United States courts have recently tightened the written description requirements for antibody claims. The scope of issued claims is now often limited to antibodies with specific.
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Claim construction is the heart of validity and infringement for almost every patent proceeding. Yet, at least two recent cert petitions brought from separate cases by Intel and Akeva.
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Last week, the Federal Circuit affirmed a jury verdict against Baxalta Inc., Baxalta US Inc., and Nektar Therapeutics for infringing Bayer Healthcare s patent to human blood clotting factor conjugates in
Bayer Healthcare LLC v. Baxalta Inc.
Bayer Healthcare sued Defendants on U.S. Patent No. 9,364,520, alleging willful infringement by Baxalta s product, Adynovate®. This product is a recombinant human Factor VIII (the blood clotting factor responsible for causing Hemophilia A) having the protein structural domains A1-A2-B-A3-C1-C2, wherein the B portion was specifically modified by addition of polyethylene glycol (PEG). PEGylation is important because Factor VIII has an 11-hour half-life which requires frequent injections and leads to reduced patient compliance. The prior art had disclosed random modification of Factor VIII with PEG, which had several drawbacks due to the multiplicity of PEGylations sites ( 15