The Patent Portfolio Strategy Behind GR-MD-02

Posted on 17-03-2016 , by: Dr. Peter Traber , in , 0 Comments

By Peter G. Traber, M.D. on March 17, 2016

We often talk about how Galectin Therapeutics’ proprietary compound, GR-MD-02, is protected by a strong intellectual property portfolio. I thought it might be useful to drill a little more deeply into that statement.

Our patent portfolio is an important asset for Galectin Therapeutics, and it took hard and careful work to put it in place. Each patent/patent application is a strategic building block which reflects present and future business objectives and protects current core technology. The Galectin Therapeutics’ patent portfolio covers the products or composition of matter (i.e. active pharmaceutical ingredient or API), formulations of the products, use of the products and methods of manufacturing.

The most valuable patent in the Galectin Therapeutics’ portfolio is a composition of matter patent which covers the active pharmaceutical ingredient. Composition patents exclude others from making, using, selling or offering for sale the API. 

Patenting complex carbohydrates can be more challenging than for a small molecule

Galectin Therapeutics’ proprietary compound, GR-MD-02, is derived from the modification of a natural pectin. Pectins are widely used in the food industry as a thickening agent for making things such as jellies and jams. There are a substantial number of patents on using pectin in pharmaceutical applications. Galectin Therapeutics had to show that GR-MD-02 was novel and non-obvious, in view of the prior pectin art.

GR-MD-02 is a complex carbohydrate molecule. A small molecule with a small molecular weight (e.g. 300 Da) in comparison can have a very specific structure and the U.S. Patent and Trademark Office (USPTO) can then compare the molecule to a chemical database to assess if the compound is different than publically available compounds.

GR-MD-02 on the other hand, is a mixture of complex carbohydrates having an average molecular weight between 20,000 to 70,000 Da. These are big molecules. This means that Galectin Therapeutics had to take a slightly different approach to characterizing the molecule in its patent applications. GR-MD-02 can be defined by its physical and chemical properties such as the average molecular weight, the carbohydrate composition, the ratio of critical carbohydrates from one to the other, and a two-dimensional NMR to establish a “fingerprint” of the molecule. One of the most critical carbohydrates in GR-MD-02 is galactose, and GR-MD-02 can be characterized by the ratio between galactose and arabinose. GR-MD-02 can be characterized by its degree of methoxylation — or the amount of methyl groups on the backbone of the molecule. Galectin Therapeutics was awarded a composition of matter patent in the U.S. on GR-MD-02 (U.S. patent 8,871,925 entitled “Compositions of Novel Carbohydrate Drug for Treatment of Human Diseases.” The U.S. patent issued on October 28, 2014 and will expire in 2032.

Protecting not just the molecule but also its manufacture and its use

Beyond the composition of matter patent for GR-MD-02 stands a portfolio of other patents that strengthen Galectin Therapeutics’ patent portfolio. Galectin Therapeutics holds a process patent that covers the manufacture GR-MD-02 from the pectin (U.S. patent No. 8,962,824). Presumably, a similar process has to be used to manufacture a drug similar to GR-MD-02, and having the process patented adds a second layer of protection to the compound as well.

Galectin Therapeutics also has 5 different patent families that cover the methods of use. These support the various indications for GR-MD-02 that Galectin Therapeutics plans to test. Method of use patents exclude others for using the API in specific indications. Galectin Therapeutics has a method of use U.S. patent for NASH (U.S. patent No. 8,658,787). Galectin Therapeutics has a method of use patent for kidney disease, specifically diabetic nephropathy as well as other similar types of glomerulopathy that patients develop, not necessarily related to diabetes (U.S. patent No. 8,828,971). We also have a method of use patent application allowed for pulmonary fibrosis, as well as method of use U.S. patents covering liver fibrosis, kidney fibrosis and heart fibrosis.

Patents pending

Galectin Therapeutics has more than 50 patent applications pending. There are a number of method of use patents pending, in both cancer immunotherapy and other disease states. The method of use patents and applications strengthen the patent portfolio and protect Galectin Therapeutics for future business objectives.

Foreign patents

Galectin Therapeutics has filed for patent protection in 10 foreign countries which are viewed are significant market for the API or the manufacture of the API (Australia, Brazil, Canada, China, Europe, Israel, Japan, Korea, Mexico and South Africa).  The U.S. patent process generally moves more quickly than the rest of the world and issuance of patents in the U.S. can be helpful to expedite prosecution in foreign countries.

These “CEO Perspectives” are a regular feature of our communication activities and may contain forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements relate to future events and use words such as “may,” “might,” “could,” “expect” and others. These statements include those regarding the hope that Galectin Therapeutic’ s development program for GR-MD-02 will show that it can be both safe and effective when used in combination with other drugs for the treatment of patients with cancer. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

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