Publications

U.S. Supreme Court Rules That “Reverse Payment” Settlements in ANDA Litigation Are Not Presumptively Unlawful But Must Be Assessed Using “Rule of Reason”

U.S. Supreme Court Rules That “Reverse Payment” Settlements in ANDA Litigation Are Not Presumptively Unlawful But Must Be Assessed Using “Rule of Reason”
The Supreme Court ruled 5-3 on June 17, 2013 in favor of the Federal Trade Commission in FTC v. Actavis. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer’s opinion reversed the decision of the Eleventh Circuit Court of Appeals dismissing the FTC’s complaint that a “reverse payment” settlement agreement between an innovator drug maker and generic challengers in ANDA litigation was anticompetitive and violated the antitrust laws. The Court refused to accept the FTC’s position that such agreements are presumptively unlawful, holding that lower courts should apply an antitrust “rule of reason” analysis when evaluating such agreements.
- by Kevin Noonan

U.S. Supreme Court Rules Human Genes Cannot Be Patented While Approving Patentability of Synthetic Genes in Issuing Key Myriad Decision

U.S. Supreme Court Rules Human Genes Cannot Be Patented While Approving Patentability of Synthetic Genes in Issuing Key Myriad Decision
The Supreme Court ruled unanimously June 13, 2013 in favor of Plaintiffs/Petitioners in Association of Molecular Pathologists v. Myriad Genetics on the question of whether isolated DNA is patent eligible. The opinion found a distinction between isolated genomic DNA and fragments thereof (including oligonucleotides), which the Court found were not eligible for patenting under Section 101 of the patent statute, and “synthetic” cDNA, which the Court found did not occur in nature and evinced a sufficient degree of the “hand of man” to fall outside the scope of the Court’s exclusions to patent eligibility.
- by Kevin Noonan

Changes in the Rules for ITC Section 337 Investigations Are Now In Effect

Changes in the Rules for ITC Section 337 Investigations Are Now In Effect
On May 20, 2013, new rules of practice and procedure go into effect for International Trade Commission Section 337 Investigations, 19 C.F.R. Parts 201 and 210. Many of these rule changes were made for the purposes of making technical corrections or clarifications to the rules and will have little direct impact upon a complainant or respondent’s strategy in navigating through a Section 337 Investigation. However, some of the changes to the rules, particularly those changes to the rules governing the initiation of an Investigation (§210.12), the termination of an Investigation (§210.21), and the scope of discovery (§210.18), are worthy of attention.
- by Alison Baldwin

U.S. Supreme Court Sides with Monsanto in Seed Patent Case

U.S. Supreme Court Sides with Monsanto in Seed Patent Case
The Supreme Court ruled unanimously May 13, 2013 in favor of Monsanto in Bowman v. Monsanto, a case involving Monsanto’s recombinant, Roundup Ready^® seeds. The opinion rejected the arguments from petitioner, Indiana farmer Vernon Hugh Bowman, that Monsanto’s rights in its seed had been “exhausted” by their first sale (here, to a grain elevator) and that the Court should reject any “special exception” to the first-sale doctrine of patent exhaustion for “self-replicating technologies.”
- by Kevin Noonan

Volume 11, Issue 2 (Spring 2013)

Tiffany & Co. v. Costco Wholesale Corp.: Has the TIFFANY trademark become generic?
On February 14, 2013, Tiffany filed a lawsuit against Costco Wholesale Corporation (“Costco”), alleging that Costco was engaging in the sale of counterfeit TIFFANY diamond engagement rings. Tiffany’s complaint against Costco alleged violations of federal and New York law, including counterfeiting, trademark infringement, dilution, unfair competition, injury to business reputation, false and deceptive business practices, and false advertising. In its defense and in support of its counterclaims, Costco mainly argued that “[t]he word Tiffany is a generic term for ring settings comprising multiple slender prongs extending upward from a base to hold a single gemstone.” This article reviews the relative strengths/weaknesses of the main arguments presented by the parties and provides an assessment of which party is more likely to prevail based on the strength of these arguments.
- by Emily Miao and Nicole Grimm
Obama Administration Focuses on Chinese Trade Secret Misappropriation
Since President Obama entered the White House in 2009, his administration has undertaken a number of steps toward stricter policing of international trade secret misappropriation. Those efforts reached a turning point early this year with the release of the “Administration Strategy on Mitigating the Theft of U.S. Trade Secrets.” At the same time, however, news reports have suggested that the Chinese government has facilitated – and even been responsible for – the misappropriation of U.S. trade secrets. As a result, the Obama Administration has ramped up efforts to protect trade secrets against Chinese misappropriation.
- by Joshua Rich
Comments on New AIA Rules
On March 16, 2013, the final (and most significant) portion of the Leahy-Smith America Invents Act (AIA) took effect, and the United States broke from a first-to-invent regime to a first-inventor-to-file (FITF) regime. Of course, this break is far from clean as applications filed before March 16, 2013, as well as certain applications filed after March 15, 2013, will continue to enjoy the advantages of the old first-to-invent system. Since the AIA was enacted on September 16, 2011, the U.S. Patent and Trademark Office (USPTO) has played an important role in implementing the new patent law. In the eighteen months between the statute's enactment and the March 16 effective date, the USPTO published twelve notices of proposed rulemaking, issued a patent trial practice guide, and published a guidance document on the FITF provisions of the AIA, all of which culminated in the revision of the rules of practice in title 37 of the Code of Federal Regulations (C.F.R.). Set forth in this article are a few rule revisions that practitioners should pay careful attention to as we proceed into the FITF regime.
- by Donald Zuhn and Cole Richter
Implementing the New Micro Entity Status at the U.S. Patent Office
As part of new rules introduced by the Leahy-Smith America Invents Act (AIA), a new section that defines a “micro entity” was added to Title 35 of the United States Code. As a subset of small entity status, micro entity status grants an applicant a seventy-five percent reduction of fees associated with filing, searching, examining, issuing, appealing and maintaining patent applications and patents. The new section sets forth procedures pertaining to claiming micro entity status, paying fees as a micro entity, notifying the United States Patent and Trademark Office (USPTO) of loss of micro entity status, and correcting erroneously paid fees. An applicant has two options for qualifying as a micro entity, which are provided in 35 U.S.C. §§ 123(a) and 123(d) (and implemented in 37 C.F.R. § 1.29). Each is addressed in this article.
- by Joshua Bosman and Gregory Huffman

USPTO Publishes Final Rules Adopting the New USPTO Rules of Professional Conduct

USPTO Publishes Final Rules Adopting the New USPTO Rules of Professional Conduct
The United States Patent and Trademark Office (“USPTO”) published its final rules in the April 3, 2013 Federal Register in preparation for adopting the new USPTO Rules of Professional Conduct (“USPTO Rules”). This is significant for any patent practitioner that has a USPTO registration number. Patent attorneys will no longer need to go back and forth between the old Model Code, as previously adopted by the Office, and the newer Model Rules, used by almost every jurisdiction in the U.S. However, Patent agents not accustomed to the ABA Model Rules will need to familiarize themselves with a completely new set of ethical obligations. We will highlight these changes in a future edition of snippets.

A number of comments were submitted when the USPTO first proposed these rules. One of the more contentious provisions involved the rules impacting the disclosure of confidential information, especially when that information belongs to a different client. The USPTO addressed these comments, and provided a potential solution should that ethical quandary occur. However, it did not change the proposed rules in response to these comments. This article provides an overview of these new rules, and describes the potential ethical quandary related to the disclosure of confidential information, and the USPTO’s response.
- by Andrew Williams

Volume 11, Issue 1 (Winter 2013)

Federal Courts Debate Safe Harbor Exemption for Patent Infringement under 35 U.S.C § 271(e) Following Merck v. Integra
Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when those activities are “reasonably related to the development and submission of information” to the Food and Drug Administration. The scope of this exemption has been hotly contested since the passage of the Hatch-Waxman Act in 1985. The Supreme Court has weighed in on this exemption twice, the last time being in Merck KGaA v. Integra LifeSciences I, Ltd.
- by Patrick Gattari and Nicole Grimm
Conducting Efficient Patent Litigation Discovery, Part 2
The costs associated with discovery, and particularly electronic document discovery, in patent litigation can be effectively controlled with upfront planning, preparation, and coordination between in-house and outside counsel. Presented in this second part of a two-part article are some practical considerations for conducting efficient document collection and review. In the first part of this article, published in the Fall 2012 issue of snippets, early collection activities and agreements with opposing counsel were discussed. In this second part, developing and implementing a collection plan and reviewing documents will be discussed.
- by Kurt Rohde
If I Prioritize Examination of my Application, Should the Patent Office?
Applications under the US Patent and Trademark Office’s (USPTO) prioritized examination program are given “special status” and examined out-of-turn until a final disposition is reached. This program has considerably reduces delay incurred during prosecution for such applications. Notably, the average application pendency remains about 32 months. In this context, the stated goal to achieve final disposition within 12 months for prioritized examination applications initially seemed ambitious, but so far the USPTO has considerably over-performed even that benchmark. Applications under prioritized examination have reached final disposition in an average of 5.4 months after special status is granted. This article reviews the requirements for requesting prioritized examination, discusses whether to request prioritized examination, and considers strategies for using prioritized examination effectively.
- by Justin Cook and Christian Hines
InterDigital Communications v. ITC: (Some) Non-Practicing Entities are Welcome
On January 10, 2013, the Federal Circuit in InterDigital Communications v. ITC denied a combined petition for panel rehearing and for rehearing en banc, holding that InterDigital’s patent licensing alone met the domestic industry requirement of § 337 of the Tariff Act of 1930, 19 U.S.C. §§ 1337(a)(2) and 1337 (a)(3). On its face, this decision seems to open the floodgates for non-practicing entities (NPEs) to file lawsuits in the International Trade Commission (ITC). However, a close reading of the Court’s opinion and the legislative history of §337 indicates that this is not the case.
- by Alison Baldwin and Jordan Pringle

Preparing for the Final Phase of the America Invents Act Going Into Effect March 16, 2013

Preparing for the Final Phase of the America Invents Act Going Into Effect March 16, 2013
The final phase of the America Invents Act (AIA) takes effect on March 16, 2013. This means that any patent application filed in the U.S. on or after that date, which, at any time during its pendency, contains a claim that is not fully supported in an application filed before March 16, 2013, will be subject to the new first-inventor-to-file rules under the AIA. As a result of this imminent change in U.S. patent law, it is recommended that companies consider several options.
- by Grantland Drutchas and Donald Zuhn

Volume 10, Issue 4 (Fall 2012)

Post-Grant Review: A Double-Edged Sword
The Leahy-Smith America Invents Act (AIA), signed into law in 2011, promises the most radical changes to U.S. patent law in over 50 years. The act eliminates the first-to-invent system of granting patents in favor of a first-to-file system, gives the U.S. Patent & Trademark Office (USPTO) the authority to set its own fees, and authorizes—indeed mandates—the establishment of USPTO satellite offices outside of the Washington, D.C. area. Another watershed change is the creation of a “post-grant review” (or “PGR”) procedure by which any member of the public can challenge the validity of an issued patent, on a variety of grounds, before a USPTO tribunal.
- by Alan Krantz
The TianRui Group Company Ltd. v. U.S. International Trade Commission: A Powerful New Weapon for Combating Trade Secret Misappropriation Abroad
What if trade secret misappropriation occurs abroad and the misappropriated trade secret is used to manufacture products that are then imported into the United States to compete with the trade secret owner’s products? Under the TianRui decision, a U.S. company doing business abroad may have recourse in the International Trade Commission (“ITC”) under section 337 of the Tariff Act of 1930 (“section 337”) to exclude the importation of products that embody a misappropriated trade secret, even when the trade secret theft occurred entirely outside of the United States and the U.S. company is not using its trade secret in its products.
- by Emily Miao
Conducting Efficient Patent Litigation Discovery
The costs associated with discovery, and particularly electronic document discovery, in patent litigation can be effectively controlled with upfront planning, preparation, and coordination between in-house and outside counsel. Presented in this two-part article are some practical considerations for conducting efficient document collection and review. In this first part, early collection activities and agreements with opposing counsel are discussed.
- by Kurt Rohde

Volume 10, Issue 3 (Summer 2012)

Generic Top-Level Domain Update
In 2012, the Internet Corporation for Assigned Names and Numbers (ICANN) introduced the generic Top-Level Domain (gTLD) Program to implement new Top-Level Domains into the Internet’s addressing system. To help explain the gTLD Program, this article highlights three important aspects of the Program, including: 1) background information on ICANN’s new gTLD Program and the evaluation process for applicants, 2) statistics from the first round of applications in the gTLD Program, and 3) mechanisms that rights holders may use to protect themselves (which ICANN labeled “Rights Protection Mechanisms”).
- by Sydney Kokjohn and Ann Palma
Does KSR’s “Common Sense” Make Sense? The Federal Circuit Adjusts Obviousness in Mintz v. Dietz & Watson
KSR v. Teleflex marks the Supreme Court’s most recent statement on the law of obviousness. In KSR, the Supreme Court at least briefly addressed such concepts as allowing for common sense, avoiding hindsight bias, and looking to problems addressed in patents. But what do these concepts really mean? And to what extent do they apply to the obviousness equation? This year, the Court of Appeals for the Federal Circuit provided some clarification of these issues in Mintz v. Dietz & Watson.
The Patent Exchange: A New Approach to Licensing Intellectual Property
Underutilized patents are holding intellectual property owners ransom to the tune of $1 trillion dollars annually. The solution? Monetize valuable intellectual property (IP) assets on the open market, and see exactly how much your IP is worth. Such a strategy is now possible through a new Chicago-based exchange called the Intellectual Property Exchange International (IPXI), which allows IP rights to be bought and sold as unit license right™ (ULR™) contracts on an open market.
- by Sarah Duda
FRAND and Injunctive Relief: Exploring a Standard-Essential Patent Owners Right to Injunctive Relief
Often, an industry-adopted technical standard includes technology covered by patents, and the owners of these patents agree to license the patents on fair, reasonable, and non-discriminatory (FRAND) terms as part of the standard-setting process. This article explores options available to the patent owners when a member of the industry declines to accept a license on terms deemed to be FRAND by the patent owner, and nevertheless, implements the standard.
- by Gregory Huffman

AIA Rules Going Into Effect September 16, 2012

AIA Rules Going Into Effect September 16, 2012
As we approach the one-year anniversary of the enactment of the America Invents Act (AIA), MBHB highlights several important provisions that will take effect as of September 16, 2012.
- by Cole Richter

U.S. Supreme Court Upholds Patient Protection and Affordable Care Act Under Taxation Clause in Nat'l. Fed'n. of Independent Business v. Sebelius

U.S. Supreme Court Upholds Patient Protection and Affordable Care Act Under Taxation Clause in Nat'l. Fed'n. of Independent Business v. Sebelius
In a history-making decision, the Supreme Court ruled June 28, 2012 that the Patient Protection and Affordable Care Act (PPACA) is constitutional under the taxation clause of the Constitution. The most controversial provision was the individual mandate or "minimum essential" coverage provision that establishes the requirement that nearly all Americans secure health insurance (26 U.S.C. §5000A).
- by James DeGiulio