Non-Proprietary Names: Why they Are Precious to Industry. Antoinette Lachat, Sr. Trademark Specialist PTMG Meeting Chicago, October 9, 2014

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1 Non-Proprietary Names: Why they Are Precious to Industry Antoinette Lachat, Sr. Trademark Specialist PTMG Meeting Chicago, October 9, 2014

2 Overview USAN & INN Programmes (Gail Karet, Raffaella Balocco): Characteristics, analogies, differences of the nomenclature systems Non-proprietary and proprietary names Timelines & requirements How to create them Stems & substems Interfaces Industry Perspective (Antoinette Lachat): Non-Proprietary / Proprietary Names Similarities INN INN, INN Trademark, INN Company Name How do you assess them? How and what do you search? Future Challenges Follow-up biologics 2 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

3 Disclaimer Any trademark use in this presentation is for illustrative purposes only 3 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

4 Non-Proprietary & Proprietary Names 2 distinct functions USANs & INNs identify the active moiety of a compound Trademarks identify the origin & quality of the product / identifies product of a specific source Identifies active ingredient 4 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

5 1 INN Identifies the Active Ingredient Irrespective of manufacturer human or veterinary use actual commercialisation and it never expires! 5 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

6 INN Derived Trademarks Are mainly redundant in their message Are confusing / misleading if not limited to the active ingredient Are difficult to enforce

7 INN Derived Trademarks everolimus filgrastim ciclosporin 7 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

8 INN-Stems Are also combined with Company Names -> without limitation to the actual active ingredient. What defensive scope do these trademarks entail? 8 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

9 9 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

10 Think what s Possible: in France 10 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

11 Applying the Pattern that We Have Seen Canmab canakinumab cantuzumab 11 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

12 Similarities: How to Address them? 12 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

13 Interfaces USAN - INN FDA requires a salt form of the generic name EMA does not Mesylate, acetate, FDA prefixes INNs for biologicals EMA does not Tbo-filgrastim, ziv-aflibercept, ado-trastuzumab emtansine 13 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

14 Future Challenges: Harmonizing USAN & INN Will there be INNs for contact lens material? For cellular therapies? Will an INN - once recommended, a USAN - once adopted remain unchanged? 14 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

15 Future Challenges: Biosimilars From a trademark owner perspective: Will the BQ Code be a basis for trademark rejections? Will the BQ Code be considered as an obstacle when assigning new INNs / USANs? Who determines similarity with earlier rights, earlier INNs? Will a BQ Code further reduce the space available for proprietary information (e.g. on a vial, on side flaps)? With retrospective application: will it replace the existing localized approaches like the prefixed INNs in the US ( ado-trastuzumab emtansine fscv )? 15 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

16 Recap: Why Precious to Everybody? INN/USAN Unique Identifier of the active molecule; scientific concept Eternal Vehicle for Patient Safety Trademark Unique Identifer of the origin; legal concept Eternal Vehicle for Quality Unmerge Keep them separate; do not add or remove any letters (Proper Trademark Use = Proper INN Use) Blurring / Mixing results in risks 16 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

17 17 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

18 Back-Ups: Some Illustrative Examples 18 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

19 The Prefixed INN: Is it a Biosimilar Identification Strategy blurred? 19 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only

20 Why are biologics in need for different & additional identifiers in the US? Why not allow 2nd TM? What if 1 MA holder only? 20 INN Onboarding

21 There is a dedicated INN / USAN for the 2nd generation drug! «Emtansine»! 21 Non-Proprietary Names Antoinette Lachat Oct 9, 2014 Business Use Only