Abstract
The high investments necessary to bring an antibody therapeutic to the market require a sound patent strategy. Although compound protection provides the broadest scope of protection, other ways of follow-up protection should be considered by innovators to achieve as long protection as possible. Further, in case a theoretical antibody against a given target is already prior art, innovators should be aware of methods to create compound protection for second or higher generation antibodies.
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Notes
- 1.
Note The phrase “key patent” refers to only one member of a patent family that exists for the product. INN, international non-proprietary name.
- 2.
Storz (2010).
- 3.
Average Cost to Develop a New Biotechnology Product Is $1.2 Billion. Tufts Center for the Study of Drug Development, November 9, 2006. Available at http://csdd.tufts.edu/NewsEvents/NewsArticle.asp?newsid=69. Accessed on October 27, 2009.
- 4.
Grabowski et al. (2006).
- 5.
Stewart et al. (2011).
- 6.
EPO decision T542/95.
- 7.
Noelle v. Lederman, 355 F.3d 1343, 2004 U.S. App. LEXIS 774.
- 8.
Overington et al. (2006).
- 9.
U.S. District Court for the Southern District of California; case 10-CV-00608 BEN (GS) of Oct 17, 2011.
- 10.
Three-step approach, as applied in the BGH decisions “Kunststoffrohrteil”, “Schneidmesser I”, “Schneidmesser II”, “Custodiol I”, “Custodiol II”, GRUR 2002, 511–531.
- 11.
“Catnic test” as applied in Kirin-Amgen, Inc. v. Hoechst Marion Roussel Ltd. (2004) UKHL 46 (2004-10-21).
- 12.
Article 2 of the Protocol on the Interpretation of Article 69 EPC.
- 13.
Festo Corp. versus Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U. S. 722 (2002).
- 14.
Biosimilars will be discussed in a later volume of this book series.
- 15.
See, among others, guideline EMEA/CHMP/42832/2005.
- 16.
The EMEA defines Biosimilars as follows: “The active substance of a similar biological medicinal product must be similar, in molecular and biological terms, to the active substance of the reference medicinal product. For example, a medicinal product containing interferon alfa-2a (…) should refer to a reference medicinal product containing as its active substance interferon alfa-2a. Therefore, a medicinal product containing interferon alfa-2b could not be considered as the reference medicinal product”.
- 17.
Scripps Clinic & Research Foundation v. Genentech, Inc., 18 USPQ 2nd 1001 (Fed. Cir. 1991).
- 18.
Scripps Clinic & Research Foundation v. Genentech, Inc., 18 USPQ 2nd 1001 (Fed. Cir. 1991).
- 19.
Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1300 (Fed. Cir. 2009).
- 20.
Article 54(5) EPC.
- 21.
The Swiss-type claim wording (“Use of a substance or composition X for the manufacture of a medicament for treatment of disease or condition Y”) had been found acceptable by the enlarged board of appeal in decision G 5/83 avoid a violation of the exclusion of therapeutic methods under old EPC (Article 52 (4) EPC 1973).
- 22.
35 U.S.C. 101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a Patent therefore”.
- 23.
Decision G2/08.
- 24.
Unigene Labs., Inc. v. Apotex, Inc. 06-CV-5571 (Fed. Cir. 2011).
- 25.
Gebauer and Skerra (2009).
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Storz, U., Flasche, W., Driehaus, J. (2012). IP Issues of Therapeutic Antibodies. In: Intellectual Property Issues. SpringerBriefs in Biotech Patents. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-29526-3_1
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