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Introductory Knowledge of Intellectual Property in Life Sciences – The Essential Relationship Between Medicines and Patents

Vol. 7: Wait what? You can squash a patent? – How to Defeat Patents That Block Advances in Life Science Business-

2025.11.30
Last time, we discussed patent litigation. The most powerful counteraction when accused of patent infringement is to “squash the patent” — that is, to invalidate it. If the patent can be invalidated, the rights that … 黒澤伸行

青色の細胞が多数浮遊している様子を表した3Dイメージ画像。顕微鏡観察をモデル化した細胞構造のレンダリング

Part 1 The “Analyzing Life’s Mysteries” Project Was Born from Analytical Instrument Development

2025.11.17
This series is based on a manuscript I had the honor of writing for the Journal of the Society for Biotechnology, Japan, “Continuation of the Fundamentals of Biotechnology Lecture Series/Miscel… 黒澤伸行

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

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

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

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

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

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

Operator performing a swab sampling on stainless steel equipment and checking TOC analyzer readings as part of MAC (Maximum Allowable Carryover) calculation in 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

Evaluating Cleaning Effectiveness in Pharmaceutical Manufacturing

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

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Vol. 7: Wait what? You can squash a patent? – How to Defeat Patents That Block Advances in Life Science Business-

Part 1 The “Analyzing Life’s Mysteries” Project Was Born from Analytical Instrument Development

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

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

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

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

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

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

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

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

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Vol. 7: Wait what? You can squash a patent? – How to Defeat Patents That Block Advances in Life Science Business-

Part 1 The “Analyzing Life’s Mysteries” Project Was Born from Analytical Instrument Development

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

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

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

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

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

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

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

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

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