Global & U.S. Patents for Digital Health Startups
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Global & U.S. Patents for Digital Health Startups
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Digital health is all around us and the health tech sector has been taking off like a rocket. Spurred by advancements in AI, ML, and mobile device tech combined with challenges brought on by everything from the needs of daily health monitoring to the challenges that came along with the pandemic. These worlds are colliding, innovation in the sector is exploding, and disruptive change to healthcare will only accelerate. Amidst all of this massive growth, startups need to maximize their use of funding and protect their IP from being copied. Patents are the strongest form of protection against this and one of the best possible returns on investment. At the most basic level, if your innovations drive your product and your business, it’s essential to develop a patent strategy that protects these innovations, increases your valuation, and extends your company’s longevity. So, growth is incredible. Patents provide great protection and can yield incredible ROI. So what’s the problem? Patent law and court rulings have been working in direct opposition to this growth, but there are some key strategies you can leverage to make the most of your funds while securing vital intellectual property.
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Global & U.S. Patents for Digital Health Startups
- 1. Global & US Patents ASHLEY SLOAT, Ph.D. May 12, 2021 This presentation is for information purposes only and does not constitute legal advice.
- 2. $34 bn AI-powered tools market will exceed $34 billion by 2025 20.4% Wearable medical device will grow 20.4% CAGR by 2025 $5.1 bn Medical virtual reality will reach $5.1 billion by 2025 Stats: TechAhead Team 4/10/21 & Rebecca Bellan 11/25/20
- 3. The value of a patent • Goal: Maximize use of funding, grow, and protect your IP from being copied. • Patents are the strongest form of protection and one of the best possible returns on investment. ”Are patents signals for the IPO market? An EU–US comparison for the software industry.” 17 September 2012 $338,000 Median portfolio value with 1 issued patent $1.1 MM Avg valuation per patent in software co IPOs 35X higher growth for companies that apply for patents
- 4. Digital Health is Fast forwarding while Software is Legging Behind Software Patenting Digital Health
- 5. ML Patent Families grew by an average of 26% annually between 2011 and 2016 Machine Learning WIPO Technology Trends 2019: AI
- 6. Top AI Application Field Categories Transportation Personal devices, computing, HCI Life & Medical Security Telecomm Business Ind. & Manuf. Doc. Mgmt & Pub. WIPO Technology Trends 2019: AI
- 7. Federal Circuit Section 101 Decisions 2014-2019 0 50 100 150 200 Software Biotech Healthcare Eligible Ineligible Robert R. Sachs (2019)
- 8. AI at the USPTO Gaudry K and Hayim S. “Artificial Intelligence Technologies Facing Heavy Scrutiny at the USPTO.” IPWatchDog, November 28, 2018.
- 10. Overview • U.S. vs. International Filing Strategies • Protecting Digital Health Innovations • FDA and Patent Term Adjustment
- 11. In exchange for a limited monopoly of 20 years, an inventor must disclose her invention with such particularity as to enable one of skill in the art to make and use the invention, and therefore build upon the invention, to promote the progress of the useful arts.
- 12. Why Startups File Patents • Stimulate investment or acquisition • Deter patent infringement lawsuit • Carve out contribution to partnership
- 13. First (Inventor) to File B WINS! File early and often! A invents B invents B files A files
- 14. Paths to Filing a Patent Provisional Nonprovisional International
- 15. Paths to Filing a Patent Provisional Nonprovisional * International App Nonprovisional* and/or International App International App 1 yr. 1 yr. Country Selection * Country Selection * Country Selection * 1.5 yr. 1.5 yr. 2.5 yr.
- 16. Things to do before filing • Publicly disclose your patent–ready invention • Sell or offer for sale your technology • Respond to an RFP if the technology is patent-ready • But, But, But... if you did: • The U.S. has a one-year grace period • Grace period does not necessarily extend to international filings
- 17. How long does it take to get a U.S. patent? Accelerated Examination Typical Prosecution Patent Prosecution Highway Prioritized Examination (TrackOne) • If claim(s) allowed in another patent office, can fast track in US • Petition: pre-exam search and report to argue patentability • Pay extra for final disposition in one year
- 18. How long does it take to get a U.S. patent? Accelerated Examination 0.5-1.25 yrs. Typical Prosecution 2-5 yrs. Patent Prosecution Highway 1-1.5 yrs. Prioritized Examination (TrackOne) 1 yr. $$$ $$ $
- 19. What is patentable? • Four categories: process, machine, manufacture, composition of matter • However… the courts have long held that there are implicit exceptions: • Laws of nature • Natural phenomena • Abstract ideas
- 20. Statutory Category? YES Judicial Exception? Practical Application? YES Significantly More? NO YES NO YES Eligible NO Subject Matter Eligibility Guidance Process machine manufacture composition of matter Laws of nature Natural phenomena Abstract ideas Not Eligible NO
- 21. Other Requirements for Patentability • Novelty: no one reference discloses all the claimed features • Inventive Step: no one or more reference, explicitly or inherently, discloses all the claimed features • Sufficiency: does the patent disclosure reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date • Enablement: is the invention described in such a way that it allows one skilled in the art to make and use the invention without undue experimentation
- 23. •Device •Device & Software Combo •Software •Method of Treatment “easiest” “hardest” Feasibility + Int’l Acceptance
- 24. Method of Treatment • Article 53(c) EPC: “European patents shall not be granted in respect of … methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body”. • Allowed in U.S. and Australia • Not allowed in most other countries (e.g., Japan, China, Canada)
- 25. •Device •Device & Software Combo •Software •Method of Treatment “easiest” “hardest” Feasibility + Int’l Acceptance
- 26. What to do when claiming Software • Don’t recite what it does Instead: claim what it is • Don’t claim the intended goal Instead: Claim how the goal is achieved • Don’t claim it in such a way that it could be performed in the mind Instead: Claim technical solution for technical problem
- 27. What TO DO when claiming Software • Claim features that contribute to an identified technological improvement • Integrate any abstract ideas into practical application(s) of the software • Recite, with particularity, features that perform the intended function
- 28. For AI/ML Innovations… • Core vs. Applied ML • In which feature(s) does the invention actually reside? • In the training process? • In the application? • In the device? • In the ML/AI structure itself? • Generic recitation of an ML/AI algorithm is not enough for the invention to be deemed patentable subject matter
- 29. •Device •Device & Software Combo •Software •Method of Treatment “easiest” “hardest” Feasibility + Int’l Acceptance
- 30. Specific device coupled with software… • Integrates into a practical application • Takes it “out of the mind” for the judicial exception analysis • Reduces the likelihood of pre-emption – gives you “something more”
- 31. •Device •Device & Software Combo •Software •Method of Treatment “easiest” “hardest” Feasibility + Int’l Acceptance
- 32. AI as an Inventor? • 2 European Patent Apps listed “DABUS” as the inventor • European Patent Convention (EPC) does not explicitly prohibit protection for autonomous machine inventions • EPO practice is intended to prevent company inventorship Lessons from Europe
- 33. EPC: Designation of Inventor • Annex: The legal framework of the EPC provides for natural persons, legal persons and bodies equivalent to legal persons…The EPC does not provide for non-persons…a clear legislative understanding that the inventor is a natural person. • Rationale: AI systems or machines have at present no rights because they have no legal personality comparable to natural or legal persons. • Holding: application is refused with Article 90(5) EPC since the designation of inventor does not meet the requirements of Article 81 and Rule 19 EPC
- 34. IP5 Expert Round Table on AI • China, Japan, Korea, Europe, and USA B. Inventorship/ownership 4. All IP5 jurisdictions require that the inventor is a human being. 5. All IP5 Offices acknowledge there may be certain difficulties for patent offices to determine whether a particular invention has been made by a human or a machine. Nonetheless, all IP5 jurisdictions require that the inventor be a natural person… “Report from the IP5 expert round table on artificial intelligence.” Munich, 31 October 2018.
- 35. Additional IP Considerations • Design patents for device ornamentation, GUIs • Trademarks for slogans, branding • Trade secret for innovations that are not patent eligible or not ready for patenting • Copyright for unique software code expressions
- 36. FDA Digital Health Software Precertification Program • Provide data so that FDA can establish regulatory framework • Currently available for Software as a Medical Device (SaMD) • “Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device” • Companies like Apple, Fitbit, J&J, Pear Therapeutics, Roche, Samsung, Tidepool, Verily were selected • Will eventually extend to Software in a Medical Device (SiMD)
- 37. Proposed Key Components of a Future Pre-Cert Program Organization-level analysis Product-level analysis Go-to-market Product Lifecycle Excellence Appraisal Review Determination Streamlined Review (if needed) verify safety, effectiveness, and performance verify culture of quality and org excellence
- 38. Patent Term Extension for Digital Health • Enables the patent owners of certain human drugs, medical devices, and other products to restore some patent lost while waiting on government approval • Currently, PTE only available for Class III Medical Devices • Most digital health devices are either Class I or Class II • As digital health becomes more pervasive and intersects more with patient care, more may become Class III
- 39. • File before you sell or publicly disclose • Digital Health Innovations are protectable through various mechanisms – including the patent office – just be specific • FDA pre-cert program may provide a regulatory pathway for digital health eventually • Currently, no patent term extension for devices that are not Class III Take-A-Ways
- 40. Questions or Comments? Contact us! ashley@aurorapatents.com (650) 380-6913 aurorapatents.com @AuroraPatents New podcast @ patentlystrategic.buzzsprout.com
- 42. Can I Practice my Invention?
- 43. Patentability vs. Freedom-To-Operate • Patentability: others are excluded from making, using, offering for sale, selling, or importing your invention into the United States • Freedom-To-Operate: you are not excluded from making, using, selling, or importing your invention into the United States
- 44. Patent Invention Patentability vs. Freedom-To-Operate New Invention
- 45. Improvement Patentability vs. Freedom-To-Operate Base Invention
- 47. The On-Sale Bar May not constitute offer for sale • Advertising a product not yet developed • Pre-announcing a product • Transferring technical knowledge about a process – since requires recipient to develop the product itself • Manufacturing agreement • Inventor maintains control in “experimental” use May constitute an offer for sale • Licensing agreements • Performance of services related to a product (providing reports) • Providing detailed technical drawings to a potential licensee • Unaccepted or cancelled orders • Secret sales where the details of the invention are not made public
- 48. TRIPS Agreement • Agreement on Trade-related Aspects of Intellectual Property Rights – 1994 • Compulsory License: In Article 31 allows governments to order domestic manufacturers to make a patented product without permission from the patent holder - compulsory licensing • IP waiver: simply asks that countries be exempt from the provisions of TRIPS that require countries to protect and enforce patent rights to COVID-19 treatments and vaccines
- 49. Creating a Vaccine Requires more than a Patent • Complex Manufacturing facilities and processes • Complex testing processes • Packaging requires hundreds of thousands of empty vials to be washed and sterilized • Packaging requires high speed visual inspection, e.g., 100 photos of each vial • Vials need to maintained at ideal temperature otherwise risk degradation of mRNA in vaccines • Distribution and logistics are also come into play
- 50. Result • Fed. Cir.: “Weighing these factors together, we conclude that Google’s use of the declaring code and SSO of the 37 API packages was not fair as a matter of law.” • SC Majority: “Google reimplemented a user interface, taking only what was needed to allow users to put their accrued talents to work in a new and transformative program, Google’s copying…was a fair use of that material as a matter of law.” • SC Minority: “three of the four statutory fair-use factors weigh decidedly against Google. The nature of the copyrighted work—the sole factor possibly favoring Google—cannot by itself support a determination of fair use” Limited copying of declaring code so that programmers can create new implementing code is an act of fair-use as a matter of law
- 51. Ruling Outcomes • Things have really been heating up at the intersection of software and IP law for some time. • The alternate case outcome had tremendous potential for a devastating impact on the software industry and its consumers. • Just a shame that it had to come at the cost of a SCOTUS ruling that really wasn't the best day for case law. ¯_(ツ)_/¯
- 52. Pending Legislation • STRONGER Patents Act. Keeps resurfacing every few years to mixed reviews. • Abolishing judicial exceptions. Senators Coons and Tillis proposing to restore patent eligibility to a broader class of inventions, making anything that provides a “specific and practical utility in any field of technology by human intervention” eligible for patent protection.
Editor's Notes
- Digital health devices are rapidly becoming a key sector of the medical device space. This revolution begs us to understand IP and licensing issues that are being presented as a result of this newly emerging field. In this webinar, we will explore how digital health looks today and what are some changes we can expect in the near to distant future.
- compound annual growth rate
- * Bloomberg Law: a patent portfolio with only one issued patent has a median price of $338,000 * 2012 Study: Software companies that IPO raise (on average) an extra $1.1 million in the US per each additional patent application A 2016 MIT study found that startup growth is 35 times higher for companies that apply for patents. Another recent study concluded that for digital health startups that eventually IPO, valuation can reach over $1 million per filed software patent application. So, market growth is red hot. Patents provide great protection, predict startup growth, and can yield incredible ROI. Sounds great, you say. So what’s the problem?
- What can you now do given everything
- Josh notes: we should figure out how to tweak the colors used in Design Ideas. These would look better with white backgrounds The labels are also going to be very hard to read
- Josh notes: See prior re: background color and label size
- Alice vs. CLS Bank – electronic escrow service Electric Power Group LLC v. Alstom SA found that data gathering, analysis and display is an abstract idea,
- US vs. International filing strategies Patent Prosecution HighwayGrace periods for disclosure (when they do and do not apply) Patenting of methods of treatment Difficulties and solutions for those difficulties in patenting "software" innovations (as they relate to digital health and ML/AI)
- Defensively – deter competitor Offensively – stop competitor from ripping off the tech Attract investment Bolster reputation A 2016 MIT study found that startup growth is 35 times higher for companies that apply for patents. Partnership bullet As one example, Amazon recently partnered with 37 healthcare startups working on innovations to improve operational and clinical effectiveness.
- Even if you are a foreign company, you can file a provisional in the US This time does away at your 20 year patent term – strategies to get some time back
- Korea
- PPH offices: Australia, Canada, EPO, China, Japan, Korea, Singapore Accelerated exam: search claimed invention, search all forms of prior art, provide text-search logic, show support in spec and drawings, claim chart, show how wach claim is patentable over each reference
- That all changed in 2012, however, when the U.S. Supreme Court broadened the scope of the law of nature exception regarding patent eligibility. In a case called Mayo Collaborative Services v. Prometheus Laboratories, the Supreme Court looked at an invention related to a method for optimizing treatment of an immune-mediated gastrointestinal disorder.
- Assuming novelty and inventive step are already there Notes – include idea that you can protect incremental improvements to your own technology
- In US, Diagnostic method only reciting an indication to change dosage is ineligible for patent protection The policy behind the prohibition of patenting methods of medical treatment are based, at least in part, on the public interest in physicians having unbridled access to advanced surgical and other medical techniques in a timely manner. Opponents argue that the physician should not fear patent infringement when caring for patents, and the practitioner should also be free from any conflicts of interest that may be associated with licensing a patent directed to one of several potential treatment modalities.
- Assuming novelty and inventive step are already there Josh Notes: I lie this
- Josh notes: I feel like this slide and the next might need spoken examples. Too much in the abstract w/o 1-2 examples
- As discussed in Part I of this series, the predictive capabilities of a trained model are captured by the statistical weighting values embedded in the model. Even if these numerical weightings are explicitly disclosed in a patent, they are unlikely to support the full scope a claimed invention because such numerical values have little meaning to even experts and cannot be reproduced due to the randomness associated with the optimizations performed by the training algorithm. a thorough and detailed description of the training data, training procedures, model output results, and system integration of the trained model must serve as the basis for demonstrating that the inventor had possession of the trained model, and for enabling one of ordinary skill in the art to make or use the trained model without undue experimentation.
- Assuming novelty and inventive step are already there Josh Notes: I lie this
- Assuming novelty and inventive step are already there Josh Notes: I lie this
- A first artificial neural network, made up of a series of smaller neural networks, that has been trained with general information from various knowledge domains. This first network generates novel ideas in response to self-perturbations of connection weights between neurons and component neural nets therein. A second “critic” artificial neural network monitors the first neural network for new ideas and identifies those ideas that are sufficiently novel compared to the machine’s pre-existing knowledge base. The critic net also generates an effective response that in turn injects/retracts perturbations to selectively form and ripen ideas having the most novelty, utility, or value. Article 81: The European patent application shall designate the inventor. If the applicant is not the inventor or is not the sole inventor, the designation shall contain a statement indicating the origin of the right to the European patent. Rule 19(1): The request for grant of a European patent shall contain the designation of the inventor. However, if the applicant is not the inventor or is not the sole inventor, the designation shall be filed in a separate document. The designation shall state the family name, given names and full address of the inventor…
- Copyright – can’t be one of only a few ways of writing the code – will weigh against copyright
- Total Product Lifecycle Approach of the Software Precertification Program
- CLASS 1 The US FDA defines Class I devices as devices which are "not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury." CLASS 2 The FDA defines Class II devices as “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”
- Link between statements in spec and claims
- EDISON PIPKIN
- countries to engage in compulsory licensing if there is a “case of a national emergency or other circumstances of extreme urgency,” or in cases of “public non-commercial use.”
- The efficacy of both of these proposals turns on a country’s internal technological capabilities to recreate and administer the vaccine. Many vaccine makers rely on trade secrets
- Now, we are told, “transformative” simply means—at least for computer code—a use that will help others “create new products.”
- Now, we are told, “transformative” simply means—at least for computer code—a use that will help others “create new products.”