Showing posts with label amici. Show all posts
Showing posts with label amici. Show all posts
Monday, August 14, 2017
BIO and PhRMA File Amici Brief Urging En Banc Reconsideration of Ariosa v Sequenom
BIO and PhRMA File Amici Brief Urging En Banc Reconsideration of Ariosa v Sequenom
The Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have jointly filed an amici brief curiae brief urging the Federal Circuit to grant en banc rehearing of Ariosa v. Sequenom. The brief is available here. I am the counsel of record.
BIO and PhRMA are concerned that the development and commercialization of a range of biotechnology and pharmaceutical innovations will be impeded if the Federal Circuit does not address the mounting uncertainty currently afflicting patentable subject matter jurisprudence. The brief points out the critical importance of effective patent protection for biotechnology and pharmaceutical innovators, and the current unprecedented level of uncertainty with respect to the scope of patent eligible subject matter. This uncertainty is affecting both the patent user community and the PTO, which has responded with an ongoing stream of revised and re-revised non-final and interim guidance documents. With each new PTO Guidance, BIO members have observed an increasing rate of claim rejections, affecting a diverse range of biotechnology, including novel antibiotic molecules, industrial enzymes, diagnostic processes, and crop production products.
The unsettled state of the law has also created doubt as to whether issued patents will be able to withstand challenge. The brief points out that the vast majority of judicial decisions addressing patent eligibility under the recently articulated standards have resulted in a determination of ineligibility. For example, Appendix 3 of the recent PTO “July 2015 Update: Subject Matter Eligibility,” identifies 24 post-Mayo subject matter eligibility cases decided by the Federal Circuit, of which 22 held allof the challenged claims to be patent ineligible.
The brief urges the court to clarify the contours of both Step I and Step II of theMayo two-step test for patent eligibility. It posits that the Supreme Court would not have articulated a two-step test if it did not intend the first step to serve some meaningful gatekeeping function, but that under the standard applied by the panel it is difficult to see how any analytical or detection method would ever not satisfy Step I, so long as that method is designed to detect something that occurs naturally. With regard to Step II, the brief asks for clarification with regard to the proper application of the “inventive concept” and “preemption” standards of patent eligibility. As an example, the brief discusses the practical challenges facing the inventor of a new diagnostic test under the new patent eligibility jurisprudence.
In its recent decisions the Supreme Court apparently assumed the existence of limiting principles that would maintain patent eligibility for truly meritorious inventions (this was Judge Linn’s characterization of Sequenom’s claimed invention in his concurring opinion), even if that invention can be deconstructed into a combination of natural phenomena and conventional technology. The brief argues that en bancreconsideration would allow the Federal Circuit to address the nature of these limiting principles suggested in Mayo. Alternatively, if the court finds that Supreme Court precedent does not provide for limiting principles that provide a meaningful opportunity for patenting important biotechnology innovations, that would suggest a need for the Supreme Court to readdress the contours of patent eligibility in the context of biotechnology. Ariosa v. Sequenom would be an appropriate vehicle for alerting the Supreme Court to the urgent need for this clarification.
Available link for download
Wednesday, May 17, 2017
Briefs Filed by Petitioner and His Amici in Bowman v Monsanto
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 Courts 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 Monsantos 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 Circuits decision is contrary to Quanta, and reiterates petitioners 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 Monsantos patented seeds could be subject to infringement lawsuits.
The American Antitrust Institute argue that the Federal Circuits decision is contrary to Supreme Court precedent, particularly Quanta, and departs from long-standing Congressional patent policy. They warn that the Federal Circuits 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 Circuits 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 Circuits ruling, "contaminated farmers are infringers," and "Monsantos 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.
Available link for download
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