What do you predict will be the most contentious patent litigation issues in your jurisdiction over the next twelve months?
Patent-eligibility of computer-implemented methods.
The scope of permanent injunctions for indirect infringement of a patented method where a product supplied is capable of both infringing and non-infringing uses. There is yet to be an authoritative decision on this and indirect infringement allegations are increasingly prominent in Australian patent litigation.
In the life sciences field, courts will have to get accustomed to more biologics litigation and the fine differences to “traditional” pharma litigation between an originator product and generics.
In addition, some legal questions concerning cross-label use and carve-out questions are ripe for a legal determination and will likely be decided by courts in the near future.
Standard Essential patents and monoclonal antibodies cases.
Patent litigators are awaiting the implications of various recent legislative amendments discussed above, including the introduction of file-wrapper estoppel, the new prior-user provisions, and the specific requirements for written demand letters (see Questions 6 and 20).
Additionally, earlier this year the Federal Court issued a decision which departed from the traditional test for obviousness and held that prior art considered for obviousness no longer needed to be that which could be located from a ‘reasonably diligent search’. This is expected to result in an increase of discussion surrounding what prior art is citable in an obviousness analysis.
It is also expected that there will be continued evolution in the law of utility as a result of a 2017 Supreme Court of Canada decision which struck down the ‘promise doctrine’. Pursuant to this doctrine, if a patent had promised a specific utility, the invention would lack utility if that promise was unfulfilled.
I predict increase in damages and distribution of burden of proof would be the most contentious patent litigation issues in China over the next twelve months.
Whether price and reimbursement can be protected from premature applications by obtaining a PI before the product is actually on the market is the question that remains unanswered.
In the coming months, the FRAND defense might be one of the most contentious issues. .
Matters of FRAND (Fair, Reasonable And Non-discriminatory) offers in case of SEPs still seem to be the most contentious legal issues. In other fields, we expect cut-throat competition to lead to an increase in litigation.
The most contentious patent litigation issues are expected to continue in the near future to involve patent infringement cases in the pharma sector.
a) Standard essential patents;
b) The concept of Markush Claims in Pharmaceutical Patents;
c) The concept of Genus and Species Patent and the fact that one product can be protected by multiple patents;
d) The interpretation and application of the Bolar exception;
e) Assessment of Patent Infringement in case of process patents;
f) Balancing equities of the parties in a patent law suit till final adjudication in the matter, by way of unique interim orders.
An important decision was delivered by the Supreme Court recently in proceedings in which Whitney Moore acted for Merck, Sharp & Dohme. The Supreme Court unanimously upheld MSD’s appeal against the decisions of the High Court and Court of Appeal refusing a preliminary injunction restraining the alleged infringement of MSD’s SPC for a cholesterol drug. The judgment has huge significance for the pharmaceutical sector in Ireland because in recent years it has been considered difficult for a rights owner to obtain a preliminary injunction in Ireland. The test for the grant of preliminary injunctions has now been clarified and rightsholders will feel more confident in applying for such relief. We expect this development to lead to more applications for preliminary injunctions and also more revocation actions being commenced given that it is now clear from the judgment that the failure to clear the way by a defendant will be a significant factor in the court deciding whether to grant such relief.
The Israeli Supreme Court is expected to release in the near future two important decisions on the scope of the Israeli inequitable conduct doctrine and its interface with the evolving Israeli abuse of dominant position doctrine. These decisions will determine the scope of the disclosure obligations by patentees when prosecuting patent applications and will formulate the formulate the position of Israeli law as to whether breach of disclosure obligations may amount to an anticompetitive conduct.
In addition, the permissible scope of antibody patents is likely to be further clarified in some significant antibody litigation in the near future. The primary concern in connection with antibody patent practice is that in many cases they claim antibodies not by what they are but instead by how they function. In these cases, a genus of antibodies is claimed by functional properties such as binding, neutralizing, inhibiting, antagonizing, competing with other antibody, binding to or recognizing a target portion of an epitope, and by various quantitative measures of these functions. Such antibody patents are significantly broader than those granted with respect to small molecules. Broad claims for small molecules based on how they function (against the same target) as opposed to what they are (defined by their structure) are generally not considered legitimate. Antibody litigation currently ongoing will assist in clarifying the permissible breadth of antibody claims.
Second medical use patents are becoming increasingly important for the pharmaceutical industry. The need to ensure that, once available on the market, the generic or biosimilar is not used in an infringing manner calls for new, practical solutions from the case law and is going to be a hot topic in the upcoming months.
The inspection system (see question 32 below) which is to be introduced on October 1, 2020 as a result of the recent revision to the Patent Act is attracting significant attention as to the ways in which infringement lawsuits may, in practice, use and operate the inspection system in an effective manner.
A recent patent-related Supreme Court judgment (August 27, 2019) involved a dispute about inventive step and an unexpected, prominent effect. The Supreme Court stated that the judgment rendered in the original instance was illegitimate in that such original judgement denied an unexpected, prominent effect of the invention immediately, merely because of the fact that, with having it as the premise that a person skilled in the art could have easily thought of applying the compound in question of the invention to the use of the invention, the existence of other compounds having the same effect as the compound in question of the invention was known on the priority date, without sufficiently discussing the following issues: whether the effect of each invention could not be expected by a person skilled in the art from the configuration of each invention on the priority date; and whether the effect of each invention was a prominent effect which went beyond the expectations of a person skilled in the art from the above configuration. The influence of this Supreme Court judgment on the positioning of a prominent effect in future determinations concerning inventive step is receiving attention.
The most contentious patent litigation issues do not vary a lot over time. Claim construction are always among the most contentious patent litigation issues both in infringement and validity cases.
In view of the widely discussed amendment of the Industrial Property Law, which may seemingly completely change the invalidation procedure, I expect to see more invalidity cases being decided quickly which will inevitably influence the infringement cases both on the preliminary injunction level as well as the full patent action.
VdA: Second medical use patents, SPCs, damages, and evidence productions (particularly, the protection of the related trade secrets)
Definitely patent litigation in pharmaceuticals is going to be the most intensively litigate sector in patents in 2020. In particular, the outcome of pending court cases on compulsory licensing between a Russian generic company (seeking compulsory license) and several largest international originators is very important.
How the Courts would treat challenges to the validity of independent and dependent claims is likely to be a hot-button issue in the months to come.
Following the Court of Appeal’s decision in Sunseap Group v Sun Electric Pte Ltd  1 SLR 645, the Court of Appeal held that if the Court finds in the Defendant’s favour that the independent claims are invalid, it follows that the dependent claims must also fail. Accordingly, once a defendant succeeds in establishing that all the independent claims are invalid, the dependent claims must necessarily fall away and the patent will be considered invalid.
The Court of Appeal reasoned that since dependent claims refer back to independent claims and incorporate all of its features, the invalidation of an independent claim would necessarily mean that a dependent claim would also be invalidated.
Traditionally, a dependent claim is likely to contain a separate and inventive integer that distinguishes it from the independent claim that it stems from. Following Sunseap Group v Sun Electric Pte Ltd  1 SLR 645, patent drafters and patent litigators are likely to keep their eyes on how the Courts will apply the Court of Appeal’s decision to an analysis of dependent claims when the validity of independent claims are challenged, which will in turn affect the utility and/or form of dependent claims in a patent moving forward.
As discussed in our response to Question 13 above, how the limited discovery available under the Korean law will be utilized by the courts in practice is not a well settled area of law in Korea. Further discussion follows below in our response to Question 32.
We expect life sciences to continue being the most contentious area.
The FSC is expected to issue a decision on the scope of protection granted by a SPC. Further, it will be interesting to see how the FPC structures infringement proceedings in the future, now that its established practice of a split reply before the instruction hearing was challenged by the FSC. Finally, until when patent claims can be amended in ongoing proceedings will be controversial.
Calculation of damage awards has always been one of the most important issues in patent litigation. The amount of damage awards has considerable impacts on patentee’s incentives to enforce their patents in courts. In recent years, the IP Court in some high-profile cases has granted enhanced damage awards.
Since 2012, in response to the patent/royalty stacking circumstances in the modern technology society, more and more patent litigation judgments have referred to the concept of patent contribution rate. Patent contribution rate is the recognition of a patent’s value in the market, and this value is possessed by the patentee.
In recent judgments of the IP Court, opinions on whether and how the patent contribution rate is to be applied are not completely consistent. However, the IP Court currently tends to comprehensively consider the overall contribution of patents to the infringing products and assess a rate therefrom.
Therefore, it is foreseeable that the patent contribution rate in patent litigation will be a very contentious issue in Taiwan over the next twelve months.
As the software-based technologies evolve and become widespread, the courts may reconsider their patentability in the upcoming years. We also expect the much-debated practices on second medical use patents to become clearer next year.
Furthermore, we anticipate that the Article 138/3 of the EPC, which allows the patent owners to amend the claims during the invalidation proceedings, to will be applied more frequently.
- One of the most contentious patent litigation issues in the UK currently is to be decided by the UK Supreme Court in late 2019 / early 2020 in the Huawei v Unwired Planet / Huawei, ZTE v Conversant appeals, and relates to whether the UK courts can and/or should make a determination of FRAND licensing terms in SEP cases on a global basis, including in circumstances where the vast majority of the implementer’s sales are in another jurisdiction. As things currently stand, an implementer found to infringe a single UK standard essential patent can be required by a UK court to take a licence for the relevant portfolio of patents across multiple jurisdictions, at risk of being enjoined from selling its products in the UK market. This is a highly contentious issue that has emerged as a result of the interplay between the globalised licensing practices for complex technological products with the territorial nature of the international patent system, whereby patents are granted and enforced on a territory-by-territory basis.
- A contentious and unresolved patent litigation issue in the UK, following on from the recognition of a doctrine of equivalents by the UK Supreme Court in Actavis v Eli Lilly  UKSC 48, is whether there exists a Formstein defence to a finding of infringement by equivalents. Under such a defence, where an accused product or process is found to fall within the scope of a claim under the Actavis doctrine of equivalents, but that equivalent would have lacked novelty or an inventive step over the prior art as at the priority date, then it will be deemed to fall outside the scope of the claim, so as to provide a defence to infringement. This is a contentious matter, because it involves a conflict between the UK Supreme Court’s recent extension of the scope of patent protection by way of equivalents, and the longstanding feature of UK patent law that a patent cannot enable the patentee to stop a trader from doing what they had been lawfully entitled to do before the patent was filed. The alternative may mean that the patentee could obtain protection via the doctrine of equivalents for something that they could not have obtained protection for directly.
Patent eligibility under 35 U.S.C. § 101 continues to be uncertain and evolving. Courts began invaliding many business method and financial services patents in 2008, and that trend continued through 2017. Nevertheless, during the last two years, courts have taken a more nuanced and flexible approach to § 101. The USPTO likewise liberalized its examination guidelines with respect to § 101 in January of 2019, which has led to increased allowances for patent applications that might previously have been rejected under § 101.
Venue also remains amorphous in several respects, even after the Supreme Court’s 2017 decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, 137 S. Ct. 1514 (2017), which clarified part of the standard for venue. The law of venue is now somewhat different in different district courts.
Appeals from PTAB decisions are another evolving area of law. While it is clear that appeals from initial decisions on institution are not appealable, exceptions to this rule (e.g., for appeals based on the statutory time-bar) are emerging and other aspects of PTAB-related appeals are still being clarified by the CAFC.
In addition to the pharmaceutical sector, patent litigation in the computer and electronics area is likely to increase in the coming time.