Greenblum & Bernstein, P.L.C.


Recent News in Intellectual Property


July 2015

In This Issue:

·    CRISPR and Patent “Interferences”

·    Kimble v. Marvel Entertainment

·    FDA Issues Final Biosimilars Guidance

·    Pharma and Biotech Industry Exceeded Expectations in 2014

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Walter Schlapkohl, Ph.D., Esq.

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CRISPR and Patent “Interferences”: “Old” Law and New Controversy

A potentially very big battle is brewing relating to intellectual property rights for the DNA-editing technology known as CRISPR. CRISPR (also known as “CRISPR-Cas” or CRISPR-Cas9”), allows scientists to modify DNA in an organism’s genome with ease and accuracy.  Industrial interest in CRISPR technology spans the food, agriculture, medical/health, and laboratory sectors, and companies with an interest in the technology for gene therapy applications alone have raised over $600 million in venture capital and public markets since 2013.

Dr. Feng Zhang, a scientist at the Broad Institute of Harvard and MIT, was the first to obtain a patent on the technique: U.S. Patent No. 8,697,359, issued on April 15, 2014.   Since then, nine additional patents relating to this technology have been granted to the Broad Institute and MIT.

However, in April the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier, a French microbiologist, requested that the U.S. Patent & Trademark Office (USPTO) reconsider the Broad Institute/MIT patents in view of an earlier-filed application, U.S. Patent Application No. 13/842,859. In particular, the parties requested that the USPTO declare an “interference” to determine who was first to invent the technology as claimed in the respective patents/patent application.  The CRISPER DNA-editing technology was described in a paper co-authored by Charpentier, Jennifer Doudna (a biologist at the University of California and a co-inventor of the claims in the ‘859 application) and others in the journal Science in 2012.

If the U.S. Patent & Trademark Office approves the request, the ensuing challenge is likely to be expensive and contentious.  Given the complexity of the technology, the possible number of patents involved, and the nature of such disputes, it may be years before the CRISPR IP landscape is fully settled.

Kimble et al. v. Marvel Entertainment, LLC

The Supreme Court continues to place its stamp on issues relating to patent and intellectual property.  In a decision issued on June 22, 2015, the Supreme Court affirmed the per se rule against accruing licensing royalties after a patent’s expiration.  Kimble, the owner of a patent on a toy that allows children to shoot simulation spiderwebs of foam (much like Spider-Man would), licensed his patent to Marvel.  The parties did not set an end date for royalties.  Later, Marvel sought a declaratory judgment in federal district court seeking confirming that under Brulotte v. Thys Co., 379 U.S. 29 (1964), which held that a patent owner cannot charge royalties for the use of his invention after the term of the patent has expired, Marvel could cease making royalty payments to Kimble upon the expiration of Kimble’s patent. Commentators and courts, including the court which heard the Kimble case below, have suggested that this per se rule is counterintuitive.  Kimble also argued that the per se rule against post-expiration royalties inhibits innovation and harms the national economy.  However, the Supreme Court was not persuaded and affirmed the so-called “Brulotte rule” against accruing licensing royalties after a patent’s expiration.

FDA Issues Finalized Guidance Regarding Biosimilars

In April the U.S. Food and Drug Administration (FDA) finalized three guidance documents first issued in 2010.  The first guidance document includes a set of questions and answers regarding implementation of the Biologics and Price Competition and Innovation Act of 2009 (BPCIA), and addresses issues relating to FDA interpretation of the BPCIA, including provisions on exclusivity, biosimilarity and interchangeability. The second guidance document provides information on quality considerations that stakeholders should take into account when applying for biosimilar approval.  This document indicates the need for use of analytical methodology that is adequately sensitive and specific to detect and characterize differences between the proposed product and the reference product.  The third guidance document is directed to scientific considerations in demonstrating biosimilarity to a reference product.  The guidance documents are available for download on FDA’s website via this link.

Pharma and Biotech Industry Exceeded Expectations in 2014

The pharma and biotech industry exceeded expectations in 2014 with a record-breaking $212 billion in merger & acquisition transactions according to the June 16, 2015, issue of “BIO Buzz”.  According to the same report, IPOs also fared well in 2014: 87 flotations for a combined raised amount of $6.3 billion.  These findings, originally published by EP Vantage (an editorial arm of the life science market intelligence firm Evaluate), also showed that the venture capital funding environment made improvements in 2014, up 33% over the year before.  The EP Vantage report also noted that FDA approved a surprising 50 new drugs in 2014, and that companies, bankers, and venture capitalists are continuing to show strong activity in 2015.