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Category Archives: Stem Cells

Monsanto Averts Declaratory Judgment Suit

Posted in Personalized Medicine; Stem Cells; Uncategorized

On June 10, 2013, the U.S. Court of Appeals for the Federal Circuit held that Monsanto’s representation that it would not pursue farmers and seed sellers for patent infringement if they inadvertently use Monsanto’s patented genetically modified seeds and plants is sufficient to deny a coalition of farmers, seed sellers and agricultural organizations the juristictional basis to challenge Monsanto’s patented seed technology. In Organic Seed Growers and Trade Ass’n. v. Monsanto Co.,  2012-1298 (Fed. Cir. 2013) (attached here), the Federal Circuit noted that Monsanto’s binding assurances to appellants that it would not take legal action against growers whose crops might inadvertently contain trace of Monsanto’s patented technology and appellants’ failure to allege any circumstances placing them beyond the scope of those assurances removed any risk of suit against appellants as users or sellers of trace amounts (less than one percent) of the patented technology. In reaching this conclusion, the Federal Circuit reaffirmed that de minimis use can still give rise to infringement liability and provides patentees a strategy to avoid patent challenges without a covenant not to sue.

Inadvertent Use of Self-Replicating Technologies

Appellants originally sought declaratory judgments of non-infringement and invalidity with respect to twenty-three patents owned by Monsanto Co. and Monsanto Technology, LLC (“Monsanto”) that cover Monsanto’s genetically modified seeds and plants that are resistant to the herbicide glyphosate, the active ingredient in Monsanto’s popular herbicide sold under the trade name Roundup. The appellants were joined in the suit by the Public Patent Foundation of the Benjamin N. Cardoza School of Law.

Monsanto sells the patented technology and licenses others to grow and sell seed under a limited-use license permitting licensees to plant, harvest and sell a single generation of the patented seeds. It was undisputed that Monsanto enforced its intellectual property. Between 1997 and 2010, Monsanto pursued over 800 claims for unauthorized use of its patented seeds.

The appellants did not want to use the patented seeds but were concerned that their crops and seeds would be contaminated with the patented seeds and that as a result, they would be sued by Monsanto for patent infringement. The appellants alleged that they their fear of suit prevented them from planting crops that may have become contaminated by Monsanto’s seeds. At one point, appellants asked Monsanto for a written covenant not to sue. Monsanto refused their request and directed appellants to its website wherein Monsanto noted that it would not exercise its patent rights where trace amounts of the patented seeds or traits are present in farmer’s fields as a result of inadvertent means. The district court ruled in favor of Monsanto who argued that the court had no jurisdiction because appellants lacked an essential element of standing – a live case or controversy.

Appellants’ Subjective Fear of Suit Is Not Enough

The Federal Circuit affirmed the district court’s holding that appellants had not demonstrated that their fear of suit does not rise to an actual controversy between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. The court noted that even though some of the appellants could be liable for infringement if they used or sold the patented seeds or plants (even very small quantities of the patented technology) Monsanto’s explicit representations not to take legal action against inadvertant use of the technology is essentially equivalent to a covenant not to sue. The appellants also failed to show that their possible use would fall outside the disclaimed minimal use.

Thus this case provides patentees a road map to avoid unwanted validity challenges from potential plaintiffs who may seek to invalidate patents that are unlikely to be asserted against them sans a covenant not to sue.

A Patent Landscape Analysis: iPSCs

Posted in Personalized Medicine; Stem Cells

There are several emerging technology clusters in the induced pluripotent stem cell (iPSC) space. Simon Elliot and I conducted a patent landscape analysis focusing on issued U.S. patents and pending applications. We found several geographical clusters and a trend in the development of the technology away from the use of genetic transforming factors. A brief report on our analysis was recently published on line - “Induced Pluripotent Stem Cells: A U.S. Patent Landscape Analysis.”

This report is interesting not only from a patent analyst’s perspective of tracking the evolution of IP in a particular technology, but also because it shows a clear evolution of the technology and processes for achieving the same result using different techniques.

 

Patent Exhaustion and Self-Replicating Technologies

Posted in Personalized Medicine; Stem Cells

Today in Bowman v. Monstanto Co., 569 U.S. __ (2013), a unanimous Supreme Court held that under the doctrine of patent exhaustion,the authorized sale of a patented article only gives the purchaser or any subsequent owner of the patented article the right to use or resell that article. It does not give the purchaser or any subsequent owner the right to make copies of the original article, even when the article being purchased inherently possesses the ability to make copies of itself. Continue reading this entry

U.S. Supreme Court Asked to Review Federal Funding of Human Embryonic Stem Cell Research

Posted in Stem Cells

On October 10, 2012, two pro-life groups petitioned the U.S. Supreme Court to review and reverse the U.S. Court of Appeals for the District of Columbia Circuit Court’s decision allowing the continued federal funding of research involving human embryonic stem cells (“hESCs”). A copy of the petition for certiorari is attached here and our review of the history of the case can be found in our prior posts of August 27, 2012 and July 28, 2011.Continue reading this entry

U.S. Supreme Court Agrees to Review Case That May Impact Patented Stem Cell Technologies

Posted in Stem Cells

On October 5, 2012, the U.S. Supreme Court agreed to review the issue of whether the Federal Circuit erred by (1) refusing to find patent exhaustion that eliminates the right to control or prohibit the use of an invention after an authorized sale in patented seeds sold for planting; and (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies. Bowman v. Monsanto Co., Docket No. 11-796 (Supreme Court 2012), proceedings below, Monsanto Co. v. Bowman, 657 F.3d 1341 (Fed. Cir. 2011).Continue reading this entry

Federal Stem Cell Funding Approved by Appellate Court

Posted in Stem Cells

Good news for patients and stem cell researchers alike. On August 24th, the United States Courts of Appeals for the District of Columbia Circuit affirmed the District of Columbia court decision granting the government’s motion for summary judgment allowing the continued funding of research involving human embryonic stem cells (“hESCs”). Sherley v. Sebelius, No. 11-5241, slip op. (D.C. Cir. August 24, 2012)(posted here). This is the most recent decision in the dispute between U.S. researchers in the field of adult stem cells, the Secretary of Health and Human Services, and the Director of the National Institutes of Health (NIH).

History of the Dispute

On March 9, 2009, President Barack Obama’s signed an Executive Order that overturned the previous administration’s policy banning the use of federal funds for research using embryonic stem cells created after August 9, 2001. (Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, Executive Order 13505, 74 Fed. Reg. 46, 10667 (March 11, 2009)). This action renewed the hope of scientists and supporters of research using embryonic stem cells that the increased availability of funding would make it easier to conduct such research in the United States.

Soon thereafter, a group of plaintiffs filed suit challenging the NIH’s authority to issue the 2009 NIH Guidelines that implemented President Obama’s 2009 Executive Order. Plaintiffs argued that legislation known as the Dickey Amendment or the Dickey-Wicker Amendment bans the use of federal funding to support research involving human embryos. Congress originally passed this legislation in 1996, and former President Clinton signed it into law. The Dickey Amendment prohibits the Department of Health and Human Services (HHS), which includes the NIH, from funding research where human embryos are destroyed. Congress has included the Dickey Amendment in every subsequent HHS appropriations bill without substantial alteration. In subsequent years, the rider was enacted in Title V (General Provisions) of the Labor, HHS, and Education Appropriations Act. 

The August 2012 Circuit Decision
 
Judge Sentelle wrote the panel’s opinion. Judges Henderson and Brown wrote separate concurring opinions. At its core, the 3-judge panel decision held that the 2009 Guidelines do not violate the Dickey Amendment because in deferring to the defendant’s interpretation of the Dickey Amendment, the research funded by the NIH did not include the banned destruction of human embryos. The judge also indicated that the NIH had authority to interpret the Dickey Amendment under a doctrine known as “Chevron” deference. Chevron U.S.A., Inc., v. Natural Resources Defense Counsel, Inc., 467 U.S. 837, 843 (1984). Under Chevron, a court must first ask whether Congress has directly spoken to the precise question at issue and if it has, a court must give effect to the unambiguously expressed Congressional intent. If however, such as the court determined here, the statute is silent or ambiguous with respect to the specific issue, then the court must defer to the agency’s (in this instance the NIH) interpretation provided it is based on a permissible construction of the statute. Under the NIH’s interpretation, Judge Sentelle noted, the Dickey Amendment permits federal funding of research projects that utilize already-derived hESCs – which are not themselves embryos – because no human embryo or embryos are destroyed in the funded projects.
 
Judge Henderson concurred but disagreed with Judge Sentelle that a Chevron review is applicable because Congress did not unambiguously delegate to the NIH the authority to interpret the Dickey Amendment. In addition, she wrote that the Dickey Amendment is not under the NIH’s area of expertise. Judge Henderson opined that the current panel, however, was bound to an earlier decision and therefore concurred with Judge Sentelle. Judge Brown agreed with Judge Henderson, but on the ground that the lower court’s holding did not rise to the level of clear error under which the district court’s decision could be vacated.
 
Looking Ahead
 
This decision moves judicial resolution one step closer to finality. Plaintiffs could seek rehearing en banc from the full Court of Appeals, based on the concurring opinions. A petition for certiorari could also be filed with the Supreme Court. In the meantime, federal funding of hESC research will continue to the end of providing potential cures for many unmet medical needs.
 

CIRM Pledges $40 Million to Support Stem Cell Genomics Centers

Posted in Bioinformatics; Biomarkers; Genomics; Stem Cells

The California Institute for Regenerative Medicine (CIRM) announced on January 17, 2012 that its governing board approved a $40 million initiative to fund one or two Stem Cell Genomics Centers of Excellence in California. CIRM was created by California’s Proposition 71, which authorized the state to issue $3 billion in grants over ten years to support biomedical research in support of regenerative medicine. Since its inception, CIRM has funded basic and translational research on all aspect of regenerative medicine. This is CIRM’s first targeted expansion into the study of the genetics of stem cell biology.

I spoke to Natalie DeWitt, Ph.D., Special Programs Officer of CIRM regarding the initiative and, in particular how the use of genomics will advance the goals of California’s initiative. Stem cells, she noted, are a good system for genetic studies because of the unique biology of the cells. For instance, stem cells can be differentiated to form specialized cell types useful for cell therapies and patient-specific disease modeling, e.g., with a particular type of stem cell – the iPS cell. Genomics technologies are important for understanding the molecular drivers of differentiation, and how genes interact with environmental conditions to produce disease states in specialized cell types. Genome characterization of cell lines destined for cell therapeutics will provide assurance that the cells are safe and do not have activated oncogenic pathways, or carry gene variants associated with disease.

Continue reading this entry