JUVE Patent's top 10 patent cases of the year 2020 reflect the headline-grabbing, multi-jurisdictional FRAND and pharma judgments so eagerly anticipated by the patent community; but also the beginnings of important new cases. Subjects such as DNA sequencing, plant patents, supplementary protection certificates and e-cigarettes shone through 2020 with important and interesting litigation. And naturally, there's another - extra - subject which continues to be at the forefront of most patent lawyer's minds.
22 December 2020 by Amy Sandys
… and 10+1: what’s next for the UPC?
Rights of priority a talking point for involved parties
CRISPR/Cas, specialised strands of DNA, has come to prominence in recent years due to its many potential applications. In October 2020, the Royal Swedish Academy of Sciences awarded inventors Jennifer Doudna and Emanuelle Charpentier the 2020 Nobel Prize in Chemistry for their discovery.
The technology can combat chronic infectious diseases and improve crop varieties easily and efficiently, and its continued development promises a global business worth billions. During 2020, priority arose as a core issue in the ongoing CRISPR/Cas proceedings.
In January, the EPO found the Broad Institute’s EP 2 771 468 invalid due to lack of novelty based on an invalid claim to priority. Board 3.3.08 upheld a first instance Opposition Division decision and revoked the patent, saying the patent claim lacked novelty over the prior art.
Broad initially applied for EP 468 in the US, where the inventors are also automatically registered as applicants. When filing an application in Europe via the international patent procedure PCT, however, Luciano Marraffini – one of the four original applicants – no longer appeared as inventor.
Marraffini had transferred his right of priority to Rockefeller University. In the EPO’s view, this did not result in an effective transfer of the right of priority to Europe and the Opposition Division decided that the EPO should not have granted the parent patent.
In February 2020, the EPO maintained the patent in its original form. The owners, the University of California (Berkeley) and University of Vienna, and Doudna and Charpentier, have thus provisionally enforced their claim for protection in Europe for CRISPR/Cas technology.
Long-running, multi-jurisdictional battle finally edges towards conclusion
The ongoing pemtrexed battle between Eli Lilly and various generics companies over EP 13 13 508 is a hugely important pan-European patent battle.
In Jun in the Netherlands, the Supreme Court rejected an appeal from Fresenius against a preliminary injunction order from the two lower Dutch courts. The ruling stated that Fresenius infringed the patent held by Eli Lilly for the drug. The Supreme Court also ordered Fresenius to pay legal costs to Eli Lilly.
In November, a separate, second-instance decision on the merits saw the Court of Appeal of The Hague overturned a first-instance decision. In June 2019, the District Court of the Hague ruled that Fresenius has not infringed the pemetrexed patent in its Netherlands jurisdiction. However, the Court of Appeal overturned this decision in a judgment based on equivalence.
The decisions in the Netherlands followed the trend of 2019, where many decisions in the dispute were largely in favour of generics companies. However, this year the tide turned for Eli Lilly as many courts made decisions in favour of the originator. In September, a French court has banned Fresenius from selling a competing pemetrexed product in France.
The important victory for Eli Lilly meant, through a sales ban ruling, Eli Lilly secured exclusivity to the French market. The court ordered its competitor Fresenius Kabi to withdraw its product and awarded Eli Lilly 28,000,000 euros in damages.
In Germany, in July’s validity proceedings the Federal Court of Justice upheld the patent in full and reversed the findings of the lower court. This was seen as a severe setback for competitors in the market with rival products. The ruling came as a blow to Hexal and its co-litigant Fresenius. Then, later that month, the Regional Court Munich issued preliminary injunctions against generics companies Stada, Zentiva and Hikma. The companies can no longer sell their imitation products with active ingredient pemetrexed on the German market.
Naturally, the dispute is important on economic level for the companies involved. But its concern with treatment for certain types of breast and lung cancer mean the dispute also has real-world consequences. As a drug which can alleviate the side effects of chemotherapy, pemetrexed is very important indeed.
UK Supreme Court releases most anticipated SEP/FRAND judgment in a patent generation
In 2018, the London patent courts calculated a global licence rate. But it was still a good three years until the patent world and the mobile phone industry received certainty. Finally, in August 20202, the UK Supreme Court finally published its long-awaited judgment in the disputes between Unwired Planet vs. Huawei, and Conversant vs. Huawei and ZTE. Now London’s patent courts are hugely important for lawsuits concerning SEPs.
In Unwired Planet vs. Huawei, the court upheld first-instance decisions from 2017 and 2018. The Supreme Court judges unanimously confirmed that the courts of England and Wales have the jurisdiction to determine global FRAND terms and rates. In his judgment in the Unwired Planet vs. Huawei dispute, former High Court judge Colin Birss was the first judge worldwide to set a fee for a global licence. If the infringer does not accept the licence ordered by the court, they face a potential injunction.
SEP owners now hope London courts will grant them a licence for a global SEP portfolio based on a UK patent. Owners also hope that the court will calculate the licence fee. Initially, most experts agreed that this ruling is very SEP-holder-friendly. Now, a few months later, patent experts remain certain that the London FRAND principle is gaining ground.
There’s already been other litigation based on some of this case’s main principles, for examples litigation between Unwired Planet parent company PanOptis, and global mobile communications giant Apple. This era-defining FRAND case will certainly not fade into the background just yet.
The global e-cigarette market heats up
Analysts consider the e-cigarette business a key driver of tobacco industry growth, with an estimated rise in global sales of up to US$30 billion by 2030. Indeed, Philip Morris has already announced its departure from traditional cigarettes. Novel smoking products netted the world’s largest tobacco company €4 billion in 2018.
The global dispute between the two tobacco giants British American Tobacco and Philip Morris broke out in 2018, when Philip Morris launched a patent infringement action in Japan against BAT’s e-heated tobacco products. In spring this year BAT hit back, suing Philip Morris in the US. BAT also filed a patent infringement suit against Philip Morris at the Regional Court in Munich. In this case, the plaintiff is Nicoventures Trading, a subsidiary of BAT.
BAT is now suing Philip Morris’ German subsidiary and parent company Philip Morris Products S.A., attacking several Iqos products. The company claims direct and indirect infringement of its patent EP 3 398 460 B1. In Germany, BAT seeks injunctive relief and damages from Philip Morris. Then, Philip Morris responded by applying to the Munich Regional Court for a preliminary injunction.
But in November, the Iqos manufacturer failed. Philip Morris withdrew its application. The Munich court appears to have had doubts as to whether the patent EP 32 66 323 was rightly granted.
BAT subsidiary Nicoventures also commenced UK litigation proceedings for a patent revocation action against Philip Morris at the High Court. The case concerns a patent family owned by Philip Morris, which protects the combustion technology used in heat-not-burn e-cigarettes. Philip Morris has also commenced proceedings against RAI Strategic Holdings, another subsidiary of BAT, for revocation of the BAT patent-in-suit. Both companies have also claimed for infringement of their patents.
In other European countries, Philip Morris was already successful. The Czech Republic, Bulgaria and Poland have recently rejected BAT’s preliminary injunction requests against PMI’s heated tobacco product, with further battles also being fought in Italy.
Kymab’s appeal successful on points of sufficiency at UK Supreme Court
This seven-year long case finally reached its conclusion in June 2020. In what surprised many pharma lawyers, the court upheld Kymab’s appeal, and revoked Regeneron’s patents. In fact, all but one judge backed the final verdict.
Regeneron first filed its patents for genetically-modified mice in 2001. In 2013, Regeneron sued Kymab for infringement of its patents relating to its VelocImmune transgenic mice platform. The patents concerned were EP UK 13 60 287 and EP UK 22 64 163. However, the two Regeneron patents were found invalid for insufficiency at the first instance. But judge David Kitchin also noted that, had the patents been valid, Kymab would have infringed them through its use of transgenic mice. This conclusion meant that both parties could appeal the respective findings.
In response, Kymab argued that Regeneron’s 2001 patents were invalid for lack of sufficiency, suggesting a person skilled in the art would be unable to reproduce the invention. Ultimately, the Court of Appeal declared that Regeneron’s patents held enough information to enable a person skilled in the art to reproduce the process to a certain extent, although also found sufficiency did not stretch to the whole patent application. The court then upheld the patents, and Kymab appealed the decision. The Supreme Court has now declared its judgment in Kymab’s favour.
The dispute is so important because it concerns ground-breaking technology involving antibody-producing mice. According to the parties, the antibodies can help tackle some of the world’s most challenging diseases including HIV, Ebola, malaria and cancer. It also supports a potential COVID-19 vaccine development.
Some UK lawyers also speculated about what the decision means for the UK life sciences industry going forward. Nevertheless, the Supreme Court’s decision sets a precedent regarding sufficiency in UK patent jurisprudence.
A blueprint for future connectivity and AI patent litigation
This bitterly-fought connected car battle between Nokia and Daimler has seen almost all procedural tricks that one could imagine in patent disputes. This includes anti-anti-suit-injunctions across the Atlantic, involvement of the EU Commission and the German Federal Cartel Office, and a full injunction win for Nokia weakened by a seven billion euro security deposit. Daimler and its suppliers challenged this, with a request to stay the enforcement of the injunction.
But the latest highlight in the Connected Cars saga was the referral of one of Nokia’s claims (4c O 17/19 over SEP EP 20 87 629) by the Düsseldorf Regional Court to the European Court of Justice.
Although Nokia has challenged the decision of the Düsseldorf patent court with an immediate appeal, the case is likely to land on the desks of the CJEU judges in spring 2021. The decision was apparently very well-coordinated between the two Düsseldorf instances in November 2020.
If the referral comes to pass, the CJEU judges must decide who an SEP holder must offer a licence in a production chain. Until September, Nokia only offered this to Daimler, but not its suppliers. Facing a potential CJEU referral, Nokia changed its strategy and offered the suppliers a licence.
If the referral is effective, the case would not only be the lead case for connected cars patents. It would be the lead case for future connectivity technologies and for SEP and FRAND cases in Europe generally. The war over connected car patents is still in full swing.
The Higher Regional court in Munich has recently stayed the enforcement of one successful claim by Nokia and another by NPE Conversant against Daimler. But if the Düsseldorf Nokia case is refered to the CJEU, the main battle ground is no longer Germany – it’s Luxembourg.
Can AI be listed as an inventor? Not quite yet…
In October, the UK High Court rejected an appeal on AI inventorship in the debate around AI system Dabus. The judgment states an artificial intelligence system cannot be an inventor, upholding a decision by the UKIPO. Now the UKIPO, European Patent Office and United States Patent and Trademark Office have aligned views. But the UK Court of Appeal has granted permission to appeal on the basis of how important the principle at stake is.
Stephen Thaler, a Doctor of Physics, created the AI which produced two patents, EP 35 64 144 and EP 35 63 896. DABUS stands for ‘device for the autonomous bootstrapping of unified sentience’. The UKIPO had accepted Dabus as devising the inventions, but decided the two patents did not meet the criteria for patentability based on Dabus not being a ‘natural person’. The office also said that Thaler could not apply for a patent based on the ownership of Dabus. The UKIPO decided that ultimately the Patents Act 1997 prohibits the granting of the two patents since Dabus is a machine and not a ‘natural person’.
The UK applications should have passed, had the courts designated Dabus as the inventor. Thus, the UKIPO could have granted the patents. On the other hand, the judge did not entirely dismiss a future re-examination of the patenting of AI. Smith said that his judgment did not mean Dabus itself was incapable of developing a creative concept, accepting that Dabus did ‘invent’ the technology behind the patents. The case is still pending in other jurisdictions globally.
In January, the EPO also refused two patent applications on the grounds that the application listed Dabus, and not a human, as the inventor. The United States Patent and Trademark Office (USPTO) also rejected them on the basis of the named inventor.
But with a renewed hope for an appeal, the case is not yet closed. There is room for future development in the understanding of AI patentability.
It all comes down to ‘essentially biological processes’
In May, the Enlarged Board of Appeal at the EPO ruled that plants and animals obtained from ‘essentially biological processes’ are not patentable, in the long-fought battle over case G 3/19. The decision upheld Article 53(b) EPC: “European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof.”
But the decision was not met with happiness from some members of the European patent community. Legally, G 3/19 clarified the long-contested issue of the differences between plants and animals derived by breeding.
But some are concerned that the decision could affect other European agricultural companies with pending plant patents. Concern arose over suspected political motivations behind the decision of the Enlarged Board of Appeal. The European Patent Convention functions independently from the EU, but in this instance the EPO has taken steps to align its case law with the supranational body.
Fear that parallel patent legislation by the European Commission could influence the EPO, and thus the European Patent Convention, arose among the decision’s critics. However, some lawyers also acknowledge that G 3/19 highlights the adaptability and flexibility of EPO legislature.
Firstly, the Enlarged Board confirmed that the decision does not affect patents granted before 1 July 2017, or pending applications made before this date. This could be a boon for some companies waiting to file their patents at the EPO. On the other hand, the EPO is bringing its own case law into line with the standards of European courts. There could be conflicts between the EPO and various regional courts, for example if the 1 July date does not align with the patent courts. Many courts in Europe already refuse to rule on plant patents. Furthermore, patents filed to protect, for example, genetically-engineered plants may not fall under the new regulations.
It seems that G 3/19 has created more questions than it answered.
After a long battle, an EPO decision helped tip the balance
Sanofi can once again distribute its drug Praluent in Germany. Since 2016, Amgen tried to stop Sanofi from selling Praluent in six European countries, the US, and Japan, on the grounds of patent infringement. In some cases, the courts have found in Amgen’s favour. However, this year the battle for Praluent in Germany took a dramatic turn when the Higher Regional Court of Düsseldorf dismissed Amgen’s application at second instance.
For Amgen, this meant the first-instance 2019 judgment was without object. The court decided the party was not entitled to injunctive relief, provision of information, accounting, recall, destruction and damages for infringement of the German part of European patent EP 22 15 124, by Sanofi’s offering, marketing, use, importation and possession of Praluent.
Furthermore, the Düsseldorf ruling was preceded by a decision of the Technical Boards of Appeal at the EPO. The Boards of Appeal had confirmed, but substantially limited, Amgen’s EP 124 for the active ingredient evolocumab. Therefore, the patent continues to protect Amgen’s active ingredient.
However, the EPO judges restricted the patent so drastically, due to lack of inventive step, that the basis for the Düsseldorf infringement action was missing. Many experts consider it likely that the Boards of Appeal decision will have a similar effect on proceedings in other European countries. In Germany, Sanofi already announced to claim damages from Amgen.
The French originator also submitted an opinion in the course of the reform of the German patent law. It calls for a stronger proportionality test for the automatic injunction and the consideration of third-party interests.
No SPCs for second medical use products, says the CJEU
In July, the CJEU handed down an eagerly-anticipated decision in the referred Santen case, clarifying that patent offices and courts cannot grant SPCs in the case of a new medical use for an existing product. The decision contrasts to the CJEU’s previous decision in Neurim regarding SPCs. The decision means that courts across Europe will have ore consistent case law.
Originally, Santen filed an SPC application for an eye drop emulsion, and a marketing authorisation for Ikervis. The latter product uses the eye drop emulsion, which uses active ingredient ciclosporin. Santen based its SPC application on EP 18 09 237. However, the French Patent Office (INPI) refused the SPC application on the basis of the existence of an earlier marketing authorisation for product Sandimmun. Santen appealed to the Paris Court of Appeal; the court referred the case to the CJEU, and the Advocate General of the CJEU published a non-binding opinion in January 2020.
In July, the CJEU definitively rejected the appeal. The Advocate General has left it to policy makers, rather than individual courts, to update existing regulations.
Pharmaceutical companies had sought guidance on how exactly to interpret Article 3(d) – that an existing product is not eligible for an SPC, if said product already has a marketing authorisation – because the previous CJEU decision acted more as a guideline. Now, however, the CJEU has set out a much more straightforward way for courts to interpret Article 3(d). Previously, the courts and patent offices had taken no uniform approach.
The decision is highly-significant, because it brings SPC regulation more closely in-line with the accepted legal procedures.
However, some patent lawyers have expressed concern that the decision might constrain innovation for second medical use products. Some pharmaceutical companies might also have to review their portfolios and existing filing strategies.
The year ends as it began
The Federal Constitutional Court has again received two complaints against the German UPC legislation. The highest German court apparently received the two complaints (case IDs: 2 BvR 2216/20 and 2 BvR 2217/20) shortly after the German Bundesrat approved the German UPC legislation. The second chamber of the German parliament had unanimously passed the laws on 18 December.
Prior to this, the German Bundestag had approved them with the necessary two-thirds majority. This cleared the way for the completion of the German UPC ratification and the launch of the UPC as a whole. At the beginning of 2020 the Constitutional Court had stopped the first attempt of the UPC legislation.
With the announcement of the two complaints, is history repeating itself?
(Co-authors: Christina Schulze, Konstanze Richter and Mathieu Klos)