Intellectual Property

Supreme Court Remands Medical Process Cases in View of Bilski

Fri, 2 Jul 2010 15:48:04 -0400

On June 29th, the U.S. Supreme Court remanded to the Court of Appeals for the Federal Circuit two medical process cases (Mayo Collaborative Services v. Prometheus Laboratories and Classen Immunotherapies, Inc. v. Biogen IDEC) in view of the Supreme Court’s decision in Bilski v. Kappos. The Supreme Court held in that decision that the "machine-or-transformation" test is not the exclusive test for patent-eligible subject matter. Under the "machine-or-transformation" test, a process claim will be deemed patent eligible subject matter if it is tied to a particular machine or transforms an article into a different state or thing.

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Supreme Court Clarified Patent Eligibility but Uncertainty Remains

Tue, 29 Jun 2010 16:27:43 -0400

In a decision announced June 28, 2010, the United States Supreme Court has attempted to clarify what constitutes patentable subject matter under the Patent Statute. In Bilski et al. v. Kappos, the Court upheld a decision by the Court of Appeals for the Federal Circuit that Bilski’s claims to methods of hedging risk in certain financial markets were unpatentable. In so doing, the Court held that the so-called "machine-or-transformation" test is not the exclusive test for patent-eligible subject matter. The Court stated that, while methods of conducting business are not excluded as a category of patentable subject matter, abstract ideas are excluded. The Bilski risk hedging process claims were found to be unpatentable because they recite an abstract idea.

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District Court Concludes that Isolated DNA is Not Patentable

Wed, 7 Apr 2010 15:51:54 -0400

Earlier this year, the American Civil Liberties Union (ACLU) and several other plaintiffs filed a lawsuit to invalidate patents covering the breast cancer susceptibility genes, BRCA1 and BRCA2. The patents are exclusively licensed by Myriad Genetics, who has made a clinical diagnostic test available. On March 29, 2010, the District Court for the Southern District of New York granted plaintiff’s motion for summary judgment concluding that isolated DNA compositions are not patent eligible subject matter under the patent statute, and invalidating the patents covering BRCA1 and BRCA2. Association for Molecular Pathology v. United States Patent and Trademark Office (09 Civ. 4515, S.D.N.Y. March 29, 2010).

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Ariad Pharmaceuticals v. Eli Lilly & Company

Wed, 7 Apr 2010 15:37:36 -0400

The Court of Appeals for the Federal Circuit (the Court that hears all patent appeals) issued a decision on March 22, 2010 in the case of Ariad Pharmaceuticals, Inc., v. Eli Lilly & Company (--F.3d--, 2010 WL 1007369 (C.A.Fed., 2010)) reaffirming a written description requirement that is separate and distinct from the enablement requirement under the patent statute.

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Potentially Curbing the Scope of Gene Patents

Fri, 2 Apr 2010 11:46:44 -0400

On March 9, 2010, the Advocate General of the European Court of Justice issued an Opinion in the case of Monsanto Technology LLC v. Cefetra BV et al., case number C-428/08, that advocates limiting the scope of protection under European Union (EU) patent law afforded by patents on DNA. The European Court of Justice will consider the Advocate General’s Opinion while deliberating their decision in the case.

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Challenge to Gene Patents

Tue, 2 Mar 2010 15:11:44 -0500

On February 9, 2010, a United Kingdom appeals court, in Eli Lilly and Co. v. Human Genome Sciences, Inc., case number A3/2008/2673, upheld a lower court decision to invalidate a patent claiming an isolated nucleic acid encoding a Neutrokine-alpha protein. The appeals court held the patent invalid for lack of "industrial application," despite the fact that the patent provided not only the sequence information but also suggested several therapeutic utilities of the sequences. Nonetheless, the court determined that the claimed nucleic acid had undetermined function, thus rendering the patent invalid.

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Supreme Court Hears Oral Arguments in Bilski v. Kappos

Fri, 13 Nov 2009 15:19:38 -0500

The Supreme Court agreed earlier this year to hear the Bilski case and address the question of whether the "machine-or-transformation" test enunciated last year by the Federal Circuit is appropriate for determining patent-eligible subject matter.

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State Regulator Files Final Massachusetts Data Security Regulations: Retains March 1, 2010 Effective Date

Fri, 13 Nov 2009 15:14:16 -0500

The Office of Consumer Affairs and Business Regulation (OCABR) filed final Data Security Regulations on November 4, 2009, retaining the March 1, 2010 effective date. As reported in prior Alerts, persons who have access to personal information regarding Massachusetts residents in connection with business or employment must have a written information security plan in place by the effective date. The requirements of the Regulations were summarized in the Alert we published on September 25, 2009.

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FTC Postpones Enforcement of Red Flags Rule: U.S. District Court Holds Rule Not Applicable to Lawyers

Mon, 9 Nov 2009 15:57:20 -0500

There have been two important developments recently regarding the Federal Trade Commission’s Red Flags Rule.
The Red Flags Rule requires financial institutions and creditors to develop and implement written identity theft prevention programs. These programs must provide for the identification, detection, and response to patterns, practices, or specific activities -- known as "red flags" -- that could indicate identity theft. Generally speaking, the Rule applies to all persons who regularly permit consumers to defer payment for goods and services purchased. An obvious example of a "creditor" that is subject to the Rule is an automobile dealer; a less obvious example is a lawn mowing service that provides the service and subsequently sends a bill.

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Massachusetts Date Security Regulations

Mon, 12 Oct 2009 17:29:59 -0400

The Massachusetts Office of Consumer Affairs and Business Regulation (OCABR) held what is likely to be its last public hearing on the proposed Data Security Regulations on September 22, 2009. The Regulations are expected to be finalized, substantially in their current form, during the month of October. Compliance is mandatory by March 1, 2010.

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Prometheus Laboratories v. Mayo Collaborative Services

Mon, 12 Oct 2009 17:26:26 -0400

The Court of Appeals for the Federal Circuit (the Court that hears all patent appeals) issued a favorable decision for medical diagnostic companies and others yesterday in the case of Prometheus Laboratories v. Mayo Collaborative Services (--- F.3d ----, 2009 WL 2950232 (C.A.Fed., 2009)).

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Like-Kind Exchanges of Trademarks and Trade Names: IRS Revises Position

Mon, 12 Oct 2009 17:24:03 -0400

Section 1031 of the Internal Revenue Code provides that certain exchanges of like-kind property may be exchanged without producing taxable income. However, the Treasury Regulations adopted to clarify and explain Section 1031 provide that the goodwill or going-concern value of a business is not of like-kind to the goodwill or going-concern value of another business. Based on the Treasury Regulations, exchanges of goodwill or going-concern value of a business for the goodwill or going-concern value of another business will not qualify for Section 1031 non-recognition treatment. Historically, the Internal Revenue Service (“IRS”) concluded that trademarks and trade names were too closely related to the goodwill or going-concern value of a business to be eligible for Section 1031 non-recognition (TAM 200602034). Recently, in Chief Counsel Advice 200911006, the IRS rejected this position and stated that intangibles such as trademarks, trade names, mastheads, and customer-based intangibles that can be separately described and valued apart from goodwill qualify as like-kind property under Section 1031.

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Massachusetts Data Security Regulations: The Latest Developments

Tue, 14 Apr 2009 13:13:33 -0400

On Friday, January 16, 2009, the Massachusetts Office of Consumer Affairs and Business Regulation (OCABR) held a public hearing concerning the recently extended Massachusetts data security regulations (201 CMR 17.00). The Regulations, described by many speakers at the hearing as the nation’s most cumbersome data security regulations, require all entities that license, store or maintain personal information about a Massachusetts resident to implement a comprehensive information security program. Compliance with many of the Regulation’s provisions is required by May 1, 2009.

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The U.S. Freedom of Information Act: Negative Emails About Competitor Need Not Be Produced

Tue, 14 Apr 2009 13:11:28 -0400

Government contractors sometimes pursue the disclosure of competitor information through requests under the U.S. Freedom of Information Act1 ("FOIA"). When a contractor is notified that the government may reveal confidential information in response to a FOIA request, that contractor has the right to assert that its confidential information be exempted from disclosure.

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Five Reasons to do a Trademark Audit

Tue, 7 Apr 2009 14:36:15 -0400

While a company's brands are among its most critical and valuable business assets, too little attention is usually devoted to identifying, developing, protecting and exploiting those assets. Gaps in trademark asset protection are often not discovered until a company seeks to enforce, or is forced to defend, its brands and encounters obstacles that could have been avoided. As trademark litigators, we have seen many circumstances where gaps in trademark protection could have been easily closed if they had been noticed.

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Compliance Deadlines Extended But Comprehensive Data Security Regulations Still Looming in Massachusetts

Thu, 26 Mar 2009 14:11:26 -0400

Following on the heels of major data security breaches at TJ Maxx and other companies, the Massachusetts Legislature enacted a data security law intended to protect consumers’ personal information. On September 19, 2008, the Massachusetts Office of Consumer Affairs and Business Regulation (OCABR) issued regulations prescribing specific policies and practices that must be adopted to comply with the law. OCABR’s regulations establish requirements that far exceed data security provisions under federal law or the law of other states. Therefore, even businesses that have adopted security “best practices” or who – like banks and other financial service providers – have been subject to federal privacy and security laws for many years, will need to implement new security procedures to comply with the Massachusetts law.

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