Transcript Generic Industry

Patents in the pharmaceutical
industry
Lars Sparre Conrad
Senior Patent Counsel
Corporate Patents and Trademarks
The patent department
• Chemical engineer, DTU (chemistry), 1990
• PhD, DTU (bio-inorganic chemistry), 1992
• European Patent Attorney, 2005
• Research chemist, Novo Nordisk, enzyme
business, 1992-2000
• Patent departments
• 2000-2003 Leo Pharma
• 2003-2005 Novo Nordisk
• 2005- H Lundbeck
Slide 2
The Patent Department
Lundbeck
• 11 patent counsels
•
•
•
•
•
5
2
2
1
1
Chemical engineers
Human biolog
Cand Pharm
Chemists
Lawyer
• 5 Counsels in the US
Slide 3
Role of the Patent Department
Target
Assay
Compound
Indication
Salts
Polymorphs
Drug
Discovery
Formulation
Process
Device
More indications
Biomarkers
Drug
Development
Freedom-To-Operate
Slide 4
Life Cycle Management
Prosecution
On the Market
Examples from real life
• Duloxetine (SNRI) from Lilly approved 2004
in the US and 2005 in EP
• First compound application 1986
• In the period 1986-2003 (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
Slide 5
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 $
Slide 6
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”
Slide 7
Slide 8
Celexa
Generic Citalopram
Zoloft
Generic Sertraline
22-09-06
25-08-06
28-07-06
30-06-06
02-06-06
05-05-06
07-04-06
10-03-06
10-02-06
13-01-06
16-12-05
18-11-05
21-10-05
23-09-05
26-08-05
29-07-05
01-07-05
03-06-05
06-05-05
08-04-05
11-03-05
11-02-05
14-01-05
17-12-04
19-11-04
22-10-04
24-09-04
27-08-04
30-07-04
02-07-04
Share of Total Rx
Why
USA
Development in Share of Total Rx
25%
20%
15%
10%
5%
0%
Why
The number of application is ever increasing
Slide 9
Slide 10
Børsen, 30 Juli 2003
Slide 11
What is a patent
• A patent is an exclusive right
which is granted in return for the
technical contribution to the
society
Slide 12
Limitations of Rights
Time – 20 years
Geography – Country by country
Scope – The claims
Slide 13
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
Slide 14
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.)
Slide 15
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
Slide 16
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
Slide 17
Claims in the Pharma Industry
• Compounds
• Salts
• Enantiomers
• Polymorphs
R1
R2
• Use of compound in therapy
• Known compound; first use in therapy
• Pharmaceutical composition comprising
compound
• E.g. in combination with specific excipients
Slide 18
Claims in the Pharma Industry
• 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
Slide 19
Claims in the Pharma Industry
• Biomarkers/patient
selection/personalized medicine
• Assays
• Devices
Slide 20
Claims in the Pharma Industry
• Method of treatment claims
• Allowed in the US
• Not allowed in EP
– Not considered industrially applicable – pre2007
– Not considered patentable for moral reasons –
post-2007
• Second medical use claims the
equivalent outside US
Slide 21
Requirements for patentability
• Three separate criteria:
• Novelty
• Inventive step
• Industrial applicability - seldom a problem
• The criteria are examined individually and all must be
fulfilled!
Slide 22
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
Slide 23
Novelty
Slide 24
Novelty
Slide 25
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
Slide 26
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
Slide 27
Stability factor
Inventive step
Inventive step
Zn++ / insulin hexamer
Slide 28
Novelty
Inventive step
Not novel
Invention
Invention
Prior art
Prior art
Inventive?
Slide 29
Slide 30
From cradle to grave
20 years
Enforcement
Opposition
Grant
7-10 years
2-7 years
National/regional
filings
Priority filing
PCT filing
Publication
30 months
18 months
12 months
Year 0
Slide 31
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
Slide 32
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
Slide 33
Stakeholders
Innovative Pharma
Long exclusivity for ensure
revenue on investments
Generic Industry
Society/Payers
Short exclusivity for early
Market entry
Stimulate innovation
- Make innovation worthwhile
- No resting on the laurels
Affordable medicine
Slide 34
Patent peculiarities in Pharma
•
•
•
•
1st medical use claim
Patent term extension
Limitation of exclusivity
Rewards for challenging pharma
patents in courts (Hatch-Waxman act)
Slide 35
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
Slide 36
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
Slide 37
SPC - Term
• (Market authorisation – Patent Filing)-5 years
• Max 5 years extension
• Max 15 years market exclusivity
Market
entry
0
•A balance of interests
Slide 38
20
+5
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
Slide 39
Patent Term Extension
IND
NDA
MA
• Investigational New Drug
• New Drug Application
• Marketing Authorisation
• PTE=
NDA  IND
 ( MA  NDA)
2
• Maximum 5 years extension
• Maximum 14 years market exclusivity
Slide 40
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.
Slide 41
Reg.
Environ
ment
Tech.
Difficulties
Patents
Slide 42
Data
Exclusivity
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
Slide 43
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
Slide 44
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
Slide 45
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
Slide 46
Orphan drug EU
• Exclusivity period reduced or annuled
if
• There is a profitable return
• A superior product is brought to the
market
Slide 47
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
Slide 48
Slide 49
Slide 50
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
•
•
I.
II.
III.
IV.
Slide 51
No patent
Patent expired
Patent will expire before marketing
Patent not infringed or invalid
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
Slide 52
Data Exclusivity US
• 3 additional years
• New indication for already marketed drug
• Requiring clinical investigations
• Exclusivity only for same drug and
new indication
Slide 53
Generic Drug
• Same active ingredient
• Same strength, dosage form and route
of administration
• Bio-equivalent
Slide 54