scholarly journals Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics

2014 ◽  
Vol 1 (2) ◽  
pp. 183-189 ◽  
Author(s):  
Ashish M. Bakshi
2013 ◽  
Vol 31 (21) ◽  
pp. 2743-2748 ◽  
Author(s):  
Kenneth Offit ◽  
Angela Bradbury ◽  
Courtney Storm ◽  
Jon F. Merz ◽  
Kevin E. Noonan ◽  
...  

Genomic discoveries have transformed the practice of oncology and cancer prevention. Diagnostic and therapeutic advances based on cancer genomics developed during a time when it was possible to patent genes. A case before the Supreme Court, Association for Molecular Pathology v Myriad Genetics, Inc seeks to overturn patents on isolated genes. Although the outcomes are uncertain, it is suggested here that the Supreme Court decision will have few immediate effects on oncology practice or research but may have more significant long-term impact. The Federal Circuit court has already rejected Myriad's broad diagnostic methods claims, and this is not affected by the Supreme Court decision. Isolated DNA patents were already becoming obsolete on scientific grounds, in an era when human DNA sequence is public knowledge and because modern methods of next-generation sequencing need not involve isolated DNA. The Association for Molecular Pathology v Myriad Supreme Court decision will have limited impact on new drug development, as new drug patents usually involve cellular methods. A nuanced Supreme Court decision acknowledging the scientific distinction between synthetic cDNA and genomic DNA will further mitigate any adverse impact. A Supreme Court decision to include or exclude all types of DNA from patent eligibility could impact future incentives for genomic discovery as well as the future delivery of medical care. Whatever the outcome of this important case, it is important that judicial and legislative actions in this area maximize genomic discovery while also ensuring patients' access to personalized cancer care.


2016 ◽  
Author(s):  
Dan Burk

Often what is not said is as significant as what is said. In its recent Myriad Genetics decision, the United States Supreme Court is curiously silent about the relationship between its holding in that case and the holding in its immediately previous patent subject matter case, Mayo v. Prometheus. This reticence is all the more puzzling given that the Court initially remanded Myriad to the lower courts for reconsideration in light of the Mayo holding. The Court's silence regarding Mayo leaves uncertain the relationship between the "products of nature" doctrine that serves as the basis for the Myriad decision, and the "laws of nature" doctrine that has been the basis of nearly all of its other subject matter cases. In this paper I assemble the clues in the laws of nature cases to suggest what the Court might have said or might still say regarding products of nature.


1999 ◽  
Vol 27 (2) ◽  
pp. 203-203
Author(s):  
Kendra Carlson

The Supreme Court of California held, in Delaney v. Baker, 82 Cal. Rptr. 2d 610 (1999), that the heightened remedies available under the Elder Abuse Act (Act), Cal. Welf. & Inst. Code, §§ 15657,15657.2 (West 1998), apply to health care providers who engage in reckless neglect of an elder adult. The court interpreted two sections of the Act: (1) section 15657, which provides for enhanced remedies for reckless neglect; and (2) section 15657.2, which limits recovery for actions based on “professional negligence.” The court held that reckless neglect is distinct from professional negligence and therefore the restrictions on remedies against health care providers for professional negligence are inapplicable.Kay Delaney sued Meadowood, a skilled nursing facility (SNF), after a resident, her mother, died. Evidence at trial indicated that Rose Wallien, the decedent, was left lying in her own urine and feces for extended periods of time and had stage I11 and IV pressure sores on her ankles, feet, and buttocks at the time of her death.


2017 ◽  
Vol 22 (4) ◽  
pp. 12-13
Author(s):  
LuAnn Haley ◽  
Marjorie Eskay-Auerbach

Abstract Pennsylvania adopted the impairment rating provisions described in the AMA Guides to the Evaluation of Permanent Impairment (AMA Guides) in 1996 as an exposure cap for employers seeking predictability and cost control in workers’ compensation claims. In 2017, the Supreme Court of Pennsylvania handed down the Protz decision, which held that requiring physicians to apply the methodology set forth in the most recent edition of the AMA Guides reflected an unconstitutional delegation of legislative power to the American Medical Association. The decision eliminates the impairment-rating evaluation (IRE) mechanism under which claimants were assigned an impairment rating under the most recent edition of the AMA Guides. The AMA Guides periodically are revised to include the most recent scientific evidence regarding impairment ratings, and the AMA Guides, Sixth Edition, acknowledges that impairment is a complex concept that is not yet defined in a way that readily permits an evidence-based definition of assessment. The AMA Guides should not be considered standards frozen in time simply to withstand future scrutiny by the courts; instead, workers’ compensation acts could state that when a new edition of the AMA Guides is published, the legislature shall review and consider adopting the new edition. It appears unlikely that the Protz decision will be followed in other jurisdictions: Challenges to using the AMA Guides in assessing workers’ compensation claims have been attempted in three states, and all attempts failed.


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