I was recently reading an article on Bloomberg about the expiration of the Lipitor patent and Pfizer’s new strategy of targeting mini blockbusters in the future. Some of the numbers were staggering. According to the article, nearly a fifth of the company’s revenue came from Lipitor, the world’s top selling medicine. With the product now off patent, the expectation, according to the article, is that sales will now drop by as much as 70% in its first year off of patent.
Lipitor is an example of how important the patent window is to the pharmaceutical manufacturer, and why the strategies to optimize that time window are so important. Businesses invest millions in research and development to bring pharmaceuticals to market. For the time that the drug is patented, the manufacturer has the opportunity to maximize its revenue while the clock ticks. Delays in production or manufacturing could delay getting the product to consumers and creating revenue. Given how drastic the drop in market share and price is when a patent expires, the manufacturer must have processes in place to ensure efficiency and quality.
Most pharmaceutical manufacturers have embraced lean and six sigma principals in production for just this reason. Only now are more and more businesses taking on the idea of lean in the lab environments.
The introduction of lean into the lab environment includes processes and improvements such as just in time ordering for lab supplies, creating workstations at lab benches, and kitting materials for QC tests. As important as process changes are, automation also plays a role in the lab, much like it does in manufacturing. Automation allows the QC lab to reduce turn around time on tests and maximize the value of the time of the QC personnel. Add to this the shortened time to result from rapid microbial detection, and the streamlined lab becomes integral to maximizing the patent window.