Attorney:
Jeffrey B. McIntyre
January 13, 2020
Last 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."... Read more
Attorney:
Marina I. Miller, Ph.D.
January 3, 2020
Multiple 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").... Read more
December 23, 2019
Oblon has been recognized as the law firm that has worked with the most members of the US Patent Elite on patent prosecutions at the USPTO. In addition, Oblon representatives are identified to have filed the highest volume of patent applications for the US Patent Elite, according to analysis conducted using Anaqua’s AcclaimIP Analytics Software.<... Read more
Attorney:
Lisa M. Mandrusiak
December 19, 2019
This 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... Read more
Attorney:
Richard D. Kelly
December 16, 2019
The 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.... Read more
Attorney:
Todd W. Baker
December 9, 2019
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.... Read more
Attorney:
Grace Kim
November 20, 2019
The 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.... Read more
Attorney:
Marina I. Miller, Ph.D.
November 6, 2019
FYF-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.... Read more
Attorney:
Lisa M. Mandrusiak
October 23, 2019
Material 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.... Read more
Attorney:
Richard D. Kelly
October 16, 2019
In patents for diagnostic methods, which natural phenomena the patent is directed to may be just as important as whether it is directed to a natural phenomenon at all. A January 2019 decision of the Patent Trial and Appeal Board (PTAB) suggests that which natural phenomena a court determines the patent claim is directed to under Alice step one could have significant implications for Alice step 2. The Board’s decision in Ex parte Lee stands in contrast to the Federal Circuit’s decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. And comparing the two side-by-side reveals that patent applicants have an incentive to not only argue whether their patent is directed to a natural phenomenon, but also to which natural phenomena it is directed.
Ex Parte Lee concerned an appeal from the Examiner’s determination that the diagnostic claims were patent ineligible. Claim 1 of the application was representative and describes:<... Read more
Attorney:
Daniel J. Pereira, Ph.D.
October 11, 2019
The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed 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:... Read more
Attorney:
Yuki Onoe
October 9, 2019
特許期間調整に関する米国特許庁ルールの変更が提案されました
米国の出願審査が特許庁の遅延により極端に遅れた場合、その遅れの日数分だけプラスアルファで特許期間を長くするよう調整されます。一方で、出願人が期限延長を行うなど、自ら遅れの原因を作ってしまった場合、プラスアルファで長くなった日数分から出願人の遅延分が差し引かれることになります。このような特許期間調整（Patent Term Adjustment, PTA）により特許期間が１日でも長くなるとビジネス上大きなメリットとなり得るため、PTAを自ら減らすことのないよう拒絶応答を進めることが大事です。
先週10月4日付のFederal Registerにおいて米国特許庁は、PTAの計算方法に関する特許庁ルールの変更を提案しました。これは、今年1月のSupernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019)の判決内容に沿ってルールを変更することを目的としています。
Supernus事件では、出願人の遅延（"a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application"）によりPTAが差し引かれる際の日数の数え方が争点になりました。関係するのは37 CFR 1.704(c)(8)で、現行のルールは下記の通りです。<... Read more
Attorney:
Richard D. Kelly
September 19, 2019
Five 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.... Read more
Attorney:
Richard D. Kelly
September 17, 2019
The 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.... Read more
September 13, 2019
On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more
Attorney:
Marina I. Miller, Ph.D.
September 9, 2019
Drs. Stephen Quake and Christina Fan ("Quake") appealed a decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board ("the Board") finding the four claims of Quake's U.S. Patent 8,008,018 and Claim 25 of their U.S. Application No. 12/393,833 unpatentable for lack of written description.... Read more
Attorney:
Lisa M. Mandrusiak
August 30, 2019
Design 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.... Read more
Attorney:
Daniel J. Pereira, Ph.D.
August 16, 2019
Nalpropion 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.... Read more
Attorney:
Yuki Onoe
August 16, 2019
「特定の」塩の組み合わせを強調して反論を行ったために包袋禁反言（審査経過に基づくエストッペル）が適用された事例<... Read more
Attorney:
Richard D. Kelly
August 12, 2019
Every 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. Such additional indications may allow for market expansion during the life of the patents protecting the original indication but offer no protection once those patents have expired. With a skinny viii the generic seeks approval only for indication with the earliest patent expiration. Formulation patents often provide scant protection because of the possibility of design arounds and being more easily challenged for invalidity since often the original patents are available as prior art... Read more
July 17, 2019
Enzo Life Sciences, Inc. ("Enzo") appealed the decision of the U.S. District Court for the District of Delaware granting summary judgment against Enzo and holding that the asserted claims were invalid for lack of enablement. The Federal Circuit affirmed.... Read more
July 15, 2019
In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that: Frequently, the Supreme Court in patent cases articulates a general principle and leaves it to our court to both administer the rule and apply it to the individual case.... Read more
July 5, 2019
On 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) (https://www.lifesciencesipblog.com/?t=39&format=xml&A=18655&p=15972).... Read more
July 2, 2019
In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101. Among other things, the guidance emphasized that claims otherwise reciting a judicial exception (i.e., not patentable), would be permitted if they were directed to some type of practical application. See our previous post for more details.... Read more
Category: PTAB 101
June 20, 2019
As all patent practitioners know, obviousness-type double patenting is a judicially created doctrine to prevent the unjust extension of patent term of follow on patents that are simply obvious variants of earlier patents. The doctrine is applied during prosecution with the USPTO and can be used to challenge the validity of issued patents in contested matters. 35 USC 121 also speaks to this issue in certain circumstances.<... Read more
June 17, 2019
During 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.... Read more
June 14, 2019
Radio 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…"... Read more
May 28, 2019
Amneal Pharmaceuticals, LLC. ("Amneal") filed two petitions for inter partes review of claims 1–13 and 16–19 of U.S. Patent No. 9,034,376 ("the '376 patent") of Purdue Pharma L.P., P.F. Laboratories, Inc. and Purdue Pharmaceuticals L.P. ("Purdue"). In the petitions, Amneal argued that claims 1–13 and 16–19 were unpatentable for obviousness over the combinations of multiple prior art references including US 2002/0187192 A1 ("Joshi").... Read more
May 22, 2019
In "United Cannabis v. Pure Hemp Collective," United Cannabis claims that Pure Hemp used a cannabis extract that United Cannabis had a patent on. Lawyers say this case is the first of its kind.... Read more
May 21, 2019
Often 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.... Read more
Category: Patent Eligibility
May 9, 2019
The 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.... Read more
April 29, 2019
Marijuana, for medical purposes and recreational purposes, is an area of great political, social and legal interest. By some accounts (https://www.forbes.com/sites/thomaspellechia/2018/03/01/double-digit-billions-puts-north-america-in-the-worldwide-cannabis-market-lead/#6d925dd76510), the industry is rapidly growing leaps and bounds. Not surprisingly, patents and disputes centered on patents for this industry are increasing in numbers.... Read more
April 16, 2019
同一特許に対するIPR再申請 ¾審理開始は不可能ではないが難しい<... Read more
April 3, 2019
In the April 1 Cleveland Clinic Foundation v. True Health Diagnostics LLC decision, the Federal Circuit has once again given itself a black eye in finding a new diagnostic procedure to be patent ineligible and with the same punch dissed the USPTO.... Read more
March 26, 2019
The Federal Circuit on March 19 in Natural Alternatives Intl. v Creative Compounds LLC. reversed a district court's opinion finding Natural's patent claims to be patent ineligible. The district court's decision arose out of a motion for judgment on the pleadings filed by Creative.... Read more
Category: Federal Circuit
March 19, 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).... Read more
March 12, 2019
A 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.... Read more
March 11, 2019
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.... Read more
March 4, 2019
In an order last month, the Delaware district court ruled that some communications involving Onyx's patent agent were not privileged and must be produced to Cipla. The court's order highlights potential pitfalls when relying upon advice solely from patent agents.... Read more
February 27, 2019
In 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).... Read more
February 24, 2019
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. If the Federal Circuit in BTG International Ltd. v. Amneal Pharmaceuticals LLC, agrees with the PTO, an ANDA sponsor would not take the risk of "winning" at the PTAB and would rather present the best argument in a district court.... Read more
February 11, 2019
In the recent decision, Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., the Federal Circuit affirmed the PTAB's finding that Claims 8 to 13 of U.S. Reissue Patent 38,551 ("the '551 patent") owned by Research Corporation Technologies, Inc. ("RCT") are not unpatentable.... Read more
January 28, 2019
Since 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. Not every case has been decided in favor of the challenger, but a fair amount has. In addition, the USPTO has identified several internal errors including not accounting for the IDS safe harbor under 37 C.F.R. §1.704(d). As such, patentees should be very mindful of this evolving and important provision of law.<... Read more
January 2, 2019
The USPTO has recently announced extension of Patents 4 Patients, also called as the Cancer Immunotherapy Pilot Program, until June 30, 2020. This pilot program was started on June 29, 2016, to provide a fast-track examination for an application related to cancer immunotherapy. The PTO’s goal is to issue a final decision within a year of the entry of the program. <... Read more
December 12, 2018
In Roche Diagnostics the Federal Circuit continued its failure to recognize that diagnostic claims were not patent ineligible because they used a natural law. Roche involved claims detecting the Mycobacterium tuberculosis strains (MTB) quickly and accurately. Prior to the invention delays often occurred in diagnosing tuberculosis because of the time necessary to detect its presence involved a three to eight week cell culture. Roche discovered that the MTB strains could be quickly identified by identifying the presence of specific nucleotide sequence which functioned as a signature for the MTB. The technique used to identify the presence or absence of the signature nucleotide was conventional PCR analysis. The Federal Circuit affirmed a finding the diagnostic claims to be patent ineligible because the PCR technique was conventional and nucleotides naturally occurring.... Read more
December 12, 2018
Since the Supreme Court's decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), there has been significant discussion on SAS's expected effect on estoppel for IPRs. Essentially universal opinion holds that estoppel will apply to all grounds raised in the IPR petition due to the all-or-nothing institution standard applied by the Patent Trial and Appeal Board ("PTAB") in response to SAS. Post-SAS, final written decisions in IPRs will address all grounds raised in the petition if at least one ground meets the standard for institution, thus making estoppel applicable to all petition grounds as grounds "that the petitioner raised … during that inter partes review" under 35 U.S.C. § 315(e).... Read more
December 10, 2018
In a November 26, 2018 order, the U.S. District Court for the District of Delaware ordered the Wisconsin Alumni Research Fund (WARF) to pay The Washington University – St. Louis (Wash. U.) $31.6 million for breach of contract (The Washington University v. Wisconsin Alumni Research Foundation, Civ. No. 13-2091-JFB). The case originated when Wash. U. filed suit against WARF for breach of contract, breach of fiduciary duty, breach of the implied covenant of good faith and fair dealing, and equitable accounting, relating to a 1995 agreement between the parties entitled "Inter-Institutional Agreement for Prevention of Hyperphosphatemia in Kidney Disorder Patients" (the "IIA"), and particularly relating to the drug paracalcitol. The IIA covered certain patent rights for US Patent 5,597,815, jointly owned by Wash. U. and WARF.... Read more
December 6, 2018
In IPR2018-00673, Paper No. 27, the Patent Trial and Appeal Board ("Board") refused to grant patent owner Wi-Lan's motion to dismiss despite its disclaimer of the only claims for which the Board had found petitioner LG as having a reasonable likelihood of success. LG filed an IPR petition seeking to invalidate claims 1-4 and 6-9 of U.S. Patent No. 9,497,743 ("the '743 patent"). The Board's institution decision found that LG had established a reasonable likelihood that LG would prevail in showing the unpatentability of claims 1-4 of the '743 patent, but not for claims 6-9. Pursuant to SAS, however, the Board instituted trial on claims 1-4 as well as claims 6-9.... Read more
December 3, 2018
Yeda Research and Development Co., Ltd. ("Yeda") is the assignee of three "Copaxone patents" that describe and claim COPAXONE® 40mg/mL (glatiramer acetate ("GA")), a treatment for relapsing-remitting multiple sclerosis ("RRMS"). For analyzing the obviousness of the Copaxone patents, a key limitation of the claims is the administration of a 40mg GA dose in three subcutaneous injections over seven days. The Patent and Trademark Appeal Board ("the Board") found (and the district court affirmed) that the prior art described all limitations of the claims except for the administration of 40mg GA 3x/week for seven days. However, the Board and the district court concluded that the claimed dosage regiment would have been obvious to a parson of skill in the art (POSITA). Yeda appealed both decisions.... Read more
November 30, 2018
Post grant reviews (PGRs) have proven to be more popular in the biotechnology space (TC 1600) than any other art unit, with 42—or 28.1%—of the PGRs filed to date classified as TC 1600 patents.[1] By way of comparison, TC 1600 makes up just 10.1% of all IPRs filed to date. Perhaps not surprisingly, PGRs are appealing for challengers of biotechnology patents because written description, enablement, and indefiniteness can all be raised, and these § 112 hurdles tend to be more challenging in the unpredictable arts of TC 1600. <... Read more
November 20, 2018
The Internet of Medical Things (IoMT) is a hot topic in the world of medical devices. This summer, at the MedTech conference in Philadelphia, IoMT was the word on everyone's lips. No wonder, as a recent report by Allied Market Research predicts that IoMT will be a $136.8 billion market by 2021.... Read more
November 16, 2018
In a November 9, 2018 decision (copy of decision linked below), the U.S. Court of Appeals for the Federal Circuit ruled that the doctrine of assignor estoppel does not apply in the inter partes review (IPR) context (see Arista Networks, Inc. v. Cisco Systems, Inc., (Fed. Cir. 2018)).... Read more
November 9, 2018
On Friday, November 2, 2018, the USPTO released its interim procedure 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) (83 Fed. Reg. 55102 (Nov. 2, 2018); see text at: https://www.gpo.gov/fdsys/pkg/FR-2018-11-02/pdf/2018-24004.pdf). The interim procedure is effective from the date of the notice until the USPTO can update the patent term adjustment computer program and provide notice to the public that the program is updated.<... Read more
November 8, 2018
The IPR estoppel provision was originally intended as a check against patent challengers attacking patents serially in the USPTO or other forums based on grounds that were raised or "reasonably could have been raised" in the original IPR. Although the Federal Circuit has interpreted estoppel narrowly, district courts were split, and estoppel's impact has remained in flux for several years.... Read more
October 26, 2018
James Love co-edited a medical device book titled "IP Strategies for Medical Device Technologies: Be Your Own Incubator".... Read more
October 25, 2018
In a non-precedential decision issued by the U.S. Court of Appeals for the Federal Circuit (FWP IP APS v. Biogen MA, Inc., October 24, 2018, http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2109.Opinion.10-24-2018.pdf), the Court was tasked with reviewing a PTAB decision of an interference between the named parties.<... Read more
October 22, 2018
Teva Pharmaceutical USA, Inc. filed a Complaint and Motion for Preliminary Injunction in the U.S. District Court for the District of Columbia, alleging that the FDA's recent interpretation of the definition of "first applicant" is unlawful.... Read more
October 12, 2018
In Rite-Hite v. Kelley Co., 56 F.3d 1538 (Fed. Cir. 1995) the Federal Circuit refused to award damages for the goods which were regularly sold as part of a package including patented goods.... Read more
October 5, 2018
Using the same invalidity evidence to address apparatus and corresponding method claims in inter partes review ("IPR") petitions can present difficulties depending on the claim language used in the apparatus claims.... Read more
October 4, 2018
Motivation to combine and reasonable expectation of success are separate requirements that must be independently considered. By capitalizing on shortcomings in the petitions related to separately arguing these issues, Genentech was able to save two of three patents covering its blockbuster drug Herceptin®.... Read more
October 3, 2018
Plaintiff-cross-appellant Trustees of Boston University ("BU") sued defendants-appellants Everlight Electronics Co., Ltd. and others for infringing BU's U.S. Patent No. 5,686,738. A jury found that Defendants infringed the '738 patent and failed to prove the patent's invalidity.... Read more
October 1, 2018
On September 24, 2018, the Solicitor General filed a motion to participate in oral argument as amicus curiae in Helsinn Healthcare v. Teva Pharmaceuticals. The U.S. government's interest in this case is obvious, as the decision would have a direct impact on how the USPTO examines and determines patentability of invention.... Read more
September 27, 2018
Hindsight bias is not simply an old chestnut argued ad infinitum in response to obviousness challenges. In this week's final written decision in IPR2017-01053 upholding all claims of U.S. Patent No. 8,268,299, the PTAB illustrated that—under the right circumstances—this argument can have teeth.... Read more
September 7, 2018
After determining that its competitor GKN's patent raised a potential risk of infringement for a product under development, JTEKT[1] challenged the patentability of claims 1–7 of U.S. Patent No. 8,215,440 via inter partes review (IPR2016-00046). When claims 2 and 3 were confirmed as patentable in the final written decision—and thus the risk of infringement remained—JTEKT appealed, and GKN moved to dismiss the appeal based on lack of standing.... Read more
September 7, 2018
In an interesting, but non-precedential, decision from the Court of Appeals for the Federal Circuit (Supernus Pharmaceuticals, Inc. v TWI Pharmaceuticals, Inc et al (Fed. Cir., September 6, 2018-http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2513.Opinion.9-6-2018.pdf), the Court affirmed a decision from the U.S. District Court of New Jersey.... Read more
August 28, 2018
Over the summer, representatives introduced bills and amendments of interest to the pharmaceutical industry. First, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee that would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation and IPR, removing the option to use both. According to Senator Hatch, this Hatch-Waxman Integrity Act of 2018 would ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop lower-cost drugs, while at the same time providing innovators a period of exclusivity to recoup investments. Specifically, Senator Hatch commented that the availability of an alternative path to challenge patents through IPRs has threatened to upend the carefully-crafted Hatch-Waxman balance by enabling companies to put added litigation pressure on drug innovators above and beyond what Hatch-Waxman already provides.... Read more
August 20, 2018
Last week the Federal Circuit denied West-Ward's petition for rehearing en banc. At the time of the original Federal Circuit decision (Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the case generated substantial commentary in regard to its patent eligibility context. West-Ward's petition focused on the question of whether "adjusting a dose of an old drug based on a patient's genetic risk of poorly metabolizing it" is patent eligible subject matter, so the pro-patent crowd will no doubt be pleased. There is another aspect of the case, however, which is worthy of consideration.... Read more
August 13, 2018
In July, the U.S. Patent & Trademark Office's Patent Trial and Appeal Board designated its ex parte Jung decision as informative (see here and here). In this decision, the Board held that the phrase "at least one of A and B" was presumed to be conjunctive. That is, the phrase was presumed to mean "at least one of A and at least one of B."... Read more
August 10, 2018
Last week, the Federal Circuit issued its opinion in Boston University (BU) v. Everlight, in which the court found that the only asserted claim (claim 19) was invalid for lack of enablement because 1/6 (17%) of the claimed subject matter was "physically impossible." Claim 19 was the only claim asserted at trial. The claim was directed to a semiconductor device comprising a substrate, a non-single crystalline buffer layer, and a growth layer grown on the buffer layer.... Read more
August 6, 2018
The Supreme Court found Ion Geophysical Corp. (Ion) responsible for profits WesternGeco LLC. lost as a result of Ion's supplying to foreign buyers the parts necessary to assemble the patented ocean floor surveying equipment. WesternGeco's damages claim included a request for the lost profits of its foreign surveying business caused by Ion's 35 U.S.C. § 271(f) infringement. The Federal Circuit has denied these profits because, in its opinion, it would extend U.S. patent protection to foreign activities. The Supreme Court disagreed not with the concept that U.S. patent laws did not extend to foreign activities but because of the patent damages statute, 35 U.S.C. § 284 which provided:... Read more
August 3, 2018
Last month, the U.S. Patent & Trademark Office's Patent Trial and Appeal Board ("PTAB") newly designated five decisions as informative. These five decisions included ex parte Jung, a Board decision regarding the construction of the phrase "at least one of A and B." According to the Board in Jung, the proper construction for this phrase is the conjunctive, i.e., at least one of A AND at least one of B. This presumptive construction now applies during patent examination absent certain exceptions.... Read more
August 1, 2018
The Federal Circuit affirmed in-part and vacated in-part the PTAB's (the Board) decision that the petitioner, Medtronic, Inc., had not proven that the challenged patent claims were unpatentable. The Court affirmed the Board's determination that challenged claims were not obvious over two prior art references, but vacated and remanded the Board's determination that other references, a video "Thoracic Pedicle Screws for Idiopathic Scoliosis" and slides "Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis and Kyphosis Surgery," were not "publicly accessible" under 35 U.S.C. § 102(b) and therefore were not prior art.... Read more
July 30, 2018
Unlike many other countries, medical procedures are not per se unpatentable in the United States. This comes with a major caveat, specifically, 35 U.S.C. § 287(c) bars a medical procedure patent owner from enforcing the patent, by obtaining an injunction, monetary damages, and attorney fees, against a medical practitioner and a related health care entity based on the medical practitioner's performance of "a medical activity" (§ 287(c)(1)).... Read more
July 26, 2018
Earlier this month, the Federal Circuit issued an opinion in Jazz Pharmaceuticals v. Amneal Pharmaceuticals, upholding the PTAB's finding that certain materials related to the FDA regulatory review process for Xyrem® were sufficiently accessible to the public to constitute prior art to seven Jazz patents. These materials (the "ACA materials") were accessible via a link on the FDA website "where background material would be posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting."... Read more
July 26, 2018
The Federal Circuit issued its decision in Saint Regis Mohawk Tribe et al v. Mylan Pharmaceuticals Inc., et al (18-1638) on July 20, 2018. The central question addressed in the Federal Circuit's decision was whether the principal of sovereign immunity can be asserted by a patent owner to avoid their patent being subjected to the Inter Partes Review (IPR) process. The decision hinged on whether the IPR process is more akin to the civil litigation-like proceedings in adjudications before the Federal Maritime Commission in which state sovereign immunity was held to apply (Fed. Maritime Comm'n v. S.C. State Ports Auth., 535 U.S. 743, 754–56 (2002) ("FMC") or whether IPR is a traditional agency action in which it has been previously held that sovereign immunity does not typically apply (see, for example, Pauma v. NLRB, 888 F.3d 1066 (9th Cir. 2018); Karuk Tribe Hous. Auth., 260 F.3d at 1074; and Fed. Power Comm'n v. Tuscarora Indian Nation, 362 U.S. 99, 122 (1960)). It is important to note, however that there is no blanket rule that immunity does not apply in federal agency proceedings.... Read more
July 20, 2018
Endo Pharmaceuticals Solutions, Inc et al v. Custopharm, Inc. (Fed. Cir. July 13, 2018), is an appeal of a Delaware District Court rejecting Custopharm's validity challenge to patents covering Endo's Aveed® testosterone undecanoate (TU) intramuscular injection as part of a Paragraph IV ANDA filing.... Read more
June 18, 2018
In Medtronic, Inc. v. Barry (2017-1169 and 2017-1170), the Federal Circuit (Circuit Judges Taranto, Plager, and Chen, decision authored by Judge Chen, hereinafter "the panel") vacated the PTAB's finding in IPRs2015-00780 and -00783 that Medtronic's slides and videos constitute "printed publications" within the meaning of 35 U.S.C. §102(b). Since only patents and printed publications are eligible as prior art in inter partes review ("IPR"), the question whether non-patent literature ("NPL") such as slides and videos distributed at a conference constitute printed publications is clearly of interest to those in the medical device field.... Read more
June 11, 2018
New USPTO Director Andrei Iancu provided the Intellectual Property Track plenary lecture at the 2018 BIO International Convention last week. As has been a common theme since being sworn in to office in February, Director Iancu's focus was on changes to provide greater certainty and quality for applicants and patent owners. Yes, we have heard this before, but the time is ripe for real change that positively impacts applicants and patent owners.... Read more
June 11, 2018
In the recent UCB v. Accord opinion, a panel of the Federal Circuit drew a distinction between (i) the enablement of a patentee's claims, and (ii) a reasonable expectation of success in an obviousness analysis. The majority found that the presumption of enablement for a claimed genus of compounds did not preclude a finding that there was not a reasonable expectation of success in creating a species falling within that genus.... Read more
June 4, 2018
In Ex Parte Bandic, the PTAB ("the Board") has given an insight into how the Office intends to examine patent eligibility under the two-step Alice test, considering the Memorandum published by the USPTO on April 19, 2018 explaining "Changes in Examination Procedure Pertaining to Subject Matter Eligibility" in view of Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).... Read more
June 4, 2018
The PTAB in the past year has loosened rules governing IPR practice. In most cases the changes have been good for the process. However, some of the changes while introducing a greater degree of fairness into the system have created traps for the unwary. One such trap is allowing patentees to submit declarations with the POPR (Patent Owner's Preliminary Response). Contrary to what many practitioners expect, the submission of a declaration actually increases the probability of the petition being instituted. Indeed, it might even guarantee institution.... Read more
May 21, 2018
Three years after a previous legal battle between Sequenom and Ariosa ended in a difficult loss for Sequenom (in what some commentators have characterized as a misapplication of the holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)), Sequenom and its exclusive licensee Illumina have just this week filed a new patent infringement case against Ariosa Diagnostics, its parent Roche Molecular Systems, Inc. and sister company Roche Sequencing Solutions, Inc., in the US District Court for the Northern District of California San Francisco Division, for patents covering DNA testing in pregnant women. <... Read more
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
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
February 9, 2018
The PTAB recently reminded Petitioners of the importance of properly framing prior art arguments, upholding all claims of U.S. Patent No. 8,664,231 in IPR2016-01370 in a final written decision issued yesterday. The '231 patent—covering Rasuvo®, a rheumatoid arthritis drug containing high doses of methotrexate formulated for subcutaneous injection—was challenged based on two primary references: Grint (a U.S. patent) and Wyeth (a pharmaceutical label for conventional uses of methotrexate). The primary grounds for each reference were based on anticipation, and the PTAB determined that neither reference anticipated claim 1, the only independent claim of the '231 patent.... Read more