title: Therapeutic compositions and uses of alpha1-antitrypsin: a patent review (2012 - 2015).
abstract: BACKGROUND
  Identified as a circulating serine-protease inhibitor, the genetic deficiency of which predisposes to the development of lung emphysema, alpha1-antitrypsin (AAT) has recently been found to possess various anti-inflammatory and immunomodulatory activities outside the biochemical inhibition of serine-proteases. AAT is presently extracted from human plasma to supply life-long infusions to patients with genetic AAT deficiency. However, its newly appreciated functions point to extended therapeutic uses; these, alongside modified production attempts, represent a novel and dynamic niche of drug repurposing, set apart from addressing lung emphysema in AAT-deficient individuals.
  
  
  METHODS
  The review provides a comprehensive summary of patent-protected inventions in the field of novel clinical indications for AAT and innovations in AAT production.
  
  
  CONCLUSIONS
  A molecule no longer patentable per se, presents with novel clinical applications; its mechanism still unfolding. While modified protein sequences are patentable and potentially superior, they are burdened by regulatory setbacks. Thus, recent approaches in the context of AAT appear in patents that describe combinations with other drugs, redefined clinical subclasses, and unique recombinant entities, carefully skirting saturated areas of AAT patentology. It will be fascinating to follow technologies and creative patenting as AAT navigates the trying trades of pharmaceutical industry towards an increasing lineup of unmet clinical needs.
authors.affiliation: a Department of Clinical Biochemistry & Pharmacology, Faculty of Health Sciences , Ben-Gurion University of the Negev , Beer Sheva , Israel.
authors.forename: Yotam
authors.initials: Y
authors.lastname: Lior
authors.affiliation: b Geyra Gassner IP Law , Tel-Aviv Yaffo , Israel.
authors.forename: Assaf
authors.initials: A
authors.lastname: Geyra
authors.affiliation: a Department of Clinical Biochemistry & Pharmacology, Faculty of Health Sciences , Ben-Gurion University of the Negev , Beer Sheva , Israel.
authors.forename: Eli C
authors.initials: EC
authors.lastname: Lewis
mesh_terms: D000818:Animals; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D015195:Drug Design; D058492:Drug Repositioning; D006801:Humans; D010330:Patents as Topic; D011656:Pulmonary Emphysema / Q000188:drug therapy / Q000235:genetics; D000515:alpha 1-Antitrypsin / Q000008:administration & dosage / Q000627:therapeutic use*; D019896:alpha 1-Antitrypsin Deficiency / Q000150:complications / Q000188:drug therapy*
chemical_list: D000893:Anti-Inflammatory Agents; D000515:alpha 1-Antitrypsin
keywords: Acute myocardial infarction; SERPINA1; allograft rejection; alpha1 proteinase inhibitor; diabetes; graft versus host disease; immunomodulation; inflammation; xenoimmune response