recent case law on SPC and Article 3 Analysing the complexities of the harmonisation of these interpretations and whether this can be achieved by the ECJ and local jurisdictions Recognising recent SPC decision trends and how they impact SPC approval Appreciating decisions and developments in each jurisdiction represented
12:00	Networking Lunch
1:00	Developing a Practical Checklist for Preparing and Prosecuting SPC Applications in Europe Brian Cordery Partner Bristows LLP Dr. Ulrike Herr Partner Isenbruck Bösl Hörschler LLP Recognising the different factors in claims interpretation across multiple-jurisdictions Devising a pan-European SPC prosecution strategy to take into consideration the diverging views of national patent offices through guidance by ECJ Analysing successful arguments for infringement cases Examining the typical steps before a product launch
2:00	ARTICLE 3(A) OF THE E.U. SPC REGULATION(S): CJEU C-114/18: Sandoz v Searle Daan de Lange Partner Brinkhof Assessing the impact of the Markush claim to determine whether it is sufficient to establish that: The ‘product’, upon examination of its structure, would immediately be recognized as one which falls within the class under Article 3(a)? OR The specific substituents needed to form the active ingredient be amongst those which the skilled person could derive?
2:30	ARTICLE 3(C) OF THE E.U. SPC REGULATION(S): CJEU C-673/18: Santen v INPI Indira Lemont-Spire Legal Expert – Europe and International INPI (France Patent Office) François Pochart Partner August Debouzy Clarifying the relevance and determining the extent of decision C-130/11 (“Nerium Pharmaceuticals”) Understanding the criteria for deciding: How to correctly identify the meaning of the term “different application” within the meaning of CJEU decision C-130/11 (“Neurim Pharmaceuticals”); The extent of coverage of the basic patent and whether it should be limited to the new medical use)
3:00	Networking Break Interpreting Findings from Recent SPC Referral Cases for Article 3(a) and Article 3(c) of the SPC Regulation
4:00	Interpreting Article 3(d) of The SPC Regulation: In Search of a New Formulation for a Known Active Ingredient Marek Lazewski Managing Partner LDS Łazewski Depo & Partners Frank Landolt Chief Counsel – IP and Legal Confo Therapeutics Adrian Spillman Head of Corporate IP Valneva Determining SPC eligibility for new formulations of old drugs in Europe Dissecting the recent CJEU decision Abraxis decision (C-443/17) regarding first marketing authorization for new formulations. Clarifying the relevance and extent of the decision in C-130/11 Neurim Pharmaceuticals How does it apply to formulation patents? Examining criteria from the European Patent Office for compliance of Article 3(d) for: New Medical use Formulation for already known for medical use SPC for any new improvement Additional SPC for a different formulation How should patent strategies be adopted for seeking SPCs in reliance of Neurim?
5:00	Chairs’ Closing Remarks and Conclusion of Day One

Day 2 - Wednesday, June 26, 2019

9:00	Co-Chairs’ Opening Remarks
9:10	Analyzing the SPC Manufacturing Waiver Amendment: From Agreement to Implementation Alfonso Callez-Sanchez Policy Officer European Commission Dr. Christian Drescher Head of Patent Affairs Midas Pharma Robin Ellis Head Patents – IP Product Strategy Sandoz Anticipating when the manufacturing waiver will come into effect? Assessing the consequences of stock piling and day one launch within the EU Determining whether a European based pharma company is able to: Produce from in Europe from day one Export to third party countries under the current rules and regulations Examining Notification and special labelling: Assessing whether a company wanting to manufacture under a SPC waiver needs to inform: 1) the competent authorities AND 2) the SPC holder (innovator company) several months in advance and provide some information to them If a product is being exported out of EU, does a special labelling apply? Understanding the legal ramifications of exporting pharmaceutical products into third party countries during the SPC term
10:30	Networking Break
11:00	Examination into the Availability of the Unitary SPC and its Practical Implementation Francesco Macchetta Director Intellectual Property Bracco Imaging Pierre Treichel International Legal Affairs European Patent Office Dr. Imre Gonda Head of Intellectual Property Gedeon Richter Plc Dr. Christopher Brückner European Patent Attorney Brückner IP How to establish regional SPC in Europe de lege ferenda: EU title or Unitary SPC? Whether it would be EU or international law based instrument? How would UK status in the EU play be taking into account for Unitary SPC? Institutional issues: who will be entrusted with the granting procedure? National IPOs, EPO, EUIPO or EMA? Substantive issues: type of basic patent and marketing authorisation for Unitary SPC? Understanding what would be the appeal system for Unitary SPC? Whether it will be governed by EPO Board of Appeal or the European Court of Justice? Debating whether enforcement of EU or unitary SPC should be linked with the unitary patent court?
12:00	Exploring the Possibility of SPCs through Third Party Marketing Authorization Louise Jonshammar Attorney at Law AWA Sweden AB Determining whether its possible for a patentee to seek an SPC based on another company’s marketing authorization under the SPC Regulation The question as posed in C-239/19, reference for a preliminary ruling (UK High Court [2019] EWHC 388 (Pat)) Review of the purpose of the SPC as a compensation for loss of exclusivity term due to the need to obtain regulatory approval for the product, under the SPC Regulation and recent practice of the CJEU. Specifically – which purpose and balance of the Regulation does the CJEU seem to favor in light of recent case law, and does that fair with the industry’s needs? The inventor’s options to commercialize on its research, should Third Party Marketing Authorizations not be available as basis for an SPC application. Scenarios and effects in practice
12:45	Networking Lunch
1:45	RUSSIA SPC in Russia and CIS: Assessing the Landscape and Analysing Developments Boris Malakhov IP Partner Lidings Jurisdiction overview Encouragements and weaknesses Case law and current legal trends Comparison to EU legal regime
2:30	CANADA Understanding how the SPC System Has Changed through the CETA Agreement David Schwartz Partner Smart & Biggar Through CETA, Canada has agreed, inter alia, to make a number of important changes to intellectual property protection for pharmaceutical patentees in order to bring Canadian practice more in line with European practice. This session will explore the practical implementation of the SPC system to improve patent term extension success: Analysing Bill C-30’s amendment of the Canadian Patent Act on how to apply and enforce an SPC for pharmaceutical companies Determining the criteria for SPC eligible patents and its relation to: Medical ingredients Combination of medical ingredients Determining the rules for eligible patents whereby there are multiple patents subject to SPC
3:15	Networking Refreshment Break
3:45	CHINA How Will the Proposed Changes to the Patent Law Benefit Pharmaceutical Companies Through Extended Patent Lifecycle? Fan Li Partner China International Patent and Trademark Law Office Analysing the latest SPC amendments to China Patent Law Exploring the proposed timeline for the implementation of these amendments How will this impact non-Chinese producers of pharmaceutical products? Examining the technicality of the proposal: “patent term extension being limited to products that are first submitted for marketing approval to China and another country, and would not apply to products first filed only in China.” How this will influence patent portfolio strategy in China?
4:30	Conference Ends

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