New strategies for patenting biological medicines used in rheumatoid arthritis treatment

ABSTRACT

Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by an inflammatory process, with a global prevalence ranging from 0.3% to 1%. The overall cost of RA drugs is estimated in $20 billion worldwide and projected to grow to $36 billion by 2021. The current RA treatment strategy consists of the aggressive therapy directed to specific targets, after diagnostic confirmation and the stepped therapy directed by the stage of the disease, aiming at the clinical remission. Conventional (methotrexate, sulfasalazine, leflunomide) and biological (infliximab, adalimumab, tocilizumab) disease-modifying antirheumatic drugs may fail, produce only partial responses, or unwanted side effects, and consequently new antirheumatic drugs are being developed to overcome these limitations.

Areas covered: In this review, the authors described the technological trends and the main players involved in the R&D process related to biological compounds employed in the treatment of RA, using patent documents as a source of technological information.

Expert opinion: Current treatments for RA still mainly target the immune system, different inflammatory targets, and mediators. Other types of therapies have also been developed, such as vaccines and gene therapies. Despite these new techniques, the main compounds of interest remain the antibodies anti-TNF-α and anti-CD20, with novelties regarding preparation methods and combination targets.

KEYWORDS:

• Antibodies
• arthritis
• biological
• medicines
• patents
• rheumatoid
• treatment

Article highlights

∙ The United States is the most important market for pharmaceutical companies investing in RA treatment.

∙ Roche and Genentech are the leading companies in the market for RA treatment. They hold the largest number of patent applications for products which are under active development and in more advanced phases of the development process, consequently having a greater chance of reaching the market.

∙ The main subject addressed in the patent applications for RA treatment referred to antibodies, which also correspond to the most cited mechanism of action in the documents, and within this type of technology the main target remains TNF-α.

∙ Biomarkers predictive of response to biological therapy together with more specific tests for antidrug antibodies could help select the most appropriate therapy for each patient and to achieve clinical remission.

∙ The complex structure of biological drugs makes oral administration impossible, restricting the treatment to parenteral routes. Drug delivery solutions can be achieved with the use of different particulate release systems such as polymeric micro- and nanoparticles.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.