Prolume Sues Companies for Infringement of GFP and Luciferase Gene Patents

With the Supreme Court about to weigh in on the controversial subject of gene patents, it bears noting that humans are not the only ones whose genes are patented. A company called  Prolume, located in Pinetop, Arizona, apparently owns a couple of gene patents claiming the DNA encoding green fluorescent proteins (GFPs) and luciferases from a variety of sea creatures of the genera Renilla, Gaussia and Pleuromamma (6,232,107 and 7,109,315).

Recently, Prolume filed a lawsuit in the Southern District of California against a multiple companies, including Gentarget, alleging infringement of the patents.  Prolume appears to have targeted these companies based on the description of products provided on the company websites. For example, the complaint states that "a search of the word ‘gaussia’ at www.gentarget.com reveals 14 products that incorporate Gaussia Luciferase.” 

The complaint notes that Prolume cannot determine from the Gentarget website which claims are being infringed without an analysis of the DNA sequence used in their products. However, Prolume infers infringement based upon the frequency of light that excites the protein, and that is emitted, as described in the company's product literature. Presumably Prolume will seek discovery to ascertain the DNA sequences used by the defendants in the production of their products.

My Amicus Brief in Bowman v. Monsanto

Over the last several days, I have posted a number of briefs that have been filed by various parties in Bowman v. Monsanto. Today I filed my own Amicus brief in the case, in support of affirmance, available here.

Here is my "Summary of Argument":

Intellectual property plays a critical role in the development of self-replicating technologies such as Monsanto's genetically modified soybeans. Without some mechanism to constrain the use and dissemination of replica products, free riders would quickly flood the market with copies and impair the innovator’s ability to secure an adequate return on investment. Because of the ease with which genetically modified soybeans can be replicated by any user who comes into possession of even a single seed, whatever the source, enforceable patent protection is essential to maintain an adequate incentive for innovation.

The potential impact of this case goes well beyond Monsanto and soybeans. A decision that results in the exhaustion of patent rights in copies of self-replicating products could dramatically undermine investment in a host of promising green technologies for sustainably feeding, fueling and healing the world. It might also discourage commercialization of synthetic biology, the much heralded next iteration of the biotechnology revolution.  Such a dramatic and far-reaching shift in the patent landscape is certainly not warranted, particularly on the facts of this case.

It is important to recognize that it is petitioner, not the Federal Circuit, who is seeking to create an exception to the doctrine of patent exhaustion.  In essence, petitioner is arguing for an expansion of the doctrine to encompass not only patented products that have been the subject of an authorized sale, but also copies of the product - copies that were never the subject of an authorized sale. Petitioner alleges that this drastic measure is warranted because the use of Monsanto’s product inherently and unavoidably results in the production of copies, citing numerous hypothetical policy concerns. But these potential concerns are not presented in this case, involving a farmer who intentionally used and benefitted from Monsanto’s patented technology without paying for it.  To the extent any of these concerns actually become an issue in the real world, they can and should be addressed in a manner that does not effectively deprive innovators of the ability to enforce their patents with respect to self-replicating technologies.

It is informative to consider how analogous concerns have been addressed with respect to another important self-replicating technology, computer software. Even though the use of many software programs inherently and unavoidably results in the production of a copy on the user's computer, which would technically constitute copyright infringement, it makes little sense for software companies to sue their customers for this sort of infringement. It is simply not a problem.  If the potential for an infringement lawsuit became a concern, the software company could address it by explicitly authorizing purchasers to make a copy of the software, at least to the extent that such copying is an essential step in using the software. In any event, to resolve any lingering concern, Congress took the step of amending the copyright statute to explicitly exempt authorized users of computer software from liability for producing a copy that is used solely as a necessary element of running the software.

Significantly, it has not been deemed necessary to expand copyright's first sale doctrine (copyright’s analog to the doctrine of patent exhaustion) in a manner that exhausts patent rights in copies of copyrighted software that are inherently created when the software is used. To do so would effectively strip software developers of meaningful copyright protection once a first round of copies has been sold and replicated. In the same way, and for much the same reasons, it is unnecessary to expand the doctrine of patent exhaustion with respect to self-replicating patented technologies like Monsanto's seeds. To the contrary, to do so would effectively deny enforceable patent protection to many self-replicating technologies.

Congress is in the position to weigh competing interests, and if necessary enact legislation to address any unique policy concerns presented by the interplay of intellectual property rights and self-replicating technologies.  It has done so with respect to computer software, and in a manner that does not deprive software producers of the ability to enforce their copyrights against free riders. It can do so with respect to patented self-replicating technologies as well. In fact, a bill is currently pending in Congress that would effectively create a compulsory license in patented seeds. Leaving aside the question of whether this would be the best approach, it illustrates that Congress is fully capable of addressing concerns expressed by petitioner and its amici without entirely stripping innovators like Monsanto of their patent rights.

 

Three Briefs Filed in Support of Affirmance in Bowman

Here are links to three Amicus briefs that have been filed in support of affirmance in Monsanto v. Bowman (other briefs filed in the case are provided in earlier posts to this blog)

The Intellectual Property Owners Association argues that "while patent exhaustion would have prevented Monsanto from restricting the distribution or use of [the original seeds that were the subject of an authorized sale by Monsanto], those original seeds were completely consumed (as intended) in the growing of the first crop. The commodity seeds that resulted from the first crop . . . constitute an entirely new manufacturer and, as such, are not subject to the doctrinal patent exhaustion." Their brief also points out that seeds are not the only technologies that would be negatively impacted if "making" is considered an exhausted "use," citing examples such as recombinant host cells used in the production of biological drugs, computer programs, and potentially "self-replicating" nanotechnology.

The New York Intellectual Property Law Association brief provides some background on conditional sales and contributory infringement, and argues that the exhaustion doctrine should not be extended beyond Quanta. The Association goes on to argue that Bowman violated valid and enforceable field of use restraints, and that each successive generation of a patented self-replicating biological material is a separate actionable "making" under 35 U.S.C. § 271(a) .

 
BayhDole25, Inc. describes itself as a nonprofit, nongovernmental organization with a mission of "educating for the powerful social and economic benefits that have continued to flow from technology transfer relating to agricultural biotechnology advances, both in the United States and in developing and developed countries around the world." BayhDole25 argues that that Bowman's activities "represent transactions intended to essentially 'launder' Respondents' Roundup Ready technology through the grain elevator,” and that there are substantial differences between the instant case and Quanta and other president supporting application of the exhaustion doctrine. The brief discusses "the historical social contract for technology transfer that has fueled growth in agricultural productivity and global development." BayhDole25 notes that Monsanto must be compensated for the use of this technology in order to support "long-term investment in new technologies for the continued vibrancy of US agricultural for biotechnology, where the private sector now provides the lion's share of R&D critical to continuing agricultural activity gains.”  They point out the importance of this technology as a means for meeting global challenges associated with population growth and climate change.

 

 

 

 

Briefs Filed by Monsanto and the Solicitor General in Bowman v. Monsanto

 

Last week, I posted briefs filed by petitioner Vernon Bowman and his amici in Bowman v. Monsanto. Today, I'm posting respondent Monsanto's brief, along with a brief filed by the US Solicitor General in support of affirmance (i.e., in support of Monsanto).

Monsanto argues that the first sale doctrine (i.e., patent exhaustion) is inapplicable to the soybeans grown by Bowman because they are second-generation seeds, and were not the subject of an authorized sale.  Monsanto further argues that if the Court were to accept petitioner's argument, it would result in utility patent owners receiving less protection than is provided under the Plant Patent Act and the Plant Variety Protection Act, which would be contrary to Congress's intent and Supreme Court precedent holding that utility patent owners receive greater protection than is provided under the PPA or PVPA. The brief concludes by explaining that contractual remedies alone are inadequate to encourage innovation in "readily replicable technologies," (a more accurate label than the one used by Bowman, i.e., "self-replicating technology").

The US Solicitor General argues that the authorized sale of one article embodying a patented invention (i.e., a patented seed) does not exhaust the patentees right to control the creation of other articles embodying the same invention (i.e., subsequent generations of that seed). The Solicitor General characterizes the Federal Circuit's Mallinkrodt line of cases applying a "conditional sale" doctrine as erroneous, but that this “do[es] not cast doubt on the correctness of the decision below.”

Briefs Filed by Petitioner and His Amici in Bowman v. Monsanto

In Bowman v. Monsanto, the Supreme Court will have the opportunity to address the extent to which the doctrine of patent exhaustion applies to progeny of patented recombinant seeds. For background on the case, see this previous post.

Here are links to briefs recently filed by petitioner Bowman and his amici, with some brief commentary:

Petitioner (Vernon Bowman) argues that an authorized sale of recombinant seeds exhausts patent rights in progeny seeds that were not themselves the subject of an authorized sale. He bases this argument on a theory that subsequent generations of seeds are "embodied” in the first-generation authorized seeds.  Bowman is apparently attempting to leverage the Supreme Court's questionable use of the term "embodies" with respect to method patents in Quanta.  He also argues that production of progeny seeds does not constitute "making" the seeds because the use of genetically modified seeds inherently results in the production of progeny seeds. Bowman contends that contract law provides adequate remedies to owners of patents on self-replicating technologies.

Center for Food Safety argues that extending patent exhaustion to progeny seeds will benefit farmers by curtailing Monsanto's patent enforcement actions targeting farmers. The Center also claims that extending the patent exhaustion doctrine in this way will benefit scientific research and innovation in agriculture, and lower the cost of farming. The Center further contends the Federal Circuit's decision is contrary to Quanta, and reiterates petitioner's argument that producing progeny seed constitutes use of the patented seed, not making it, and hence falls within the scope of patent exhaustion. The amici voice is concerned that farmers whose fields have been "contaminated” by Monsanto's patented seeds could be subject to infringement lawsuits.

The American Antitrust Institute argue that the Federal Circuit's decision is contrary to Supreme Court precedent, particularly Quanta, and departs from long-standing Congressional patent policy.  They warn that the Federal Circuit's decision "portends dangerous unintended consequences" for other industries, particularly the computer software industry. They suggest that Monsanto should learn from the software industry, and engage in "effective product differentiation and efficient third-degree price discrimination" in order to counter the threat posed by the ease with which their products can be replicated. They contend that Monsanto could have avoided its need to rely on patents by not working with soybean seeds and other inbred seed lines, and confining their activities to hybrid seeds (i.e., corn) that do not produce true copies of themselves. Somewhat surprisingly, the Institute suggests that Monsanto "could have developed its ‘terminator’ gene, which would have rendered progeny seeds sterile." “Terminator” is a pejorative term for Genetic Use Restriction Technology (GURT), highly controversial technology that Monsanto pledged not to use in 1999.

The Automotive Aftermarket Industry Association et al. are concerned that affirmance of the Federal Circuit's decision weakens the patent exhaustion doctrine. This brief was filed on behalf of companies that market automotive replacement parts and refurbished inkjet cartridges.

Knowledge Ecology International essentially argues that effective patent protection is not necessary for self-replicating genetically engineered crops, because "a plethora of alternative mechanisms to patent regimes exist to reward research and development."  For example, they argue that an inventor "can still protect his investment through contractual agreements governing post-sale uses” (while at the same time acknowledging that contract law would not have helped in this case, due to a lack of privity between Bowman and Monsanto).  The plethora of alternative mechanisms includes "sui generis systems of rewards or cash innovation inducement prizes," which KEI characterizes as "viable alternatives to the patent system."  They voice concern that "even plants exhibiting the genetically modified trait found in the wild as a result of cross-pollination, would fall under the patent rights the patent holder.)

The Public Patent Foundation expresses concern that under the Federal Circuit's ruling, "contaminated farmers are infringers," and "Monsanto's customers routinely make and sell new infringing articles." In a previous post, I discussed a lawsuit that the Public Patent Foundation has filed against Monsanto on behalf of a variety of groups including associations of organic farmers.

 

 

 

MIT Sues Shire Alleging that Dermagraft Infringes Cell-Scaffold Patents

On January 4, 2013, MIT sued Shire Pharmaceuticals in the District of Massachusetts for infringing US Patent Numbers 5,759,830; 5,770,417; and 5,770,193. The patents all issued in 1998, and are generally directed towards “three-dimensional fibrous scaffolds containing attached cells for producing vascularized tissue in vivo.”  For example, claim 1 of the ‘830 patent recites:

1. A cell-scaffold composition prepared in vitro for growing cells to produce functional vascularized organ tissue in vivo, comprising:

a fibrous three-dimensional scaffold composed of fibers of a biocompatible, biodegradable, synthetic polymer; and
cells derived from a vascularized tissue attached in vitro to the surface of the fibers of the scaffold uniformly throughout the scaffold;
wherein the fibers of the scaffold provide sufficient surface area to permit attachment in vitro of an amount of the cells effective to produce the functional vascularized organ tissue in vivo;
wherein the fibers of the scaffold are spaced apart such that the maximum distance over which diffusion of nutrients and gases must occur through a mass of cells attached to the fibers is between 100 and 300 microns; and
wherein the diffusion provides free exchange of nutrients, gases and waste to and from the cells uniformly attached to the fibers of the scaffold and proliferating throughout the scaffold in an amount effective to maintain cell viability throughout the scaffold in the absence of vascularization.

The allegedly infringing product is Dermagraft, a human fibroblast-derived dermal substitute approved by FDA in 2001 for use in treatment of full thickness diabetic foot ulcers. According to the complaint, Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue, which are seeded onto a bioabsorbable polyglactin three-dimensional mesh scaffold. MIT alleges that the fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrixproteins, growth factors,  and cytokines to create a three-dimensional human dermal substitute containing metabolically active,  living cells.