July 31, 2012
In a major development over how genetic testing is to be regulated, a leading personalized genomics company is seeking FDA review for some of its direct to consumer (DTC) genetic tests. 23andme offers genetic testing services directly to its consumers by having them send a saliva sample in a kit to the company for DNA testing, and then receive an analysis of various genetic permuations which may have relevance for diseases or benign traits. There is no medical intermediary between consumer and company. In an announcement on its blog, 23andme stated that it has filed documentation for what is known as 510(k) premarket notification to receive clearance for some of its genetic services. This refers to a review by the FDA of a proposed medical device for similarity to existing devices, or for affirmation that the device does not require any premarket approval and may be marketed. The field of DTC genetic testing has met with official criticism from a number of sources in recent years (see here for background on regulatory conflicts). The Secretary's Advisory Committee on Genetics, Health and Society issued a report in 2010 which found many irregularities in the field, and warned of the dangers to medical consumers who are directly receiviing genetic information that has little reliability and may be making medical decisions based on what they learn.The FDA sent warning letters to a number of genetic testing companies in 2010, including 23andme, advising them that their genetic services, although direct to consumer, met the classification of a device that required FDA approval as medical devices. A Government Accountability Office report and investigation in 2010 found that several companies provided inconsistent results to undercover consumers, and that the information provided also did not line up with the consumer’s actual clinical status. Another watchdog at the federal level is the Federal Trade Commission, charged with general consumer protection, that has alerted consumers to the possibility that the services offered by these DTC companies are not reliable and consumers may be deceived by marketing claims. However, it is this pending review by the FDA that will have the most impact on the DTC field, partly from the results of the FDA review, but also because of the paradigm shift for the industry that the action by 23andme portends. The industry has long argued that its services were simply laboratory-derived tests (LDTs) that did not require formal review as devices, but simply had to meet the CLIA standards for clinical laboratories. This submission acknowledges the significant demand for FDA involvement in the field of DTC genetic testing, for which it has jurisdiction, but has largely avoided.
July 30, 2012
There are new legal developments regarding the collection of DNA evidence from those arrested, but not convicted, of crimes. As has been reported here, the expansive trend in the use of DNA evidence by the states has been to require those arrested for crimes to submit a DNA sample for inclusion in the state database. The crimes for which arrestees must provide samples vary by state, but at a minimum include many violent crimes. Recent court cases brought by those affected have made their way in the courts, with plaintiffs alleging a violation of their 4th Amendment rights against unreasonable search and seizure by characterizing the collection of DNA as violative of their privacy interests. In Haskell v. Harris, issued in February, the 9th Circuit upheld California’s DNA collection law which includes arrestees (see here). However, this week, the 9th Circuit set aside that ruling, and a full panel of the court will review the case. A contrary holding was issued by the Maryland Court of Appeals in King v. Maryland, where the court ruled that the practice was unconstitutional (see here). This week, the Supreme Court issued an order that granted Maryland’s request for a stay of the judgment pending its petition for certiorari (thus restarting its collection of DNA from arrestees). In granting the stay, Chief Justice Roberts noted that the Court was likely to grant the petition and that the decision faced a strong possibility of reversal. The order noted the conflicting opinions from the 3rd and 9th Circuits (although the Supreme Court had not granted cert for the 9th Circuit case) as backdrop for the likely reversal (but now the developments at the 9th Circuit indicate some instability there). The Court also seems to telegraph that it will disfavor the prospect of disparate collection practices among the states, partly because it undermines the cohesion of the national DNA database (CODIS). This does clash with state prerogatives to set the parameters for their criminal justice systems (within constitutional limits). However, the order this week seems likely to signal that the Court may endorse DNA collection from arrestees (as the courts have generally upheld DNA collection from parolees and inmates), with a likely reasoning that the privacy interest advanced by the plaintiffs does not outweigh a compelling government interest in the prosecution and deterrence of crime that expanded DNA collection practices provide.
Labels: DNA Evidence
July 29, 2012
In a case with ramifications for the emerging field of stem cell medicine, a federal district court has ruled that a stem cell preparation offered by a Colorado stem cell clinic met the classification of both a “drug” or “biological product” - and therefore subject to federal regulation by the FDA. The case posed the general issue of when a biotechnology-related procedure was no more than the practice of medicine – state and professionally-regulated – or whether the use of a novel biotech product (the stem cell preparation) triggers federal drug regulation as enforced by the FDA. In U.S. v. Regenerative Sciences (D.D.C. 2012), the FDA asked a court to order the company to stop performing the Regenexx stem cell treatment it offered to patients suffering from a number of musculoskeletal conditions, because it involved the use of an unapproved drug (stem cells). The procedure involved withdrawing bone marrow from a patient, extracting mesenchymal stem cells from the patient, and processing the cells to create a therapeutic preparation for injection to a site of interest, with a goal of restoring function to impaired joints. This is an “autologous” stem cell treatment – the patient’s own cells are used; immune rejection should be avoided. The FDA argued that the stem cell preparation used by Regenerative became a ‘drug”– subject to existing federal regulation by the FDA under the Federal Food Drug and Cosmetic Act (FDCA). The judge found that the interstate commerce requirements to invoke federal jurisdiction were met, as the stem cell preparation included an antibiotic that had been procured out of state. The judge rejected the argument of Regenerative that the procedures used to product the stem cell preparation constituted “minimal manipulation.” In contrast, the judge recited the techniques used to take the harvested cells from the patient and distill it down to the stem cell population, and regarded them as extensive enough to support the FDA’s argument that the stem cells met the “drug” classification. In addition, the judge also reviewed several FDA inspections of the facility which revealed a failure to comply with good manufacturing practices (GMP); such deficiencies supported the FDA’s further assertion that the Regenexx product was “adulterated.” Two definitional questions were posed in the case – were the stem cells a drug, regulated under the FDCA, and/or were the stem cells a biological product regulated under the Public Health Services Act (PHSA)? In both cases, the answer was yes. The stem cells performed as an “article” intended to impact patient health, and are also a biologically-derived product, subject to the separate requirements that such products must meet. Because the company had not sought FDA approval to use this product, the FDA sought a permanent injunction to stop Regenerative from offering the stem cell procedures, and it was granted. The company intends to appeal. This case provides a foundation for the FDA to assert its jurisdiction over many such clinics in the U.S. which are providing such services, using the FDCA. The FDA has been stepping up its oversight and investigations of stem cell clinics in the U.S., including the issuing of a 2012 critical report on Celltex, a Texas based stem cell clinic (where Gov. Rick Perry received treatment); the FDA found numerous manufacturing deficiencies that undermined the legitimacy of the claims made for its stem cell products. With this new ruling in hand, the FDA can now use the FDCA to target stem cell clinics where the treatment involves more than a “minimal manipulation” of biological materials – and it remains to be seen whether any of the treatments that use a patient’s own cells will meet that standard and escape the FDCA.
July 25, 2012
On Friday, the Federal Circuit heard oral arguments in AMP v. USPTO, the litigation challenging the validity of the Myriad Genetics patents on the BRCA1 and BRCA2 genes; link to audio recording. The basis of the lawsuit is whether isolated genes are patentable subject matter, so any ruling in this case affects the patenting of all genes; see earlier posts here and here. This case was previously heard at the Federal Circuit last year, where the court issued a 2-1 ruling that invalidated the method claims in the patents, but upheld the patent claims to the genes. Since then, the Supreme Court’s ruling in Mayo v. Prometheus issued, where the Court decided that a patent to a method of adjusting drug dosage relied on preempting the use of a law of nature, and therefore invalided the patent. In response to the plaintiffs' petition for certiorari on the gene patent claims, the Supreme Court issued a remand and instructed the Federal Circuit to reconsider the gene patent claims in AMP in view of Mayo. I filed an amicus brief in this case last month. One significant difference between the cases is that AMP involves the patenting of compositions of matter, while Mayo involved method claims. This theme echoed throughout the oral argument last week, where the judges (Lourie, Moore, Bryson, recreating the earlier panel) frequently challenged the attorneys to relate their arguments to Mayo and its effect on this case. Each party takes an opposite view. The plaintiffs believe that the overriding policy objective in Mayo – making sure that laws of nature or natural phenomena are not patented – can be extended here, where they argue that the isolated genes in dispute are nothing more than naturally occurring products of nature that cannot be patented. In contrast, the defendants maintain that Mayo does not change the analysis of the eligibility of the gene patent claims because the method claims there are inapposite, and so their central argument that isolated genes are human-made inventions and therefore patentable remains. An interesting exchange occurred near the end of the oral argument where Judge Moore persisted in asking defendants to precisely characterize the inventive work on the isolated genes, and the Myriad attorney recited the scientific decisions on the start and stop positions of the isolated genes as constituting invention-level work; the judge seemed skeptical of that argument. However, Judge Moore also revisited a concern that influenced her 2011 opinion, which was whether a decision invaliding gene patent claims at this point would undermine too many settled expectations and contravene the decades-long practice of the PTO; she asked why this challenge had not been brought much earlier. In my view, that question is understood by realizing the import of a patentable subject matter challenge in the context of patent litigation – the effect of a judicial ruling that certain types of inventions are not patent-eligible creates ripples effects across a technological field – and litigants in patent cases are often similarly situated competitors who do not wish to disturb general patenting expectations. Note that this litigation is unusual in that it is not a case between competitors – it is essentially a public interest challenge brought by a wide coalition (ACLU, PubPat, physicians, scientists, patients) who filed a declaratory judgment on the basis that some of the plaintiffs were directly targeted by potential patent infringement actions by Myriad (the standing issues have been litigated here as well), but the plaintiffs’ team represents many stakeholders who are collaterally affected by the patents and their effects on the BRCA1 and BRCA2 genetic testing field. At the end of the oral argument, Judge Lourie noted that “it remains to be seen whether we’ll be back,” a nod to the fact that the Federal Circuit decision this fall may simply set up the next round of appeals. It’s impossible to gauge how this court will rule, but it appeared, on balance, that the court was not convinced that it was left in possession of a clear Mayo-directed route to a decision, which is the question that they started with.
July 16, 2012
The FDA has approved a rapid, in-home test for Human Immunodeficiency Virus (HIV), the virus that causes AIDS. This is an approval of the premarket approval application (PMA) by the FDA's Center for Biologics Evaluation and Research, which oversees the review of devices that involve the use of a biologic reagent. This is the first in-home test for HIV infection that produces immediate results, and will be sold over the counter (OTC) by pharmacies. The single-use test, OraQuick, detects antibodies to viral strains HIV-1 and HIV-2, and allows an individual to take an oral swab (no blood required) and receive results at home in 20-40 minutes. The package insert instructs users that this test be a predicate to confirmation by a physician. This is the first at-home test for an infectious disease, and the need (and potential market) for such a test is supported by HIV statistics from the CDC, which suggest that at least 20% of those infected with HIV are unaware of their status. Several developments in the last several decades suggest that this test might be useful to some who suspect possible HIV infection – decreased stigma over HIV-positive status, coupled with the availability of more effective antiviral treatments. However, the cost of the test will be over $17.50 (current price to clinics), which will be pricey for many, and, furthermore, to note that antiviral regimens for HIV have improved over time does not mean that access to treatment is universal. The test is only approved for sale to those 17 and older, and pharmacies may screen for verified age in selling the product. There are other FDA-approved HIV home tests available, but they require sending a sample to a laboratory. While this test expands options for those at risk of HIV infection, it is a relatively straightforward application of long-existing technologies; the FDA resisted the approval of other HIV home test applications for years. The CDC estimates that approximately 50,000 people are newly infected with HIV each year in the United States. Although some of the stigma associated with HIV has decreased, there is still a visible effort to encourage testing for high-risk groups (or those engaged in high-risk behaviors); National HIV Testing Day was just observed on June 27 of this year.
July 9, 2012
There is an update in the litigation that involves a challenge to various Monsanto patents on genetically engineered (GE) seeds (Organic Seed Growers and Trade Association v. Monsanto). The lawsuit was filed by a coalition of farmers, seed businesses and agricultural organizations who are concerned with potential allegations of patent infringement if GE crop material inadvertently travels onto their properties. See here for earlier background on this case. The lawsuit was dismissed in federal district court in March.The judge ruled that the plaintiffs lacked standing, not presenting a sufficient immediate controversy to the courts to warrant declaratory judgment jurisdiction. An appeal was lodged at the Federal Circuit and the plaintiffs’ appellate brief has now been filed at the court. The plaintiffs elaborate on their injury, asserting that they have to forego the use of property in order to reduce their risk of contamination by adjacent GE crops and/or they must undertake expensive genetic testing to monitor the appearance of a GE contaminant in their native crops.The brief goes to lengths to detail the specific circumstances of some named plaintiffs as they face imminent potential contamination of their crops, and it asserts that any countervailing measures that plaintiffs take to reduce potential contamination do not defeat their right to standing. The governing standard provided by the Supreme Court in Medimmune v. Genentech is “whether the facts alleged, under all the circumstances show that there is a substantial controversy between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” The defendants have offered a statement that renounces an intention to sue the plaintiffs; however, this has not allayed their concerns and the litigation moves forward. Note that this threshold dispute over standing is simply a predicate to the merits of the complaint; should plaintiffs win on standing, they gain the right to fully contest the validity of the Monsanto patents.
Labels: Genetically Engineered Crops