NAIP Patent Blog

By HsinHao Tsai, NAIP Engineering Research

"Duplicity" was finally released in Taiwan cinemas in June. I was rather excited to see this film not just because of the chemistry between lead actors Julia Roberts and Clive Owen, but also because it dealt with the subject of industrial espionage.

In the film, industrial espionage is portrayed in a standard Hollywood manner. Ex-government agents Claire Sternwick (Julia Roberts) and Ray Koval (Clive Owen) are spies for competing corporations who—surprise!—fall in love while on the job(s). As we watch the story unfold in non-linear fashion, we learn about the perils of trust, try to detangle duplicitous dialogues and ponder over mysterious meetings. Eventually, we learn Claire and Ray plan to double-cross both their employers by taking a copy of a secret, patentable compound to yet another corporation. The result you'll have to see for yourself.

But no matter how exciting, entertaining and dizzyingly complex the film industry makes it, industrial espionage, in the real world, no longer requires as much thrilling undercover effort.

In this post-Information era, we have email BCCs and address typos to give us access to sensitive internal correspondence. Google cache regularly makes encrypted documents accessible. Employees on Facebook and Twitter reveal a company's latest moves or projects. The distance between business rivals is now only one click short.

Today, however, the tool of industrial espionage is a familiar one: the patent system.

The patent system has been leveraged and exploited into creating higher degrees of openness and transparency about an invention that the applicant may desire. This is because as inventions become more intricate and involve ever-expanding, cross-organizational research teams, businesses and employees struggle to define, enforce and adhere to suitable codes of conduct regarding information disclosure. The patent system, conceptual rules implemented onto real-world business practices, is intended to protect IP rights while allowing the technology to be shared with society. But as with any system loopholes exist, and an undesired openness may sneak in the sanctuary of patent protection—a situation that the Max Planck Institute (Max Planck) knows all too well.

On June 26, 2009, a complaint¹ related to two series of RNAi technologies², Tuschl I and Tuschl II inventions, was filed in Suffolk Country Superior Court in Boston, U.S. by Max Planck against Whitehead Institute for Medical Research (Whitehead). At the centre of the various issues raised in the complaint is the deliberate expansion of the scope of Tuschl I series, which allegedly incorporates the scope of its half-brother, Tuschl II series³.

That Tuschl I and Tuschl II inventions share similar or even some common features is not strange, since both were developed under the continuing diligent work led by Dr. Thomas Tuschl. However regardless of the similarities in content or inventors, these two groups of inventions were filed, and are owned and managed by two different sets of governing bodies. To allow easier management of these patents, the scope of the subject matters in these patents ideally should be clearly distinguished.

This complaint leads us to wonder how exactly these crucial elements of the Tuschl II inventions made their way into the Tuschl I inventions. Was it the deliberate breach of confidentiality by the patent practitioners (perhaps per instruction from the owner/applicant)? Could it be that Dr. Tuschl and his colleagues innocently shared too much of their comprehensive scientific insight when addressing the one family of inventions? Or is it simply a case of the patent specialist not understanding the technical subtleties of one thriving new RNAi advance from another?⁴

Conspiracy theorists may want to pay particular attention to this announcement that states the Tuschl I patent applications, being managed by co-owner Whitehead, has only recently received signs of maturation into a patent for Europe (but nowhere else in the world, except in Australia and New Zealand). In contrast, the later-filed Tuschl II inventions, as managed by Max Planck, have been granted various patents in vital regions including the U.S. and Europe.

	Tuschl I	Tuschl II
PCT Filing	PCT/US01/10188 on Mar 30, 2001	PCT/EP01/13968 on Nov. 29, 2001
Inventors	Tuschl Thomas [DE]; Sharp Phillip A [US]; Zamore Phillip D [US]; Bartel David P [US]	Thomas Tuschl [DE]; Sayda Elbashir [DE]; Winfried Lendeckel [DE]
Owner(s)	WHITEHEAD BIOMEDICAL INST [US]; MAX PLANCK GESELLSCHAFT [DE]; MASSACHUSETTS INST TECHNOLOGY [US]; UNIV MASSACHUSETTS MEDICAL [US]	MAX PLANCK GESELLSCHAFT [DE]
Countries granting the inventions	Australia, Europe (Intention to grant), New Zealand	Australia, Europe, Japan, US
Gist of the applications	Identification, production and use of small 21-23nt dsRNAs. Experimental data results largely from Drosophila embryo lysate	Properties and pharmaceutical applications of synthetic dsRNAs duplexes with 3' overhangs. Data results from Drosophila as well as mammalian cells.

What spices up the RNAi story even further is the fact that the owners of both Tuschl inventions had previously drawn up two agreements to ensure each party would legally enjoy its fair share of any benefits resulting from the Tuschl I and Tuschl II inventions.

Max Planck, Whitehead, Massachusetts Institute of Technology (MIT) and University of Massachusetts (UMass), who jointly claim the ownership of Tuschl I inventions, first set up an "Old Agreement" in late 2001 to delineate the rights and responsibilities on Tuschl I and II inventions for research purposes. Two years later, Max Planck, Whitehead and MIT drew up another agreement—one in which UMass declined to participate—for Tusch I and II inventions with respect to their therapeutic uses. This seeded Max Planck's concern that, should the Tuschl I inventions successfully broaden their claim scope, the Tuschl II subject matter would essentially be available through licensing from UMass.

	"Old" Agreement	"Therapeutic Use" Agreement
Scope of Agreement:	Research Use for Tuschl I & II	Therapeutic Use for Tushcl I & II
Signed by:	MIT, Whitehead, Max Planck, UMass	MIT, Whitehead, Max Planck
Tuschl I Licensing Managed by:	MIT	Max Planck
Tuschl II Licensing Managed by:	MIT	Max Planck
Patent Prosecution Managed by:	Whitehead for Tuschl I; Max Planck for Tuschl II
By not signing the Therapeutic Use agreement, UMass (as a listed owner of the Tuschl I patents) can choose to individually assign licensing rights for the Tuschl I series.

No comment has been provided by any of the officials at MIT, Whitehead or UMass. Max Planck and the Tuschl II licensee also stated in a press release, that they will not provide specific details on this matter during active litigation.

Despite their silent treatment, the ramifications of this suit will continue to be heard by many industries in years to come. Previously, large research institutions tended to settle before taking legal action. This rare, complex lawsuit may alarm researchers from open-minded collaboration and stir up more concerns and regulations on research funding and cross-institutional collaboration. Internal confidential information has now become a new platform on which to meddle with the breadth of patent applications. The management of intellectual properties in this internal, "domestic" sense is clearly as important (if not more than) as strategizing against external "foreign" competitors.

Another very interesting aspect to this lawsuit is the possibility of it creating a new door to patent litigation, wedged open by commercial laws governing contractual agreements. Since the core issues arose from the allegedly intentional juxtaposition of Tuschl I and II inventions, the scope of the inventions need to be interpreted for any fair judgment on any disputed matter even before the actual issuance of a Tuschl I patent in the US. This is in stark contrast from usual circumstances where the effective scope of an invention is determined under a granted set of claims. Max Planck (and joined by Tuschl II licensee, Alnylam Pharmaceuticals) are in a way asking for compensation from car insurance prior to actually buying a clearly drafted insurance policy.

As this real-life court drama for RNAi continues to unfold, we may not have juicy performances by researcher-equivalents of Julia Roberts and Clive Owen, but we will gradually learn more of how businesses have leveraged the patent system to elevate industrial espionage into a new art. For now, we can only accept the fact that increasing transparency is becoming an unavoidable part of business. And to protect ourselves in this open, transparent environment, we must be at once specific and ambiguous, both forthright and discreet—that is, skilled in the art of duplicity.

For now, it is hard to say who is going to leave the court empty-handed, if not severely damaged in financial terms. However, I do remember in the film "Duplicity," the upper hand eventually goes to the one most skilled in the game of espionage, who picked up on the unmistakable evidence of a relationship between the film’s two major players. Unfortunately, whether the winner goes to the plaintiffs or the defendants, it is very likely in these patent rights disputes, the general public will end up joining Claire and Ray, sitting in the glorious foyer of the exhibition hall of modern medicines, in total loss, without even a glass of complimentary champagne.

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Notes

¹In the complaint, Max Planck Institute and its technology-transfer arm, Max Plank Innovation GmBH, together with Alnylam Pharmaceutical, the semi-exclusive licensee of the Inventions in suit, have sued three American research institutions, Whitehead Institute for Biomedical Research, the Massachusetts Institute of Technology and the University of Massachusetts for breach of contract, breach of fiduciary duty, and misappropriation of and damage to two groups of RNAi inventions.


²RNAi is short for RNA interference and refers to short double-stranded ribonucleic acids (dsRNA) which are 21-23 nucleotides in length. RNAi is a natural mechanism of gene silencing—that is, an ability to effectively turn off specific genes in vivo. Many envision RNAi as one of the most promising in treating diseases caused by upregulated genes.


³The Tuschl I inventions are directed to general RNAi methods covering the identification and use of small 21-23nt dsRNAs. This series of inventions is jointly owned by Max Planck, Whitehead, MIT and UMass. On the other hand, the Tuschl II inventions, which have been assigned solely to Max Planck Institute, claim the use and properties of synthetic dsRNAs duplexes with three prime overhangs (that is, unpaired nucleotides sticking out at the 3'end of a dsRNA molecule) for RNAi in human cells.

⁴Max Planck states in the complaint that "they have repeatedly informed Whitehead on the impermissible expansion of the scope of Tuschl I inventions, but Whitehead has failed, and affirmatively refused, to remove the Tuschl II inventions from the Tuschl I patent applications.” In this regard, Max Planck has subsequently filed another complaint suing the Whitehead-assigned attorney for malpractice.

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