Publications

January 13, 2020ArticlePersion v. Alvogen: Inherency in Obviousness AttacksLast month, the Federal Circuit affirmed the District Court of Delaware's decision in Persion Pharmaceuticals v. Alvogen invalidating as obvious two Persion patents claiming methods of treating pain in patients with hepatic impairment (compromised liver functionality) using hydrocodone. Important to the Federal Circuit's decision was the concept of "inherency." More
January 3, 2020ArticleRepeated Description of an Embodiment as the Present Invention that Solves Problems in the Prior Art may Lead to Disavowal of Claim Scope, Even Without an Express Concession of Other EmbodimentsMultiple companies (collectively "Techtronic Industries" or "TTI") appealed from a final determination of the United States International Trade Commission (the "Commission") that their imported product (garage door opener products) infringed the claims of U.S. Patent 7,161,319 (the "319 patent"). More
December 19, 2019ArticleNot-So-Safe Harbor for Hospira's Erythropoietin BiosimilarThis week the Federal Circuit affirmed Amgen's win against Hospira with respect to Hospira's erythropoietin ("EPO") biosimilar—a drug used to increase red blood cell number—in a Delaware trial where Amgen's U.S. Patent No. 5,856,298 was found to be infringed and not invalid and Amgen was found to be entitled to $70 million for damages associated with its EPO drug Epogen®. Part of the appeal was also dedicated to examining the so-called Safe Harbor provision of 35 U.S.C. § 271(e)(1), where the Federal Circuit agreed with Amgen that Hospira manufactured at least 14 batches of the drug that were not protected by this provision. The Court's decision provides lessons in how companies should be careful to avoid stretching the bounds of the Safe Harbor provision. More
December 16, 2019ArticleSolicitor General on Patent EligibilityThe Solicitor General (SG) was invited by the Supreme Court to provide comments on the certiorari petitions filed by Berkheimer and Hikma to review the Federal Circuit's 101 decisions adverse to them. The two briefs have numerous similarities including identifying the Court's decision in Bilski[1] as starting the patent eligibility confusion by not grounding its decision on interpreting the meaning of the 35 U..S.C. 101 terms "process, machine, manufacture, [and] composition of matter." The SG asserts that in Bilski the Court did not ground its decision on the stature terms but instead found three exceptions to be not required by the statutory text: laws of nature, physical phenomenon, and abstract ideas. While these concepts are found earlier Supreme Court decisions, Bilski represented the first time they were used independent of the statutory language or constitutional concept of the "useful arts." The SG then described Mayo[2] as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice[3] characterized the Mayo decisional approach as a two step process. More
December 9, 2019ArticleMotions to Amend in Inter Partes Review: Why did Ethicon Cut Against the Grain?Motions to amend (MTAs) are generally disfavored. The prevailing approach calls for patentees to file an MTA in Inter Partes Review (IPR) only in limited circumstances. In particular, most patentees are moving to narrow or clarify claim scope via an MTA only in cases where (i) there is no related application pending at the Office and (ii) the specter of lost past damages due to intervening rights outweighs the risk of an invalidity finding. At first glance, neither (i) nor (ii) appears to be true in the case of Intuitive Surgical, Inc. v. Ethicon, LLC, (IPRs2018-00933, 00934, and 00935), yet Ethicon elected to pursue an MTA in each of the IPRs and was successful in doing so. More
November 20, 2019ArticleShort-Term Uncertainties after ArthrexThe Federal Circuit in a precedential opinion in Arthrex, Inc. v. Smith & Nephew, Inc., vacated and remanded a final written decision of the Patent Trial and Appeal Board (PTAB), finding that the Administrative Patent Judges (APJs) are not constitutionally appointed, violating the Appointments Clause. Arthrex, Inc. v. Smith & Nephew, Inc., No. 2018-2140 (Fed. Cir. Oct. 31, 2019). The opinion in Arthrex also indicates that an Appointments Clause challenge should be timely raised on appeal, and thus, is waived when not presented in an appeal that has passed or been decided. More
November 6, 2019ArticlePatent Eligibility Under 35 U.S.C. 101 of Articles of ManufactureFYF-JB, LLC sued Pet Factory, Inc. for infringing its U.S. Patent 9,681,643 ("the ‘643 patent") covering a tug toy for animals that emits a sound when it is pulled on both sides. Pet Factory moved to dismiss FYF-JB's complaint, arguing that the asserted claims were directed to patent ineligible subject matter under 35 U.S.C. § 101. The United States District Court for the Northern District of Illinois ("the Court") denied Pet Factory's motion to dismiss. More
October 23, 2019ArticleThink Before You Sign: Protecting IP Rights with MTAsMaterial transfer agreements (MTAs) are contracts that allow one party to perform research using the materials of another party. These agreements provide a mechanism to protect the interests of the owners of discoveries and inventions, while promoting data and material sharing in the research community. Although these are admirable goals in principle, MTAs have a bad reputation with some researchers and institutions for being overly complex and, in fact, hindering research. Nonetheless, MTAs are important for defining the rights, responsibilities, and obligations of the parties with respect to research collaborations and need to be carefully considered, particularly with respect to ownership of IP rights implicated by the transferred materials. More
October 11, 2019ArticleThe Flip Side of Reasonable Expectation of Success is UnpredictabilityThe Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1925.Opinion.10-4-2019.pdfreversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably: More
September 19, 2019ArticlePrior Art Introduced During Prosecution Has Important Implications for 101 ChallengesFive years after Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) and the institution of the Alice test, district courts are still wading through precedent set by the Federal Circuit while it attempts to apply the test. Recently, one New Mexico District Court turned to prior art introduced during the prosecution process that was aimed at the questions of novelty and non-obviousness to determine whether there was an "inventive concept" for the Alice/Mayo test. More
September 17, 2019ArticleProsecution History Estoppel And Amendments Tangential To PatentabilityThe doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel. More
August 30, 2019ArticleThinking Outside the (Utility Patent) Box - Don't Overlook Design Patent Protection in the Life SciencesDesign patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined in scope by the content of the drawings rather than the words of a set of claims. Further, design patents have a 15 year term, as opposed to 20 years from filing for utility patents. More
August 16, 2019ArticleNon-Limiting Clauses and Written Description Based on Substantially Equivalent DisclosureNalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time. More
August 12, 2019ArticleAn Approach to Pharma Life Cycle ManagementEvery innovative pharma company faces the same challenge, how to delay the patent cliff. The existence of the "skinny viii" (21 U.S.C. § 355(j)(2)(A)(viii)) makes developing additional FDA approved indications unattractive from an LCM viewpoint. More
July 5, 2019ArticleUpdate & Reminder: Patent Term Adjustment Related to IDS Safe HarborOn November 9, 2018, I wrote about the USPTO's release of interim procedures for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (http://www.lifesciencesipblog.com/?t=39&format=xml&A=18655&p=15972). More
June 17, 2019ArticleCommercial Success of Claimed Product over Non-Infringing Competitive Products as Evidence of Non-ObviousnessDuring litigation or contested proceeding the patentee can point to commercial success of a product as evidence of non-obviousness of the claimed product. Although some work is necessary to show the nexus between the success in the market and the claimed invention, the evidence showing, for example, the product taking sales from competitive products could help the patentee's case. More
June 14, 2019ArticleSOVEREIGN IMMUNITY AND IPR'S: AND NOW, THE REST OF THE STORYRadio great Paul Harvey would always leave listeners hanging during his broadcast, then return from a commercial with "the rest of the story". Previously, I wrote on the Federal Circuit ruling with respect to Tribal Immunity (https://www.oblon.com/publications/tribal-immunity-in-ipr-is-dealt-a-death-blow-by-the-federal-circuit). At the end of that article I stated: "I note, however, that in the final sentence of their analysis, the Federal Circuit explicitly stated that this decision did NOT address whether there is any reason to treat state sovereign immunity differently with respect to IPR proceedings. That will remain to be seen…" More
May 21, 2019ArticleWhat You Say Can Hurt YouOften in writing applications there is a tendency to denigrate prior art techniques. This is not risk free as the patentee in Nuvo Pharmaceuticals (Ireland) v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. May 15, 2019) discovered. More
May 9, 2019 ArticlePTAB Issues Two New Precedential Opinions On Discretion to Deny Review - Implications for GenericsThe PTAB designated two decisions as precedential this week (in addition to several in previous weeks), both relevant to the Board's discretion to deny review. These cases illustrate that the PTO is in the process of designating precedential opinions on a number of issues, in line with revised Standard Operating Procedure 2 for designating precedential and informative decisions. See my previous posts on other recent precedential decisions here and here. More
March 19, 2019ArticleInvention by "Another": Duncan Parking Technologies, Inc. v. IPS Group, Inc., Appeal No. 2018-1205, -1360 (Fed. Cir. Jan. 31, 2019)IPS Group Inc. ("IPS") appealed from two decisions of the United States District Court for the Southern District of California granting summary judgment of non-infringement of U.S. Patents 8,595,054 and 7,854,310. Duncan Parking Technologies Inc. ("DPT") appealed from a related decision of the Patent Trial and Appeal Board ("the Board") in an inter partes review holding that claims 1–5 and 7–10 of the '310 patent were not shown to be unpatentable as anticipated under 35 U.S.C. § 102(e). More
March 12, 2019ArticleBiologic Patent Transparency Act - New Bill Aimed at BiologicsA bipartisan group of senators sponsored a bill this week—the Biologic Patent Transparency Act, S. 659—aimed at making patent information associated with biologics easier to identify and easing the approval process for biosimilar manufacturers encountering patent roadblocks. More
March 11, 2019ArticleMotions to Amend: Is the PTAB's Lectrosonics Order Just of Western Digital?Spring gardening season has begun and the USPTO is once again planting its Motion to Amend ("MTA") seeds. In a substantial redux of Western Digital Corporation v. Spex Technologies, IPR2018-00082, -00084, paper 13, the PTAB this past week designated paper 15 of Lectrosonics v. Zaxcom, IPR2018-01129, 01130("Lectrosonics Order") as an informative decision. More
February 27, 2019ArticleThe Federal Circuit Stays the Course in Patent Ineligibility for an Abstract IdeaIn a precedential opinion issued on February 26, 2019, the Federal Circuit affirmed the District Court's finding of patent ineligibility for a claim "directed to the abstract idea of "collecting, analyzing, manipulating, and displaying data."" University of Florida Research Foundation Inc. v General Electric Company et al (Fed. Cir. 2019). More
February 24, 2019ArticleNo More IPRs From Generic Drug Makers?The USPTO argues that a petitioner who has received a favorable final written decision in an IPR is estopped from reusing the same winning argument in a district court. More
January 28, 2019ArticleUSPTO's Patent Term Adjustment Policies Reigned in Yet AgainSince the Federal Circuit's decision in Wyeth v. Kappos, 591 F.3d 1364, 93 U.S.P.Q. 2d 1257 (Fed. Cir. 2010), aff'g, Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 U.S.P.Q.2d 1538 (D.D.C. 2008), which held that the USPTO was improperly reducing patent term adjustment (PTA) by improperly calculating "overlapping" days of agency delay under 35 U.S.C. §154, the courts have been asked on numerous occasions to look at how the USPTO is calculating PTA. More