The UK and US patent courts go to extremes against an Iranian American inventor in favor of a ventilator manufacturer, Hamilton Medical
The UK and US patent courts go to extremes against an Iranian American inventor in favor of a ventilator manufacturer, Hamilton Medical
Due to the COVID-19 crisis, some of the major manufacturers of ICU mechanical ventilators have made unprecedented profits in the past couple of years. One of those is Hamilton Medical which has signed contracts worth hundreds of millions of dollars to provide ventilator equipment to the western
governments.
The flagships of this corporation are its advanced ventilation systems known as “Adaptive Support Ventilation” or “ASV” and its newer system known as IntelliVent-ASV. The system is known as “ASV” has been marketed under the license of a patent (US4,986,268)1 by an Iranian American inventor since 2004. The newer system known as IntelliVent-ASV is not yet marketed in the US due to regulatory problems but has been marketed in many other countries, including the UK for around a decade.
The brain cells die within a couple of minutes of oxygen deprivation.
Any automatic oxygenation system for ICU patients needs to determine the oxygenation parameters of the ventilator, which are the fraction of inspired oxygen (FIO2) and the positive end-expiratory pressure (PEEP) on a breath-by-breath basis to be effective. Look-up tables that provide suggested discrete pairs of PEEP and FIO2 for trial-and-error adjustments of the parameters and protocol-driven systems based on those tables can only be used intermittently and are not effective for ICU patients. A system for automatic oxygenation and ventilation for every breath was developed, tested, and patented (US7,802,571)2. This patent covers the 1st fully automatic ICU oxygenation and ventilation system, and the inventor developed that system by testing it in
different ICU settings to prevent death and brain damage due to inefficient ICU oxygenations and ventilations. This patent has counterparts in several countries.
In the patented system, FIO2 and PEEP are determined for every breath. FIO2 is adjusted by using interactive stepwise and/or Proportional-Integral-Derivative (PID) control. PEEP is determined in relation to FIO2 for every breath to keep the ratio of PEEP/FIO2 within a prescribed range. While maintaining a prescribed range of PEEP/FIO2, PEEP is increased if the patient’s oxygen level falls below a pre-defined value. PEEP is not determined independent of FIO2 and cannot be controlled by PID. The Patent specification advises not to change PEEP unless a minimum time (e.g., 4 minutes) has passed since the last adjustment in PEEP for safety. The system further controls the tidal volume of breaths, the breathing frequency, and the ratio of inspiration to expiration time (I:E) by using the patient’s measured oxygen and carbon dioxide levels and the respiratory resistance and compliance data for every breath.
Hamilton’s IntelliVent ASV system is an advancement of their ASV system. In IntelliVent ASV, the system determines tidal volume, breathing frequency, and the I:E automatically, and oxygenation is controlled by automatic determination of PEEP and FIO2. The adjustments of PEEP and FIO2 in IntelliVent ASV can be made in seconds3
After Hamilton Medical refused any negotiation in regard to its IntelliVent ASV system, the inventor of US7,802,571 patent2, whose financial resources were limited, had to take legal action against Hamilton Medical in a court known as “Intellectual Property and Enterprise Court” or “IPEC” in the UK which proclaims to be a streamlined low-cost court designed for small businesses to assert their patent rights.
The legal action was started in 2019 and before the onset of the COVID-19 crisis. During more than two years of prolonged legal proceedings, Hamilton Medical was given numerous exemptions against the deadlines by the court to submit thousands of pages of filings against the patentee, while the patentee was financially bleeding along the way. Despite that Hamilton was not marketing its IntelliVent-ASV system in the US, it filed litigation against the inventor’s US patent in 2020 in a US court known as PTAB. A virtual trial on the UK case was held in July 2021, and the court issued a judgment two days before Christmas of 2021.
A hearing on the US case was held in October 2021 and a decision in favor of the corporation was issued in early January 2022.
The main documents that Hamilton brought to the courts against the inventor were basically old manual look-up tables for oxygenation. In the US court the focus was on a) combining an intermittent look-up table in a conference presentation7 with a manual chart for adjustment of oxygenation parameters several hours apart8 and b) combining the same manual chart with a US patent9 that presented an unstable positive feedback method against the clinical practice and had been rejected by the patent examiners against the application of US7,802,571 patents in the past.
The main document focused by Hamilton in the UK court was another look-up table in a conference presentation10 for adjustments of oxygenation parameters by trial-and-error in 15 minutes to 2 hours intervals. Hamilton Medical claimed that IntelliVent ASV used the look-up table in the said paper for adjustment of PEEP and FIO2 to single discrete pairs intermittently.
They further focused on the same look-up table to attack the validity of the UK counterpart of the patent. It should be obvious to anyone with even preliminary knowledge of systems control that manual charts or look-up tables that are basically manual tools for trial-and-error adjustment of parameters intermittently have no place in automatic continuous feedback systems such as the system of the US7,802,571 patent2 and its counterparts for breath-by-breath determination of parameters and can neither be combined with such systems nor describe them. These matters were explained in detail to the courts.
The “claims” in a patent are the legal parts of the patent that are used to provide protection against infringement as well as invalidity challenges to a patentee. It should be clear that if the keywords of any legal documents are removed or altered, there can be no legal protection left. In the US7,802,571 patent2 and its counterparts, the term “a next breath” is used to refer to a patient’s next breathing cycle. Against the Patent Cooperation Treaty (PCT) conventions, the engineering expert of Hamilton Medical in the UK court (Stephen Edward Rees) stated in his report that “a next breath” does not mean the same as “the next breath” and it simply means “a point in the future.” the UK court completely ignored the PCT conventions and decided in its Judgment that in the patent claims “a next breath” just means a breath some time in the future “and does not have to be a patient’s next breath.
11 By this baseless definition of a major claim term of the patent, the word “next” which means “immediately following in time” was arbitrarily removed from the claims and the entire purpose of the patent at issue and its software and hardware details that were designed for a patient’s breath-by-breath oxygenation and ventilation became totally meaningless. Still, the court could not justify equating the 60-page patent to a look-up table10 in a few-page non-reviewed conference paper brought in by Hamilton against the patentee. Therefore, in its Judgment, the court relied on alleged “evidence” against the patentee that did not exist in the records12.
Shocked by seeing such a judgment, the inventor requested the court to revoke its Judgment that was based on alleged evidence that did not exist, but her request was rejected by the court. The UK court even went further against the inventor and, despite that it had found the patent infringed by Hamilton Medical product in its Judgment, 13 gave an order to make the inventor pay a fine of £50,000.00, which is the maximum allowable fine in that court, to Hamilton Medical.
Hamilton Medical’s expert in the US court was a biologist who claimed to be a respiratory therapist despite that he had not renewed his RT certificate for forty years and he had been disqualified as an expert in another case. Based on his testimonies, the US court concluded that a manual survey chart for adjustment of parameters several hours apart8 was for automatic control of parameters for a next breath against all evidence14. The US court went even further by ruling that despite that one of the main references of Hamilton9 that had been rejected by patent examiners in the past admittedly described a “fatal” method, it could still be used against the inventor’s patent15.
What the courts have done against the inventor has different facets. The Swiss-based ventilator manufacturer with many lucrative contracts with the Western governments at the time of the COVID crisis was obviously “the boss” in the courts, and the patentee did not have any real rights. However, the treatments that the inventor received in the courts have other underlying reasons. These treatments exemplify how Iranians, and especially Iranian scientists, are treated by some of the Western governments. It is time for such highly biased treatments that are heavily influenced by international politics against Iranians to end.
The author, Fleur T. Tehrani, Ph.D., P.E., is a Professor of Electrical Engineering at California State University Fullerton, USA.
——————————————————————————————————————————————————–
1 US4,986,268
2 US7,802,571
3 IntelliVent ASV Operator’s Manual Hamilton-G5/S1 2018, 62447005, Table 1-19 on page 70.
4 IntelliVent ASV Operator’s Manual Hamilton-G5/S1 2018, 62447005, page 68, figs. 1-27 and 1-28.
5 Tehrani v Hamilton Bonaduz AG & Ors [2021] EWHC 3457 (IPEC) (22 December 2021) (bailii.org)(Judgment)
6 https://s3-us-west-1.amazonaws.com/ptab-filings%2FIPR2020-01199%2F57 (Decision)
7 Anderson JR, East TD. A closed-loop controller for mechanical ventilation of patients with ARDS. 39th annual
Rocky Mountain bioengineering symposium 2002;289-294.
8 Figure 7 in Carmichael LC, Dorinsky PM, Higgins SB, Gordon RB, Dupont WD, Swindell B, Wheeler AP.
Diagnosis and therapy of acute respiratory distress syndrome in adults: an international survey. J Crit Care
1996;11(1):9-18.
9 Taube JC. Adaptive controller for automatic ventilators. US Patent No. 5,388,575 issued Feb. 14, 1995.
10 Figure 1 in Waisel et al., PEFIOS: An Expert Closed-Loop Oxygenation Algorithm, Medinfo’95: Proceedings of
the 8th WCMI, pp. 1132-1136, Vancouver Trade & Convention Centre, Vancouver, British Columbia, 23-27 July
1995.
11 Paragraph 52 of the Judgment.
12 Paragraphs 98-99 of the Judgment.
13 Paragraph 74 of the Judgment
14 Decision at pages 28-29.
15 Decision at page 46 in the footnote.