Foley Hoag LLP

SUMMARY

Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act.

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Today, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars.  Biosimilar products are biological products shown to be highly similar to, or interchangeable with, biological products previously approved by FDA (known as reference products).  Section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act, established an abbreviated approval pathway for biosimilar products.  Applications to FDA seeking approval of biosimilar products are known as 351(k) applications.

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Foley Hoag’s Trademark, Copyright & Unfair Competition group releases “The Best of the Blog Trademark Posts - 2011 Edition.”

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Effective tomorrow, January 10, 2012, applicants filing international patent applications under the Patent Cooperation Treaty (PCT) in the U.S. Patent and Trademark Office (USPTO) will be able to designate the Russian Federal Service for Intellectual Property (Rospatent) as the International Search Authority (ISA) and pay a Search Fee of only $415.  [more...]

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The last decade has seen the creation of complex genomic tests, sometimes as the outcome of tens of millions of dollars of research, designed from ground up to solve a recognized clinical problem. These tests, which range in price from $500 to $3000, are the “poster child” for the potential as well as the challenges when genomics and advanced bioinformatics are brought together and enter the clinic. According to a number of published studies, at least some tests in these categories can be net cost-saving in real-world scenarios, in addition to improving medical decision-making.

In March 2012, the local Medicare contractor for all California-based laboratories plans to launch an elaborate program for genomic test evaluation, coding, and pricing. This essay discusses major features of the program, as they have been released up to November 2011. The program is likely one of the most distinctive strategic policy efforts proposed by a Medicare contractor in the forty-five year history of the Medicare program. 

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Insurance companies consistently assert that Commercial General Liability (“CGL”) insurance, routinely purchased by most businesses, provides no coverage for patent infringement lawsuits. An October 17, 2011 decision of a federal appeals court in Colorado has rejected that view, however, holding that CGL insurers may be bound at least to fund an insured company’s defense of patent litigation where the invention at issue has potential promotional uses.  [more...]

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On September 16, 2011, President Obama signed into law the Leahy-Smith America Invents Act (the "AIA"). The law makes the most sweeping reform of the United States patent system in at least 60 years. The changes under the AIA will be phased in over the next eighteen months. While a number of significant changes will not take effect until late 2012 and early 2013, patent applicants can optimize their positions under the new law by taking certain steps now:  [more...]

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An overview and summary tables of federal and state laws regulating data security privacy in the United States as of September 2011.

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Today President Obama signed into law the Leahy-Smith America Invents Act, considered by many to be the most sweeping reform of the United States patent system in 60 years. Among many changes, one which takes immediate effect is the creation of a new “Micro-entity” status which offers qualified applicants a 75% reduction in many Patent Office fees. The Micro-entity status is available to universities as well as to some very early stage companies and individual inventors.  [more...]

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In Microsoft Corp. v. i4i Limited Partnership, a unanimous Supreme Court held last week that an accused infringer must prove the facts underlying any challenge to the validity of a United States patent by clear and convincing evidence.

Under 35 U.S.C. § 282, “[a] patent shall be presumed valid” and “[t]he burden of establishing invalidity . . . rest[s] upon the party asserting” such invalidity. Writing for the Court, Justice Sotomayor interpreted this language as codifying not only the burden of proof to establish invalidity, but also a heightened standard of proof rooted in the common law and recognized in Supreme Court jurisprudence dating back to the 19th century. [more...]

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After a lengthy and contentious approval process, the Internet Corporation for Assigned Names and Numbers (ICANN) recently entered into an agreement with ICM Registry to delegate the new .xxx top-level domain (TLD). The .xxx domain, intended to serve as an Internet "red light district" (despite being strongly opposed by many in the adult entertainment community itself), will likely go live later this year. In the meantime, ICM Registry has opened a "pre-reservation period" for interested members of adult entertainment industry, and for trademark owners in other industries.

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The Federal Circuit yesterday issued a ruling in In re BP Lubricants USA, Inc., available here, that is likely to have a significant impact on the recent spate of lawsuits claiming “false marking.” In these lawsuits, a plaintiff alleges that the defendant is marking a product with a patent that does not, in fact, cover the product, and that the defendant is doing so “for the purpose of deceiving the public.”

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Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 08-1403, (December 17, 2010), available here.

In the first case to consider the patentability of a life sciences invention since the U.S. Supreme Court decided Bilski v. Kappos, the Federal Circuit held that medical treatment claims asserted by Prometheus Laboratories were eligible for patent protection.

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The Affordable Care Act (§ 9008, as amended by § 1404 of the Reconciliation Act), established an annual fee that will be imposed on covered entities that manufacturer or import branded prescription drugs.

The Department of Treasury recently issued guidance on this new annual fee, available at http://www.irs.gov/pub/irs-drop/n-10-71.pdf . The guidance describes a proposed methodology for calculating the fee, how the IRS will use the methodology to provide covered entities with a preliminary 2011 fee calculation, and solicits public comments. Comments must be submitted by June 2, 2011.

IRS Form 8947, which is referenced in the guidance, is available at http://www.irs.gov/pub/irs-pdf/f8947.pdf

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The Supreme Court today affirmed the Federal Circuit’s holding that Bilski’s business method was unpatentable subject matter because it sought to claim patent protection on an abstract idea. But the Court rejected the Federal Circuit’s bright-line “machine or transformation” test as the sole test for determining whether an invention is eligible for patent protection.  [more...]

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An important mechanism for bringing suit against healthcare providers and pharmaceutical and medical device companies – the Qui Tam Action – has been expanded as part of the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) (the "PPACA").

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In a much anticipated decision that has attracted the attention of pharmaceutical and biotech companies, medical researchers, physicians, attorneys and patients concerned about their risk for breast or ovarian cancer, Judge Robert W. Sweet of the U.S. District Court for the Southern District of New York ruled in favor of the plaintiffs on March 29, 2010 in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.  [continues... ]

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On December 24, 2009, the U.S. Senate passed the Patient Protection and Affordable Care Act (H.R. 3590), its version of comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives also passed this legislation. Included therein is a provision (Section7002) amending the Public Health Service Act to permit approval of biosimilar biological products through an abbreviated biological license application (ABLA) submitted to the Food and Drug Administration (FDA).

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On March 8, 2010, the Federal Circuit affirmed a ruling of the International Trade Commission invalidating the asserted claims of two U.S. patents for failure to meet the best mode requirement. Ajinomoto Co., Inc. v. ITC, available here. Foley Hoag represented the prevailing party, Global Bio-Chem Technology Group Company Limited (GBT), a Chinese biotechnology company. The patents covered the production of lysine using genetically modified bacteria.

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The Food and Drug Administration (FDA) announced on September 30 that it has released a draft guidance [.pdf] for industry, titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.”  Comments to the draft guidance are due by December 30, 2009, and should be submitted according to the instructions in the Federal Register [.pdf] notice announcing the draft guidance.