| Foreword |
|
v | |
|
|
|
xi | |
| Abbreviations |
|
xiii | |
|
Part I Generals of the Supplementary Protection Certificate in the European Law |
|
|
|
A Purpose, History and Legal Character of the Certificate |
|
|
4 | (9) |
|
|
|
4 | (2) |
|
II Relationship between Grant of the Patent and Authorisation under Pharmaceutical Law |
|
|
6 | (4) |
|
|
|
10 | (1) |
|
|
|
11 | (2) |
|
B Substantive Granting Prerequisites |
|
|
13 | (19) |
|
|
|
13 | (1) |
|
|
|
13 | (2) |
|
|
|
15 | (10) |
|
IV First Marketing Authorisation |
|
|
25 | (5) |
|
V No Earlier Certificate -- Multiple SPCs for the Same Product |
|
|
30 | (2) |
|
|
|
32 | (6) |
|
|
|
32 | (1) |
|
II Relevant Date for the Calculation of Term |
|
|
33 | (3) |
|
|
|
36 | (2) |
|
|
|
38 | (1) |
|
|
|
39 | (3) |
|
I Rights of the Certificate Holder |
|
|
39 | (2) |
|
II Limitations and Obligations |
|
|
41 | (1) |
|
F Specific Practical Problems |
|
|
42 | (15) |
|
I Scope of Protection: "Salt Issue" |
|
|
42 | (1) |
|
II First Marketing Authorisation: Use Patents |
|
|
43 | (4) |
|
III Substance Combinations |
|
|
47 | (10) |
|
|
|
57 | (8) |
|
|
|
57 | (1) |
|
|
|
57 | (6) |
|
III Grant and Announcement |
|
|
63 | (1) |
|
IV Fees to Maintain the SPC |
|
|
64 | (1) |
|
H Expiry, Invalidity and Revocation |
|
|
65 | (3) |
|
|
|
65 | (1) |
|
II Reasons for Invalidity |
|
|
66 | (1) |
|
III Revocation of a Term Extension |
|
|
67 | (1) |
|
|
|
67 | (1) |
|
|
|
68 | (1) |
|
|
|
69 | (28) |
|
I Intentions to Revise and Amendments to the RegSPC |
|
|
69 | (14) |
|
II Calls for the Creation of SPC Regulations for Other Products |
|
|
83 | (6) |
|
III Accession of New Member States to the European Union |
|
|
89 | (5) |
|
IV Withdrawal of the United Kingdom from the European Union |
|
|
94 | (3) |
|
Part II Specialities of National Jurisdictions |
|
|
|
|
|
97 | (14) |
|
I National Pharmaceutical and Patent Law |
|
|
97 | (1) |
|
II Application of the Art. 3 RegSPC Conditions |
|
|
98 | (6) |
|
III Calculation of the Term of the SPC |
|
|
104 | (1) |
|
IV Rights, Limitations and Obligations |
|
|
104 | (1) |
|
V SPC Grant, Termination and Remedies |
|
|
105 | (6) |
|
M The SPC in the United Kingdom |
|
|
111 | (26) |
|
I National Law relating to SPCs |
|
|
111 | (5) |
|
II Application of the Art. 3 RegSPC Conditions |
|
|
116 | (15) |
|
III SPC application procedure |
|
|
131 | (4) |
|
IV Transitional Provisions relating to Pre-existing SPCs and Applications from before or during the Transitional Period |
|
|
135 | (1) |
|
V Invalidation of SPCs and/or SPC Extensions |
|
|
136 | (1) |
|
|
|
137 | (10) |
|
I French National Patents and Pharmaceutical Law |
|
|
137 | (1) |
|
II The Conditions for Obtaining an SPC |
|
|
138 | (4) |
|
III Grant Procedure for SPCs in France |
|
|
142 | (2) |
|
|
|
144 | (1) |
|
|
|
144 | (1) |
|
|
|
145 | (1) |
|
VII Paediatric Extensions |
|
|
145 | (2) |
|
|
|
147 | (9) |
|
I National Pharmaceutical and Patent Law |
|
|
147 | (2) |
|
II SPC Obtaining Provisions and Term |
|
|
149 | (2) |
|
III Subject Matter and Scope of Protection |
|
|
151 | (1) |
|
IV Rights, Limitations and Obligations |
|
|
152 | (1) |
|
V SPC Grant, Termination and Remedies |
|
|
153 | (3) |
|
P The SPC in The Netherlands |
|
|
156 | (9) |
|
I National Pharmaceutical and Patent Law |
|
|
156 | (1) |
|
II SPC Obtaining Provisions and Term in the Dutch Context |
|
|
157 | (3) |
|
III Substantive Requirements |
|
|
160 | (2) |
|
IV Rights, Limitations and Obligations |
|
|
162 | (1) |
|
|
|
163 | (1) |
|
VI Termination and Remedies |
|
|
163 | (1) |
|
|
|
164 | (1) |
|
|
|
165 | (20) |
|
I Sources of Law and Legislative History |
|
|
166 | (2) |
|
II Substantive Granting Prerequisites |
|
|
168 | (7) |
|
III Subject-Matter of Protection and Effects |
|
|
175 | (2) |
|
|
|
177 | (3) |
|
V SPC for Plant Protection Products |
|
|
180 | (1) |
|
VI Application, Fees, Examination and Remedies |
|
|
181 | (2) |
|
|
|
183 | (1) |
|
VIII Swiss Federal Patent Court |
|
|
184 | (1) |
|
|
|
|
A Selected Decisions of the European and National Case Law |
|
|
185 | (68) |
|
A1 Court of Justice of the European Union |
|
|
185 | (27) |
|
|
|
212 | (10) |
|
|
|
222 | (10) |
|
|
|
232 | (5) |
|
|
|
237 | (2) |
|
|
|
239 | (3) |
|
|
|
242 | (11) |
|
|
|
253 | |
|
B1 International Treaties |
|
|
253 | (1) |
|
|
|
254 | (5) |
|
|
|
259 | (24) |
|
|
|
283 | (3) |
|
|
|
286 | |
