Max-Planck-Gesellschaft Zur Förderung Der Wissenschaften E v. v. Whitehead Institute for Biomedical Research

650 F. Supp. 2d 114, 2009 U.S. Dist. LEXIS 78518, 2009 WL 2777031
CourtDistrict Court, D. Massachusetts
DecidedSeptember 1, 2009
DocketCivil Action 09-11116-PBS
StatusPublished
Cited by7 cases

This text of 650 F. Supp. 2d 114 (Max-Planck-Gesellschaft Zur Förderung Der Wissenschaften E v. v. Whitehead Institute for Biomedical Research) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Max-Planck-Gesellschaft Zur Förderung Der Wissenschaften E v. v. Whitehead Institute for Biomedical Research, 650 F. Supp. 2d 114, 2009 U.S. Dist. LEXIS 78518, 2009 WL 2777031 (D. Mass. 2009).

Opinion

MEMORANDUM AND ORDER

SARIS, District Judge.

I. INTRODUCTION

This dispute is about a process called “RNA interference” that can be used to “silence” genes and has potentially huge therapeutic value. Plaintiffs are Max-Planck Society for the Advancement of Science, a non-profit academic research institution located in Germany 1 and Alnylam Pharmaceuticals, Inc., a Delaware corporation with a principal place of business in Cambridge, Massachusetts. They claim that the defendants Whitehead Institute for Biomedical Research (“Whitehead”), Massachusetts Institute of Technology (“MIT”) and the Board of Trustees of the University of Massachusetts (“UMass”) misappropriated an invention owned by Max-Planck. 2

Among other things, plaintiffs allege that defendants have filed a patent application (the so-called Tuschl I patent application) with the United States Patent and Trademark Office (“USPTO”) that contains plaintiffs’ invention, which is itself the subject of another pending patent application (the so-called Tuschl II patent application). Plaintiffs seek a preliminary injunction pursuant to Fed.R.Civ.P. 65 enjoining defendants from prosecuting the Tuschl I patent applications and from paying the issuance fee in the event that the USPTO issues a notice of allowance.

After hearing and a review of the voluminous submissions, the Court DENIES the request for preliminary relief on the ground that plaintiffs have not shown a substantial likelihood of success on the merits.

II. BACKGROUND FACTS

The record contains evidence of the following facts, which are undisputed except where noted.

A. A Primer on RNA Interference

The parties provided a tutorial to explain the scientific background of RNA interference: genes in a cell are regions of DNA that hold codes for directing the synthesis of proteins. DNA is a double-stranded structure: two chains, oriented in opposite directions, which are bound together. When a gene is active, it is transcribed into a single stranded chain called messenger RNA (“mRNA”). The code contained in the mRNA is then translated into a protein. The chains of DNA and mRNA are composed of nucleotides. One end of these DNA and RNA strands is referred to as the 3-prime (3') end, and the other is referred to as the 5-prime (5') end.

*117 RNA interference, RNAi, is a process in which a double-stranded RNA (dsRNA) is used to silence a specific gene in a cell by directing the destruction of mRNA produced by that gene before it is translated into a protein. The process works because when a dsRNA molecule is introduced into a normal cell, the cell will recognize it as abnormal or foreign to the cell because mRNA is ordinarily composed of a single chain. As a result, the cell will direct the destruction of the dsRNA and all other RNA in the cell.

B. The First Patent Application— Tuschl I

Dr. Thomas Tuschl, Ph.D., is the first named inventor for the Tuschl I patent application. (Tuschl Aff. [Docket No. 51] ¶ 3.) He is currently an Associate Professor and the head of the Laboratory of RNA Molecular Biology at the Rockefeller University in New York. (Id. ¶ 1.) He is also the co-founder of plaintiff Alnylam. (Id.) His co-inventors on the Tuschl I patent are Philip Sharp of MIT, David Bartel of Whitehead, and Philip Zamore. (Id. ¶ 3.) Tuschl and Zamore were post-doctoral fellows at Whitehead. (Id. ¶ 10.) Their work involved a system for studying the process of RNAi in a test tube using the contents from inside certain cells of the fruit fly, Drosophila. (Id.) They discovered that introducing long dsRNA into their Drosophila system led to RNAi. (Id.) The inventors also determined that during the process, the dsRNA inserted into the cell was breaking into 21-23 nucleotide fragments. (Id. ¶ 12.) These fragments turned out to be capable of initiating RNAi. (Id.)

Because an article describing their work was scheduled to appear in the scientific journal Cell, on March 31, 2000, Whitehead decided to file the first Tuschl I provisional 3 patent application (“the '594 application”) in the USPTO. (Id. ¶ 13.) The application was assigned to Whitehead, MIT, UMass and Max-Planck. (Granahan Aff. [Docket No. 36] ¶ 5.) It claimed “Isolated RNA of from about 21 to about 23 nucleotides which mediates RNA interference.” (Haberny Aff. [Docket No. 15] Ex. A at 41.)

C. The Second Patent Application— Tuschl II

In late 1999, Dr. Zamore and Dr. Tuschl left WTiitehead to become independent investigators in their own laboratories. (Tuschl Aff. ¶ 16.) Dr. Tuschl started his laboratory at Max-Planck and hired the two other Tuschl II inventors Sayda Elbashir and Winfried Lendeckel. (Id. ¶¶ 3, 16.) These inventors assert that they were the first to invent a synthetic dsRNA molecule with features that allow it to perform RNAi in mammalian cells — as opposed to fruit flies. (Id. ¶ 38.) In plaintiffs’ view, this was “groundbreaking” “because it opens the door for using RNAi technology as a human therapeutic agent.” (Id.)

In the fall of 2000, the Tuschl II inventors discovered a particular species of short RNA molecules, specifically, double-stranded molecules with a 1-3 nucleotide “overhang” on the 3' ends of the dsRNA strands. (Id. ¶ 24.) On October 25, 2000 they submitted the discovery to the scientific journal, Genes & Development, which published it in January 2001. (Id.) On *118 December 1, 2000, Max-Planck filed a patent application (“the '325 application”) in the European Patent Office (“EPO”). (Id. ¶25.) It claimed an “[ijsolated double-stranded RNA molecule, wherein each RNA strand has a length from 19-23 nucleotides, wherein said RNA molecule is capable of target-specific nucleic acid modifications.” (Granahan Aff. ¶ 11.) The '325 application is directed to the isolated, synthetic 21-23 nucleotide strands of RNA having at least one 3' overhang, which had been demonstrated to produce RNAi. (Tuschl Aff. ¶ 26.) Whitehead asserts that it did not know Max-Planck was filing this patent application with the EPO. (Mullins Aff. [Docket No. 34] ¶ 9.)

Shortly thereafter, the inventors learned that the synthetically produced, 21-nucleo-tide strands of RNA with 3' overhangs could cause RNAi in mammals. (Tuschl Aff. ¶27.) The data was subsequently published by the Tuschl II inventors in a May 2001 article in Nature entitled “Duplexes of 21-Nucleotide RNAs Mediate RNA Interference in Cultured Mammalian Cells.” (/¿¶28.)

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650 F. Supp. 2d 114, 2009 U.S. Dist. LEXIS 78518, 2009 WL 2777031, Counsel Stack Legal Research, https://law.counselstack.com/opinion/max-planck-gesellschaft-zur-forderung-der-wissenschaften-e-v-v-whitehead-mad-2009.