Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)

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FEDERAL COURT OF AUSTRALIA

Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477

File number: NSD 1381 of 2017
Judge: BURLEY J
Date of judgment: 14 October 2020
Catchwords:

PATENTS – two standard patents relating to a 13-valent pneumococcal conjugate vaccine (composition patents) – one standard patent relating to a container means for stabilising an immunogenic composition (container patent) – infringement – validity

PATENTS – infringement – construction of product claims – whether “comprising” inclusive or exhaustive – infringement found

PATENTS – validity – novelty – implied disclosure – whether person skilled in the art can supply integers by assumption or from common general knowledge – no anticipation of claims

PATENTS – validity – lack of inventive step – s 7(2) of the Patents Act 1990 (Cth) – findings of common general knowledge – availability of prior art information under s 7(3) of the Patents Act – invention in composition patents not shown to lack an inventive step – invention in container patent found to lack an inventive step in light of the common general knowledge alone and in light of prior art information within s 7(3) of the Patents Act

PATENTS – validity – lack of support – legal test – United Kingdom and European Law – technical contribution to the art – lack of support established for one composition patent

PATENTS – validity – lack of fair basis – legal test – claims fairly based

PATENTS – validity – lack of utility – promise of the invention – whether promises met – ground not established

PATENTS – validity – manner of manufacture – threshold test – face of the specification – ground not established

PATENTS – validity – lack of clarity – ground not established
Legislation:

Acts Interpretation Act1901 (Cth) s 15AB

Federal Court of Australia Act 1976 (Cth) s 37M

Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)

Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 [2012] (Cth) Explanatory Memorandum

Patents Act 1990 (Cth) ss 7(1), 7(2), 7(3), 7A, 18, 40(2)(b), 40(3), 138(3)(e)

Patents Amendment (Innovation Patents) Act 2000 (Cth)

Convention on the Grant of European Patents, opened for signature 5 October 1973, 1065 UNTS 199 (entered into force 7 October 1977) art 83, 84

Patents Act 1977 (UK) ss 5(2)(a), 14(3), 14(5)(c), 72(1)(c)

Statute of Monopolies (21 Jac, c 3) s 6
Cases cited:

Abbott Laboratories v Corbridge Group Pty Ltd [2002] FCAFC 314; 57 IPR 432

Actavis Pty Ltd v Orion Corporation [2016] FCAFC 121

Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59; 212 CLR 411

Allsop Inc v Bintang Ltd [1989] FCA 428; 15 IPR 686

Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134; 82 IPR 416

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 226 FCR 324

AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30; 257 CLR 356

Austal Ships Pty Ltd v Stena Rederi Aktiebolag [2005] FCA 805; 66 IPR 420

Banque Commerciale…

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Details
Case
[2020] FCA 1477
Decision Date

CaseChat Overview and Summary

The case before the court involves a dispute between Merck Sharp & Dohme Corporation and Wyeth LLC over the validity and infringement of patents related to a 13-valent pneumococcal conjugate vaccine. Merck Sharp & Dohme Corporation brought an action for patent infringement against Wyeth LLC. The court was required to decide several legal issues, including whether the patents were valid, if the accused product infringed the patents, and if the patents were valid, whether they were infringed.

The court found that the composition patents were valid and infringed by Merck Sharp & Dohme Corporation's 15-valent vaccine. The court found that the container patent claims would have been infringed, but were invalid for lack of inventive step. The court held that the invention in the composition patents was not shown to lack an inventive step, while the invention in the container patent was found to lack an inventive step in light of the common general knowledge alone and in light of prior art information within section 7(3) of the Patents Act. The court also found that one of the composition patents lacked support within section 40(3) of the post-RTB Patents Act.

The court ordered that the parties confer and propose short minutes of order giving effect to this judgment. The interlocutory application filed by the applicants/cross-respondents on 24 July 2020 was dismissed, with no order as to costs.

Orders

Orders of the court

1. The parties provide short minutes of order to chambers as to the appropriate form of orders giving effect to these reasons and costs, with any areas of disagreement marked up, by 4 November 2020.

2. The interlocutory application filed by the applicants/cross-respondents on 24 July 2020 be dismissed, with no order as to costs.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

The parties cooperated to produce a detailed primer of background information relevant to the composition patents. They accept that the material in it forms part of the common general knowledge before 8 April 2005. What follows in this section has been extracted from the primer.3.1 General backgroundThe immune system The immune system protects the body against infections that might be caused by exposure to pathogens. There are two major interconnected immune responses in humans – the innate immune response and the adaptive immune response. The innate and adaptive immune responses do not operate in isolation. The adaptive immune response is dependent on, and enhanced by, elements of the innate immune response. The innate immune response The innate immune response is the first line of defence against pathogens. In many cases, an infection is completely controlled by innate immune mechanisms before adaptive immunity is triggered. The most virulent pathogens, however, usually have ways to overcome the innate defences. The innate system is not augmented by previous exposure to the same pathogen. Should the same pathogen infect on a subsequent occasion, the innate immune system will respond in the same way as during the first encounter. The cells of the innate immune system include a diverse range of leukocytes, also known as white blood cells. These cells can, individually or in combination, identify and eliminate pathogens. Some white blood cells are capable of killing pathogens by engulfing them, a process called phagocytosis. Others express a set of receptors which recognise and bind to molecular patterns on pathogens. This binding activates the release of signalling proteins, defensins and other anti-bacterial peptides, and degradative enzymes. Inflammation is an important feature of the innate immune response to a bacterial infection, such as an infection by pneumococcus. An infection-driven inflammatory response is characterized by redness, heat and swelling at the site of the infection. Cytokines mediate the inflammatory response, increasing the permeability of blood vessels to fluid and proteins. This leads to local swelling and an accumulation of proteins that assist in eliminating pathogens. Cytokines may also stimulate other cells in order to attract, and facilitate the movement of, leukocytes to the site of the infection. The innate immune system includes the complement system, which consists of over 20 interacting proteins. These complement proteins enhance other parts of the immune system. The complement proteins are activated in a cascade, where the activation of one protein leads to the activation of the next. The individual proteins are given designations C1 to C9, and the sub-fragments of these proteins are given designations such as C3a, C3b and C5a. The complement system can be activated directly, by a pathogen, or indirectly, by pathogen-bound antibodies produced during an adaptive immune response. The complement system assists the immune system in various ways: by attachment of C3b to the surface of pathogens, to mark them and make them susceptible to phagocytosis; by promoting an inflammatory response (through C3a and C5a) and thereby bringing more phagocytes and lymphocytes to the site of infection; and by direct killing of some types of bacteria by rupturing the bacterial membrane (through a complex comprising C5b, C6, C7, C8 and C9). The adaptive immune response

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

The consequence is that example 4 provides a clear teaching that the positive control produces an unstable formulation. However, that does not yield the result that the ground of inutility succeeds. The specification teaches in no uncertain terms that the positive control failed because of the high amount of silicone used. Containers with lesser amounts significantly reduced the antigenicity losses to minor amounts. The experiment showed something of the parameters of the invention. The skilled reader is able to understand and interpret the results, and then apply them to produce something within the claims. Put another way, by following the directions in the complete specification, the effects which the patentee professed to produce could be produced. Accordingly, this final ground of inutility must also fail. 30. CONCLUSION For the reasons set out perhaps far too fully above, I have found that the asserted 013 patent claims are valid and will be infringed by MSD’s 15-valent vaccine. I have found that the asserted 844 patent claims would have been infringed, but are invalid because they lack support within s 40(3) of the post-RTB Patents Act. I have also found that the asserted container patent claims would have been infringed, but that they are invalid for want of inventive step. I will direct that the parties confer and propose short minutes of order giving effect to this judgment.

Ratio Decidendi

Legal Principle Established

MSD secondly advances what it calls the protein concentration argument. It notes that claim 1 does not limit the protein concentration in the formulation of claim 1. The argument runs as follows. Professor Dalby gives evidence that as a rule of thumb, problems may arise with protein aggregation in solution where there is a protein concentration above 1000 μg/ml. Example 3 of the container patent concerns a formulation within the scope of the asserted container patent claims, namely, a 13-valent polysaccharide-protein conjugate with a buffer, salt and adjuvant. An experiment was conducted whereby serotypes 4 and 6B were formulated with protein concentrations ranging from 25 μg/ml to 200 μg/ml in the absence and presence of AIPO4 (aluminium adjuvant) in containers using siliconised stoppers. Where the concentration of serotypes 4B and 6B was 100 μg/ml and 200 μg/ml respectively, fibre-like particulates were observed for both the adjuvanted and the unadjuvanted formulations. These results are displayed in table 5 of the container patent. MSD submits that, by applying the rule of thumb that the experts adopt of 1000 μg/ml, the person skilled in the art may have been led, in the absence of a limitation of the protein concentration to be used in claim 1, to adopt a protein concentration that produced visible precipitate. In short, the results in example 3 demonstrate that visible precipitation may be caused by the use of 100 μg/ml or 200 μg/ml. This shows that the person skilled in the art could have used what he or she considered to be a normal amount of protein concentration for different serotypes in a formulation within the claims which would not have achieved the promise of the invention. The decision of the Full Court in Sandvik demonstrates that where a claim is broad in compass, it is not to be applied in such a way that it is to be made unworkable. In that case, claims 1 to 3 did not lack utility, even though they included within their scope the breadth of claim 4, because the skilled addressee would understand that a drill rod with a round end cannot be driven by a drive chuck or an adaptor and would therefore not use a rod with a round end (at [201]). Accordingly, it was only claim 4, which upon its proper construction required the rod profile to be round, that was rendered inutile (at [202]). The present case is somewhat different. MSD submits here that by applying a sensible construction to claim 1, the person skilled in the art could select a protein concentration of up to 1000 μg/ml and not expect protein aggregation. Yet at much lower concentrations, specifically at 100 or 200 μg/mL, visible aggregation was not only encountered, but was not resolved by the use of the formulation claimed in claim 1. Put another way, by adopting an entirely orthodox approach to formulating a polysaccharide-protein conjugate within a formulation, within the range of protein concentration usual in the art, the person skilled in the art would have found that the formulation of claim 1 did not avoid visible precipitation.