API and IP Newsletter
Contents
FDA approvals in May 2021.
General information.
Lonza bags three deals in one week.
Here’s how pharma companies can leverage digital to market better.
Intellectual Property.
Degarelix claims construction.
FDA approvals in May 2021
Every month we follow approvals by USFDA and comment about processes followed to manufactured small molecule APIs.
In one of the earlier weeks, we covered process chemistry details of Infigratinib. This week, let us understand chemistry of Samidorphan.
WO2006052710A1, relates to the compound Samidorphan, where example 1 and sample 3 describes Samidorphan.
Example 1 -Synthesis of 3-Carboxyamido-4-hvdroxy-naltrexone derivative 3
(A) Synthesis of 3-Carboxyamido-naltrexone 2
Naltrexone (starting material for Samidorphan) was first made in 1965 and was approved for medical use in the United States in 1984.
There are not many Indian companies who are active in Naltroxone. Sun Pharma has filed a DMF and Intas and Mylan, major importers of Naltroxone, could develop Samidorphan.
General information
Lonza bags three deals in one week
Lonza will develop an immunotherapeutic drug candidate for SelectImmune, an antibody for ValenzaBio and extends its collaboration with Pinteon. All in a week’s work for the Swiss CDMO
Here’s how pharma companies can leverage digital to market better
Digital adoption across industries has transformed the way companies function and is continuing to do the same. Similarly, the sweeping digital wave is revolutionizing the US$ 42 billion pharmaceutical industry in India for better pharma marketing, improved reach, production, and development. Though the pharma industry is the late adopter of digital technologies, pharma brand managers are running hard to keep pace with the digital revolution. (Read more)
Intellectual Property
Degarelix claim construction
Degarelix: Used for treatment of prostate cancer. There are several patents listed in OB
Patentee: Ferring Pharmaceuticals and Polypeptide
ANDA filer: Fresenius Kabi USA, LLC.
The matter before the Court was ‘claim construction’. The ultimate question of the proper construction of the patent is a question of law. Below are the general rules applied by the Courts in claim construction.
1. The words of a claim are generally given in their ordinary and customary meaning.
2. The ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent.
3. The patent specification is considered highly relevant to the claim construction analysis. It is possible that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess.
4. The claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope.
5. In addition to the specification, a court would consider the patent’s prosecution history (intrinsic evidence). The prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention during prosecution, making the claim scope narrower than it would otherwise be.
6. In some cases, courts see beyond the patent’s intrinsic evidence and consults extrinsic evidence in order to understand meaning of claim terms, for example, the background science or the meaning of a term in the relevant art during the relevant time period etc.
Applying these general rules, the Court decided, “terms” in OB listed Degarelix patents would have following meaning
1. “prostate cancer” means “any cancer of the prostate gland in which cells of the prostate mutate and begin to multiply out of control” (’359 Patent claim 1; ’739 Patent claim. 1, 14, 27; ’085 Patent claim. 1; ’398 Patent claim. 1, 8);
2. “monthly” means “about once every 28 days” (’359 Patent claim. 2; ’739 Patent claim. 2, 15, 28; ’085 Patent claim. 3, 5, 9; ’398 Patent claim. 3, 5);
3. “IUIL” means “IU/L” (’081 Patent claim. 16–18); and
4. “having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP” means “having a S-ALP level above 147 IU/L” (’999 Patent claim. 1, 12–15, 17, 24).
Decision is here.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
