Patents - Insulet Corporation v Roche Diabetes Care Ltd


 











Jane Lambert

Patents Court (Ms Pat Treacy) Insulet Corporation v Roche Diabetes Care Ltd [2021] EWHC 1907 (Pat) (9 July 2021)

This was a patent infringement claim with a patent revocation counterclaim. The patent in suit was EP (UK) 1 335 764 for a device and system for patient infusion.  The action and counterclaim came on before Ms Pat Treacy sitting as a judge of the High Court between 11 and 13 May 2021. She delivered judgment on 9 July 2021 (see Insulet Corporation v Roche Diabetes Care Ltd [2021] EWHC 1907). At para [452] of her judgment, she found that claim 2 of the patent had been anticipated by the PCT application known as "PhiScience".  At [525] she concluded that all claims other than claim 3 had been obvious over PhiScience but not over another PCT application known as "MiniMed."   At para [587] she held that all the claims in issue were invalid by reason of added matter.  Finally, she found that none of the claims in issue had been infringed.

The Patent

The abstract described the invention as follows by reference to the drawings on pages 24 to 34 of the specification:

"A device (10) for delivering a fluid to a patient, including an exit port (70), a dispenser (40) for causing fluid from a reservoir to flow to the exit port, a local processor (50) programmed to cause a flow of fluid to the exit port based on flow instructions from a separate, remote control device, and a wireless receiver (60) connected to the local processor for receiving the flow instructions. The device also includes a housing free of user input components for providing flow instructions to the local processor, in order to reduce the complexity and costs of the device so that the device lends itself to being disposable in nature. A system and a kit are also described that include the fluid delivery device, a separate, remote control device, and accessories for transcutaneous delivery of fluid medications. Methods of utilizing the fluid delivery device to infuse fluid medications are additionally disclosed."

Ms Treacy described the patent further in her overview at para [108] of her judgment and summarized it between [111] and [126].

The Claims in Issue

The Insulet Corporation ("Insulet"), the claimant in this action, alleged that claims 1, 2, 3, 43 and 45 were valid and had been infringed.  They are set out in Appendix B to the judgment.

The Alleged Infringement

Insulet complained that the defendant, Roche Diabetes Care Ltd ("Roche") had infringed its patent directly, by the manufacture and sale of kits containing the Solo device and/or indirectly, by the supply of Solo Consumables at para [237]. The deputy judge described the Solo Device, Solo Consumables and Solo System between [228] and [236]. 

The Counterclaim

Roche counterclaimed for the revocation of the patent on the grounds that it was not new, did not involve an inventive step and was bad for added matter.

The Issues

Ms Treacy set out the issues to be tried in para [12] of her judgment:
  • "Does Claim 2 lack novelty over PhiScience;
  • Does any of the Claims in Issue lack inventive step over PhiScience and/or MiniMed;
  • Is any of the Claims in Issue invalid by reason of added matter;
  • Is the Claimant permitted to amend EP ‘764 (the Patent);
  • Does the Solo fall within the scope of the Claims in Issue;
  • Do the Solo and/or Solo Consumables (together or individually) constitute means relating to an essential element of the invention of any of the Claims in Issue;
  • Does the Defendant supply the Solo and/or Solo Consumables (together or individually) knowing, or where it is obvious to a reasonable person in the circumstances, that these are means suitable for putting and are intended to put the invention as claimed in the Claims in Issue into effect in the United Kingdom?"
Whether Claim 2 lacks Novelty over PhiScience

One of the conditions of patentability is that the invention is new.  At para [349] of her judgment, Ms Treacy noted that s.2 (1) of the Patents Act 1977 provides: 

“An invention shall be taken to be new if it does not form part of the state of the art”.

She said that Lord Hoffmann set out the principles to be applied when addressing lack of novelty in Synthon BV v SmithKline Beecham Plc (No.2) [2005] UKHL 59, [2006] RPC 10, [2006] 1 All ER 685 at [19]‑[33]. There are two requirements, namely prior disclosure and enablement.

A prior disclosure must be a clear and unambiguous disclosure of something that would have infringed the patent.  She said at [351]:

"If a document, the disclosure must be construed as it would have been understood by the skilled person at the date of disclosure. Hindsight, informed by the subsequent patent or other developments is to be avoided: the meaning of a document does not change over time. ‘Cherry-picking’ from different aspects within the disclosure of a single document risks straying beyond what would have been disclosed to the skilled person."

Turning to enablement, the deputy judge said at [352]:

"Enablement means that the skilled person would have been able to perform that which was disclosed."

She noted that Lord Hoffmann had approved in Synthon the following passage of Lord Justice Sachs's judgment in General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 485:

“To determine whether a patentee’s claim has been anticipated by an earlier publication it is necessary to compare the earlier publication with the patentee’s claim. The earlier publication must, for this purpose, be interpreted as at the date of its publication, having regard to the surrounding circumstances which then existed, and without regard to subsequent events.

If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated …

If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented ... A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”

She observed at [354] of her judgment that Lord Hoffmann added at para [22] of his speech in Synthon:

“But patent infringement does not require that one should be aware that one is infringing: “whether or not a person is working [an] . . .invention is an objective fact independent of what he knows or thinks about what he is doing”: Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] RPC 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so.”

Her ladyship noted at [355] that Lord Hoffmann had explained the difference between obviousness and anticipation in para [25] of his speech in Synthon:

“… it is this requirement that performance of an invention disclosed in the prior art must necessarily infringe the patent which distinguishes novelty from obviousness. If performance of an invention disclosed by the prior art would not infringe the patent but the prior art would make it obvious to a skilled person how he might make adaptations which resulted in an infringing invention, then the patent may be invalid for lack of an inventive step but not for lack of novelty.”

Lord Hoffmann also explained the difference between disclosure and entitlement at para [30] of his speech:

“… I have explained that for the purpose of disclosure, the prior art must disclose an invention which, if performed, would necessarily infringe the patent. It is not enough to say that, given the prior art, the person skilled in the art would, without undue burden, be able to come up with an invention which infringed the patent. But once the very subject matter of the invention has been disclosed by the prior art and the question is whether it was enabled, the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work.”

Lord Hoffmann observed  at para [32] of his speech that both the patent and the allegedly anticipating prior art has to be read as it would be understood by the person skilled in the art:  

“In the case of disclosure, when the matter relied upon as prior art consists (as in this case) of a written description, the skilled person is taken to be trying to understand what the author of the description meant. His common general knowledge forms the background to an exercise in construction of the kind recently discussed by this House in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9. And of course the patent itself must be construed on similar principles. But once the meanings of the prior disclosure and the patent have been determined, the disclosure is either of an invention which, if performed, would infringe the patent, or it is not. The person skilled in the art has no further part to play.”

Construing the Patent

In order to determine whether a claim would have been infringed by the prior art,  it first has to be construed.  Ms Treacy took para [5] of Lord Justice Jacob's judgment in Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Group [2010] RPC 8, [2009] EWCA Civ 1062:

“The task for the court is to determine what the person skilled in the art would have understood the patentee to have been using the language of the claim to mean. The principles were summarised by Jacob LJ in Mayne Pharma v Pharmacia Italia [2005] EWCA Civ 137 and refined by Pumfrey J in Halliburton v Smith International [2005] EWHC 1623 (Pat) following their general approval by the House of Lords in Kirin-Amgen v Hoechst Marion Roussel [2005] RPC 9. An abbreviated version of them is as follows:
(i) The first overarching principle is that contained in Article 69 of the European Patent Convention;
(ii) Article 69 says that the extent of protection is determined by the claims. It goes on to say that the description and drawings shall be used to interpret the claims. In short the claims are to be construed in context.
(iii) It follows that the claims are to be construed purposively—the inventor’s purpose being ascertained from the description and drawings.
(iv) It further follows that the claims must not be construed as if they stood alone—the drawings and description only being used to resolve any ambiguity. Purpose is vital to the construction of claims.
(v) When ascertaining the inventor’s purpose, it must be remembered that he may have several purposes depending on the level of generality of his invention. Typically, for instance, an inventor may have one, generally more than one, specific embodiment as well as a generalised concept. But there is no presumption that the patentee necessarily intended the widest possible meaning consistent with his purpose be given to the words that he used: purpose and meaning are different.
(vi) Thus purpose is not the be-all and end-all. One is still at the end of the day concerned with the meaning of the language used. Hence the other extreme of the Protocol—a mere guideline—is also ruled out by Article 69 itself. It is the terms of the claims which delineate the patentee’s territory.
(vii) It follows that if the patentee has included what is obviously a deliberate limitation in his claims, it must have a meaning. One cannot disregard obviously intentional elements.
(viii) It also follows that where a patentee has used a word or phrase which, acontextually, might have a particular meaning (narrow or wide) it does not necessarily have that meaning in context.
(ix) It further follows that there is no general “doctrine of equivalents.”
(x) On the other hand purposive construction can lead to the conclusion that a technically trivial or minor difference between an element of a claim and the corresponding element of the alleged infringement nonetheless falls within the meaning of the element when read purposively. This is not because there is a doctrine of equivalents: it is because that is the fair way to read the claim in context.
(xi) Finally purposive construction leads one to eschew the kind of meticulous verbal analysis which lawyers are too often tempted by their training to indulge.”

The learned deputy judge cautioned that (ix) and (x) must now be read subject to the judgment of the Supreme Court in Actavis UK Limited and others v Eli Lilly and Company, [2017] Bus LR 1731, [2017] UKSC 48, [2017] RPC 21 but the Lord Justice's overall approach remains good law,  Sbe noted that Lord Neuberger had explained at para [10] of Actavis v Eli Lilly that the overall exercise is similar to construing a contract.  Accordingly, she referred to paras [8] to [15] of Lord Hodge's judgment in Wood v Capita Insurance Services Ltd [2017] CILL 3971, [2017] AC 1173, [2017] 4 All ER 615, 171 Con LR 1, [2017] 2 WLR 1095, [2017] UKSC 24, [2017] WLR(D) 220:

“The court’s task is to ascertain the objective meaning of the language which the parties have chosen to express their agreement. It has long been accepted that this is not a literalist exercise focused solely on a parsing of the wording of the particular clause but that the court must consider the contract as a whole and, depending on the nature, formality and quality of drafting of the contract, give more or less weight to elements of the wider context in reaching its view as to that objective meaning. In Prenn v Simmonds [1971] 1 WLR 1381 (1383H-1385D) and in Reardon Smith Line Ltd v Yngvar Hansen-Tangen [1976] 1 WLR 989 (997), Lord Wilberforce affirmed the potential relevance to the task of interpreting the parties’ contract of the factual background known to the parties at or before the date of the contract, excluding evidence of the prior negotiations. When in his celebrated judgment in Investors Compensation Scheme Ltd v West Bromwich Building Society [1998] 1 WLR 896 Lord Hoffmann (pp 912-913) reformulated the principles of contractual interpretation, some saw his second principle, which allowed consideration of the whole relevant factual background available to the parties at the time of the contract, as signalling a break with the past. But Lord Bingham in an extra-judicial writing, A new thing under the sun? The interpretation of contracts and the ICS decision Edin LR Vol 12, 374-390, persuasively demonstrated that the idea of the court putting itself in the shoes of the contracting parties had a long pedigree.” [10]

Ms Treacy added that since Actavis the ‘normal’ approach to the construction of a patent had been that of ‘purposive construction’ as Mr Justice Arnold had explained in Generics (UK) Ltd v Yeda Research and Development Co Ltd [2017] EWHC 2629 (Pat) at [138] which the Court of Appeal approved in Icescape Ltd v Ice-World International BV [2018] EWCA Civ 2219 at [60]:

“… As has often been pointed out, patents differ from commercial contracts in two key ways. First, a contract is (at least in principle) a bilateral statement agreed between the contracting parties, whereas a patent is a unilateral statement made by the patentee and addressed to the class of persons represented by the person skilled in the art. Secondly, whereas a contract is a document containing promises by the contracting parties to each other (in some cases for the benefit also of third parties), a patent is a document which describes and claims an invention for the purposes of establishing a legal monopoly with regard to that invention. One cannot rationally interpret a patent claim without taking these matters into account. Moreover, I do not consider that Lord Neuberger can have meant anything different, even though he appears to have eschewed the expression “purposive construction” when describing the correct approach. On the contrary, in the passages relied upon by counsel for the Claimants, he expressly stated that a patent was to be interpreted through the eyes of the person skilled in the art and that the exercise involved interpreting the words of the claim in context. The context must include the very purpose for which the document exists, namely to describe and claim an invention.” 

Skilled Addressee

At para [24], Ms Treacy said:

"A patent is addressed to a ‘skilled person,' who is a person (or team of people) likely to have a practical interest in the subject matter of the invention, with practical knowledge and experience of the kind of work in which the invention is intended to be used. There was no dispute about the basic principles that the skilled person or team has a practical interest in putting the invention into effect. A skilled person reading a patent specification applies the common general knowledge of those skilled in the relevant art and reads it knowing that its purpose is to describe and demarcate an invention. The skilled person has no inventive capacity and lacks imagination."

The parties agreed that the patent was addressed to a team working on the design of insulin pumps which would have been led by a medical device engineer, supported by other engineers, and with the benefit of input from clinicians.  The engineer member would have a university degree in engineering or perhaps biological sciences and experience in designing medical devices including possibly insulin delivery devices, or software-controlled drug delivery devices,

Common General Knowledge

The "practical knowledge and experience of the kind of work in which the invention is intended to be used" is k known as the skilled addressee's common general knowledge.  The judge referred to Mr Justice Arnold's judgment in  KCI Licensing Inc and others v Smith & Nephew Plc and others [2010] EWHC 1487 (Pat), [2011] Bus LR D27, [2010] FSR 31 and defined common general knowledge as "that which is generally known to, and generally regarded as a good basis for further action by, those who are engaged in the particular art."She discussed the agreed common general knowledge in this case between para [31] and [79] and considered the disputed common general knowledge between [80] and [107].

PhiScience

The prior art relied upon by Roche was PCT application number WO2000029047A1 for a “Portable device and method for the mobile supply of medicaments with wireless transmission of data for control or programming purposes”. It was referred to by the parties and judge as "PhiScience", The abstract describes the invention as follows:

"The invention relates to a portable device and a method for supplying medicaments by a mobile, portable, non-implantable means with wireless operation or programming. The device preferably consists of a delivery unit, which is directly connected to the body of the patient by a cannula or is indirectly connected by means of a catheter, and an operating unit for operating the device, programming or inputting data. This operating unit wirelessly communicates with the delivery unit. The operating unit preferably consists of a wristwatch, which in addition to performing its normal time or date functions, can be used for inputting data and for operating, monitoring and programming the delivery unit. The operating unit enables the delivery unit to control the delivery of medicaments in terms of time and quantity, in relation to a basal rate or a basal profile, and bolus doses."

Ms Treacy discussed the invention between para [370] and para [377].  She said at [385] that Roche’s case on anticipation rested on PhiScience. It was limited to claim 2. the disputed integers of which were:
  • "Integer 2C/1B: an exit port assembly adapted to connect to a transcutaneous patient access tool (the dispute relating to disclosure of an EPA also goes to Integers 2D, 2F and 2G/1C, 1D and 1F);
  • Integer 2A/1G: wherein the housing is free of user input components for providing flow instructions to the local processor;
  • Integer 2I/1H: wherein the transcutaneous patient access tool is integrated into the exit port assembly;
  • Integer 2M: and further comprising a proximity alarm."
Her ladyship introduced the parties' arguments on whether PhiScience disclosed only that the remote control or operating device should be part of another electronic device between [387] and [390] and the
the weight to be attributed to PhiScience between [391] and [393].  

She addressed the arguments and evidence on the "Integer 2C/1B" point between [394] and [436].   She directed herself as follows at [415]:

"In the light of the views of both experts, which I found helpful, I must now consider what, on balance, the skilled person would have understood the author of the description to have meant, bearing in mind his common general knowledge, starting with the language used by the inventor in the context of the patent and the inventor’s purpose."

She concluded at [436]:

"If the disclosure in PhiScience were to be performed it would necessarily infringe the aspects of the Patent which teach an EPA adapted to connect to a TPAT and also those which teach an integrated TPAT. Those integers are therefore anticipated."

The learned deputy judge proceeded to "Integer 2A/1G" wherein the housing is free of user input components for providing flow instructions to the local processor.  It was common ground that PhiScience discloses and prefers a device in which the dispensing unit has emergency buttons:

“In a preferred variation of the above embodiments the dispensing unit has emergency operating elements (such as for example an emergency off and an emergency bolus button).”

Both experts had agreed that PhiScience discloses as one possibility that the dispensing unit could have no operating controls, with all the controls instead being on the remote control. It would therefore be free of user input components for providing flow instructions to the local processor.   Ms Treacy concluded that Integer 1G of the Patent had been anticipated by PhiScience in the light of the teaching of the optional feature.

She said at [443] that she had already covered Integer 2I/1H and found that it had been anticipated.

The deputy judge addressed "Integer 21/H" between [444] and [451].  There had been a dispute between the experts and Ms Treacy preferred the opinion of the defendant's.  She said at [340]:

"I consider that the skilled person reviewing PhiScience in context, given that a remote control is being taught and the safety critical nature of the system, would have considered excessive distance between the remote control and the device to be a critical situation in the same way as excessive time without connection. An extended duration without connection is given only by way of example, and the teaching in PhiScience is not limited to distance. While PhiScience does not have the discussion of how to trigger the alarm that is contained in the Patent and discussed by Mr Causey, it does teach the use of alarms in critical situations that can affect a system involving separate components and I agree with Mr Treneman that a skilled person would have understood a lack of proximity to be such a situation."

She held at [452[ that all the disputed aspects of Claim 2 had been disclosed by PhiScience.

Do any of the Claims in Issue lack Inventive Step over PhiScience and/or MiniMed?

Another condition of patentability is that the invention involves an inventive step.  Ms Treacy noted that s.3 of the Patents Act 1977 provides that “An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art…”   She said at [359]:

"It is for Roche to establish on the balance of probabilities that the skilled person or team would have considered it obvious to move from the teaching of the prior art to the invention claimed in the Patent."

She referred to para [60] of the Lord Hodge's judgment in Actavis Group PTC EHF and others v ICOS Corp. and another  [2019] UKSC 15, [2019] Bus LR 1318:

“In addressing the statutory question of obviousness in section 3 of the 1977 Act it is common for English courts to adopt the so-called Windsurfing/Pozzoli structure which asks these questions:
'(1) (a) Identify the notional ‘person skilled in the art’;
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the ‘state of the art’ and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?”

She also observed that Lord Justice Jacob had said in Pozzoli Spa v BDMO SA and another  [2007] EWCA Civ 588, [2007] Bus LR D117, [2007] FSR 37, [2007] BusLR D117 that 

"The fourth question is the statutory question and the first three questions or tasks, the second and third of which involve knowledge and consideration of the invention, are a means of disciplining the court’s approach to that fourth question …”

PhiScience has already been discussed in relation to novelty.   The skilled addressee had already been identified, the common general knowledge is discussed above and the claims in issue have been construed.   After performing steps (3) and (4)  of the Pozzoli test in respect of PhiScience, the learned deputy judge concluded at [525] that all claims in issue other than claim 3 were obvious.

MiniMed was a PCT application for an External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities. It was published under international application number WO 00/10628.  The abstract describes it as follows:

"An infusion system for infusing a liquid into a body includes an external infusion device and a remote commander. The external infusion device includes a housing, a receiver, a processor and an indication device. The receiver is coupled to the housing and for receiving remotely generated commands. The processor is coupled to the housing and the receiver to receive remotely generated commands and to control the external infusion device in accordance with the commands. The indication device indicates when a command has been received and indicates when the command is being utilized to control the external infusion device so that the external infusion device is capable of being concealed from view when being remotely commanded. The remote commander includes a commander housing, a keypad for transmitting commands, and a transmitter for transmitting commands to the receiver of the external infusion device,"

Ms Treacy observed at para [531] that it sought to improve comfort and discretion by removing functions to a remote control, improving the programming of insulin delivery and resolving some of the difficulties arising from the use of tubed devices.

The deputy judge identified the differences between MiniMed and the patent in suit between [534] and [544].  She said at [545]:

"Having considered the evidence of the experts as to the likely approach of the skilled team in the light of the specific teaching of MiniMed and the CGK and having considered the teaching in MiniMed specifically, I conclude that it would have involved significant inventive capacity to proceed from the teaching of MiniMed to the claims of the patent and that to do so would not have been obvious."

She set out her reasoning in [546].  She concluded that the patent as a whole was not obvious river MiniMed.

Is any of the Claims in Issue invalid by reason of Added Matter?

S.72 (1) (d) of the Patents Act 1977 enables a court or comptroller to revoke a patent if the matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent, as filed.   Ms Treacy referred to Mr Justice Jacob's observation in Richardson-Vicks Inc’s Patent [1995] RPC 568 at [576] "that the test of added matter is whether a skilled man would, upon looking at the amended specification, learn anything about the invention which he could not learn from the unamended specification.”  

She added that that test had recently been restated by Mr Justice Meade in Philip Morris Products, SA and another v RAI Strategic Holdings, Inc and another [2021] EWHC 537 (Pat) at [112]-[120] who had said that the overall approach involves asking whether the claim as amended presents the skilled person with information about the invention which is not derivable directly and unambiguously from the original disclosure of the application as filed.  Mr Justice Meade also said that it is a matter for the court, not the expert witnesses, although the court will carry out this task through the eyes of the skilled person. Mr Justice Meade had referred to the three-stage test in Bonzel v Intervention Ltd [No 3] [1991] RPC 553 at [574] which requires the court:

"(i) to ascertain through the eyes of the skilled addressee what is disclosed, both explicitly and implicitly, in the application;
(ii) to do the same in respect of the patent as granted (or as in this instance also as proposed to be amended); and
(iii) to compare the two disclosures and decide whether any subject matter relevant to the invention has been added whether by deletion or addition, bearing in mind that the comparison is a strict one in the sense that subject matter will be added unless such matter is clearly and unambiguously disclosed in the application either explicitly or implicitly."

The alleged added matter was the insertion of the following integer into claim 1: 

“and wherein the transcutaneous patient access tool is integrated into the exit port assembly”.

In the application, claim 1 had stated only that the claim covered a device comprising “an exit port assembly adapted to connect to a transcutaneous patient access tool”. It was not specified how the exit port assembly and the transcutaneous patient access tool were to be connected. There had been no mention of integration in the draft claims and, as in the patent, there was no definition of exit port assembly or transcutaneous patient access tool.

Ms Treacy considered the parties' arguments and expert evidence between paras [555] and [586].  She concluded at [587] that the insertion of that integer plus disclaimers in the specification would provide the skilled addressee with information about the invention that was not obtainable directly and unambiguously from the application as filed.   The insertion, therefore, added matter.  As the other claims in issue either contained a feature equivalent to that insertion or were dependent on claim 1, all the claims in issue were invalid by reason of added matter.

Is the Claimant permitted to amend the Patent?

S.72 (1) (e) of the 1977 Act provides that a patent may be revoked if the protection conferred by the patent has been extended by an amendment that should not have been allowed.  Roche objected to the amendment of claim 43 on the ground that Insulet had not identified anything in the claims or the application that disclosed a system or kit with the features (and only the features) of the system or kit of the proposed claim 43.

The proposed amendments had been reviewed by the comptroller who opined that:

“The description as filed discussed the use of systems and kits interchangeably with a number of different feature configurations and it is felt no matter is added in amending the dependent claims to reflect this”.

The deputy judge agreed and allowed the proposed amendments.

Does the Solo fall within the scope of the Claims in Issue?

Her ladyship considered a product process description of Insulet's Solo device between paras [228] and [236].   At para [238] she cited s.60 (1)  of the Patents Acy 1977 and directed herself at [239] that to "succeed, Insulet must establish on the balance of probabilities that the product falls within the scope of protection of the Patent and that there has been an infringing act."   She referred to the Supreme Court's judgment in Actavis and the Court of Appeal;s in Icescape and reminded herself of Lord Kitchin's two-step approach at [240]:

"The first (and always necessary) step is to establish whether there is infringement of any of the claims as a matter of normal interpretation. Lord Kitchin confirmed that, when carrying out his exercise (and as previously noted by both Arnold J in Generics v Yeda and by Carr J in Illumina, Inc v Premaitha Health Plc [2017] EWHC 2930 (Pat)), the claims are to be construed purposively; the question is whether the product falls squarely within the wording of the claims as so interpreted. If infringement is established on that basis, nothing more is required.

If infringement is not established on the ‘normal’ basis following step 1, there may be a need to consider whether the product nevertheless infringes because the way or ways in which it departs from the invention are immaterial."  

She added at [241] that step 1 involves interpretation, while step 2 is a question that usually requires assessment of the facts and of the expert evidence.

The deputy judge identified the integers of claim 1 that were in dispute at para [246].  In subsequent paragraphs, she considered whether the solo device fell within any of the integers of any of the claims.  She summarized her findings in respect of claim 1 at [390]:
  • "Roche accepts that Integers 1A to 1E are present in the Solo device;
  • Integer 1F is not present in the Solo device because the housing once assembled does not have the characteristics required by this integer, in particular, as it is not sufficiently water resistant to be worn during daily life by the user;
  • Integer 1G is not present in the Solo device. It does not infringe this aspect of the claim either on a normal basis or by equivalents. Having construed the Claim, the device does not fall squarely within it, nor does it achieve substantially the same result by substantially the same means;
  • Integer 1H is present in the device;
  • Integer 1I is present in the device.."
Because of the absence of integers F and G, claim 1 had not been infringed.

She said that there were no additional issues relating to claim 2 as they largely corresponded to claim 1.

Amended claim 43 required a device, system or kit in which the fluid delivery device receives flow instructions from the separate remote control device, and the housing of the fluid delivery device does not have any user output components.  Roche submitted that a speaker to provide audible feedback to user commands met that requirement.   The deputy judge rejected that submission on the basis that the speaker fell outside her construction of that claim.

Do the Solo and/or Solo Consumables (together or individually) constitute Means relating to an essential element of the invention of any of the Claims in Issue?

Claim 3 claimed 
a kit comprising a single remote control device including a plurality of fluid delivery devices.   Insulet submitted that the Solo kit included multiple fluid delivery devices and a single remote controller which was a separate non-disposable device. It also submitted that it was obvious that the user would also receive an initial supply of reservoirs and infusion assemblies such as pump holders and cannulas.  On the face of it the claim would have been infringed had integers G and H been present.   As they were not, the claim was not infringed.

Does the Defendant supply the Solo and/or Solo Consumables (together or individually) knowing, or where it is obvious to a Reasonable Person in the Circumstances, that these are Means suitable for putting and are intended to put the Invention as claimed in the Claims in Issue into effect in the United Kingdom?

The only claim that could have been infringed in this way was amended claim 45.   As that claim depended on "a fluid delivery device according to Claim 1 for attachment to a skin surface of a patient" As that claim had not been infringed it followed that the amended claim had not been infringed either.

Further Information

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