Cilj predmeta je osposobiti studente/ice za rješavanje problema povezanih s razvojem i zaštitom izuma u području biotehnologije.

a) uvod u biotehnologiju – razvoj bioprocesa i bioproizvoda (2 sata)

b) predmeti i izuzeci zaštite u području biotehnologije – pregled (1 sat)

c) patentna zaštita u području bioprocesnog inženjerstva i industrijske mikrobiologije (1 sat)

d) patentiranje nukleinskih kiselina, gena, vektora, staničnih linija (1 sat)

e) patentiranje transgeničnih životinja i biljaka, matičnih stanica, genska terapija, cjepiva, hormoni, biomaterijali u tkivnom inženjerstvu (2 sata)

g) sastavljanje patentnih zahtjeva u biotehnologiji – primjeri (2 sata)

h) poslovni aspekti zaštite izuma u području biotehnologije (1 sat)

Obvezna literatura

1.     Zakon o patentu NN 173/03, 87/05, 76/07, 30/09, 128/10, 49/11

2.     Pravilnik o patentu NN 117/07, 03/11, 66/11

3.     Ugovor o suradnji na području patenata NN 3/98 i 10/98

4.     Pravilnik prema Ugovoru o suradnji na području patenata (PCT) NN 10/98, 3/01, 4/02, 15/02, 1/03, 18/03, 3/05, 3/06, 5/08, 12/08, 5/09, 4/10, 9/11

5.     Europska patentna konvencija 2000 (EPC 2000) NN 8/07 i 1/08

6.     Provedbeni pravilnik Europske patentne konvencije 2000. usvojen odlukom Upravnog vijeća od 7. prosinca 2006. godine koje je sastavni dio Europske patentne konvencije kako je izmijenjena i dopunjena NN 13/09

7.     Zakon o potvrđivanju Sporazuma o primjeni članka 65. Konvencije o priznavanju europskih patenata (Londonski sporazum) NN 8/07 i 4/08

8.     Strasburški sporazum o međunarodnoj klasifikaciji patenata NN 11/99 i 4/00

9.     Budimpeštanski ugovor o međunarodnom priznavanju depozita mikroorganizama za potrebe patentnog postupka NN 11/99 i 4/00

10.  Ugovor o patentnom pravu (PLT) NN 10/04 i 3/05

11.  Zakon o upravnim pristojbama na području intelektualnog vlasništva NN 64/00, 160/04, 62/08, 30/0, 49/11

12.  Zakon o zastupanju u području prava industrijskog vlasništva NN 54/05, 49/11

Dopunska literatura

1.      Y. KO, An Economic Analysis of Biotechnology Patent Protection, in 102 Yale L. J., 1992, 777 ff.

2.      L. WESTERLUND, Biotech Patents. Equivalency and Exclusions under European and U.S. Patent Law, Kluwer, The Hague, 2002.

3.      H.C. WEGNER, Patent Law in Biotechnology, Chemicals and Pharmaceuticals, Stockton, New York, 1994.

4.      E.S. VAN DE GRAAF, Patent Law and Modern Biotechnology: A Comparative Study about the Requirements and the Scope of Protection, Sanders Institute, Rotterdam, 1997.

5.      P. DUCOR, Patenting the Recombinant Products of Biotechnology, Kluwer, The Hague, 1997.

6.      S.J.R. BOSTYN, Enabling Biotechnological Inventions in Europe and the United States. A study of the patentability of proteins and DNA sequences with special emphasis on the disclosure requirement, European Patent Office, Munich, 2001.

7.      L. WESTERLUND, Biotech Patents. Equivalency and Exclusions under European and U.S. Patent Law, Kluwer, The Hague, 2002.

8.      S.J.R. BOSTYN, A European Perspective on the Ideal Scope of Protection and the Disclosure Requirements for Biotechnological Inventions in a Harmonised Patent System. The Quest for the Holy Grail? in 5 JWIP 2002, 1013 ff.

9.      V. SANTANIELLO, Intellectual Property Rights of Plant Varieties and of Biotechnology in the EU, in V. SANTANIELLO-R.E. EVENSON-D. ZILBERMAN-G.A. CARLSON (eds.), Agriculture and Intellectual Property Rights: Economic, Institutional and Implementation Issues in Biotechnology, CABI Publishing, Oxon and New York, N.Y., 2000 (PRIV 2612), 27 ff.

10.    Matthew Rimmer, Intellectual Property and Biotechnology. Biological Inventions, Edward Elgar, Cheltenham, 2008.

11.    Han Somen (ed.), The Regulatory Challenge of Biotechnology. Human Genetics, Food and Patents, Edward Elgar, Cheltenham, 2007.

12.    Oliver Mills, Biotechnological Inventions: Moral Restraints and Patent Law, Ashgate, 2005.

13.    Suzanne L.W. Wisniewski, Effects of Foreign Intellectual Property Rights on U.S. Bilateral Exports of Biotechnolology-Related Agricultural Inputs, 8 JWIP (2005).

14.    S. Safrin, Hyperownership in a Time of Biotechnological Promise: the International Conflict to Control the Building Blocks of Life, in 98 Am. J. Int. L. 2004, 641-686.

15.    L.J. Demaine-A.X. Fellmeth, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent, in 55 Stanford Law Rev. 2002, 303-462 ss.

16.    T. SAMPSON, Rewriting the Genetic Code: the Impact of Novel Nucleotides on Biotechnology Patents, in 24 EIPR 2002, 409 ff.

17.    F. FUKUYAMA, Our Posthumous Future. Consequences of the Biotechnology Revolution, Farrar, Straus and Giroux, New York, 2002.

18.    E.R. GOLD-A. GALLOCHAT, The European Biotech Directive: Past as a Prologue, in Eu L.J., 2001, 331 ff.

19.   R. TESCHEMACHER, The Practice of the European Patent Office regarding the Grant of Patents for biotechnological Inventions, in 19 I.I.C. 1988, 18 ff.

20.    S.J.R. BOSTYN, Enabling Biotechnological Inventions in Europe and the United States. A study of the patentability of proteins and DNA sequences with special emphasis on the disclosure requirement, European Patent Office, Munich, 2001.

21.    G. KAMSTRA-M. DOERING-N. SCOTT-RAM-A. SHEARD-H. WIXON, Patents on Biotechnological Inventions: The EC Directive – Special Report, Sweet & Maxwell, London, 2001.

22.    S. D. MURPHY, Biotechnology and International Law, in 42 Harvard Int. L. Journal, 2001, 47 ff.

23.    V. SANTANIELLO-R.E. EVENSON-D. ZILBERMAN-G.A. CARLSON (eds.), Agriculture and Intellectual Property Rights: Economic, Institutional and Implementation Issues in Biotechnology, CABI Publishing, Oxon and New York, N.Y., 2000.

24.    D.D. EVENSON, Patent and Other Private Legal Rights for Biotechnology Inventions, in V. SANTANIELLO-R.E. EVENSON-D. ZILBERMAN-G.A. CARLSON (eds.), Agriculture and Intellectual Property Rights: Economic, Institutional and Implementation Issues in Biotechnology, CABI Publishing, Oxon and New York, N.Y., 2000 (PRIV 2612), 11 ff.

25.    P. DUCOR, Patenting the Recombinant Products of Biotechnology, Kluwer, The Hague, 1997 (PRIV 471).

26.    T. Sampson, Achieving Ethically Acceptable Biotechnology Patents: A Lesson from the Clinical Trials Directive? in EIPR 2003, 419-425.

27.    Ph. W. GRUBB, Patents for Chemicals, Pharmaceuticals and Biotechnology. Fundamentals of Global Law, Practice and Strategy, Oxford University Press, Oxford, 1999 (PRIV 1398).

28.    B. DOMEIJ, Pharmaceutical Patents in Europe, Kluwer Law International, 2000 (PRIV 2296).

29.    W.L. Hayhurst, Validity and Infringement of Claims for Pharmaceutical Formulations and their Use, in EIPR 2004, 226-228.

30.    B. DOMEIJ, Patent Claim Scope: Initial and Follow-on Pharmaceutical Inventions, in 23 EIPR 2001, 326 ff.

31.    J. R. THOMAS, On Preparatory Texts and Proprietary Technologies: the Place of Prosecution Histories in Patent Claim Interpretation, in 47 UCLA Law Review, 1999, 183 ff.

32.    J. HUDSON, Generic Take-Up in Pharmaceutical Markets Following Patent Expiry: A Multy Country Study, in 20 Int. Rev. of Law & Economics, 2000, 205 ff.

33.    L. BRAZELL, The Protection of Pharmaceutical Products and Regulatory Data: EU Enlargement Update, in 24 EIPR 2002, 155 ff.

34.    W. McARTHUR, Intellectual Property Righs and the Pharmaceutical Industry: the Consequence of Incomplete Protection, O. LIPPERT, Competitive Strategies for Intellectual Property Protection, Vancouver, BC, The Fraser Institute, 1999, 85 ff.

35.    P. Rey-J.S. Venit, Parallel trade and pharmaceuticals: a policy in search of itself, in 29 Eu. L. R. 2004, 153-177.

36.    R.S. Eisenberg, Patents, Product Exclusivity, and Information Dissemination: How Law Directs Biopharmaceutical Research and Development, in 72 Fordham L.R. 2003, 477-491.

37.    P. Rey-J.S. Venit, Parallel trade and pharmaceuticals: a policy in search of itself, in 29 Eu. L. R. 2004, 153-177.

38.    C. Heath, Parallel Imports of Patented Pharmaceuticals from the New EU Accession States, in 35 IIC 2004, 776-787.

39.    C.T. Feddersen, Parallel Trade in Pharmaceutical in a Europe of 25: What the Specific Mechanism Achieves and What It Does Not, in EIPR 2003, 545-555.

40.    S. VASTANO VAUGHAN, Compulsory Licensing of Pharmaceuticals Under TRIPs: What Standards of Compensation? in 25 Hastings International and Comparative Law Review, 2001, 87 ff.

41.    S. VASTANO VAUGHAN, Compulsory Licensing of Pharmaceuticals Under TRIPs: What Standards of Compensation? in 25 Hastings International and Comparative Law Review, 2001, 87 ff.

42.    R. Dinka, The “Bermuda Triangle” of Pharmaceutical Law in JWIP 2005, 517 ff.

43.    P. M. DORAN: Bioprocess Engineering Principles, Academic Press, 1998.

44.    V. MARIĆ, B. ŠANTEK: Biokemijsko inženjerstvo, Golden marketing-Tehnička knjiga, Zagreb, 2009

Ishodi učenja na razini programa kojima predmet doprinosi

Nakon odslušanog predmeta i položenog pismenog i usmenog ispita iz ovog predmeta, student/ica je osposobljen/a rješavati praktične probleme i pitanja srednje razine složenosti, vezane uz razvoj i zaštitu izuma u području biotehnologije. Detaljna obradba pojedinih primjera zaštite izuma usmjerena je ka osposobljavanju studenata/ica za rješavanje praktičnih zadataka vezanih uz stjecanje i iskorištavanje patenata u biotehnologiji te pravnu zaštitu. Ovaj predmet objedinjava znanja stečena u obveznom predmetu Patentno pravo s ovoga studija i nadograđuje i usmjerava osnovna znanja iz patentnog prava ka patentnom sustavu u biotehnologiji

Ishodi učenja na razini predmeta

• Stjecanje temeljnog znanja o biotehnologiji i predmetima patentne zaštite u biotehnologiji.
• Stjecanje temeljnih vještina potrebnih za sastavljanje patentnih zahtjeva za izume u području biotehnologije.
• Osposobljavanje za rješavanje pravnih problema i pitanja srednje razine složenosti, vezanih uz izume u području biotehnologije.
• Osposobljavanje za provođenje analize i rješavanje pitanja poslovne naravi povezane sa stjecanjem, održavanjem u vrijednosti, gubitkom i iskorištavanjem patenata u području biotehnologije.