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.
Analysis of R V Kelkar's Criminal Procedure Code ppt- chapter 1 .pptx
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
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
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
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)
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
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”
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
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
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.
Notes de l'éditeur
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.”