2013 International Series Korea U.S. IP Judicial Conference. Patentability of Chemical/Pharmaceutical Inventions. Isomers/Enantiomers

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2 2013 International Series Korea U.S. IP Judicial Conference Patentability of Chemical/Pharmaceutical Inventions October 22, 2013 Nicholas M. Cannella, Esq. 1

3 Chemical Structure: Stereochemistry The three-dimensional nature of compounds Stereoisomers: molecules that have the same molecular formula (number and type of atoms) and same sequence of bonded atoms, but with a different orientation in space Enantiomers: stereoisomers with the same chemical structure that are not superimposable mirror images of each other in three-dimensional configuration Left and Right Hands Mirror Images Not Superimposable 2

4 Chemical Structure Mirror Images Not Superimposable 3

5 Statutory framework: Anticipation A person shall be entitled to a patent unless - - (a) the invention was... patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or (b) the invention was patented or described in a printed publication in this or a foreign country... more than one year prior to the date of the application for patent in the United States U.S.C. 102 (a) & (b). 4

6 The Anticipation Analysis: To be anticipatory, a reference must disclose all elements of the claimed invention arranged as in the claim being challenged Genus/species A prior art reference that discloses a genus does not inherently disclose all species within that category At once envisage The allegedly anticipatory reference must be enabling 5

7 Statutory Framework: Obviousness A patent may not be obtained though the invention is not identically disclosed or described as set forth in section if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person of ordinary skill in the art U.S.C. 103 (a). 6

8 The Obviousness Analysis: Motivation to modify the reference compound to the claimed compound Reasonable expectation of success of both preparing the claimed enantiomer without undue experimentation Achieving the unique combination of properties of the resulting enantiomer The role of objective evidence of nonobviousness long-felt need failure of others commercial success 7

9 Double-Patenting: To prevent the unwarranted extension of the term of patent protection by prohibiting the issuance of the claims in a second, later patent that are not patentably distinct from the claims of the first, earlier patent Two step inquiry Court, as a matter of law, construes the claims of both the first, earlier patent and of the second, later patent Determination of whether the second, later claims are patentably distinct from the first, earlier claims Analogous to the obviousness determination under 35 U.S.C

10 Double-Patenting (cont d): In the double-patenting analysis, the claims of the first, earlier patent are not prior art But, they are treated as such for determining whether the second, later claims are patentably distinct over them N.B., however, that only the claims of the first, earlier patent can be so considered. The specification of the first, earlier patent, as a general rule, cannot be considered or used as prior art Must consider the claims as a whole, not just the differences between the first, earlier claims and the second, later claims 9

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