By Ulrich Storz
SpringerBriefs in Biotech Patents current well timed experiences of highbrow houses (IP) concerns and patent elements within the box of biotechnology. This new quantity within the sequence makes a speciality of the actual IP problems with therapeutics, vaccines and molecular diagnostics. the 1st bankruptcy concentrates on fundamentals rules for shielding antibody compounds. extra how you can create follow-up safeguard for antibody therapeutics also are mentioned. the second one bankruptcy offers an summary of the patent panorama in molecular diagnostics, and discusses problems with patentability with admire to different applied sciences and compounds used therein. The 3rd bankruptcy supplies a wide evaluate of parts of legislation which are fairly proper to the patenting of peptide vaccines and healing peptides as items and in compositions. The scope of patentable material is mentioned, because it has been the point of interest of a lot wrangling and debate within the courts.
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Extra info for Intellectual Property Issues: Therapeutics, Vaccines and Molecular Diagnostics
Example text
The USPTO is always quick in issuing such rejections. It might not be restricted to the field of (therapeutic) peptides but we see a lot of times that the examiners do not know the art at all. Given the extensive art on how peptides work and how they can be modified without destroying the activity and given a description that already discloses variants and modifications to be employed and last but not least the speed of synthesis and the measurements needed to determine the immunogenic effects, the burden of experimentation for somebody with skill in the art (see artisan) is minor.
9084. Even if the wording of the claim is more open, for example ‘‘consisting of SEQ ID NO. 5 and up to ten amino acids added to the C-terminus and/or the N-terminus of SEQ ID NO. 5’’ one cannot start the alignment anywhere in any given peptide or protein. The alignment always must start with the position 1 of any given peptide/protein. • There is only one wording, that allows for an alignment as done by the PTO in the example: ‘‘a peptide or protein comprising a continuous stretch of amino acids according to (or given in) SEQ ID NO.
1). The short comment by the respective examiner was: ‘‘… amino acids 676–684 of SEQ ID NO. 9084 read on applicant’s SEQ ID NO. 5’’. There are some things that instantly come to mind: • Consisting of means that ‘‘amino acids 676–687 of SEQ ID NO. 9084’’ is at least 675 amino acids too long, to fall under the claim. • ‘‘SEQ ID NO. 9084’’, so finding anything in at least 9083 sequences is nearly impossible. • Most important is that the alignment is wrong. If you have the consisting of language in the claim, the alignment must be made with the first amino acids in any given sequence.