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
Attorney:
Matthew E. Barnet, Ph.D.
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:
Marina I. Miller, Ph.D.
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
Attorney:
Richard D. Kelly
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
Attorneys:
Richard D. Kelly and Yuki Onoe
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
Attorney:
J. Derek Mason, Ph.D., CLP
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
Attorney:
Marina I. Miller, Ph.D.
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Richard D. Kelly
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
Attorney:
Richard D. Kelly
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
Attorney:
Jeffrey B. McIntyre
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Yuki Onoe
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
Attorney:
Stephen G. Baxter, Ph.D.
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
Attorney:
Vincent K. Shier, Ph.D.
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
Attorney:
Matthew E. Barnet, Ph.D.
December 27, 2018
An article by Matthew Barnet on "Federal Circuit Reiterates That Nucleotide Sequences Are Not Patent Eligible under 35 U.S.C. § 101" is published in the IP Litigator journal. Click to read article.... Read more
Attorney:
Richard D. Kelly
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
Attorney:
Marina I. Miller, Ph.D.
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
Attorney:
J. Derek Mason, Ph.D., CLP
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
Attorney:
Lisa M. Mandrusiak
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Matthew E. Barnet, Ph.D.
October 12, 2018
On October 9, 2018, in Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit upheld a district court decision that claims reciting nucleotide primers in U.S. Patent No. 5,643,723 (“the ‘723 patent”) were invalid under 35 U.S.C. § 101.<... Read more
Attorney:
Richard D. Kelly
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
Attorney:
Marina I. Miller, Ph.D.
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
Attorney:
Lisa M. Mandrusiak
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Stephen G. Baxter, Ph.D.
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
Attorney:
Jeffrey B. McIntyre
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
Attorney:
Richard D. Kelly
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
Attorney:
Marina I. Miller, Ph.D.
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
Attorney:
Jeffrey B. McIntyre
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
Attorney:
J. Derek Mason, Ph.D., CLP
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Todd W. Baker
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
Attorney:
Matthew E. Barnet, Ph.D.
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
Attorney:
Tia D. Fenton
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
Attorney:
Jacob A. Doughty
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Yuki Onoe
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
Attorney:
Daniel J. Pereira, Ph.D.
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
Attorney:
Richard D. Kelly
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
Attorney:
Stephen G. Baxter, Ph.D.
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
Attorney:
Lisa M. Mandrusiak
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
Attorney:
Marina I. Miller, Ph.D.
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
Attorney:
Jacob A. Doughty
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