patents in the pharmaceutical industry lars sparre conrad senior patent counsel corporate patents...
TRANSCRIPT
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Patents in the pharmaceutical Patents in the pharmaceutical industryindustry
Lars Sparre Conrad
Senior Patent Counsel
Corporate Patents and Trademarks
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Slide 2
The patent departmentThe 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
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Slide 3
The Patent DepartmentThe Patent DepartmentLundbeckLundbeck
• 11 patent counsels• 5 Chemical engineers• 2 Human biolog• 2 Cand Pharm• 1 Chemists• 1 Lawyer
• 5 Counsels in the US
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Slide 4
Role of the Patent DepartmentRole of the Patent Department
DrugDiscovery
Drug Development
On the Market
Target Assay Compound Indication Salts Polymorphs
Formulation Process Device More indications Biomarkers
Life Cycle Management Prosecution
Freedom-To-Operate
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Slide 5
Examples from real lifeExamples 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
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Slide 6
Why PatentsWhy 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 $
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Slide 7
Patent Department involvementPatent 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”
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Slide 8
WhyWhy
USA Development in Share of Total Rx
0%
5%
10%
15%
20%
25%
02-0
7-0
4
30-0
7-0
4
27-0
8-0
4
24-0
9-0
4
22-1
0-0
4
19-1
1-0
4
17-1
2-0
4
14-0
1-0
5
11-0
2-0
5
11-0
3-0
5
08-0
4-0
5
06-0
5-0
5
03-0
6-0
5
01-0
7-0
5
29-0
7-0
5
26-0
8-0
5
23-0
9-0
5
21-1
0-0
5
18-1
1-0
5
16-1
2-0
5
13-0
1-0
6
10-0
2-0
6
10-0
3-0
6
07-0
4-0
6
05-0
5-0
6
02-0
6-0
6
30-0
6-0
6
28-0
7-0
6
25-0
8-0
6
22-0
9-0
6
Sh
are
of
To
tal R
x
Celexa Generic Citalopram Zoloft Generic Sertraline
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Slide 9
WhyWhy
The number of application is ever increasing
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Slide 10
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Slide 11Børsen, 30 Juli 2003
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Slide 12
What is a patentWhat is a patent
• A patent is an exclusive right which is granted in return for the technical contribution to the society
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Slide 13
Limitations of RightsLimitations of Rights
Time – 20 years
Geography – Country by country
Scope – The claims
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Slide 14
What rightsWhat rights
• Gives the right to stop others frommakingofferingputting on the market or using the product or process using/importing a product
obtained by a process which is patented
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Slide 15
What rightsWhat rights
A patent does not give you the right to:
Exercise your own inventionSomebody may have a dominating patentFreedom-to-operate
Circumvent legislation in particular fields (pharmaceuticals, agrochemicals, chemicals in general, biotechnology, weapons, broadcasting etc.)
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Slide 16
What can not be patented 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
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Slide 17
What can not be patentedWhat 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
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Slide 18
Claims in the Pharma IndustryClaims 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
R2R1
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Slide 19
Claims in the Pharma IndustryClaims 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
US OnlyUS Only
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Slide 20
Claims in the Pharma IndustryClaims in the Pharma Industry
• Biomarkers/patient selection/personalized medicine
• Assays• Devices
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Slide 21
Claims in the Pharma IndustryClaims 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
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Slide 22
Requirements for patentabilityRequirements for patentability
• Three separate criteria:
• Novelty
• Inventive step
• Industrial applicability - seldom a problem
• The criteria are examined individually and all must be fulfilled!
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Slide 23
NoveltyNovelty
• 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
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Slide 24
NoveltyNovelty
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Slide 25
NoveltyNovelty
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Slide 26
Inventive stepInventive step
• The invention must not be obvious to the skilled person in view of the state of art
• A leap in cognitionKnown to use alkali metal salts Probably
obvious to use the sodium salt
• Allowed to combine documents or information when evaluating inventive step
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Slide 27
Inventive stepInventive 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
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Slide 28
Inventive stepInventive stepS
tab
ility
fact
or
Zn++ / insulin hexamer
Inventive step
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Slide 29
Novelty Inventive step
Prior art
Not novel
Invention
Prior art
Invention
Inventive?
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Slide 30
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Slide 31
From cradle to graveFrom cradle to grave
Year 0
Prio
rity fi
ling
12 m
onth
sPC
T fi
ling
18 m
onth
sPublica
tion
2-7
years
Gra
nt
7-1
0 y
ears
Oppositio
n
20 y
ears
Enfo
rcem
ent
30 m
onth
sN
atio
nal/re
gio
nal
filin
gs
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Slide 32
How to obtain a patentHow 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
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Slide 33
How to obtain a patentHow to obtain a patent
• National/regional filings (T=30 months)EPO – European Patent OfficeOne application for ~35 European countriesIssues patents – bundle of national patents
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Slide 34
StakeholdersStakeholders
Innovative PharmaLong exclusivity for ensure revenue on investments
Society/PayersStimulate innovation - Make innovation worthwhile - No resting on the laurelsAffordable medicine
Generic IndustryShort exclusivity for earlyMarket entry
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Slide 35
Patent peculiarities in PharmaPatent peculiarities in Pharma
• 1st medical use claim• Patent term extension• Limitation of exclusivity• Rewards for challenging pharma
patents in courts (Hatch-Waxman act)
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Slide 36
Supplementary Protection Supplementary Protection CertificateCertificate
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
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Slide 37
SPC – conditions for grantSPC – 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
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Slide 38
SPC - TermSPC - Term
• (Market authorisation – Patent Filing)-5 years• Max 5 years extension• Max 15 years market exclusivity
•A balance of interests
0Marketentry
20 +5
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Slide 39
SPC – Scope of protectionSPC – 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
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Slide 40
Patent Term ExtensionPatent Term Extension
• Investigational New Drug• New Drug Application• Marketing Authorisation
• PTE=
• Maximum 5 years extension• Maximum 14 years market exclusivity
)(2
NDAMAINDNDA
IND NDA MA
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Slide 41
Limitation of scopeLimitation of scopeBolar ProvisionBolar Provision
• 2004/27/ECConducting 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.
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Slide 42
Patents
Tech.Difficulties
Reg.Environ
mentData
Exclusivity
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Slide 43
Data Exclusivity EUData 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
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Slide 44
Data Exclusivity EUData 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
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Slide 45
Data Exclusivity EUData Exclusivity EU
• Generic drugSame active substance
Salt, ester, ether, derivative etc unless they differ significantly
Same pharmaceutical form All oral IR formulation are ”same”
Bio-equivalence
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Slide 46
Orphan drug EU 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
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Slide 47
Orphan drug EUOrphan drug EU
• Exclusivity period reduced or annuled if• There is a profitable return• A superior product is brought to the
market
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Slide 48
Paediatric exclisivity EUPaediatric exclisivity EU1901/20061901/2006
• 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
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Slide 49
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Slide 50
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Slide 51
Data exclusivity USData 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. No patentII. Patent expiredIII. Patent will expire before marketingIV. Patent not infringed or invalid
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Slide 52
Data Exclusivity USData 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
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Slide 53
Data Exclusivity US Data Exclusivity US
• 3 additional years• New indication for already marketed drug• Requiring clinical investigations
• Exclusivity only for same drug and new indication
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Slide 54
Generic DrugGeneric Drug
• Same active ingredient• Same strength, dosage form and route
of administration• Bio-equivalent