Patent Law Weblog
The National Association of Patent Practitioners (NAPP) will be offering a webinar entitled "Implications of File History Estoppel During Litigation" on September 16, 2022 from 12:00 pm to 1:00 pm (EDT). Niky Bagley of Cole Schotz P.C. will, using various examples, provide insights into how statements made and actions taken during prosecution impact litigation, particularly during claim construction and arguments.
Those interested in registering for the webinar should do so here.
By Kevin E. Noonan –
It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs (see "Trump Administration Considering Reduction in Biologics Exclusivity Period; A Solution in Search of a Problem"; "FDA Issues Plan for Further Facilitating Biosimilar Development"; "Senators Ask FTC to Investigate Biosimilar Litigation Settlement Agreement"; "Biosimilars Action Plan: Balancing Innovation and Competition"; "Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term"). These sentiments were largely from outcome-oriented groups with little understanding or regard for process or an appreciation of what has been required of the FDA and biosimilar applicants to bring safe and effective biosimilar drugs to market (and to be sure the same chorus would be vocally critical should a biosimilar fail to be safe, effective, and cheaper than the reference biologic drug product).
Things are looking up, however. On September 6th, Fresenius Kabi announced FDA approval for its Stimufend® (pegfilgrastim-fpgk) product, as a biosimilar to Amgen's Neulasta® (pegfilgrastim). This biologic drug is a recombinant human granulocyte colony-stimulating factor (or G-CSF) approved for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Fresenius Kabi plans on marketing the product in a prefilled syringe by early 2023, and further plans to develop an "on-body injector" product to compete with Amgen's Neulasta Onpro (which has captured 45% of the $3.1 billion Neulasta® market as of the fourth quarter 2019). Previously, Fresenius Kabi received marketing authorization in March 2022 for its Stimufend® product in Europe.
This approval brings to 38 the number of approved biosimilar products.
By Donald Zuhn —
Earlier today, the National Academy of Inventors (NAI) and the Intellectual Property Owners Association (IPO) published their annual list of the top 100 worldwide universities that received the most U.S. utility patents during the 2021 calendar year. The NAI is a member organization comprising U.S. and international universities, and governmental and non-profit research institutions, with over 4,000 individual inventor members and Fellows spanning more than 250 institutions. The organization was founded in 2010 to recognize and encourage inventors with patents issued from the U.S. Patent and Trademark Office, enhance the visibility of academic technology and innovation, encourage the disclosure of intellectual property, educate and mentor innovative students, and translate the inventions of its members to benefit society. The joint effort by the NAI and IPO is based on data obtained from the U.S. Patent and Trademark Office. For their report, the NAI and IPO defined a university as an institution that grants undergraduate-level degrees, and when a patent is assigned to one or more entities, credit was given to the first named entity. The report indicates that the number of patents granted to a particular university does not necessarily indicate the value of a university's technology, the effectiveness of its research, or whether its patents will be successfully licensed and/or brought to market. The top 25 universities on the NAI/IPO listing are as follows (click on table to expand):
The complete list of 100 universities can be found here.
For additional information regarding this and other related topics, please see:
• "IPO & Harrity Analytics Release List of Top 300 Patent Holders for 2021," January 23, 2022
• "NAI & IPO Release List of Top 100 Universities Receiving Patents in 2020," July 14, 2021
• "IPO & Harrity Analytics Release List of Top 300 Patent Holders for 2020," February 18, 2021
• "NAI & IPO Release List of Top 100 Universities Receiving Patents in 2019," June 3, 2020
• "IPO & Harrity Analytics Release List of Top 300 Patent Holders for 2019," May 25, 2020
• "IPO Releases List of Top 300 Patent Holders for 2018," August 7, 2019
• "IPO Releases List of Top 300 Patent Holders for 2017," July 4, 2018
• "Top 100 Universities Worldwide Granted U.S. Patents in 2016," June 15, 2017
• "IPO Releases List of Top 300 Patent Holders for 2016," June 14, 2017
• "NAI & IPO Release List of Top 100 Universities Receiving Patents in 2014," July 5, 2015
• "IPO Releases List of Top 300 Patent Holders for 2014," July 1, 2015
• "IPO Names Top 100 Patenting Universities," July 24, 2014
• "IPO Releases List of Top 300 Patent Holders for 2013," July 7, 2014
• "NAI & IPO Release List of Top 100 Universities Receiving Patents in 2012," January 7, 2014
• "Brookings Paper Calls for Technology Transfer Model Based on University Start-ups," December 12, 2013
• "IPO Releases List of Top 300 Patent Holders for 2012," June 24, 2013
• "Another Look at IPO Top 300 and Life Sciences Top 53," June 11, 2012
• "IPO Releases List of Top 300 Patent Holders for 2011," June 7, 2012
• "IPO Releases List of Top 300 Patent Holders for 2010," June 30, 2011
• "IPO Releases List of Top 300 Patent Holders for 2009," May 26, 2010
• "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
• "IPO Releases List of Top 300 Patent Holders," May 22, 2008
• "IPO Posts List of Top 300 Patent Holders," April 20, 2007
By Kevin E. Noonan –
On August 2nd, Coherus Biosciences announced FDA approval for its Cimerli™ (ranibizumab-eqrn) product, as an interchangeable biosimilar to Genentech/Roche's Lucentis® (ranibizumab). This biologic drug is a vascular endothelial growth factor (VEGF) inhibitor having five approved indications for Lucentis: the retinal diseases age-related macular degeneration, retinal vein occlusion, diabetic macular edema, diabetic retinopathy, myopic choroidal neovascularization. Cimerli™ has been approved for all of the Lucentis®-approved indications. FDA approval of Cimerli™ as an interchangeable biosimilar was attributed by Coherus Biosciences to the outcome of a clinical trial, the COLUMBUS-AMD study.
The FDA had approved another biosimilar, Byooviz (ranibizumab-nuna) from Biogen/Samsung Bioepsis in September 2021 but for only three of the five indications. As an interchangeable biosimilar, Cimerli™ is entitled to a one-year term of interchangeable exclusivity, which can be expected to have significant economic benefits in the annual $7 billion anti-VEGF ophthalmology market. Coherus Biosciences is expected to launch Cimerli™ in October 2022 in both 0.3 mg and 0.5 mg dosages.
This approval brings to 37 the number of approved biosimilar products and is the third interchangeable biosimilar to be approved (the others being Semglee (insulin glargine-yfgn) and Cyltezo (adalimumab-adbm)).
By Donald Zuhn —
USPTO Launches Webpage on PTE Applications and Patent Terms Extended under 35 U.S.C. § 156
In a Patent Alert email distributed to stakeholders last week, the U.S. Patent and Trademark Office announced the launch of a new webpage providing information regarding applications for patent term extension (PTE) that have been filed within the past five years and patent terms that have been extended under 35 U.S.C. § 156. With regard to PTE applications, the new webpage provides access to a spreadsheet listing the application number, patent number, and trade name identified in the PTE application, and provides a link to the electronic file containing the PTE papers. The USPTO alert indicates that the new webpage was launched in response to stakeholder feedback requesting readily available information about PTE applications. The USPTO plans to update the information on the webpage on a quarterly basis.
USPTO Announces Fourth Extension of Modified COVID–19 Prioritized Examination Pilot Program
In a notice published in the Federal Register (87 Fed. Reg. 38714) in June, the U.S. Patent and Trademark Office announced that it was extending the modified COVID–19 Prioritized Examination Pilot Program, and that requests to participate in the pilot program would be accepted until December 31, 2022. The pilot program, which was implemented in May of 2020 and has been extended three times previously, allows applicants that qualify for small or micro entity status to request prioritized examination without paying the fees typically associated with such prioritized examination (see "USPTO Announces COVID-19 Prioritized Examination Pilot Program").
In addition to the requirement that applicants qualify for small or micro entity status, the claims of a participating application must cover a product or process related to COVID–19, and such product or process must be subject to an applicable FDA approval for COVID–19 use. Such approvals may include, for example, an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologics License Application (BLA), a Premarket Approval (PMA), or an Emergency Use Authorization (EUA). Other requirements for participating in the pilot program include making the request at the time of filing of a non-continuing original utility or plant nonprovisional application; at the time of filing of an original utility or plant nonprovisional application claiming the benefit of an earlier filing date under 35 U.S.C. §§ 120, 121, or 365(c) of one prior nonprovisional application or one prior international application designating the United States; or at the time of filing or after the filing of a Request for Continued Examination of a plant or utility application or a national stage of an international application. However, any application that claims the benefit of the filing date of two or more prior filed nonprovisional U.S. applications or international applications designating the United States under 35 U.S.C. §§ 120, 121, or 365(c) is not eligible for participation in the pilot program. In addition, requests to participate in the pilot program must include an Application Data Sheet, be made via the Office's patent electronic filing systems (EFS-Web or Patent Center), and qualifying applications cannot present more than four independent claims, more than 30 total claims, or any multiple dependent claims.
In announcing the extension of the pilot program, the Office noted that as of May 16, 2022, 261 patents had issued from applications that had been accepted under the pilot program, and the average total pendency, from filing date to issue date, for those applications was 280 days.
As we reported earlier this year in our "Top Patent Law Stories of 2021" webinar, of the 149 patents that recite "COVID-19" or "SARS-CoV-2" in the claims (as of January 2022), 89 issued from applications that had been accepted under the pilot program, and the average total pendency for those applications was 280 days. This compared favorably with the 41 patents that recite "COVID-19" or "SARS-CoV-2" in the claims where examination was accelerated under the Track One Prioritized Examination Program, and where the average total pendency was 259 days.
USPTO Announces Continuation of PPH Pilot Program with IMPI
In a notice published in the Official Gazette (1499 OG 496) in June, the U.S. Patent and Trademark Office announced that the Mexican Institute of Industrial Property (IMPI) and USPTO had agreed to extend the Patent Prosecution Highway (PPH) pilot program between the two offices. Under the PPH pilot program, which was extended to June 30, 2027, the USPTO will treat as timely any PPH request based on IMPI work product filed in the USPTO on or before June 30, 2027.
USPTO Makes Electronic Filing of PTE Applications Permanent
In May 2020, the U.S. Patent and Trademark Office announced that because it considered the effects of the COVID-19 pandemic to be an "extraordinary situation" within the meaning of 37 C.F.R. § 1.183, the Office would permit patentees to file initial Patent Term Extension applications that meet certain criteria via EFS-Web or Patent Center (see "USPTO News Briefs, June 2, 2020). At the time, the Office noted that while the waiver would be "effective only until the USPTO provides further notice," it was making efforts to allow for electronic filing of PTE applications on a permanent basis.
In a notice of proposed rulemaking published in the Federal Register (87 Fed. Reg. 27043) in May, the U.S. Patent and Trademark Office announced a proposal to amend the Rules of Practice in Patent Cases to require that patent term extension (PTE) applications, interim PTE applications, and any related submissions to the USPTO be submitted electronically via the USPTO patent electronic filing system (EFS- Web or Patent Center). According to the Office, the proposed rule changes would reduce the administrative burden on PTE applicants, as well as improve administrative efficiency by facilitating electronic file management, optimize workflow processes, and reduce processing errors. The Office noted that it had received informal feedback with respect to the processing of electronic PTE applications under the COVID-19 pandemic waiver, and stakeholders had communicated unanimous support for electronic filing of initial PTE submissions. The Office also noted that the USPTO and its partner agencies had successfully implemented a system by which the USPTO electronically transmits a copy of any initial submission for PTE to the relevant agency, and that the new system had not caused any processing errors.
September 13, 2022 – 2022 Business Methods virtual customer partnership meeting (U.S. Patent and Trademark Office) – 10:00 am to 3:00 pm (ET) on
September 14-15, 2022 – FDA Boot Camp conference (American Conference Institute)
September 15, 2022 – Stakeholder Offerings and Resources (SOaR) virtual training session on Patent Center and Patent Public Search tool (U.S. Patent and Trademark Office) – 1:00 pm to 3:00 pm (ET)
September 16, 2022 – "Implications of File History Estoppel During Litigation" (National Association of Patent Practitioners) – 12:00 pm to 1:00 pm (EDT)
September 21-22, 2022 – Paragraph IV Disputes Master Symposium (American Conference Institute) – Chicago, IL
September 29, 2022 – "Computer-Implemented Inventions in the EPO" – Part II (Schwegman Lundberg & Woessner) -12:00 pm (CT)
American Conference Institute (ACI) will be holding its 39th Annual FDA Boot Camp conference on September 14-15, 2022 as a VIRTUAL conference.
The conference will provide attendees with presentations on these topics:
• Exploring New FDA Initiatives under Commissioner Robert M. Califf
• Navigating the approval process for drugs and biologics
• Exploring FDA's Expedited Programs with regard to applicability and eligibility
• The Nuances of Obtaining Approval for Controlled Substances
• Clinical Trials for Drugs and Biologics
• Patents and Related IP Protections and Mechanisms
• Hatch-Waxman and BPCIA Essentials, follow-on products and generic entry
• Drugs and Biologics Labeling
• The Role of Current Good Manufacturing Practices (cGMP) in the post-approval process
• Advertising and Promotion for Drugs and Biologics
• Off-label Communications: subtleties and safe zones
• Adverse Events Monitoring, Pharmacovigilence, Risk Management, and Recalls
• FDA Enforcement Authority and Actions
In addition, two pre-conference workshops will be offered on September 13, 2022. The first, entitled "FDA Law 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws," will be offered from 9:00 am to 12:00 pm EST, and the second, entitled "Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations," will be offered from 1:30 pm to 4:30 pm. There will also be a post-conference workshop held from 2:30 pm to 5:30 pm on September 15th entitled "Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group."
A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference and all three workshops is $2,495 for registration by September 14, 2022. Registration for the conference alone is $1,795. The workshops are $400 apiece. Patent Docs readers are entitled to a 10% discount off of the registration fee using discount code D10-999-PATENTDOCS. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's 39th Annual FDA Boot Camp.
American Conference Institute (ACI) will be holding its 8th Annual Paragraph IV Disputes Master Symposium on September 21-22, 2022 in Chicago, IL.
The conference will offer presentations on the following topics:
• Proposed Hatch-Waxman Reform Measures including live audience polling
• The Fate of "Skinny Labeling" at the Supreme Court in GSK v Teva
• The Relationship between Written Description and Enablement in view of Biogen v Mylan
• Patent Eligible Subject Matter after the Supreme Court Denied Cert in American Axle v. Neapco
• Venue in the Litigation War Room: Planning Attacks in view of MDL with Joint Defense Groups
• Diversity, Including Implicit Bias in Life Sciences IP (and How to Reduce It)
• The Role of the Magistrate Judge in Hatch-Waxman Litigation
• Perspectives on ANDA Litigation from District Court Judges
• Analyzing the Impact of FDA Initiatives On Generic Drug Access and ANDA Litigation
• The APJs Speak: Practice, Policy and Procedure
• Interplay of Co-Pending IPR Proceedings and ANDA Litigation and Winning Strategies in Each Forum
• Restrictions on Reverse Payment Settlement Agreements, in Non-monetary Settlements and FTC Review
• Cross-Border Business Considerations in Hatch-Waxman Litigation: A Global Approach
• Obviousness-type Double Patenting and Patent Term: the Effects on Ex Parte Cellect
• Damages in At-Risk Launch Scenarios
• Ethical Dilemmas in Paragraph IV Practice: Discovery, Privilege, and Professional Responsibility
The agenda for the Paragraph IV Disputes master symposium can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference is $2,395 (or a special $1,895 in-house rate for pharmaceutical & biotech organizations). Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-999-PATENTDOCS. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's Paragraph IV Disputes Master Symposium.
The U.S. Patent and Trademark Office and U.S. Food and Drug Administration will be discussing the intricacies that biotech and medtech independent inventors and startups face when securing intellectual property (IP) rights from the USPTO and when seeking regulatory approval from the FDA. The online program will be held on September 8, 2022 from 10:00 am to 2:00 pm (PT). Topics to be covered during the webinar will include:
• Navigating USPTO patent and FDA regulatory processes with an emphasis on biotech and medtech industries
• Initiatives, strategies, tips, and best practices to protect your discoveries and innovations
Those interested in registering for the webinar can do so here.
J A Kemp will be offering a webinar entitled "National Phase Entry Strategy" on September 8, 2022 from 16:00 pm to 17:00 pm (GMT). Lucy Barnes and Andrew Clark of J A Kemp will explore the factors and national/regional phasing strategies that can be used to optimise international examination from both the cost perspective and for maximising scope of protection. The webinar will address the following topics:
• Where to enter the national/regional phase
• When to enter the national/regional phase (for example we will explore strategies involving staggering national/regional phase entry)
• What claims to include
• Prosecution strategies, such as acceleration
There is no registration fee for this webinar. However, those interested in registering for the webinar, should do so here.
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