The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost . . . will be recovered from sales in the United States of such drug.” See 21 U.S.C. § 360bb(a)(2). H.R. 4712 (the “Fairness in Orphan Drug Exclusivity Act”), which passed the House on November 17, seeks to amend the latter “cost recovery” pathway in order to address what has been called a “loophole” in the Act.
Effective December 1 of this year, Rule 23 of the Federal Rules of Civil Procedure – governing class action lawsuits – was amended. Among other things, the amendments modernize the rule with respect to electronic communications, set forth a more unified approach to approving settlements, and discourage bad faith objectors to class action settlements.
On December 1, 2017, two amendments to the Federal Rules of Evidence came into effect that impact how courts authenticate digital evidence. The addition of two categories to Rule 902’s list of self-authenticating documents seeks to streamline the introduction of digital evidence by avoiding costly delays that often serve little purpose. In doing so, it promises greater efficiency to those who adapt their practices to the new requirements.
Rule 902(13) waives the requirement of external authentication for “records generated by an electronic process or system,” provided that the accuracy of the process or system is certified by a person who meets the qualification requirements of 902(11) or (12). Examples of such records provided by the Advisory Committee include an operating system’s automated log of all USB devices connected to the computer, or a phone software’s machine-generated record of the time, date, and GPS coordinates of each picture taken.
We previously covered a proposed amendment to the New York Commercial Division Rule 20 that aimed to require moving parties seeking a temporary restraining order (“TRO”) to, absent significant prejudice, provide opposing parties with copies of all supporting papers as well as notice before any TRO could be issued.
On February 28, 2017, Southern District of New York Magistrate Judge Andrew J. Peck issued a warning shot, stylized as a “wake-up call,” to the SDNY Bar: comply with the now 15-month-old amendments to the Federal Rules of Civil Procedure when objecting to requests for the production of documents and electronically stored information (ESI), or do not bother objecting at all.
Currently, the New York Civil Practice Law and Rules permit temporary restraining orders (“TROs”) to be issued without notice to the opposing party – though this practice is discouraged by most judges. CPLR § 6313(a). Notice is not required if the moving party can demonstrate that there will be significant prejudice by reason of giving the notice. Commercial Division Rule 20. When notice is required, however, there is no requirement that the movant attach the underlying papers describing the ground for issuing a TRO.
The New Year brought with it many new rule changes for federal and California courts, including in the area of electronic service and filing. A few key rules regarding requirements for electronic paperwork and service are summarized below.
Several amendments to the Federal Rules of Appellate Procedure are scheduled to take effect on December 1, and one of those amendments is causing consternation among appellate practitioners: a 1000-word reduction in the word limit for principal briefs, along with a 500-word reduction for reply briefs. Since 1998, the Rules have allotted parties 14,000 words for their principal briefs, provided that they comply with certain typeface requirements. Under the new Rules, that limit will be reduced to 13,000 words. Reply briefs will continue to be limited to half the length of principal briefs, and will therefore be shortened by 500 words.
In support of the rule change, the Advisory Committee noted that the current 14,000-word limit resulted from an attempt in 1998 to convert the 50-page limit then in effect into a cap on words. At that time, the Committee concluded that briefs generally contained about 280 words per page — and 280 words-per-page times 50 pages equaled 14,000 words. Now, the Committee has revised its view and concluded that appellate briefs prior to 1998 actually had closer to 250 words per page, which in its view justified reducing the word limit to 12,500 words. Pushback from appellate practitioners resulted in the new limit being upped from 12,500 to 13,000 words.