Patent Cliffs in the Era of Complex Therapies and Biologics

  title={Patent Cliffs in the Era of Complex Therapies and Biologics},
  author={Marco T. Sabatini and Miguel Silva},
  journal={Pharmaceutical Medicine},
  pages={271 - 278}
The rise of new product classes such as biologics and complex molecules over the past two decades have brought to light some of the unique market dynamics that such products face. While we have seen and experienced the inception, growth and expansion phase of such products, the ongoing incumbent decline due to loss of exclusivity (LoE) is yet to be fully experienced. This raises the question of how one may go about modelling such a scenario given that forecasting the expected erosion curves… 


The patent cliff steepens
The availability of generic atorvastatin will provide health-care payers with another price-discounted option in addition to statins such as simvastasin for managing cholesterol levels in patients, says Gideon Heap, an analyst at Datamonitor Healthcare.
The economics of biosimilars.
Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market.
Patent expiry dates for biologicals : 2017 update
  • Medicine
  • 2018
Estimated patent expiry dates for some of the best-selling biologicals, mainly as a result of the World Trade Organization’s TRIPS agreement, give the case for using biosimilars clear.
May your drug price be evergreen
The author analyses all drugs on the market between 2005 and 2015, combing through 60,000 data points to examine every instance in which a company added a new patent or exclusivity, showing a startling departure from the classic conceptualization of intellectual property protection for pharmaceuticals.
The Biosimilar Action Plan: An Effective Mechanism for Balancing Biologic Innovation and Competition in the United States?
The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while
May your drug price be evergreen.
Presenting the first comprehensive study of evergreening, this article examines the extent to which evergreening behavior—which can be defined as artificially extending the protection cliff—may
Are trade secrets delaying biosimilars?
It is estimated that even by 2020, biosimilar competition will reduce consumer prices only modestly, and one key reason is the barrier to competitive entry created by trade secrecy in biologics manufacturing.
Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry
This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies and offers both theoretical and practical guidelines for strategy transformation that companies can use to prolong the market exclusivity.
Did the Demand for Crestor Shrink when Lipitor’s Patent Expired?
This paper uses micro-level data from the Medical Expenditure Panel Survey to investigate whether, following the expiration of Lipitor’s patent, demand for Crestor shrank. The topic holds important
The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars
Differences in approach in phase 3 testing must be viewed in the totality of evidence demonstrating biosimilarity, with differences in clinical trial design (equivalence or non-inferiority design), patient population, patient population and endpoint (overall response rate or pathological complete response).