Product Life Cycle Management

Transcription

1 Product Life Cycle Management Moderator Gwilym Atwell (Principal, Fish & Richardson) Panelists Lisa Greenwald-Swire (Principal, Fish & Richardson) Jeffery Grimes (Aradigm Corporation) Len S. Smith (Medicis) Terry Mahn (Principal, Fish & Richardson)

2 Protecting Your Brand Name Obtaining PTO and FDA Approval Lisa Greenwald-Swire February 4, 2010

3 Importance of Trademarks Promote brand name awareness Cost-effective means of marketing Allow for streamlined labeling Decrease the confusion between medications Decrease the risk of medication errors 12.5% of medication errors are contributed to confusion of one name with another by health professional 15% of deaths from medication errors are due to brand name mix-up The proprietary name is like an unsleeping salesman that ceaselessly promotes the product. -- Brand Institute, Inc.

4 Trademarks and Life Cycle Management Search for marks early File for marks early Choose a back-up mark

5 PTO Conduct trademark searches/file intent to use application Notice of Allowance Issued Submit Statement of Use based on use of mark in Phase I clinical trials Final 3 year deadline for commencing use in commerce Timelines FDA File application with FDA File request for review of trademark after Phase II clinical trials complete; FDA will give tentative approval FDA review again 90 days before final approval

6 Trademark Basics Trademark J -- Identifies a source of goods from other sources Service markk -- Distinguishes a source of services from other sources Trade name/ House Mark -- Identifies and distinguishes a business organization from other companies

7 Types of Marks Word marks:

8 Types of Marks (cont.) Slogan: Helping Make Hair Loss History Life should take your breath away, not asthma Non-functional appearance: Pepto-Bismol Pink NOT protectible because found to have a soothing therapeutic value so it was considered functional

9 Benefits of Registration with the PTO Discourages others from using or registering confusingly similar marks Treats the mark as if used nationwide as of the application date Provides nationwide notice of ownership of the mark as of the registration date Serves as evidence of the validity and exclusive ownership of the mark for goods and services listed Grants the right to use the symbol, giving the products more cachet and putting competitors on notice Grants the right to sue in court Provides a basis for foreign registrations, facilitating protection of your marks worldwide Empowers US Customs and Border Protection to block imports that infringe the mark

10 Obtaining Registration with the PTO Goal is to ensure that consumers will not be confused between the proposed mark and another mark already in use PTO considers several factors when determining whether a brand name is likely to be confused, including: (1) the similarity of the goods; (2) the channels of product distribution; (3) the similarity of the marks in sight, sound, and meaning; and (4) the sophistication of the consumer

11 Obtaining Registration with the PTO Cont. Application can initially be filed based on intent to use To obtain registration, must show use in commerce Clinical trails are sufficient evidence of use PTO approval does not guarantee that FDA will approve of the name for use!

12 Registration with the FDA MUST receive FDA approval prior to selling product commercially FDA goal is to: evaluate the safety of the proposed brand name; prevent confusion between pharmaceutical brands; and prevent use of a name that would mislead or falsely imply something about the drug s effectiveness or composition

13 Obtaining Registration with the FDA Submission requires: Two (and only two) names, in order of preference. If first is rejected, FDA will evaluate the second Proposed package labeling (inserts and outer labeling) Review by FDA: Initial risk-benefit evaluation by a DMETS safety evaluator (60 days for review) Names that pass receive a tentative approval and a second evaluation (in 30 days or less) 90 days before NDA approval to compare with drug names that have been approved since the first evaluation Not a first to file system! No public database of pending names.

14 Obtaining Registration with FDA Cont. FDA will not approve name if it: (1) suggests greater safety or efficacy than supported by clinical data; (2) includes or suggests indications, dosage regimens, dosage forms, or routes of administration other than those for which the product is labeled; (3) has the potential to contribute to medication errors or cause confusion because spelling or pronunciation is similar to other products on the market; (4) includes or suggests an active component that is not part of the product; and (5) is a different name for a nearly identical product, but a different indication.

15 Recommendations for Brand Names Search and file for a top choice and at least second choice brand name with the respective trademark agencies. Try to make up a word to use as a brand name rather than using a word that is already known, and make sure that it does not look or sound similar to existing pharmaceutical marks. Consider sound of name when spoken Zantac v. Xanax Consider appearance of name when printed Celebrex v. Celexa Consider appearance when scribbled by a doctor

16 Recommendations for Brand Names Cont Avoid using numbers or letters that could suggest product ingredients or dosage. Example 1: BID=twice daily to pharmacists Example 2: XL may sound like SL, which indicates sub lingual to pharmacists Stay away from using a name that suggests the product s function. Example: ROGAIN marked as REGAINE in most of the word Avoid referring to inactive ingredient that suggests effectiveness Avoid incorporating generic names

17 Thank you! Questions?

18 Life Cycle Management and Patents Len S. Smith February 4, 2010

19 Where are We? Patents are Harder to get Harder to enforce Risky?

20 Our Many Challenges

21 The Risks of Patenting?

22 The LCM Playbook & Challenges with Execution

23 New Therapeutic Methods Infringers? Implications Inherency Prevention

24 Combinations

25 More Calls from the LCM Playbook Dosages USPTO starting point optimization is routine Formulations Is the substitution predictable? Delivery Routes

26 Summing it Up Patents are Harder to get Harder to enforce Risky?

27 But the typical pharma patenting MO remains the same: 1. File early, file often, file everything We ll make it work later 2. File on the little we have but claim everything 3. Reactive, not proactive 4. It s difficult to measure success, so don t bother Result - - IP lottery

28 What to Do?

29 First, Do No Harm: Use provisionals Maximize PTA Maximize PTR/PTE There can be only one Conduct a thorough analysis If available, ensure harmonized with IND/regulatory program Ensure you have your OB position in order Watch out for marking issues Claim analysis

30 Begin LCM at the Beginning Employ risk management-based rather than traditionbased planning Only advisable under some conditions How is competition; how dominant is your position? Pitalls Need time to think/plan! Best mode, double patenting, inherency, and IC risks

31 Portfolio Planning 201 Employ a mix of claims and patents Singles and doubles can still win the game (especially post ebay/seagate) Plan for the pendulum to swing

32 Coping with KSR Have your KSR story ready Make discovery of the problem part of the invention! Coordinate with Marketing Showing of nexus for commercial success Ensure ability to disclose license information Commercial success CREATE act

33 Failure [Data]

34 Dig in New Places and Dig Deep Untapped opportunities? Pick your fights, and fight to win Will not work with patent management by the numbers

35 Back to Reality?

36 Regulatory-Patent Synergy Obtain non-patent exclusivity Pediatric Claim the label If in safety or efficacy Claim the standard But disclose, disclose, disclose The product for product switch Requires regulatory and legal to come out of silos Watch out for antitrust issues

37 Don t Forget Trade Secret Protection

38 Thank You and Good Luck! Len S. Smith

39 BAY AREA PHARMA AND LIFE SCIENCES IP SUMMIT LIFE CYCLE MANAGEMENT PROTECTING NEW USES FOR OLD DRUGS TERRY G. MAHN February 4, 2010

40 LIFE CYCLE MANAGEMENT OVERVIEW H-W Exclusivity (3 years) requires clinical studies new users new patient populations administrative and dosage changes efficacy improvements new formulations Patent genus/species polymorphs (defensive) combination drugs formulations

41 LIFE CYCLE MANAGEMENT OVERVIEW (cont ) release profiles indications and uses improvements in safety/efficacy misc. (particle size, molecular weight, etc) TM Strong branding and DTC advertising Can overcome generic substitution

42 THE COMPETITIVE ENVIRONMENT Generics today account for 60% of all scripts ; 20% of all $ sales $74 Billion in annual pioneer drug sales coming off patent by 2012 Deloitte & Touche (2009)

43 THE LCM CHALLENGE Protecting market share for old drugs Re-formulations and ingredient changes New uses Adding novel features or new indications Improving safety or efficacy profiles Adding new patient populations

44 LCM PROTECTIONS AVAILABLE 3 year or orphan exclusivity Patents Adding drug claims to label (reformulations, physical and chemical features, etc.) evidence of direct infringement Adding use claims to label (indications, dosage and administration, warnings, ADR, etc.) generic label infringes by inducement

45 LCM THE GENERIC RESPONSE Skinny labeling carving exclusivity or patent protection out of the generic label Off label activities marketing prohibited by FDA prescribing practice of medicine dispensing governed by State law

46 GENERIC LABELING RULES Statutory sameness requirement generic must track pioneer label word for word Limited exceptions suitability petitions to change dosage, strength, route of administration or AI in combination drug formulation changes trials often required for BE aspects of labeling protected by patent or exclusivity can be carved out of a generic label but only if the generic is no less safe or effective than pioneer for all remaining nonprotected conditions of use.

47 GENERIC CARVE OUT RULE Method of Use Patents Only Patent must be listed in Orange Book Orange Book use code determines scope of carve out Pioneer selects its use code

48 GENERIC CARVE OUT RULE (cont ) Case Study: Prandin (2009) Orange Book patent use code (narrow) use of repaglinide in combination with Metformin to treat diabetes Generic sought carve out requested approval for monotherapy only FDA allowed carve out of combination therapy; would be S&E as pioneer for monotherapy Pioneer amended use code (broadened) to include monotherapy use of repaglinide to treat diabetes FDA reversed generic would have to certify to Orange Book patent

49 MECHANICS OF CARVE OUT RULE ANDA files a section viii rather than certification for the Orange Book patent No notice to pioneer No opportunity for 30 month stay of generic approval Citizen Petition only weapon for pioneer to stop generic labeling carve out before it occurs

50 HISTORY OF CARVE OUT DISPUTES 9 Pioneer CPs filed between 2002 and 2009 asserting skinny labeling would be less safe or effective than pioneer Generics won 8 times! Sole pioneer victory dealt with a migrating patient population

51 WHY DO GENERICS KEEP WINNING? Pioneers Fail to Grasp FDA Carve Out Rule: Step 1 identify protected language on pioneer label Step 2 carve protected language out of generic label leaving only non-protected conditions of use on generic label Step 3 compare S&E of generic label vs. pioneer label Step 4 if generic is less S or E no carve out allowed if exclusivity ANDA cannot be approved if patent forces generic label to infringe

52 FDA CHALLENGES IN CARVE OUT CASES Identifying non-protected conditions of use on a drug label i.e., carving out label language matching the OB use code Applying the less safe or less effective standard to generic drug easy case significant S&E improvement in significant % of targeted patient population

53 FDA CHALLENGES IN CARVE OUT CASES (cont ) more difficult case significant S&E improvement in small % of patient population more difficult case small S&E improvement in large % of patient population

54 PIONEER CHALLENGES EVERGREENING THE LABEL WITH PATENTS THAT CANNOT BE CARVED OUT Claims dealing with newly discovered safety issues: administering the drug to treat [the condition] monitoring the patient for the [safety-related risk] determining if patient is at risk continuing/discontinuing administration of drug based on the determination

55 PIONEER CHALLENGES (cont ) Claims dealing with newly discovered efficacy issues administering the drug to treat [the condition] administering [second drug/substance] to patient determining if patient s [condition] improves continuing/discontinuing administration of drug based on determination

56 PIONEER CHALLENGES (cont ) Are these types of claims patentable subject matter? Prometheus v. Mayo (CAFC 9/2009) Administration and determination steps are part of the treatment protocol and are transformative methods of treating the patient. CAFC: series of transformative steps that optimize efficacy and reduce toxicity of a method of treatment for particular diseases using particular drugs are patentable subject matter.

57 PIONEER CHALLENGES (cont ) Are these types of claims enforceable under the CAFC s joint infringement doctrine? Yes, provide one actor (doctor) controls the others (patient)

58 PIONEER CHALLENGES DISCOVERING PATENTABLE USES RELATED TO SAFETY AND EFFICACY Clinical trials for new indications Phase IV Studies REMS reports Field reports from doctors, patients, hospitals

59 PIONEER CHALLENGES (cont ) Post Marketing Requirements (PMR) 2007 Amendments give FDA broad discretion to order PMRs 1531 PMRs currently in effect requirements can include full range of studies, trials, etc.

60 PIONEER CHALLENGES (cont ) based on mere signal of serious risk or effectiveness of REMS costs fall on pioneers

61 PIONEER CHALLENGES COORDINATING PATENT AND REGULATORY FUNCTIONS Develop internal guidelines to coordinate patent, clinical and regulatory functions to focus on carve out issues Regulatory personnel need to understand the kinds of labeling protections likely to survive generic carve out efforts Clinical trials and PMRs should be designed with carve out rules in mind

62 PIONEER CHALLENGES (cont ) Patents should be prosecuted with carve out rules in mind Inventorship issues need to be anticipated in licenses and contract Orange Book use codes should be carefully reviewed with carve out rules in mind

63 Thank You Terry G. Mahn