Insights

Vol. 6: Sued for Patent Infringement? – Here’s How the Litigation would Unfold –

2025.11.01
Unlike the United States—a country known for its litigious culture – Japan sees relatively few patent lawsuits. However, the situation is somewhat different in the life sciences sector. In May of this year, a high-profile p… 黒澤伸行

Insights

Vol. 5: Do they really creep in? – Development schedules of Generics and Biosimilars

2025.09.30
This time, we are going to talk about generic drugs and biosimilars. These days in Japan we don't hear the word "zoro", but up until about 20 years ago, generic drugs were commonly referred to as "zoro." The word “zoro” stems … 黒澤伸行

Insights

Vol. 4: What do you mean “patents can be extended”? – Patent Term Extension: A special system for pharma–

2025.09.01
Last time, we discussed how to obtain a patent, following the process from application to obtaining a patent. I touched on the length of a patent term at the end. Do you remember how long a patent term was? The answer is 20… 黒澤伸行

Insights

Vol. 3: Shall we talk about how to obtain a patent? – Process flow from patent application to obtaining a patent –

2025.07.31
So far, we’ve explored the medicine classification and patents (Vol. 1), and the reasons why Medicines and Patents are inseparable (Vol. 2). In this volume, the spotlight fa… 黒澤伸行

Insights

Vol. 2: Wow! The success rate of drug development is shockingly low!

2025.07.01
In the previous volume, we discussed the types of pharmaceutical medicines and patents, so you will remember that “new drugs” are brand drugs under the category of ethical drugs… 黒澤伸行

Insights

Vol. 1: First, let’s talk about medicine classification and patents

2025.05.30
Most people understand that patents are important in the life sciences industry, including pharmaceuticals and biotechnology. However, many might feel that the complexities of patents make them difficult … 黒澤伸行

Cleaning Validation

7-Part Series: Part 6 – Calculating MAC in Cleaning Validation

2025.06.12
Hello everyone. In this article, we will discuss how to calculate the Maximum Allowable Carryover (MAC), which plays a critical role in cleaning validation in the pharmaceutical industr… 黒澤伸行

Cleaning Validation

7-Part Series: Part 5 – Evaluating Cleaning Effectiveness: The Role of Swab Recovery Rate Testing

2025.05.26
This time, we will discuss the feasibility testing of swab recovery rates for compounds. This test is designed to verify the recovery rate of Total Organic Carbon (TOC) analysis when dealing w… 黒澤伸行

Cleaning Validation

7-Part Series: Part 4 – A New Approach to Cleaning Validation: The Effectiveness of TOC

2025.05.12
Cleaning validation in the pharmaceutical industry plays a critical role in ensuring that manufacturing equipment is properly cleaned and free from residues before the next production batch. Ho... 黒澤伸行

Cleaning Validation

7-Part Series: Part 3 – Cost Comparison Between TOC Analyzers and HPLC in Cleaning Validation

2025.04.14
Cleaning validation is a critical process in the pharmaceutical industry. Various analytical methods are used to confirm that manufacturing equipment is properly cleaned. Among these methods, Tot… 黒澤伸行