Agennix has a strong worldwide patent position protecting talactoferrin, including 95 issued patents and 48 pending patents covering composition of matter, use, and the manufacturing process. The patents broadly cover talactoferrin, all natural lactoferrin variants, recombinant human lactoferrin with substitutions and subset lactoferrin sequences. Human lactoferrin has been expressed recombinantly only in eukaryotic cells, and Agennix's patents also cover the production of recombinant human lactoferrin in any eukaryotic cell. Agennix's U.S. core composition of matter and production patents expire (after available Hatch-Waxman extension) in November 2018. Similar patents in Europe and Japan also expire (after applicable extensions) in 2018.

Agennix patents have not only issued but have also been challenged and upheld. In Europe, Agennix patents were challenged by Pharming Group N.V. The European Technical Board of Appeal (Europe's highest patent authority) held that Agennix's patents are valid and enforceable. The opposition claims were also submitted to the U.S. Patent and Trademark Office, which explicitly considered and rejected these arguments, even before the European Technical Board of Appeal decision, and issued Agennix a U.S. patent despite these challenges. Other companies seeking to work with recombinant human lactoferrin have requested (but have not been granted) licenses from Agennix.

The 48 additional patents still pending will further strengthen and extend Agennix's worldwide patent portfolio. Agennix believes that the pending use patents in core indications will issue and provide additional protection until May 2023.

Agennix also has Orphan Drug designation for NSCLC (from FDA) and RCC (from FDA and EMEA). This provides exclusivity for these lead indications, independent of patent protection, for seven years following U.S. marketing approval and ten years following European marketing approval.