1. Patents in the pharmaceutical industry
Lars Sparre Conrad
Senior Patent Counsel
Corporate Patents and Trademarks
Version 1 - Juli 2004

2. The patent department Chemical engineer, DTU (chemistry), 1990
PhD, DTU (bio-inorganic chemistry), 1992
European Patent Attorney, 2005
Research chemist, Novo Nordisk, enzyme business,
Patent departments
Leo Pharma
Novo Nordisk
H Lundbeck

3. The Patent Department Lundbeck
11 patent counsels
5 Chemical engineers
2 Human biolog
2 Cand Pharm
1 Chemists
1 Lawyer
5 Counsels in the US

4. Role of the Patent Department
Target
Assay
Compound
Indication
Salts
Polymorphs
Formulation
Process
Device
More indications
Biomarkers
Life Cycle Management
Prosecution
Drug
Discovery
Drug
Development
On the Market
Freedom-To-Operate

5. Examples from real life
Duloxetine (SNRI) from Lilly approved 2004 in the US and 2005 in EP
First compound application 1986
In the period (at least)
2 compound applications
11 indication applications
13 combo application
2 formulation applications
1 process application
Janssen lists 16 patents for Risperidone in Orange Book

6. Why Patents Value of company not associated with tangible assets
Value associated with an “idea” and exclusive execution of the “idea”
IPR is they way to protect ideas
Protection of investments
The average cost of developing a prescription drug is about 800 mill $

7. Patent Department involvement
Extreme cost and duration of pharmaceutical development
=> Focus on exclusivity
“The right to prevent others form doing something”
=> Focus on Freedom-to-Operate
“The right to do what you plan to do”

8. Why

9. The number of application is ever increasing
Why
The number of application is ever increasing

10. Version 1 - Juli 2004 Roles for patents Defensive
Protection against copying
Freedom-of-operation
Prior art effect
Cross-licensing
Bargaining power
Offensive
Sale/outlicensing/enforce-ment
Attract partners or investments
Access to technology
Barrier of entry (competitive blocking)
Customer/supplier control
Version 1 - Juli 2004

11. Børsen, 30 Juli 2003

12. What is a patent
A patent is an exclusive right which is granted in return for the technical contribution to the society

13. Limitations of Rights Time – 20 years Geography – Country by country
Scope – The claims

14. What rights Gives the right to stop others from making offering
putting on the market or
using the product or process
using/importing a product obtained by a process which is patented

15. What rights A patent does not give you the right to:
Exercise your own invention
Somebody may have a dominating patent
Freedom-to-operate
Circumvent legislation in particular fields (pharmaceuticals, agrochemicals, chemicals in general, biotechnology, weapons, broadcasting etc.)

16. What can not be patented
Discoveries, scientific theories and mathematical methods
Artistic creations
Plans, rules or methods for intellectual activity, for games or for business activity or computer programs (outside US)
Presentation of information

17. What can not be patented
Methods for surgery / therapy / diagnosis (Patentable in the US!!!!!)
Cloning human beings
Germ line modification
Uses of human embryos
Modifying the genetic identity of humans
Metoder, der erstatter læger er ikke patenterbare.
Methoder, der kan udføres af teknikere er patenterbare
Metoder til aflivning af dyr er patenterbare.
Apparater anvendt til diagnostic /operation er patenterbare
Cloning af mennesker og anvendelse af fostre er specifikt undtaget, som et specialtilfælde af at moralsk og etisk stødende patenter ikke udstedes.
Modification af dyrene – ikke tilladt hvis det påfører dem lidelse.
Dog – hvis det giver en tilstrækkeligt stort bidrag til menneskeheden, så er det alligevel patenterbart.
Generelt er plante-sorter og dyre-arter ikke patenterbare. Dog er ikke-stabile ændringer patenterbare.
Version 1 - Juli 2004

18. Claims in the Pharma Industry
Compounds
Salts
Enantiomers
Polymorphs
Use of compound in therapy
Known compound; first use in therapy
Pharmaceutical composition comprising compound
E.g. in combination with specific excipients

19. Claims in the Pharma Industry
US Only
A method of treating X by the administration of compound
Compound for use in the treatment of X
Use of compound in the manufacture of a medicament for the treatment of X
Process of manufacture
Dosing regimes
Combination treatments

20. Claims in the Pharma Industry
Biomarkers/patient selection/personalized medicine
Assays
Devices

21. Claims in the Pharma Industry
Method of treatment claims
Allowed in the US
Not allowed in EP
Not considered industrially applicable – pre-2007
Not considered patentable for moral reasons – post-2007
Second medical use claims the equivalent outside US

22. Requirements for patentability
Three separate criteria:
Novelty
Inventive step
Industrial applicability - seldom a problem
The criteria are examined individually and all must be fulfilled!

23. Novelty Absolute novelty approach
Everything which is made public available prior to the filing date belongs to prior art
Photographic identity
Written, orally or in any other way
Not a question of whether somebody has actually read the document but whether it was available to anyone who wanted to see it

24. Novelty

25. Novelty

26. Inventive step
The invention must not be obvious to the skilled person in view of the state of art
A leap in cognition
Known to use alkali metal salts  Probably obvious to use the sodium salt
Allowed to combine documents or information when evaluating inventive step

27. Inventive step
Insulin solution characterised in that it comprises Zn2+ ions in an amount of above 4 Zn2+ per hexamer insulin but below the limit for precipitation of zinc-insulin complexes
Prior art disclosed insulin solutions with 4 Zn2+ per hexamer insulin

28. Inventive step
Inventive step
Stability factor
Zn++ / insulin hexamer

29. Novelty Inventive step
Not novel
Invention
Invention
Prior art
Prior art
Inventive?

30. PAUSE!!!!

31. From cradle to grave 18 months 30 months 2-7 years 7-10 years
Grant
PCT filing
Priority filing
Publication
Opposition
Enforcement
National/regional
filings

32. How to obtain a patent File application, pay fees and prosecute
Priority application (T=0)
One application in one country
Filing date determines what is prior art
Provides 12 months period to evaluate the invention
PCT – Patent Corporation Treaty (T=12 months)
One application for “the whole world”
Does not issue patents
Issues a preliminary opinion on patentability
Delays need for expensive translations

33. How to obtain a patent National/regional filings (T=30 months)
EPO – European Patent Office
One application for ~35 European countries
Issues patents – bundle of national patents

34. Stakeholders Innovative Pharma Generic Industry Society/Payers
Long exclusivity for ensure
revenue on investments
Generic Industry
Short exclusivity for early
Market entry
Society/Payers
Stimulate innovation
- Make innovation worthwhile
- No resting on the laurels
Affordable medicine

35. Patent peculiarities in Pharma
1st medical use claim
Patent term extension
Limitation of exclusivity
Rewards for challenging pharma patents in courts (Hatch-Waxman act)

36. Supplementary Protection Certificate
Counsel regulation 1768/92
Pharmaceutical research plays a decisive role in public health
Pharmaceutical research long and costly
Effective exclusivity period ineffective to cover investment
Extension of the patent term

37. SPC – conditions for grant
Product must be protected by the patent in force
MA has been issued
An SPC has not already been issued for the active compound
The MA is the first MA in EU

38. SPC - Term A balance of interests
(Market authorisation – Patent Filing)-5 years
Max 5 years extension
Max 15 years market exclusivity
Market
entry 20 +5
A balance of interests

39. SPC – Scope of protection
Only the product covered by the patent within the limits of the patent
The patent as such is not extended
Esters and salts covered – ECJ392/97

40. Patent Term Extension Investigational New Drug New Drug Application
IND
NDA MA
Investigational New Drug
New Drug Application
Marketing Authorisation
PTE=
Maximum 5 years extension
Maximum 14 years market exclusivity

41. Limitation of scope Bolar Provision
2004/27/EC
Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products
35 U.S.C §271(e)(1)
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (..)solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

42. Generic Avenue Patents Data Exclusivity Tech. Reg. Difficulties
Environ
ment
Data
Exclusivity
Patents

43. Data Exclusivity EU Counsel regulation 2001/83 and 2004/27
A generic may refer to the originators registration data 8 years after originators MA
A generic drug cannot be marketed before 10 years after originators MA
Global Marketing Authorisation

44. Data Exclusivity EU
Data exclusivity extended to 11 years if originator obtains MA for new indication
Within 8 years
Requiring clinical trials
Superior to existing treatment

45. Data Exclusivity EU Generic drug Same active substance
Salt, ester, ether, derivative etc unless they differ significantly
Same pharmaceutical form
All oral IR formulation are ”same”
Bio-equivalence

46. Orphan drug EU EU regulation 141/2000
Life-threatening or debilitating disease affecting less than 5 out of 10000, or
Where the development of drug is unlikely to generate sufficient return, and
With no existing treatment
10 years exclusivity for similar drug and same indication

47. Orphan drug EU Exclusivity period reduced or annuled if
There is a profitable return
A superior product is brought to the market

48. Paediatric exclisivity EU 1901/2006
Paediatric Investigation Plan (PIP) after Phase I
Deferral
Waiver
Data must be included in MA application and leaflet
Incentives
6 months extension of SPC
Paediatric Use Marketing Authorisation (PUMA)
10 years data exclusivity
Orphan drug period extended to 12 years

49. Questions

51. Data exclusivity US NDA – New Drug Application
ANDA – Abbreviated New Drug Application
505(b)(2)
FDA cannot accept an ANDA for same active moiety before 5 years after originators MA
4 years if §IV certification
Certification
No patent
Patent expired
Patent will expire before marketing
Patent not infringed or invalid

52. Data Exclusivity US Orange Book
List all patents allegedly covering a product
If patent owner challenges ANDA => 30 months stay at FDA
§IV certification is patent infringement in and of itself
180 days exclusivity for first §IV applicant

53. Data Exclusivity US 3 additional years
New indication for already marketed drug
Requiring clinical investigations
Exclusivity only for same drug and new indication

54. Generic Drug Same active ingredient
Same strength, dosage form and route of administration
Bio-equivalent