Heavy birth with patent expiring in 2021-2026...

Patent expiration is a key node in the life cycle of a drug and a challenge that all pharmaceutical companies are bound to face.
the world every year a number of original research drug patents expire, when the original research brand drugs lost patent protection, a large number of generic drugs will flood the market, and then the emergence of a well-known "patent cliff."
companies lose patent protection, with shrinking sales and profits.
for mono-resistant biologics, the core patents are compound and sequence patents.
General monoclonal antibody rights are to protect antibody heavy chain and light chain sequence related information, including heavy chain and light chain amino acid sequence full length, or heavy chain and light chain variable area amino acid sequence full length, more in order to obtain a larger and more stable protection range, requires the protection of heavy chain and light chain variable zone domain complementary decision area (CDRs) amino acid sequence.
the use of this closed way to write claims, can also be used sequence esoxuality for functional qualification, for example, with the sequence 99% of the same origin.
as of 23 January 2021, 657 primary biopharmaceons had been approved for sale worldwide (illustrated below), with adaptation mainly concentrated in areas related to cancer, infection, blood disease and immunization.
some of these biologic drugs will face market challenges from biosynthic drugs when their patents expire between 2021 and 2026, such as dharetoyu monoanti, saccharide peptides, and ottojutamic monoantigens.
Heavy Biopharmaceuticals due 2021-2026 Serial Patents (2020 Sales: US$100 million) Source: Pharmaceutical Rubik's Cube NextPat, Pharmaceutical Rubik's Cube NextPharma Biosethics Patents are the core patents of biopharmaceuticals, and the expiration of biosethic patents is the clearest clue for generic pharmaceutical companies to seize the market.
the sequence patent layout of several heavy-duty biologic drugs are briefly described below.
Teprotumumab (Tepezza) Teprotumumab is a recombinant human monoclonal antibody developed by Horizon Therapeutics in collaboration with Genmab that inhibits the downstream effects of IGFR1 signaling (i.e., tissue inflammation and remodeling of symptoms that cause thyroid eye disease).
the drug was approved in the U.S. in January 2020 for the treatment of thyroid eye disease (TED).
a CN100453645C (Application Date 2004-07-09) claim 1 protects a combination of IGF-IR and inhibits IGF-I. and IGF-II. IR-binding IgG1 isotopic antibody, the heavy chain of which contains a CDR of 31-35 amino acids as CDR SEQ ID NO: 1 (teprotumumab heavy chain variable zone full length) CDR2 consisting of 1,50-66 bit amino acids and CDR3 of 99-107 amino acids; The full length of the umab light chain variable zone) is located in 24-34-bit amino acids composed of CDR1, in 50-56 amino acids composed of CDR2 and in 89-98 amino acids composed of CDR3.
patent protects the light and heavy chain length of teprotumumab and the CDR zone sequence.
Orijuku monoantigen (Ocrevus) Oriju monoantigen is a dissolved cell antibody targeted at CD20 that can be used to treat patients with relapsed or primary multiple sclerosis, it is a second generation recombinant humanized monoclonal IgG1 antibody, selectively targeting B lymphocytes that express CD20 antigens; Claim 1 of 0421C (Application Date 2003-12-16) protects a humanized antibody binding to human CD20 or its antigen binding fragment, which contains the heavy chain amino acid sequence of SEQ ID NO: 39 and the light chain amino acid sequence of SEQ ID NO: 40.
-degree saccharide is a new type of glucagolycline-like peptide-1-1or agonist, consisting of glutatronase-IV-protected GLP-1 similars that are co-priced through a small peptide joint to a human IgG4-Fc heavy chain and can be injected once a week for the treatment of type 2 diabetes.
CN1802386B (Application Date 2004-06-10) claim 1 protects an isogeneic fusion protein that contains a GLP-1 similar, which can be selected from the sequence of SEQ ID NO:1, and when Xaa is Gly, SEQ ID NO: 1 is the sequence of GLP-1 in the saccharide peptide.
the expiration of patents for the original research drugs is inevitable, in the face of the pace of generic drug companies, large pharmaceutical companies at home and abroad will find ways to extend the duration of drug patents through various strategies.
In order to break the protection of all the original pharmaceutical companies with the intention of layout hierarchical and echelon-level patent terms, the following recommendations are made for generic drug companies: the patent database can be used to accurately locate the "expected expiration date" of a patent, screening out patents that are about to expire in five to eight years as a priority research Object, on this basis should continue to track the real-time dynamics of these key drugs, avoid the risk of infringement and ready to adjust their research and development direction, in addition, through the positioning of the patent of the same family to maintain effective analysis, mining the original research institutions on the patent layout framework of the drug, in-depth analysis of the source of technology to avoid the process to bypass the limitations of subordinate patents.