By Pratima Bhat B.E (BT), Medical Writer
First let’s see what patent ever-greening is and how it came into existence?
Patent ever-greening refers to a strategy of obtaining multiple patents that covers various aspects of the same product. Even though it is not a formal concept of patent law, patent owners utilize this process to extend their monopoly privileges.
Some examples include seeking subsequent patents on derivatives of existing drugs, altering the mixture of isomers, identifying compounds with the same molecular formula but different structural formulas, or patenting methods of administration of an existing drug.
It has been in practice since the passage of the Waxman-Hatch legislation (Drug price competition and Patent term restoration act) in 1984, in which the pioneer drug can receive an extension term equal to one-half the time of the investigational new drug (IND) period, running from the start of the human clinical trial to the time till the new drug application (NDA) is submitted.
Evergreening strategies usually followed by the pharmaceutical industries involve:
- Redundant extensions and creations of ‘next generation drugs’ which result in superfluous variation to a product and then patenting it as a new application.
- Prescription to over-the-counter (OTC) switch.
- Exclusive partnerships with cream of generic drug players in the market prior to drug patent expiry thus significantly enhancing the brand value and interim earning royalties on the product.
- Defensive pricing strategies practice wherein the innovator companies decrease the price of the product in line with the generic players for healthy competition and
- Establishment of subsidiary units by respective innovator companies in generic domain before the advent of rival generic players.
How does it affect?
Extending the patent period seizes the generic drug manufacturing. Once the generic drugs are being produced, the price of the drug can drop by as much as 90%. Additional costs caused by delay in generic entry can be very significant for the public health budgets and ultimately the consumer.
The European Commission estimated a loss of around three billion Euros due to delays in the entry of generic products caused by misuse of the patent system (European Commission, 2009). In 2002, an extensive and lengthy inquiry by the US Federal Trade Commission (FTC), found that the Waxman-Hatch legislation had resulted in as many as 75% of new drug applications by the generic drug manufacturers experiencing legal actions under patent laws by the original brand name patent owner.
This process helps in extending the exclusivity of the manufacturer over the drug however this process has left a wider gap between innovation and access. Competition leads to innovation, prolonging the protection of ideas may freeze the development and utility of the product.
Can it be controlled?
Even though the courts have made some minimal efforts to limit evergreening practices using existing doctrines, it fails to completely abolish this practice from the industry. In 2005, India took a proactive step and amended the Indian Patent Act to introduce, inter alia, to curb evergreening practices by statutorily prohibiting these practices.
Section 3(d) of India’s Patent Act states that the following are not inventions:
“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process results in a new product or employs at least one reactant. Explanation - For the purpose of this clause, salts, esters, polymorphs, metabolites, pure form, particle size, isomers, and mixture of isomers, complexes, combinations and other derivatives of known substances shall be considered to be same substance, unless they differ significantly in properties with regard to efficacy.”
Australian law also includes safeguards against evergreening, by introducing penalties for such activities in Section 26C and 26D of Australia Patent Act 1990 and a mechanism for damages to be paid to the government for proven evergreening practices.
Article 18.9.4 of the Republic of Korea-United States Free Trade Agreement (KORUSFTA) has been specifically drafted to permit the establishment of pharmaceutical patent “anti-evergreening” oversight agency.
To Conclude: The patent evergreening promotes development of unfair means of competition. Enhanced intellectual property scrutiny may remove the roadblock for generic drugs and thereby provide the masses with cost effective medicines. This will be required to bring balance between inventions and affordability. If we see the actions taken by a few countries, it leaves others with a ray of hope.
Will the patent rights be utilized in a proper way for the benefit of all or will only a minor part of population get benefits out of it?
By Lisa Pierchala, MPH, Manager, Biostatistics and Medical Writing
The 2012 Drug Information Association (DIA) Annual Meeting in Philadelphia is in the books, and I am very grateful to have had the opportunity to speak at a lecture session in the Medical Writing and Medical Communications track. The 90-minute session, titled, “Medical Writing Competencies and Best Practices in the Global Environment”, focused on specific, applied ways that medical writers can employ strategies for efficient drafting, review, and management of documents. From developing and effectively using style guides, managing stakeholders during document review, and functioning as a single point of contact across CROs, freelance medical writers, and sponsors, the session was well-received by attendees looking for information on best practices for medical writers. Even though the session was the last time slot on the last day of the meeting, a sizable crowd attended and was an attentive audience, providing excellent questions for me and my fellow panelists. One attendee even stated that our session was “the highlight of the DIA” for her (there are witnesses, I swear!).
This year’s DIA conference highlighted many hot topic areas for the pharmaceutical industry, including drug development in emerging markets, evolving strategies for evaluating benefit-risk, impacts of social media on product promotion and patient recruitment, and new guidelines in clinical trial disclosures. These informative presentations provided unique insights to the current thinking in the industry, as well as future directions for drug development. Many of the sessions I was able to attend presented multi-faceted perspectives on topics that were particularly relevant to me as a medical writer, but also topics that provided a wider understanding of many aspects of drug development, all which will ultimately enhance my skills as a medical writer and the quality of a sponsor’s deliverable. I was also able to share much of the knowledge gained from these presentations with my colleagues upon my return to keep all of us on the forefront of changes in the industry.
Overall, there were a wide variety of educational opportunities at this year’s DIA meeting. I hope that I was able to contribute a small piece to the larger, global conversation through my presentation. In case you missed it, we will be posting about many of the topics in my presentation in the upcoming weeks, so stay tuned!