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On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.” St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).
In invalidating the claims, the PTAB interpreted the patent claim limitation of a “frame sized and shaped for insertion between the upstream region and the downstream region.” The PTAB found that the limitation also covers a frame that fits in place after removal of a damaged heart valve. The cited prior art allegedly also disclosed a valve insert sized to fit the valve after the damaged native valve was removed. Therefore, the PTAB found that the prior art anticipated the claims.
The Federal Circuit held that the PTAB erred in determining that the “sized and shaped” limitation “does not require the frame be sized and shaped for insertion into a damaged heart valve,” but “only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.” The Federal Circuit reasoned that the PTAB’s construction was incorrect because “it covers frames sized and shaped for installation with the native valve removed, rather than only with the native valve in place.” The Federal Circuit cited language in the patent specification allegedly stressing that the disclosed artificial heart valve can be inserted without removing the native valve, an alleged express improvement on the prior art.
(This is an executive summary. The full report can
be found on AutoTechInsight. See links below.)
As the automotive sector struggles to sustain production in
light of semiconductor shortages, new concerns emerge around the
stability of the supply for magnesium, which is key to aluminum
production and is heavily sourced from Mainland China. The price of
the raw material has recorded a three-fold increase when compared
to pre-pandemic levels, further corroborating shortage concerns in
the industry.
The issue has been raised at the governmental level at a recent
EU Council held one week ago as it could have "far-reaching
ramifications on entire European Union value chains". There is
little doubt that a prolonged shortage of magnesium could have a
devastating impact on vehicle and components production. This
article analyzes why this has become an issue and whether it will
trickle down to vehicle and component production.
Magnesium in automotive
Magnesium is considered the lightest material among all commonly
used ones for structural applications. It is roughly one-third
lighter than aluminum. It has also the property of bonding with
other elements easily, which makes it difficult to find magnesium
in its pure form. Automotive applications of magnesium started from
racing cars, adopting the material in some components as early as
the 1920s. The adoption of the material in light vehicles started
with commercial vehicles.
The majority of this material is produced from natural minerals
such as dolomite and magnesite and it is extracted typically
through two processes, both needing high energy levels and
producing high emissions levels: pidgeon process and electrolysis
process (mainly used in the United States), one respectively
starting from the dolomite mineral, the latter from magnesium
chloride.
It must be noted that the vast majority of automotive
applications comes from alloys in which magnesium is present with
different levels, mainly aluminum alloys. The following aluminum
series commonly used in automotive components are impacted by
magnesium or silicon usage (and thus potential shortages): 5xxx,
6xxx, 7xxx, and 3xx.x.
Aluminum alloys are highly recycled within the automotive value
chain, so specific attention should be paid to market demand
increases for wrought alloys, which burden the minerals supply
chain with additional raw materials. For the automotive value
chain, an extensive amount of wrought alloy demand comes from
aluminum sheets used in body construction.
Is there a shortage?
The origins of the concerns are to be found in Mainland China,
which in 2020, accounted for 85% of global output of magnesium
metal, in particular in the Shaanxi Province, which accounted for
63.5% of total production output with its 0.61 million metric tons.
Magnesium producers in Shaanxi Province are dealing with high coal
and electricity prices, and stricter "dual control" of energy
consumption.
To further cut 2% of energy consumption in per capita GDP growth
in the third quarter, and 3.2% in the whole year 2021, Shaanxi's
Yulin city urged industrial facilities, including magnesium plants,
which are categorized as high-emission units, to either completely
shut down or run at 50% of production capacity in the last two
weeks of the third quarter. Most magnesium plants have resumed
operations since early October, but they are being asked to run at
about 40% of capacity until the end of this calendar year.
This has sparked concerns, particularly in the automotive
industry about an imminent shortage of material. John Mothersole,
economics director at IHS Markit in the Price and Purchasing
division, clarified that there is no certainty about the imminent
shortage, but markets are reacting to the scale of production cuts
in Mainland China and comparatively low inventory coming into the
fall. "The fear that if this lasts for a few months will result
into a material shortage is well placed," Mothersole explained.
There are indications that the mandated cuts in production
imposed in China may soon be relaxed, perhaps as early as November.
Chinese authorities have intervened in both coal and electricity
markets in an attempt to alleviate the crisis. If the electricity
supply begins to improve, it is likely that those mandated
production cuts will be relaxed.
To date, no shortages of aluminum have been reported.
Possible long-term implications
The current energy market within Shaanxi Province and guidance
provided by Yulin city officials is the determining factor for both
the near-term and long-term direction of the magnesium market. The
duration of production limits, as constrained by province-level
grid energy demand, will become a key metric to monitor to
understand pricing and supply availability of magnesium. Most
plants within this province will run at 40% production capacity
until the end of 2021.
Beyond the immediate next quarter of magnesium production,
energy capacity investments within Shaanxi Province, relaxations in
energy cuts, or changes in prioritization of energy restrictions
will establish market direction for both the availability of
magnesium as well as the cost basis of production. While
relaxations in policy may alleviate the supply chain bottleneck of
this material, the energy-intensive nature of magnesium production
will not be impacted within a mid to long-term period. Substantial
research and development is required for any material production to
reduce energy requirements. Beyond this, there is not a clear
pathway to adjust for the fact that Shaanxi Province is responsible
for producing nearly 54% of the global magnesium supply.
In a worst-case scenario, extended production cuts will lead
inevitably to a material shortage, as capacity outside of Greater
China will not be able to make up for the shortfall in global
supply. In this situation, we could see a cascade effect on the
aluminum sector, although aluminum prices seem stable so far. IHS
Markit, to date, does not have any confirmations about this
happening, nor that the aluminum producers are concerned about this
magnesium situation.
The automotive industry remains concerned about this situation,
with the immediate impact of substantial input cost increases as an
ominous signal that shortage is imminent. The next two months will
be crucial to understand whether this will result in a journey
similar to what was observed with the semiconductor shortage or is
an overreaction in the metals market. In the meantime, long-term
risks about supply should also be in focus.
A recent study by the US Department of Defense identified
magnesium as one of the key strategic minerals for the country.
Such over-reliance on China might not bode well in the context of
the economic decoupling the United States is pursuing or Europe's "strategic autonomy" policy. In this context, it would be wise for
OEMs and suppliers to explore some pathways to alleviate their
exposure to magnesium-intensive alloys in the longer run.
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China's new Judicial Interpretation on Plant Varieties harmonized IP protection for plant varieties with other reforms in IP laws in China. It also reflects China's increasing efforts to accelerate agricultural reforms including strengthening legal protection for germplasm resources.
It should be said at the outset that the US law is very different to that of Australia, and it is therefore unlikely that anything in Judge Brinkema’s legal reasoning will be influential upon the Full Court. It has also become apparent through the UK High Court and Court of Appeal decisions that while the UK law shares some similarities with the corresponding provisions of the Australian Patents Act 1990, there are also some significant differences. Even so, there are aspects of the reasoning of Lord Justice Arnold in the Court of Appeal that the Australian appeals court may consider persuasive, and that could therefore influence the outcome here.
There are two key questions likely to be addressed in the appeal, both of which also arose in the UK, although only the first received substantive attention in the US. These are:
Can DABUS, as an ‘AI’ machine and not a human being, validly be named as an inventor on a patent application?
Can Dr Thaler, not being (at his own insistence) the inventor, establish a proper legal basis for entitlement to the grant of patents on inventions said to be generated by DABUS?
The issues in the UK case are somewhat different, and more nuanced, than in the US. While all three judges on the Court of Appeal agreed that an ‘inventor’ under the UK law must be a human being, the fact that DABUS is a machine was not immediately determinative of the outcome. An inventor is not required to play any active role in the filing, prosecution, or grant of a patent in the UK, so arguably there remains a question as to whether an application can be permitted to proceed even if a legally valid inventor has not been – or cannot be – named. In the event, the answer to this question turned on whether or not the applicant (i.e. Dr Thaler) could satisfy statutory requirements to name the inventor, and to indicate how he is entitled to be granted patents on inventions that he did not claim to have devised himself.
Lord Justice Arnold and Lord Justice Birss disagreed on the outcome, with the tie being broken by Lady Justice Elisabeth Laing, agreeing with Arnold LJ that the DABUS applications should be deemed withdrawn.
Arnold LJ is the preeminent patent law specialist on the Court of Appeal. He was elevated to the Court of Appeal in 2019, after being appointed to the High Court in 2008, and as Judge in Charge of the Patents Court in April 2013. In March 2016 he was appointed as an External Member of the Enlarged Board of Appeal of the European Patent Office. Impressive as this is, however, Birss LJ is no lightweight. In 2010 he was appointed as a Specialist Circuit Judge sitting in what was then the Patents County Court. In 2013 he was appointed to the High Court, and in 2019 he filled the place formerly held by Arnold LJ as Judge in Charge of the Patents Court, before being elevated to the Court of Appeal in January 2021.
So this is a case in which the dissenting judgment must be taken seriously, especially with the possibility still open of an appeal to the Supreme Court. But for now, at least, the balance of the law remains against DABUS in the UK.
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