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  • Valeant Pharmaceuticals Int’l v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealSummary judgment, while clearly advantageous, requires that there be no disputed question of material fact and that the moving party is entitled to judgment as a matter of law.  When a district court grants judgment improvidently, by misapplying the law, judgment can be reversed and the matter returned to the court for proceedings under the correct application of the law.  These are the circumstances that resulted in the opinion of the Federal Circuit in Valeant Pharmaceuticals Int'l v. Mylan Pharmaceuticals Inc.

    This ANDA litigation arose over Defendants' attempt to obtain regulatory approval under the Hatch-Waxman Act for generic formulations of Relistor® (methylnaltrexone), in particular ones having certain stability properties that the inventors of the Orange Book-listed patents had shown depended on the pH of the formulation.  In particular, methylnaltrexone is stable in aqueous solution when the pH of the formulation is adjusted to remain between 3 and 4.  U.S. Patent No. 8,552,025 recites claims to such formulations; claim 8 was at issue in the litigation:

    1.  A stable pharmaceutical preparation comprising a solution of methylnaltrexone or a salt thereof, wherein the preparation comprises a pH between about 3.0 and about 4.0.

    8.  The pharmaceutical preparation of claim 1, wherein the preparation is stable to storage for 24 months at about room temperature.

    ANDA plaintiff Valeant brought suit, and Defendant Mylan stipulated to infringement but contended that asserted claim 8 was obvious, under a stipulated claim construction that "the phrase 'the preparation is stable to storage for 24 months at about room temperature' means 'the methylnaltrexone degradation products in the preparation do not exceed 2.0% of the total methylnaltrexone present in the preparation and the preparation is suitable for pharmaceutical use when stored for 24 months at room temperature.'"  The District Court granted Valeant's motion for summary judgment; in doing so, the court "rejected Mylan's expert testimony and cited references as being insufficient, largely because the references did not teach methylnaltrexone formulations but instead formulations of similar but different compounds, naloxone and naltrexone."  In addition, the District Court rejected Mylan's second argument that using the claimed pH range would have been obvious to try.

    On appeal the Federal Circuit reversed and remanded, in an opinion by Judge Lourie joined by Judges Reyna and Hughes.  Relevant to the panel's decision (unavoidable perhaps in view of Judge Lourie's background in chemistry), the opinion notes the resemblances between methylnaltrexone and the prior art compounds naltrexone and naloxone; as set forth in the opinion, these differences are small:

    The only structural difference between these three molecules is the identity of the functional group attached to the nitrogen atom.  Naloxone is a neutral tertiary amine.  Naltrexone, also a neutral tertiary amine, has a cyclopropylmethyl group attached to the nitrogen.  Methylnaltrexone, a derivative of naltrexone, is a quaternary ammonium salt and has both a cyclopropylmethyl group and a methyl group attached to its nitrogen with a positive charge.

    The District Court summarily dismissed Mylan's argument regarding the prior art due to these differences, basing its conclusion on the grounds that what the art taught for naloxone and naltrexone would not have provided sufficient guidance to the skilled worker to appreciate that the prior art teachings would be relevant to methylnaltrexone.  This basis for the District Court's decision is important because one reference, U.S. Patent No 5,866,154, taught that naloxone formulations were stabilized at pH 3.0-3.5, and another, U.S. Patent Application Publication No. 2003/0229111, taught that naltrexone formulations could be stabilized with various organic acids (including butylated hydroxytoluene and ascorbic acid) having a pH adjusted to between 3 and 5 but preferably pH 4.  In addition, there were pharmaceutical treatises teaching the benefits of maintaining the pH for formulations of this general class of compounds at acidic pH.

    The Federal Circuit held that the District Court's disregard for the prior art on this basis was error, and found that Mylan had asserted a prima facie case of obviousness precluding summary judgment, citing In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (citing In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997)); In re Woodruff, 919 F.2d 1575, 1578 (CCPA 1990); and In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974), in support of its decision to reverse.  The opinion states that such a prima facie case exists when there is, as here, an overlap in ranges of a property or characteristic of a claimed composition.

    The Court recognized the underlying question of "whether prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range can establish a prima facie case of obviousness," holding that "they can, and in this case, do."  Structurally similar compounds are expected by skilled artisans to have similar properties, according to the opinion, citing Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1352 (Fed. Cir. 2010), citing In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc); In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995); In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986); Application of Payne, 606 F.2d 303, 314 (CCPA 1979); In re Wood, 582 F.2d 38, 641 (CCPA 1978); and Application of Rosselet, 347 F.2d 847, 850 (CCPA 1965).  The opinion recognizes that this case law focuses on compounds and uses thereof, but the Court maintained that "the principle established in these cases applies more broadly: a person of skill in the art can expect that compounds with common properties are likely to share other related properties as well," citing Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1384 (Fed. Cir. 2018).  Further, relevant to the question before the panel, "[w]hen compounds share significant structural and functional similarity, those compounds are likely to share other properties, including optimal formulation for long-term stability."  The opinion then recites the similarities between the prior art naloxone, naltrexone, and methylnaltrexone, including that they are all opioid antagonists and bind to opioid receptors but don't activate them; and that they are all oxymorphone derivatives with only minor structural variations limited to substituents attached to the same nitrogen atom (naloxone and naltrexone being uncharged tertiary amines differing by substitution of a cyclopropylmethyl group in the latter, while methylnaltrexone is a charged, quaternary ammonium salt substituted by both a cyclopropylmethyl group and a methyl group).  According to the opinion, "[b]ecause of the strong structural and functional similarity between the molecules, a person of skill could expect similar stability of the molecules at similar pH ranges in solution" (a conclusion that seems inconsistent with the significant differences, inter alia, with the molecule comprising the claimed formulation being positively charged at neutral pH while the compounds comprising the prior art formulations were not).

    But the opinion makes the point that the District Court erred because the similarities were sufficient to preclude summary judgment.  It makes the further point that the Federal Circuit's opinion should not be construed to mean that "molecules with similar structure and similar function can always be expected to exhibit similar properties for formulation."  Rather, the case deserved to be tried to a factfinder (here, the District Court) to determine whether Valeant can overcome Mylan's prima facie obviousness case.

    The opinion next turned to the District Court's summary rejection of Mylan's obvious-to-try argument.  This rejection was expressly based on the "infinite" values of pH between pH 3 and pH 7 as a matter of "basic math."  Further, the District Court refused to credit Mylan's experts' testimony regarding the skilled artisan's apprehension that adjusting pH could improve stability, because the evidence did not show that adjusting pH would have been the first variable the artisan would have considered.  The District Court further did not accept that improved long-term methylnaltrexone stability would be a predictable result of adjusting formulation pH to between 3 and 4.

    The Federal Circuit reversed the District Court on this argument as well, citing the eternal aphorism from KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) that "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp."  For Judge Lourie and the panel, the "bounded range of pH 3 to [pH]4" fell within the scope of the Supreme Court's teachings as a "finite number" of pH values for the skilled artisan to try.  While it may be a matter of math that there are an infinite number of numerical values between the numbers 3 and 4, as a practical matter the panel found that there was "no indication that pH is measured to any significant figure beyond two digits."  The panel also found there is no requirement in the law that a variable (to support an obvious-to-try determination) must be the first variable that the skilled artisan would consider.  "Absolute predictability that the proposed pH range would yield the exact stability parameters in the claim is not required," according to the opinion, and thus the District Court erred in granting summary judgment in the face of this argument as well.

    The case was sent back to the District Court for further action under the principles set forth in the opinion.

    Valeant Pharmaceuticals Int'l v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)
    Panel: Circuit Judges Lourie, Reyna, and Hughes
    Opinion by Circuit Judge Lourie

  • USPTO Answers FAQs on Extension of Patent Deadlines under CARES Act

    Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – April 6 UPDATE

    By Donald Zuhn –-

    USPTO SealIn a USPTO Alert e-mail distributed earlier today, the U.S. Patent and Trademark Office announced the release of a series of Frequently Asked Questions (FAQs) regarding extensions of time for filing certain patent-related documents and paying certain required fees that resulted from the temporary authority provided to the USPTO under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).  The Office announced the availability of such extensions on March 31 (see "USPTO Announces Extension of Certain Patent Deadlines").

    The Office released 21 FAQs regarding patent-related extensions.  In its responses to the FAQs, the Office noted that the statement that the delay in filing or payment was due to the COVID-19 outbreak, which must accompany the filing or payment, "need not be verified or provided in affidavit or declaration form."  However, the Office reminded applicants and practitioners that such statements constitute a certification under 37 C.F.R. § 11.18(b), and that violations of 37 C.F.R. § 11.18(b) may be subject to sanctions pursuant to 37 C.F.R. § 11.18(c).  The Office also noted that statements can be included in the paper being filed, but if included in the paper being filed, "should be made in a conspicuous manner."

    The Office reiterated that the standard for determining whether a delay in filing or payment was due to the COVID-19 outbreak is that "the outbreak materially interfered with the filing of a paper or fee" (emphasis added).  As noted in the Office's original announcement of the extensions, and repeated in the FAQs, "[c]ircumstances that qualify as materially interfering include, without limitation, office closures, cash flow interruptions, lack of access to files or other materials, travel delays, personal or family illness, or other similar circumstances."

    The Office concludes the FAQs by stating that it "will continue to evaluate the evolving situation around COVID-19 and the impact on the USPTO's operations and stakeholders," and if the Office extends relief under the CARES Act, it "will provide timely notice."  The Office also indicates that it will continue to evaluate the evolving situation concerning the COVID-19 pandemic and will update the FAQs as needed.

    The Office also announced the release of a series of Frequently Asked Questions (FAQs) regarding extensions of time for filing certain trademark-related documents and paying certain required trademark-related fees.  The trademark-related FAQs can be found here.

    All of the USPTO's updates regarding the COVID-19 pandemic can be found here.

    For additional information regarding this and other related topics, please see:

    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – April 2 UPDATE," April 2, 2020
    • "USPTO Announces Extension of Certain Patent Deadlines," March 31, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 29 UPDATE," March 29, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 26 UPDATE," March 26, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 19 UPDATE," March 19, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 18 UPDATE," March 18, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 17 UPDATE," March 17, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – UPDATED," March 16, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts," March 15, 2020

  • Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

    By Donald Zuhn –-

    Federal Circuit SealLast month, in Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit reversed a decision by the U.S. District Court for the District of New Jersey finding certain claims of U.S. Patent No. 8,853,156 to be directed to ineligible subject matter under 35 U.S.C. § 101, and remanded for further proceedings.  The Federal Circuit also affirmed the District Court's finding that the asserted claims of U.S. Patent Nos. 9,173,859 and 8,673,927 were invalid for obviousness and obviousness-type double patenting.

    Plaintiffs-Appellants Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Corp.; and Boehringer Ingelheim Pharma GmgH & Co. KG ("Boehringer") filed suit against Defendants-Appellees Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories, Ltd.; Aurobindo Pharma Ltd.; and Aurobindo Pharma USA, Inc. ("Mylan") for infringement of the '156, '859, and '927 patents.  The asserted patents relate to the treatment of type 2 diabetes mellitus with DPP-IV inhibitors such as linagliptin.  Mylan moved for partial summary judgment on the pleadings, alleging that claims 10-17, 24, and 25 of the '156 patent are directed to ineligible subject matter under 35 U.S.C. § 101.  The District Court granted Mylan's motion, finding that claims 10-17, 24, and 25 of the '156 patent are directed to the "abstract idea" of "administering the DPP-IV inhibitor to the targeted patient population," and that these claims fail to recite an inventive concept.

    At trial, the District Court determined that claims 1, 14, 15, 20, and 21 of the '859 patent and claims 7, 9, 15, 17, 19, 25, and 26 of the '927 patent are invalid for obviousness-type double patenting in view of the claims of U.S. Patent No. 8,178,541, and invalid as obvious in view of U.S. Patent Application Publication No. 2004/0097510.  In particular, the District Court determined that because the claimed invention's doses of linagliptin in 2.5 mg and 5 mg fall within the '510 publication's disclosed range of 1–100 mg, there is a presumption of obviousness.  The District Court alternatively found that a person of ordinary skill in the art would have obtained the claimed dosages through routine experimentation.

    In an opinion by Judge Moore, joined by Judges Dyk and Hughes, the Federal Circuit concluded that claims 10–17, 24 and 25 of the '156 patent are directed to patent eligible subject matter.  The opinion notes that the '156 patent relates to the treatment and/or prevention of metabolic diseases such as type 2 diabetes mellitus with DPP-IV inhibitors such as linagliptin in patients for whom normal metformin therapy is not appropriate, setting forth claims 1 and 10 of the '156 patent:

    1.  A method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally ad-ministering to the patient a DPP-IV inhibitor wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.

    10.  The method according to claim 1 wherein the metabolic disorder is type 2 diabetes mellitus and wherein the contraindication is renal disease, renal impairment or renal dysfunction, and wherein said DPP-4 inhibitor is used for said patient in the same dose as for a patient with normal renal function.

    On appeal, Boehringer argued, echoing language from Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), that the claims are directed to a "method of treating a specific disease ([type 2 diabetes mellitus]) for specific patients (with renal impairment) using a specific compound (linagliptin) at specific doses (same dose in patients with renal impairment as in patients with normal renal function) to achieve a specific outcome."  Mylan argued that the claims are directed to the natural law that "certain DPP-IV inhibitors (including linagliptin) are metabolized by the liver rather than the kidney."

    In finding claims 10–17, 24 and 25 of the '156 patent  to be patent eligible, the Federal Circuit determined that "consistent with this court's decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the claims are directed to a particular method of treatment under step one and are therefore patent eligible."  The Court explained that even though "certain DPP-IV inhibitors (including linagliptin) are metabolized by the liver rather than the kidney," this "does not make the claim 'directed to' that natural ability."  The panel also noted that because the claims are directed to a method of treatment at step one, the Court could "conclude [that] the claims are patent eligible and need not reach step two" under the two-step framework of Alice Corporation Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014).  The Federal Circuit therefore reversed the District Court's grant of judgment on the pleadings of patent ineligibility and remanded to the District Court for further proceedings.

    Turning to the District Court's finding that claims 1, 14, 15, 20, and 21 of the '859 patent and claims 7, 9, 15, 17, 19, 25, and 26 of the '927 patent were invalid for obviousness-type double patenting and invalid as obvious in view of the prior art, the opinion notes that the claims at issue relate to the treatment of type 2 diabetes mellitus with linagliptin in 2.5 or 5 mg doses, setting forth claim 14 of the '859 patent:

    14.  An oral tablet formulation comprising 1-[(4-me-thyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in an amount of 2.5 mg or 5 mg optionally in combination with metformin, and a pharmaceutically acceptable carrier or diluent.

    and claim 7, which depends from claim 1, of the '927 patent as illustrative:

    1.  A method of treating type II diabetes mellitus comprising administering to a patient in need thereof a pharmaceutically effective oral amount of 1-[(4-methyl-quinazolin-2-yl)-methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, and a pharmaceutically effective amount of metformin, which is from 300 mg to 1000 mg once or twice a day, or delayed-release metformin in a dose of 500 mg to 1000 mg once or twice a day or 500 mg to 2000 mg once a day.

    7.  The method according to claim 1, wherein the 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is administered in an oral dosage of 2.5 mg or 5 mg.

    On appeal, Boehringer argued that the District Court's conclusions of invalidity for obviousness-type double patenting and obviousness depended on its determination that the claimed dosages would have been obvious.  In affirming the District Court's findings of invalidity for obviousness-type double patenting and obviousness, the Federal Circuit concluded that the District Court's alternative finding (i.e., that a person of ordinary skill in the art would have obtained the claimed dosages through routine experimentation) is not clearly erroneous.  The Court therefore did not need to decide whether the District Court's presumption determination of obvious was correct.  The Federal Circuit thus affirmed the District Court's decision finding the asserted claims of the '859 and '927 patents to be invalid for obviousness and obviousness-type double patenting.

    Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)
    Nonprecedential disposition
    Panel: Circuit Judges Dyk, Moore, and Hughes
    Opinion by Circuit Judge Moore

  • Conference & CLE Calendar

    CalendarApril 6, 2020 – "CARES Act: PPP Impact on Life Sciences Companies" (Biotechnology Innovation Organization) – 2:00 to 3:00 pm (ET)

    April 8, 2020 – "Managing IP in Times of Crisis" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 9, 2020 – "Willful Blindness and Enhanced Damages: Litigation and Patent Search Policy" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 9, 2020 – "Pains and Perils of NOT Proofreading Your Patents" (Sagacious IP) – 11:00 am to noon (ET)

    April 14, 2020 – "What's in the Trump Trade Agreements regarding Intellectual Property?" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

  • Webinar on Trump Trade Agreements

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "What's in the Trump Trade Agreements regarding Intellectual Property?" on April 14, 2020 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorney and Patent Docs contributor Joshua R. Rich will run through the IP protection in the "Phase 1" bilateral economic and trade agreement with China and the United States-Mexico-Canada Agreement ("USMCA"), and also how that protection has changed from previous agreements.  Topics will include:

    • What will China have to do to comply with the terms of the trade agreement, and how will it affect US businesses?
    • What are the new IP provisions of the USMCA, and how do they differ from NAFTA?
    • How do these provisions differ from those proposed in the TPP?

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • IPO Webinar on Managing IP in Times of Crisis

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Managing IP in Times of Crisis" on April 8, 2020, from 2:00 to 3:00 pm (ET).  Karen Cochran of Shell Oil Co., Henry Hadad of Bristol-Meyers Squibb Co., Mike Ray of Sterne Kessler Goldstein Fox, and Todd Walters of Buchanan Ingersoll & Rooney PC will address the following questions concerning the management of a corporate IP department or IP practice during a crisis:

    • How can the you continue supporting clients' innovation when significant numbers of employees are teleworking and many are without childcare?
    • How do strategies change in response to the disruption of regular research and development and effects on the supply chain?
    • How can IP professionals continue to assist companies in extracting maximum value from their portfolios and continue to create new products and services?
    • Are some industries at a comparative advantage or disadvantage?

    There is no registration fee for this webcast.  Additional information regarding the webcast can be found here.

  • BIO Webinar on CARES Act

    BIOThe Biotechnology Innovation Organization (BIO) will be offering a webinar entitled "CARES Act: PPP Impact on Life Sciences Companies" on April 6, 2020 from 2:00 to 3:00 pm (ET).  Christian Plaza, Chris Kimball, and Laura Berezin of Cooley will discuss the Payment Protection Program, a key small business provision of the Coronavirus Aid, Relief, and Economic Security (CARES) Act which provides eligible small businesses forgivable loans in order to maintain payroll, and pay for other costs including rent, interest payments, and utilities.  The webinar will address what the program means for your company along with key items to know and understand in advance of applying, including:

    • A CARES Act PPP Loans Overview
    • Eligibility and Restrictions
    • Affiliation Rules
    • Application Process and Key Considerations

    There is no registration fee for this webcast.  However, those interested in registering for the webinar, should do so here.

  • IPO Webinar on Willful Blindness and Enhanced Damages

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Willful Blindness and Enhanced Damages: Litigation and Patent Search Policy" on April 9, 2020, from 2:00 to 3:00 pm (ET).  Thomas Cotter, Professor of Law, University of Minnesota School of Law; Charlotte Jacobsen of Ropes & Gray; and Jenifer Ward, executive counsel-corporate IP technologies, operations and transactions, General Electric Co. will analyze:

    • The current state of relevant case law, including Halo v. Pulse, GlobalTech, Exmark, Eko, and the gaps where case law hasn't yet reached;
    • The factors in-house counsel must balance to determine the appropriate level of search diligence, including the industry and the risk of another patent covering R&D or new product, cost of search and of investment, and understanding of changing case law;
    • Teachings of district court cases such as Motiva Patents v. Sony Corp.; HTC Corp., Nonend Inventions N.V. v. Apple Inc., et al.; and VLSI Tech. LLC v. Intel Corp.; and
    • Evidence that a jury aware of alleged willful infringement is more likely to find infringement and ensuing defense tactics such as trying to knock willfulness allegations at the pleading stage or in summary judgment.

    The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Webinar on Proofreading Your Patent

    Sagacious IPSagacious IP will be offering a webinar on "Pains and Perils of NOT Proofreading Your Patents" on April 9, 2020 from 11:00 am to noon (ET).  Melvyn Thomas, Prateek Mohunta, and Sameer Kumar of Sagacious IP will discuss the following topics:

    • What is Patent Proofreading
    • Elements of Patent Proofreading
    • Benefits of Patent Proofreading
    • U.S. Patent Proofreading — with USPTO best practices
    • Amendments, incorporations, grammatical mistakes, bibliography details, eye-for-detail

    There is no registration fee for this webcast.  However, those interested in registering for the webinar, should do so here.

  • Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – April 2 UPDATE

    By Donald Zuhn –-

    World Health OrganizationOn March 11, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear."  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally; in its situation report for April 2, the WHO indicates that there have been 896,450 cases globally.  The WHO's declaration earlier this month — and global developments since then — raise the question of how the pandemic has been affecting the patent community.

    We have been reporting (see links below) on the impact of the COVID-19 pandemic on the U.S. Patent and Trademark Office, World Intellectual Property Organization, European Patent Office, IP Australia, Intellectual Property Office of New Zealand (IPONZ), Brazilian Patent and Trademark Office (INPI), Canadian Intellectual Property Office (CIPO), Mexican Institute of Industrial Property (IMPI), National Office of Intellectual Property (ONAPI) in the Dominican Republic, Intellectual Property India, National Intellectual Property Office (NIPO) in Sri Lanka, Israel Patent Office, Intellectual Property Office of Vietnam (NOIP), and Directorate General of Intellectual Property (DGIP) in Indonesia, as well as U.S. Federal courts, including, in particular, the Supreme Court and Federal Circuit.  Today we present further developments at WIPO and the USPTO, and in Canada, Indonesia, and Vietnam in response to the COVID-19 pandemic.

    WIPOOn March 16, WIPO announced that it had implemented its business continuity plans and would therefore be able to continue to process applications filed through the Patent Cooperation Treaty (PCT), the Madrid System for the International Registration of Marks, the Hague System for the International Registration of Industrial Designs, as well as administer other IP and related systems.  On Monday, WIPO announced that as a result of the COVID-19 pandemic, the International Bureau had suspended the transmittal of PCT documents (e.g., PCT Forms, letters) on paper, and that until further notice, the International Bureau would be transmitting documents only via e-mail.  WIPO encouraged users who have not yet provided the International Bureau with an e-mail address in relation to their international applications to provide such information urgently by:

    i.  populating the information directly in relation to one of their pending international applications in ePCT;
    ii.  using the PCT Contingency upload service;
    iii.  sending an email to one of the following addresses: pct.eservices@wipo.int or pct.infoline@wipo.int; or
    iv.  using the WIPO (PCT) customer Contact Us page.

    Additional information on how to provide information in ePCT can be obtained by consulting the WIPO webpage on electronic communication methods with the International Bureau or referring to ePCT FAQs.  Applicants and practitioners may also contact pct.eservices@wipo.int for assistance.

    WIPO noted that PCT-related documents for individual applications can be viewed through WIPO's IP portal, ePCT, or after publication, via PATENTSCOPE.  WIPO is encouraging all users to communicate with the International Bureau exclusively by electronic means; with the best means for communicating electronically with the International Bureau being ePCT.

    USPTO SealIn a notice published in the Federal Register (85 Fed. Reg. 17502) on Monday, the U.S Patent and Trademark Office announced that as a result of the COVID-19 pandemic, the Office was waiving its requirements for submitting an original handwritten signature personally signed in permanent dark ink or its equivalent for certain correspondence with the Office of Enrollment and Discipline and certain payments by credit card.  In both instances, the Office will accept copies of handwritten signatures.  The notice also indicated that other than the two requirements being waived, the Office has no other requirements for original handwritten, ink signatures.

    CIPOOn March 16, CIPO announced that it intended to remain open and in operation during the pandemic, and encouraged applicants and representatives to use its online services for all transactions with CIPO.  CIPO also automatically extended all deadlines falling between March 16 and March 31 to April 1.  On Tuesday, Canadian patent law firm Bereksin & Parr notified the patent community that CIPO had announced a further extension of all deadlines to May 1, 2020.

    DGIPYesterday, Indonesia patent law firm LSP Partnership notified the patent community that the DGIP had extended its closure from March 31 to April 21, 2020.  As a result, the DGIP would be providing a further extension of time for the submission of any formality documents and payment of any annuity fees that fall due between March 23 and April 21, 2020 until the DGIP resumes service.

    NOIPLast week, the Intellectual Property Office of Vietnam (IP Vietnam) noted that it was continuing to operate on its normal schedule, but was limiting in-person interviews with IP Vietnam's examiners in response to the COVID-19 pandemic.

    Yesterday, Vietnamese patent law firm Vision & Associates notified the patent community that IP Vietnam issued Notification No.5277/TB-SHTT on March 31, in which it indicated that as of April 1, 2020, all transactions between IP Vietnam and Applicants were to be performed only through postal service or the e-filing system until further notice, and that deadlines falling on March 30, 2020 to April 30, 2020 for establishing IP rights for all IP matters (i.e., claiming priority, submitting documents, responding to Decisions/Notifications from IP Vietnam, paying annuity and renewal fees, making payment of relevant fees, filing appeals) are automatically extended to May 30, 2020.  IP Vietnam also noted that it would resume receiving Patent Prosecution Highway (PPH) requests under the PPH program between IP Vietnam and the Japan Patent Office (JPO) on May 4, 2020.

    Patent Docs will continue to monitor and report on patent-related developments related to the COVID-19 pandemic.  In addition, we encourage our readers to let us know about developments related to the COVID-19 pandemic at other patent offices.

    For additional information regarding this and other related topics, please see:

    • "USPTO Announces Extension of Certain Patent Deadlines," March 31, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 29 UPDATE," March 29, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 26 UPDATE," March 26, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 19 UPDATE," March 19, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 18 UPDATE," March 18, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts — March 17 UPDATE," March 17, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – UPDATED," March 16, 2020
    • "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts," March 15, 2020