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January 22, 2013
'Scotus Opts Out Of Patent Safe Harbor Case, Leaving Legal Uncertainty'
FDA Week and Inside Health Reform
D. Christopher Ohly
Partner Christopher Ohly was quoted these articles after the Supreme Court's decision to not review GlaxoSmithKline v. Classen Immunotherapies, analyzing the extent of Hatch-Waxman patent infringement safe harbors spurred continued uncertainty about which post-approval activities are subject to the exemption because of a separate filing opinion. Another case, Momenta Pharmaceuticals v. Amphastar, raises questions about how the safe harbor should be defined in the postmarket space in light of the emerging biosimilar market. Mr. Ohly said that if the Momenta and Classen decisions are left standing, without further appellate review, the relative certainty that the Solicitor General suggested might now exist may, in fact, be absent, since both Classen and Momenta are entitled to equal respect as precedent. Mr. Ohly also said that when the Solicitor General says don't take this case because Momenta 'cabined' the earlier decision, it is signaling that Momenta isn't far behind, and that it may be the better case for Supreme Court review.
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December 4, 2012
'Biotechs Urged to Weigh in as Supreme Court Considers Myriad'
BioWorld Today
D. Christopher Ohly
Schiff Hardin partner D. Christopher Ohly was quoted in this article about the Supreme Court's decision to grant cert in Association for Molecular Pathology v. Myriad Genetics Inc. When Myriad came before the Supremes earlier this year, the justices remanded the case to the Federal Circuit with instructions to reconsider it in light of the high court's Mayo v. Prometheus ruling a week earlier. Mr. Ohly said that the Federal Circuit had an opportunity to apply the reasoning of Prometheus in its second review of Myriad but declined to extend the reasoning of that case, which dealt with processes, to a case involving a product. He said that the Federal Circuit did so, in part, because the Supreme Court jurisprudence in each area is different. By taking the Myriad case, the Supreme Court may smooth the edges between its precedents in these two areas. Mr. Ohly explained that the Myriad decision turned on the molecular difference in a segment of DNA that was ‘isolated’ by manmade processes, from the same segment as it may be found in its natural state as part of a much longer DNA molecule. He said that it remains to be seen whether this difference, which may be as small as a single atom on each end of the isolated segment, will be enough to allow the Supreme Court to agree with the Federal Circuit.
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November 6, 2012
'Obama's Tough-Minded FDA Faces Funding Test'
Law 360
D. Christopher Ohly
Schiff Hardin partner D. Christopher Ohly was quoted in this article regarding future funding of the U.S. Food and Drug Administration (FDA). As the so-called fiscal cliff nears, nearly $320 million would be removed from the FDA budget. In addition to potentially curtailed research programs and major program delays, Mr. Ohly said that the future of approvals and safety also hangs in the balance. Mr. Ohly said that drug and device reviews are only partly funded by corporate fees. He added that averting the impending fiscal crisis and continued FDA funding would allow the FDA to continue to be regarded globally as a gold standard.
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September 12, 2012
'Cases Defining Patent Safe Harbors Could Influence Biosimilar Development'
Inside Health Reform
D. Christopher Ohly
In this article from Inside Health Reform, Schiff Hardin partner Chris Ohly comments on how recent cases regarding Hatch-Waxman patent infringement could affect the growing biosimilar industry. The U.S. Court of Appeals for the Federal Circuit recently held that Amphastar Pharmaceuticals did not infringe patents alleged to cover test methods used during manufacturing of Amphastar's FDA-approved generic product, based upon the court's application of a 'research exemption' in the U.S. patent statute. The decision appears to diverge from an earlier case in which the Federal Circuit ruled that this statutory 'safe harbor' only applies to uses of patented technologies prior to FDA approval, and then only in connection with activities intended for use in submissions to the FDA. Mr. Ohly notes that the decision could affect how brand companies manage product life cycles and that the two cases could eventually reach Supreme Court review.
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July 18, 2012
'Biosimilars Makers See Gold Mine in EU Clinical Data'
Law360
D. Christopher Ohly
Schiff Hardin partner Chris Ohly is quoted in this article about a release of clinical trial data by the European Medicines Agency and its possible benefit to makers of biosimilar drugs. Mr. Ohly, who focuses on pharmaceuticals in the firm's Intellectual Property Group, points out that the published data could help drug manufacturers design biosimilars and speed the approval process.
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February 27, 2012
'Switching Study Required for Biosimilar Interchangeability Draws Questions'
Inside Health Reform
D. Christopher Ohly
Schiff Hardin partner Chris Ohly is extensively quoted in this article on the failure of FDA guidelines for biosimilar pharmaceuticals to address interchangeability. Mr. Ohly commented that, based on the FDA's limited comments in the recently released guidelines and other data, cross-over studies may well be required to establish interchangeability of a biosimilar product. He noted that the FDA said it is unlikely to approve a biosimilar as an interchangeable product based on an original application.
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February 13, 2012
'New Biosimilar Path Is Anything But Predictable'
BioWorld Today
D. Christopher Ohly
This article about recent guidance from the U.S. Food and Drug Administration on biosimilar drug development quotes Schiff Hardin partner Chris Ohly. Mr. Ohly, who focuses on pharmaceutical industry issues in the firm's Intellectual Property Group, notes that the guidance could encourage companies previously considering biosimilar development to proceed along that path.
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February 10, 2012
'Biosimilar Guidance Silent on Industry's Biggest Questions'
Law360
D. Christopher Ohly
Schiff Hardin partner Chris Ohly is quoted in this article about new guidance from the U.S. Food and Drug Administration regarding the development of generic versions of biological drugs. Mr. Ohly, a partner in the firm's Intellectual Property Group, points out that the guidance contains no information about clinical trial requirements or interchangeability, two factors that will greatly affect biosimilar development costs.
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February 1, 2012
'Fresh from the biotech pipeline — 2011'
Nature Biotechnology
D. Christopher Ohly
This article about the U.S. FDA approval process for biosimilar drugs quotes Schiff Hardin partner Chris Ohly. Mr. Ohly, who focuses on pharmaceuticals in the firm's Intellectual Property Group, comments that companies moving through the biosimilar and interchangeable drug approval process may end up innovating their products as a result.
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January 27, 2012
'BIO Vows to Protect Biosimilar Provisions from Health Reform Repeal Efforts'
FDA Week
D. Christopher Ohly
Schiff Hardin partner Chris Ohly is quoted in this article about the potential severability of the Biosimilars Act from the Affordable Care Act in a forthcoming decision by the Supreme Court in litigation attacking the ACA's 'individual mandate.' He commented about possible turmoil in the generic pharmaceutical industry if the Affordable Care Act is overturned as a whole by the Court. Mr. Ohly, a partner in the firm's Intellectual Property Group, pointed out that the 'individual mandate' is completely unrelated to the Biosimilars Act. He added that the Biosimilars Act can be readily severed from the rest of the health care reform law without difficulty and in a manner consistent with the Court's prior decisions about severability.
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April 25, 2011
'Patents on the line'
BioCentury
D. Christopher Ohly
In this article about challenges in the Supreme Court to patent protections, Schiff Hardin partner Chris Ohly is quoted regarding the standards used to invalidate a patent.
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February 11, 2011
'Patent reform looks likely to pass this year'
BioPharm Insight
D. Christopher Ohly
Schiff Hardin's Christopher Ohly, a partner in the firm's Intellectual Property group, is quoted in this pharmaceutical news service story on patent reform legislation. Mr. Ohly points out likely consequences of the legislation, including the significant change to first-to-file priority in patent applications.
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November 20, 2006
'On The Move'
Washington Legal Times
D. Christopher Ohly
D. Christopher Ohly was featured in this daily column that spotlighted his intellectual property practice and his move to Schiff Hardin’s expanding Washington, D.C. office.