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
March 29, 2018
Urvashi Bhagat appealed the decision of the PTAB ("the Board") affirming the examiner's anticipation rejections and the rejection under Section 101 of multiple claims in application 12/426,034. The Federal Circuit affirmed the Board's decision in the recent In re Urvashi Bhagat nonprecedential opinion. The claims of this application were directed to lipid-containing formulations comprising omega-6 and omega-3 fatty acids. The '034 application stated that dietary deficiency or imbalance of these fatty acids might lead to a variety of illnesses, and that omega-6 and omega-3 fatty acids are naturally occurring in oils, butters, nuts, and seeds. The '034 application claimed ranges and ratios of the fatty acids and other limitations.... Read more
March 23, 2018
Oblon recently participated in the Association of University Technology Managers (AUTM) annual meeting in Phoenix, Arizona (https://www.autm.net/2018-annual-meeting/home/). This conference draws over 1700 tech transfer professionals to discuss licensing and IP issues in the context of technology transfer. This year, at the AUTM meeting, a pitch and play venture competition was held where several start-up companies pitched their business opportunity for a chance to be awarded a cash prize.... Read more
March 19, 2018
In the recent, nonprecedential Exergen opinion, a panel of the Federal Circuit considered the subject matter eligibility of a diagnostic method patent claim. The majority found a diagnostic method to be directed to patent-eligible subject matter, notwithstanding the Supreme Court's decision in Mayo and the Federal Circuit's subsequent decision in Ariosa.... Read more
March 13, 2018
There has been a lot of discussion recently regarding claims by the Saint Regis Mohawk Tribe ("Saint Regis") of sovereign immunity as a defense against inter partes review of certain patents owned by Saint Regis. The issue came about as a result of a deal made between Allergan and Saint Regis under which Allergan (the original owner of the six patents involved) paid Saint Regis $13.75 million to take ownerhip of the six patents for Allergan's Restasis drug, and license them back exclusively to Allergan, with the promise of ongoing royalties. When those six patents were challenged in an inter partes review at the Patent Trial and Appeal Board (PTAB), Saint Regis asserted that the patents were shielded from such inter partes review by the theory of tribal sovereign immunity, by extension of a 2017 PTAB ruling that the University of Florida (as a state entity of the state of Florida) was immune to such IPR challenge by Covidien LP. In other decisions, the PTAB has reiterated that state sovereign immunity applies in IPR's.... Read more
March 8, 2018
As patent prosecution practitioners, we often look for direction from the judges at the PTAB, particularly when agreement cannot be reached at the examining level. This is very evident when there is imprecise guidance as to what constitutes patent eligible subject matter for inventions including natural products following the Supreme Court's decision in Myriad as well as the various iterations of PTO guidance and training materials. Here is a tale of two cases with two different panels (yet each panel interestingly includes one common APJ (New)) and each panel renders very different decisions.... Read more
February 12, 2018
In a recent IPR between Apotex v. OSI Pharmaceuticals, the PTAB relied on an OSI Securities and Exchange Commission (SEC) filing, a 10-K, to find the challenged claims unpatentable. (A 10-K is an SEC filing that provides a summary of a company's financial performance).... Read more