May 17, 2018
On May 14, 2018, in Anacor v. Iancu, the Federal Circuit issued its opinion affirming the Board's invalidation of Anacor's tavaborole patent. The patent-in-suit, U.S. Patent No. 7,582,621, entitled "Boron-containing Small Molecules," is directed to the use of tavaborole to treat fungal infections. According to the disclosure, tavaborole can be used to treat a fungal infection known as onychomycosis, which is a nail disease responsible for approximately half of all nail disorders in humans. In an inter parties review, the Patent Trial and Appeal Board found all of the claims of the '621 patent unpatentable for obviousness. Anacor appealed with respect to only one of the claims and the Federal Circuit affirmed.... Read more
May 15, 2018
In the recent AIDS Healthcare Foundation v. Gilead opinion, the Federal Circuit considered whether AHF's desire to "‘clear out the invalid patents' so that it ‘would have the ability then to partner with generic makers'" immediately upon expiration of the five-year NCE exclusivity for the antiviral agent tenofovir alafenamide fumarate (TAF) was sufficient to give rise to declaratory judgment jurisdiction. It was not.... Read more
May 3, 2018
The USPTO announced that Deputy Commissioner for Patent Examination Policy Robert Bahr will be presenting a webinar pertaining to Subject Matter Eligibility on May 8, 2018 at noon (Eastern Time). See, https://www.uspto.gov/patent/initiatives/patent-quality-chat. The webinar "will discuss the USPTO's recently-issued memorandum implementing changes to examination procedure in view of the U.S. Court of Appeals for the Federal Circuit decision in Berkheimer v. HP, Inc. This judicial decision provides clarification on the subject matter eligibility analysis." See also: https://www.oblon.com/publications/uspto-issues-memorandum-and-publishes-fed-reg-notice-for-comment-regarding-101-eligibility/... Read more
May 2, 2018
In March, the PTAB denied institution of Coherus's IPRs against Hoffman-LaRoche (2017-1916 and 2017-2066). Previously, however, the PTAB instituted Coherus's early IPRs against Abbvie (2016-172, 2016-0188, and 2016-0189). Can any lessons be learned from the different outcomes in these cases?... Read more
April 25, 2018
As re ported earlier, the Federal Circuit in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd. held that jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent. The Court also decided that an injunction is available to prevent inducement of infringement by a label.... Read more
April 23, 2018
On April 20, 2018, the USPTO published (https://www.gpo.gov/fdsys/pkg/FR-2018-04-20/pdf/2018-08428.pdf) in the Federal Register a "Request for Comments on Determining Whether a Claim Element is Well-Understood, Routine, Conventional for Purposes of Subject Matter eligibility" that references a memorandum to the Examiner Corps the day before pertaining to examination procedure regarding Subject Matter Eligibility (https://www.uspto.gov/sites/default/files/documents/memo-berkheimer-20180419.PDF). The public comment period ends on August 20, 2018.... Read more
April 16, 2018
On April 13 the Federal Circuit affirmed the lower court decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd., appeal Nos. 2016-2707 and 2016-2708. The opinion addresses a number of concerns in ANDA litigation including whether jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent (it does), the availability of an injunction to prevent inducement of infringement by a label (it is available), and the patent eligibility of a claim to using a drug based upon the results of a diagnostic technique. It is this latter point which is of significant importance. Claim 1 of the patent (USP 8,586,610 (‘610)):... Read more
April 13, 2018
The recent decision by the Federal Circuit in In re Merck & Cie shows what an uphill battle it can be to overcome a finding of obviousness by the PTAB. Merck argued that the PTAB's interpretation of the prior art, van Etten et al., was simply unreasonable and, thus, the PTAB's decision was not supported by substantial evidence.... Read more
April 9, 2018
In an attempt to understand the frequency of commercial success arguments and the likelihood of success of those arguments in TC 1600 IPRs, I used information from Oblon's TC 1600 library to compile statistics. As seen below, commercial success is not often relied upon, even for IPRs challenging patents covering named drugs. And, digging into the details of the cases reveals that—even when argued—commercial success very rarely wins the day.... Read more
April 2, 2018
As others have observed, the January 2018 MPEP revision instructs the examiners to reject Markush claims. It asserts that "this is a rejection on the merits and may be appealed to the Patent Trial and Appeal Board." Page 700-110. In form ¶ 8.40 it asserts as authority In re Harnisch, 631 F.2d 716, 721-2(CCPA 1980) and Ex Parte Hozumi, 3 USPQ2d 1050, 160 (Bd. Pat. App. & Int. 1984). No statutory authority exists since it has been held the restriction statute, 35 USC § 121 does not provide a basis for a substantive rejection of a claim. In re Weber, 580 F.2d 455 (CCPA 1978) and In re Haas, 580 F.2d 461 (CCPA 1978).... Read more