This schedule may change at any time at the direction of House and Senate leadership. Calendar updates can be found at our blog, www.hlregulation.com.
On December 10, 2013, Law360 published a feature article authored by Todd Overman, Partner, and Marta Thompson, Associate, of Hogan Lovells’ Government Contracts Practice in our Washington, D.C. office. The article, titled “A Call for Clarification of SBA, FAR Recertification Rules,” focuses on the confusion current SBA and FAR regulations, as well as recent changes, create for agencies and contractors regarding when a contractor should know that a contracting officer has requested recertification of a small business’s size status. Overman and Thompson write:
As it stands, too much is left to interpretation to accomplish the SBA’s goal of ensuring that “procurements meant for small businesses should be awarded to small businesses.” With the likely increase of small business set-aside orders under GSA schedules, the SBA and the FAR Council would be wise to consider adopting standard recertification language that could be incorporated in task order solicitations, so that no uncertainty exists as to when recertification is required. Standardized language would take the “guessing game” out of what “explicitly requires” means and provide small (and large) businesses greater transparency and predictability into which procurements they qualify for.
A copy of the article can be viewed here (subscription required).
Concerned that differences between the physical characteristics of generic drugs and their reference listed drugs (RLDs) could affect patient outcomes, FDA has issued a draft guidance for industry on the topic. Today’s Federal Register includes a notice announcing the availability of the guidance document, Size, Shape and Other Physical Attributes of Generic Tablets and Capsules, and the opening of a 90-day public comment period. FDA believes differences in characteristics such as product size, shape, weight, coating, surface area and disintegration time may affect patient compliance, the acceptability of medication regimes, and product performance, and could lead to medication errors. For that reason, the draft guidance recommends that manufacturers of generic drugs consider physical attributes in developing quality target product profiles for their products, and provides suggested limits of variation from an RLD, as well as absolute maximums of some characteristics.
The draft guidance would apply to ANDAs and ANDA supplements for additional strengths. Unless there are safety issues, approved generic products would not be expected to change their characteristics to conform to the draft guidance, or to match changes in the RLD.
Comments are due by March 10, 2014, although FDA regulations permit comments on guidances to be submitted at any time. Manufacturers may want to comment on the appropriateness of the identified characteristics (perhaps there are others that FDA missed) or of the amount of variation presented as presumptively acceptable.
The author thanks Katelyn Ruiz for her assistance.
On Saturday, 7 December 2013, the Ninth Ministerial Conference of the World Trade Organization (WTO) announced the successful conclusion of an agreement on Trade Facilitation (Agreement) — an agreement that is intended to streamline customs clearance procedures around the world by imposing new multilateral disciplines on customs procedures in all member countries. The Agreement imposes basic globally applicable principles for transparency, due process, and reasonableness in the development and implementation of customs clearance requirements.
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A bill designed to crack down on patent assertion entities, sometimes called “patent trolls,” easily passed the U.S. House of Representatives yesterday. Sponsored by House Judiciary Committee Chairman Robert Goodlatte (R-VA), the Innovation Act targets oft-criticized patent assertion entities for conduct like sending large numbers of demand letters to small businesses without determining if they are actually infringing.
The Innovation Act, H.R. 3309, sailed through the House with a vote of 325 to 91. The Senate Judiciary Committee, which is considering a similar measure, has scheduled a hearing on it for Dec. 17. The White House supports the legislation, which it sees as responsive to the Administration’s call for steps to curb abusive patent lawsuits in June.
Rep. Jared Polis (D-Colo) added a provision at the 11th hour requiring plaintiffs upon filing of an initial complaint to disclose real-party-in-interest information to the USPTO, the court, and the adverse party. That measure was designed, among other reasons, to stop the practice of patent trolls sending multiple demand letters to the same target by hiding behind various shell corporations. In addition, the bill encourages judges to enforce a “loser pays” system, which generally requires plaintiffs who bring losing patent infringement suits to pay the winner’s costs unless the losing party’s conduct is “reasonably justified.” The bill would also require patent plaintiffs to provide specific details on what patents are infringed and how they are used, and it would limit discovery until after claim construction to prevent plaintiffs from using the cost of discovery to leverage higher settlement payments.
While the bill received widespread support in the House, some opponents – including House Judiciary Committee ranking Democrat John Conyers – argue that the “pleading requirements will keep legitimate inventors out of the courts, and fee shifting will favor wealthy parties and chill meritorious claims.” Other commentators, on the other hand, like Santa Clara Law School Professor Brian Love, argue that the bill does not fix the entire “patent troll” problem and there is even more work to be done.
On 28 November 2013, the Court of Justice of the European Union (“CJEU”) set aside the order of the General Court of the European Union (“General Court”) in the Case T‑44/13 R AbbVie v EMA, wherein AbbVie successfully sought the suspension of the operation of a decision by the European Medicines Agency (“EMA”) to grant a third party access to AbbVie’s clinical study reports in relation to the medicinal product Humira. The CJEU has referred the case back to the General Court for re-examination.
In September 2012, requests were made by third parties to have access to AbbVie’s clinical study reports, which were submitted to the EMA in 2006 and 2009 in their application for extension of the therapeutic use of Humira for the treatment of Crohn’s Disease. This request was submitted by the third parties under Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents (“Regulation”).
Despite AbbVie’s opposition, the EMA granted the request for access to the documents on the grounds, inter alia, that “it was under no legal obligation to consider all of the information submitted in connection with an MA application as confidential information and that clinical information concerning the safety and efficacy of a medicinal product authorised for treatment in human beings need not be considered commercially confidential.”
In response, on 29 January 2013, AbbVie brought an application for annulment of the EMA decision to grant access to these documents, and a separate order to suspend the operation of the EMA decision until the General Court had ruled on the annulment of the EMA decision.
In order to support their application, AbbVie argued that the EMA’s decision infringed Article 4(2) of the Regulation which protects the commercial interests of a natural or legal person, including intellectual property, and that it infringed their fundamental right to protection of confidential information under Article 7 of the Charter of Fundamental Rights of the European Union, Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms and Article 339 Treaty on the functioning of the European Union.
On 25 April 2013, the General Court, satisfied that the order requested by AbbVie was justified, prima facie, in fact and in law and that it is urgent in order to avoid serious and irreparable harm to the applicant’s interests, granted an injunction in favour of AbbVie which prevented the EMA from releasing the documents.
Paragraph 45 of the order of the General Court stated:
“Since, following the weighing up of interests, the balance is thus in the applicants’ favour, there is a clear urgency in protecting the interest defended by them, provided that they are likely to suffer serious and irreparable harm in the event of their application for interim measures being dismissed. In that regard, the applicants maintain, in essence, that the situation which would result from disclosure of the disputed reports could not be undone.”
However, the EMA appealed, to the CJEU, the order of the General Court to suspend the operation of the EMA’s decision.
On 28 November, the CJEU concluded that the General Court “erred in law” by relying on the very existence of AbbVie’s fundamental rights as being sufficient to establish a risk of serious and irreparable harm to AbbVie if the documents were to be disclosed.
Paragraph 43 of the judgment states:
“that the alleged infringement of the AbbVie companies’ fundamental right to the protection of their business secrets, enshrined in Article 339 TFEU, in Article 8 of the ECHR, and in Article 7 of the Charter, and of their right to an effective remedy, enshrined in Article 6 of the ECRH and Article 47 of the Charter, was sufficient in itself to establish the risk of serious and irreparable harm in the circumstances of the present case.”
The CJEU stressed that the applicants seeking interim measures, such as the suspension of the operation of the EMA decision, are required “to prove the facts forming the basis of its claim that serious and irreparable damage is likely”. In order to meet these requirements, the applicant must “show that damage is foreseeable with a sufficient degree of probability”.
As a result, the CJEU set aside the previous order of the General Court suspending the operation of the EMA’s decision, and referred the final judgment back to the General Court for a re-examination on this matter.
There is a concern that if the General Court overrules its previous order, thus granting access to AbbVie’s documents, this could have significant commercial consequences for medicinal products manufacturers in the European Union.
On the same date, the CJEU also delivered a similar ruling in Case C-390/13 P(R) EMA v InterMune UK and Others.
The Cabinet Office has again failed to justify its attempts to avoid the transparency it so often vociferously promotes.
Last week, we reported on the Upper Tribunal’s dismissal of the Cabinet Office’s appeal which effectively sought to avoid the application of the government’s own policy on the reduction of the “30-year rule” to a “20 year rule” for Cabinet Papers. This week, the First-tier Tribunal (the “FTT“) has rejected the Cabinet Office’s attempts to avoid disclosure of the number of times the Reducing Regulation Committee has met in the case of Cabinet Office v Information Commissioner (EA/2013/0119, 27 November 2013).
On November 18, 2013, the Department of Defense (DoD) published a Final Rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to address requirements for safeguarding unclassified controlled technical information. This rule has been in development for over two years with DoD originally publishing a rule-making Notice on March 3, 2010, and a Proposed Rule on June 29, 2011. The Proposed Rule would have created two categories of security protections: “Basic” and “Enhanced.” We summarized the Proposed Rule in a Client Alert in July 2011 here. After receiving extensive industry comments, DoD amended the Proposed Rule to limit the categories of covered information and require only one level of security protection. However, there are still some uncertainties in the Final Rule, such as the lack of a safe harbor for contractors that adopt stringent security measures.
DoD issued a statement on November 19 stating that the Final Rule is “one of many significant follow-on actions to Secretary Hagel’s Oct. 10 memo directing actions to protect DoD unclassified controlled technical information from cyber intrusions and minimize the consequences associated with loss of this information.” Hagel’s October memorandum explained that such data was of increasing concern to the Pentagon because it could give adversaries “extraordinary insight into the United States’ defense and industrial capabilities” and allow them to more quickly develop similar capabilities of their own. Continue Reading
On 23 November 2013 the United States, United Kingdom, Germany, France, Russia, and China facilitated by the European Union (the P5+1), reached an interim agreement with Iran (Iran Agreement or Agreement). While this agreement may ease sanctions in certain limited areas in the future, the provisions of the Agreement must be implemented by the United States, EU, and other countries. In addition, the opportunities for U.S. companies (and their operations outside the United States) generally will not be materially changed as a result of this Agreement.
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Many federal contractors were forced to temporarily stop work during the recent government shutdown, which lasted more than two weeks. In some cases, the government may have formally issued a “Stop Work Order” in response to the shutdown. In others, contractors may have been unable to start or continue work due to the closure of government sites in situations where telework was not a viable or approved option for continuing work. Some contractors also may have experienced delays due to lack of timely approvals and notices to proceed because their contracting officers were on furlough. And now that the contracting officers are back on the job, they may be directing contractors to accelerate performance to make up for lost time caused by the shutdown.
All of these impacts have caused some contractors to question whether the federal government has any legal obligation to compensate them for increased costs suffered because of the shutdown. Unlike the federal government, most contractors could not simply place their salaried employees on temporary furlough during the shutdown, free of any obligation to pay them. For example, contractors may have instructed salaried employees that normally work at government sites to record their time to “Administrative” or “PTO” accounts during the shutdown period. This time not billed to federal contracts could result in increased overhead cost that was not accounted for upon contract formation. Additionally, contractors may have to absorb increased labor or material costs based on acceleration or delay of anticipated delivery schedules resulting from the shutdown. These are just some of the financial repercussions facing contractors in the wake of the government shutdown. Continue Reading