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Merck Sharp & Dohme Corp & Anor v Hovid Bhd [2019] 12 MLJ 66
August 21, 2019

Outcome: (By the majority decision) When an independent claim in an adjudication process is deemed to be invalid, it does not necessarily follow that all dependent claims which refer to such independent claim will automatically fail. The invalidity notwithstanding, the trial court is still duty bound to consider the validity of dependent claims based on the merits of the respective claims. (The Federal Court departing from its own decision in SKB Shutters Manufacturing Sdn Bhd v. Seng Kong Shutter Industries Sdn Bhd & Anor).

The Federal Court allowed the appeal and remitted the case to the High Court to determine whether each of the dependant claims (i.e. claims 2022) possesses independent validity (notwithstanding the fact that this case may entail type 1 claims or unless there is an express concession).

Facts:

  1. The first plaintiff is a company incorporated in the United States of America (USA). It was granted a Malaysian Patent No MY-118194-A (194 Patent) under the Patents Act 1983. Under the said patent, the first plaintiff produced a pharmaceutical product of alendronic acid or a pharmaceutically acceptable salt (alendronate) under the trade name ‘Fosamax’ to inhibit bone resorption in humans. The second plaintiff is a Malaysian company which holds the exclusive license from the first plaintiff to distribute, sell, and offer to sell ‘Fosamax’ products in Malaysia. The defendant, a Malaysian company, has been approved by the National Pharmaceutical Control Bureau to market ‘Alendronate 70mg’ tablets.
  2. The 194 Patent consists of one independent claim, i.e. claim 1 and 21 other subsidiary claims, also known as dependent claims (claims 2-22). The dependent claims refer to the independent claim.
  3. Essentially, the element of 194 Patent is the use of alendronic acid (or a pharmaceutically acceptable salt thereof) for making an oral medicament for inhibiting bone resorption in humans: (a) in a unit dosage that comprises from 8.75 to 140 mg of alendronic acid, on an alendronic acid active weight basis; and (b) according to a continuous schedule, having aperiodicity from about once every three days to once every 16 days.
  4. The dependent claims 2-22 refer to the independent claim differ from one another in terms of, among other things, the range of the unit dosage, and the frequency of the dosage. The common feature of all the dependent claim 2-22 start with the common description of ‘use according to Claim 1’. Some refer to the earlier dependent claims with reference to the independent claim.
  5. In the High Court, on 30th August 2016, learned judge granted the application for invalidation of 194 Patent on the grounds that the said patent was evident as at the priority date and therefore lacked inventive step. With respect to claims 2-22, the High Court held that it was bound by the Federal Court decision in SKB Shutters Manufacturing Sdn Bhd v Seng Kong Shutter Industries Sdn Bhd & Anor [2015] 6 MLJ 293 and ruled that once the independent claim 1 was found to be invalid for lack of inventive steps, all the dependant claims 2-22, were consequently invalidated with no defence to adduce evidence individually to invalidate each of them; nor was there a requirement for the Court to consider the validity of each of them separately. The invalidation of 194 Patent also led to plaintiff’s infringement claim against the defendant to fall.
  6. The plaintiffs appealed to the Court of Appeal. The Court of Appeal, in turn, dismissed the appeal on the grounds that there was no inventive step involved in the creation of 194 Patent. The plaintiff’s invention was obvious to a person having ordinary skill in the area of technology connected with the invention, thereby disqualifying it from being patented. The Court affirmed the consequential ruling that once the principal claim was found by the Court to be invalid, all other dependent claims derived no legitimacy on which they could survive.
  7. The plaintiffs applied for leave to appeal to the Federal Court. On 26th June 2018, the Federal Court allowed the leave application on only one question of law, namely:

Where an independent claim is adjudged to be invalid, whether claims dependent on the said independent claim would be rendered invalid without the need for the Court to consider the validity of each and every dependent claim[s] separately?

Decision:

Majority decision (delivered by Nallini Pathmanathan FCJ)

    1. The concept of an independent claim is that it is the claim defining the broadest penumbra of monopoly. A dependent claim defines a narrower scope of monopoly. The parts of the inverted pyramid represent the scope of each claim. The independent claim has the broadest scope of monopoly, and the dependent claim has narrower scopes of monopoly. In terms of invalidity of proceedings, the invalidity of the independent claim would only nullify the top part of the pyramid but would leave the dependent claims unaffected. There is no technical definition of an independent claim or dependent claim in the Malaysian patent law to shed light on the comprehension of such terms. The only definition is set out under regulation 14 of the Act and Patents Regulations 1986. [Paras 68-77]
    2. The US statutory description of dependent claim is instructive. Under the US Code of Federal Regulations [37 CFR §1.75(c)] and the US Manual of Patent Examining Procedure [section 1824, 6.49a)] also describes a dependent claim similarly as the aforementioned federal provision. The provision describes a dependent claim as containing a reference to a claim previously set forth and further limiting the scope claimed. It acknowledges the close relationship between such claims but does not assert that their survival is interdependent. It is inaccurate to perceive a dependent claim as only an extension of an independent claim based on the above understanding of the universal concept of how an independent claim interrelates with a dependent claim. It is included to further narrow the scope of monopoly to protect such features against infringement by third parties. [Paras 79-80]
    3. Patentees may draft their claims however they please, incorporating as many or as few features in the specification to form the basis of their claims. Type 1 claims comprise one or more independent claims which are supersets of their dependent claims incorporating all features to have the broadest scope possible. Naturally, the dependent claims would be subsets of the independent claim, focusing on specific features and having a narrower scope. Type 2 claims comprise one or more broad independent claims which do not include all the features listed in the specification. Their dependent claims, however, include additional features over and above the independent claim(s), making more specific, having a narrower scope, and thus harder to infringe. [Para 81, Paras 87 to 88]
    4. Determining the interdependency of claims is paramount for deducing, which dependent claims might fall when the claim(s) they depend on fail(s). It is incumbent upon the trial court to not only read and construe the independent and dependent claims in full but to also hear evidence regarding each of those claims or category of claims as may have been defined by counsel at the outset of the trial. Here, and in SKB Shutters there was no such consideration of oral evidence regarding the dependent claims. This is in line with the English and American position. The treatment of interdependent claims in other jurisdiction is relevant, especially to Types 2 claims. Dependent claims in independent claims do not include additional features. [Paras 90-99]
    5. Since the dependent claim is a subset of the independent claim, and all its features are present in the independent claims it is justifiable that when the independent claims invalid, the dependent claims fell. However, it is crucial to note that to ascertain the claims, perusal to evidence by the trial court must be done beforehand. When the validity of a patent is challenged based on prior art and where the form of claims is of type 1, the dependent claims may be invalidated by the independent claim being invalid. However, the determination of the type or form employed requires careful considerations of the (a) language; (b) the content of the claims themselves; and (d) the expert evidence regarding each of the claims. [Paras 105-111]
    6. Where the language and construction of the claim are less than intelligible, the court should guard against being impressed by the form and language of the claims rather than the substance of the patentee’s alleged technical language. The drafting of the claims may be convoluted, but it is the court’s duty to work through them by breaking free of the language and concerning itself with what the claims really mean. If the claims are ambiguous, the court has the duty to give appropriate meaning to the claims in question. [Paras 113-114 and Para 135]
    7. SKB Shutters that established the blanket rule only referred to both independent and dependent claims without emphasizing the need for a trial court to undertake the exercise of hearing evidence on each of the claims separately. The putative effect of the blanket rule is not negligible. Patents applicants, based on this case, may now have to reconsider the insertion of dependent claims as the effect of invalidity of an independent claim would be fatal to their dependent claims. The decision in SKB Shutters is premised upon an incomplete consideration of the law relating to invalidation of claims and restricted solely to the independent claims and theoretical perusal of the dependent claims. This decision should be departed. [Paras 141-153 and Paras 167-169]
    8. The position of SKB Shutters which links the demise of a dependent claim to that of an independent claim is not tenable. The court in that case liked the prohibition of amendment of claims pending proceedings under section 79A(3) to the failure of a dependent claim as soon as it invalidated the independent claim. However, a perusal of section 79A(3) discloses that while the registrar is prohibited from effecting amendments during proceedings, it does not bar amendments from being applied during proceedings, and made after proceedings. Therefore, amendments per se are not barred by section 79A(3). [Para 172]

      Dissenting (per Ahmad Maarop PCA and Ramly FCJ)

       

    9. A plain reading of the 22 claims clearly shows that the strength and validity of all the dependent claims 2-22 depend entirely on the independent claim. Once the independent claim is declared invalid by being obvious of lack of inventive steps, all the dependent claims 2-22 will suffer the same fate, i.e. they are all also obvious in their ‘use’ features and therefore lack of inventive step. An independent claim usually has a preamble that does not recite another claim number. Conversely, a dependent claim usually will recite a prior claim number and often recites features that might be secondary. Some dependent claim might have elements of independent claims that may survive in the event the independent claim invalidated. Here, there are no independent features in the dependant claims 2-22. [Paras 26-27]
    10. Most dependent claims come with added features which effectuate to narrowing the scope of the monopoly in the patent. The scope of monopoly in the independent claim is much wider and general compared to the dependent claim where the features in the dependent claims do not create any new claim or any new monopoly. They only describe the general claim in more specific features. Dependent on the wordings of the description, the narrow scope of claims in dependant claim would fall within the scope of a wider general claim of independent claim within the same patent monopoly. Therefore, it is logical for a dependent claim to fall when an independent claim is declared invalid. [Para 28]
    11. Section 26 of the PA provides that an application for the grant of a patent shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept. The said patent was granted based on the said premise where it relates to one invention only. Therefore, all the dependent claims of 2-22 cannot stand by themselves. The plaintiffs, as the patentees have never contended that 194 Patent contains more than one invention at the material time. Even their own expert had testified that there is only one invention in 194 Patent,e. the sole invention claimed in the independent claim 1. No indication in the plaintiff’s claims that all or any of the dependent claims 2-22 have an independent validity on its or their own to survive in the event the independent claims 1 falls. Such indication, if any, must be made before trial starts and not when the trial is complete. [Paras 29, Paras 31-32]
    12. When an independent claim falls, all the dependent claim falls together. This proposition is consistent with the case of SKB Shutters and other foreign decisions on the same patent. However, the decisions of foreign decisions are not binding on the Malaysian courts, and at most are only persuasive. [Paras 34-43]
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