clinical trials and research tools in practical ......1 30/03/04 1 los lunes del centro de patentes...
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Page 1
30/03/04 1
Los lunes del Centro de PatentesPatentes de Investigacion
Clinical Trials and Research Toolsin Practical Pharmaceutical R&D
with an Emphesis on US Law and Pactice
(Dr. Hajo Peters – Laboratorios Dr. Esteve S.A.)
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Los lunes del Centro de PatentesPatentes de Investigacion
Fears associated with Biotech-PatentsNo Patents on Life!
(How can a part of the body be patented?)
Rights to clone food, animals and ultimately : INDIVIDUALS!
Less Progress in Life Science
Worse Medical treatment
Monopoly for and ultimately Control of Companies on Treatment
Undeservedly Large Rewards for the Inventors
Patents are the Death of Small Companies
Clinical Trials and Research Tools
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30/03/04 3
Los lunes del Centro de PatentesPatentes de Investigacion
Fears associated with Biotech-PatentsNo Patents on Life!
(How can a part of the body be patented?)
Rights to clone food, animals and ultimately : INDIVIDUALS!
Less Progress in Life Science
Worse Medical treatment
Monopoly for and ultimately Control of Companies on Treatment
Undeservedly Large Rewards for the Inventors
Patents are the Death of Small Companies
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
No Patents on Life(How can a part of the body be patented?)
Not a new issue: see Patented Plant Extracts
Patenting of isolated natural products is well established in Patent law asan selection invention.
Legal:
R.23c EPC (established since 09/1999)
(“biological material which is isolated from its natural environment”)
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Fears associated with Biotech-PatentsNo Patents on Life!
(How can a part of the body be patented?)
Rights to clone food, animals and ultimately: INDIVIDUALS!
Less Progress in Life Science
Worse Medical treatment
Monopoly for and ultimately Control of Companies on Treatment
Undeservedly Large Rewards for the Inventors
Patents are the Death of Small Companies
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Rights to clone food, animals and ultimately: INDIVIDUALS!
Patents are primarily a negative right!
They allow the patentee to forbid the use of his invention
but:
Patents do not give an allowance to use the patented matter
This is regulated by national law!
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Fears associated with Biotech-PatentsNo Patents on Life!
(How can a part of the body be patented?)
Rights to clone food, animals and ultimately: INDIVIDUALS!
Less Progress in Life Science
Worse Medical treatment
Monopoly for and ultimately Control of Companies on Treatment
Undeservedly Large Rewards for the Inventors
Patents are the Death of Small Companies
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Less progress/less companies
USAThe most Biotech patents issued
(at least in part thanks to a more liberal attitude of the US-Patent Office).
The most and most successful Biotech firms.
The quantitatively broadest and most successful life science research.
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Less progress/less companies
USAThe most Biotech patents issued
(at least in part thanks to a more liberal attitude of the US-Patent Office).
The most and most successful Biotech firms.
The quantitatively broadest and most successful life science research.
Patents are the only true tool of small companies for protecting theirinventions and ultimately produce income!
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Fears associated with Biotech-PatentsJuly 06, 1998 Directive 98/44 EG of the European Parliament/Council
concerning the Protection of Biotechnological Inventions comes into force.
Effective September 01, 1999 it becomes part of the EPC
The Netherlands objected but were rejected before the Court of Justiceof the EC.
The German “Via Dolorosa”
(compulsary licence; limitation of substance claims; no utility patents)
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Expectations associated with Biotech-Patents
Expert Opinion of the Boston Consulting Group
December 1999:
“Gene/Biotech Patents are filed much earlier in the Research chain”Patents on targets
Patents on Assays
Patents based on therapeutic concepts
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Problems associated with Biotech-PatentsMonopoly for and Blocking of a Target for the Cure of a certain Disease
(Breast Cancer Mutation Gene / Myriad Genetics (US) vs. Curie Institute (FR))
Key Patents on certain well established Technology(Reporter Gene Assay (SIBIA))
Necessity to licence a load of different Patents to conduct Research(bgh-Polydadenylation Signal (RCT))
Blocking the Progress or best Technology in Medicinal Testing/Diagnosis(Merz et al., Diagnostic testing fails the test, Nature 415, 577-579 (2000))
Reach Through Claims/Extended Use Claims(EP0552 202 B1 (SIBIA))
Antibodies (production)(Cabilly patent (Genentech); Morrison Patent (Stanford))
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
ααααs
luciferase-geneSV406 x CREPol IICREB
AC
ATP cAMP
forskolin
P
luciferinATP + O2
luciferinox.AMP + light
luciferasecytosol
ββββγγγγ
Host -cell
FGGFTGARKSARKLA
NQ
Messenger
Receptor Co-expressedstructure
Hypothetical model of a test system: Reporter gene assay
bgh
nucleus
Clinical Trials and Research Tools
Molecule
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Los lunes del Centro de PatentesPatentes de Investigacion
General problems with test systems
• receptor (EST)• necessarily coexprimed proteins• test method, test principle• modified cells or animals•gene constructs (vectors, plasmids, hybrids and so on)• antibodies (use and production)• measuring procedures, the (optical, electrical) signal• materials: devices, colour markers, plasmids, cells• „reach-through claims“
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
General AspectsReach through claims
Example:Invention: Gene encoding an enzymeClaim: enzyme, DNA encoding the enzyme, homologues, screeningassay with enzyme, any inhibitor of the enzyme, medicamentcontaining an inhibitor of the enzyme, use of the inhibitor of the enzymein the preparation of a medicament for treatment of disease X,...
“Scope of protection should be commensurate or be justified by the invention”(Guidelines EPC; Art 83 & 84)
Reach through claims may be allowable in case of a pioneer inventionof broad applicability.
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
THE BLOWPIPE
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
THE BLOWPIPE
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
General AspectsReach through claims (USA)
Clinical Trials and Research Tools
•Limited by Bayer vs. Housey (by District Court of Dellaware, 2001)but still not completely dismissed (pending parallel cases). StillBayer vs. Housey mostly deals with the misuse of patents in regardsto the licencing deal rendering the patents unenforceable) .
•Additionally: claims for data importation infringing patents weremade but largely dismissed (Bayer vs. Housey US Court of Apeals,2003).
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Los lunes del Centro de PatentesPatentes de Investigacion
General AspectsExtended Use
Example:Claim: USE of a cGMP PDE inhibitor in the preparation of amedicament for the oral treatment of erectile dysfunction in man(EP 702 555 B1; Pfizer)
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
General AspectsReceptors and EST’s
Scope of Receptor claims:An isolated nucleotide comprising a nucleic acid sequencewhich encodes the amino acid sequence of Figure 1 or akainate-binding fragment thereof or an amino acid sequencethat is at least 97% homologues to the amino acid sequenceof Figure 1 or a kainate binding fragment thereof.
(Claim 1; issued patent EP 0 617 123 B1; Allelix)
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
General AspectsEST’s
EST’s (Expressed Sequence Tags):Thousands of EST’s were applied for following the Human GenomeProject.Many were issued.
But now:The industrial application of a sequence of a gene must be disclosed inthe patent application.
(Rule 23e) 3) EPC)Guidelines for Utility of the USPTO.
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
General AspectsResearch Privilege
EUThe most important help for Researchers:
The patent does not prevent activities for experimental purposes, if:- the invention is the object of the experimental activities- but not if the invention is the means or the tool of the experimentalactivities.
This will apply also to Universities!!
But beware also:. Not in the same way in:e.g. Switzerland, Sweden, USA etc.
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
General AspectsResearch Privilege
USA
VERY LIMITED:
Integra vs. Merck: any use of a patent tool/ “safe harbour (HATCH-WAXMAN)not for general biomedical research” (US Court of Appeals, 2003).
As in the eyes of US Judges University make part of their living throughpatents they are willing to enforce them on University groups (Duke University).
Exceptions are all drawn to research on fully “philosophical” background.
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Clinical Trials (with patented substance/super generic)EU
Research Privilege?
Complete different view of courts in the European Union.
(depending on different wording in enforcing the guideline ion national law)
Germany (very liberal)Netherlands (very strict)Spain (no case law but tendency: infringements)
Please check locally!!
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Clinical Trials (with patented substance/super generic)USA
Research Privilege through Hatch-Waxman Act
No problem (safe harbour) as long as the trials are for the FDA (notonly EMEA!)
But: HATCH-WAXMAN gives this privilege to ANDA filing.
What about a later NDA filing using a biotech invention in productionwithout an NDA to it (Integra vs. Merck)?
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Clinical TrialsEU
Careful with literature/articles!
According to Art. 10.1(a) Directive 2001/83 only 3 ways to copy aproduct without own data in an abridged application exists:
consent of data owner,use of published literature with well established medicinal use. (This isbeing obviously discouraged by authorities at the moment,cross-referral without consent after 10 (6) years from first EU approval for“essentially similar” product.
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
Clinical TrialsGeneral Aspect
Ethical pressure to market product in countries with Clinical Trial
Patent applications?
Clinical Trials and Research Tools
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Los lunes del Centro de PatentesPatentes de Investigacion
THE END
Clinical Trials and Research Tools
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