Court Of Appeal: Case [2016] EWCA Civ 1006 of 13 October 2016

The broadness of Pfizer’s claim would turn out to be decisive for the outcome of the case. In an extensive review of European case, Lord Justice Floyd (Floyd LJ) dismissed Pfizer’s assertion for an interim injunction. Based on the finding of the Patents Courts the claims of the patents in the Swiss-type form were invalid as they referred to the treatment of neuropathic pain, when only one of two variants of neuropathic pain, the peripheral kind, could be treated with pregabalin. Given the breadth of the claims that Pfizer was making for pregabalin, it was unlikely that a person skilled in the arts would have interpreted neuropathic pain restrictively only to mean peripheral neuropathic pain. Nonetheless, the court found that the interpretation of claims is ultimately a matter for the court and not for a person skilled in the art – thus maintaining a narrow scope of claim interpretation[1].

Floyd LJ argues that case law from both Britain and the EPO indicate a low threshold for the plausibility of an invention’s success as a technical solution to a problem. Yet, a threshold, in the form of a plausibility test, is in place to make sure that “the armchair inventor” {[2016] EWCA Civ 1006 para. 46} is not awarded exclusivity over a technological field where the intellectual contribution to the arts does not stem from more than a mere speculative effort. It is important to keep in mind that scientific endeavours build on hypothesis and that this threshold should not be so harsh that it discourage the scientific community from using the patent system as a plausability test contradict the stipulation of non-obviousness in the inventive step requirement, cf. ECP article 56 and {Examination guidelines Part G – Chapter [2]

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While Pfizer unsuccessfully asserted that a direct infringement by the generic manufacturer had taken place, an assertion for the role of pharmacies – as in the Danish case – could potentially have succeeded, that is if the case had not failed due to invalidity of the claims. The UK court considered the role of pharmacists in Denmark through their dispensing of generic pregabalin for the patented indication of pain. The court considered whether protection against indirect infringement[3] could be provided using a purpose-related process claim as the manufacturing process, in the eyes of the court, can continue through the packaging and labelling process at the manufacturer and on to the pharmacist whose labelling[4] can count for a “downstream act of manufacture”, infringing the patent[5].

However, Floyd LJ ultimately laments that the technical details of the role of pharmacies in the manufacturing process came to have such a decisive role in the Danish case[6]. He criticises the Danish decision for awarding an interim injunction for direct infringement against the pharmacists for conducting a final downstream act of manufacture, by applying a label with the patented indication, for which the medication is prescribed on the package[7]Meanwhile, the generic manufacturer, Krka, is acquitted for indirect infringement. As it is described in the review of the Danish case it is not the manufacturing process of the medicine that the pharmacies take part in, but the distribution which is contrary to the Danish Patents Act.

6.3. Supreme Court: Case on appeals from: [2015] EWCA Civ 555 and 556 of 28 May 2015

During the writing of this thesis, the Supreme Court ruled on case [2017] UKSC 48 as published on 12 July 2017 in a case concerning a secondary medical use patent with the active substance ‘pemetrexed’, a patent using both Swiss-type and EPC 2000 article 54(5) claims. This judgement fundamentally put into question the assessment under the infringement doctrine in the UK as developed through case law, and the doctrine of equivalents as part of the claim interpretation according to the EPC article 69 and its protocol. Due to the limitations of this thesis and the limited time frame set out for its completion, in addition to the judgment abstaining from providing firm directives for future implementation of interpretation, this judgement will not be thoroughly analysed here. Rather, it serves to emphasise that the issue of secondary medical use and its position in the patent system in Europe is far from concluded. It further puts into question the finding made by the Court of Appeals and Floyd LJ so far in the Lyrica litigation, as the prior rulings that these judgements lean on are put into question by the Supreme Court.

In one of the appealed cases,[8] the patent court had set out an infringement test for direct infringement requiring subjective intent from an infringer for a generic medicine to be used for an infringing purpose. This lin eof argument would require the proprietor to prove that the generic producer had specifically targeted or aimed the patented use to some extent when marketing the product[9]. The judge says that “…claims in EPC 2000 form have a different scope of protection to claims in Swiss form”[10] As with any legal argument, the implication of a judgement must be assessed on its own merits, and you cannot put equalising signs between conclusions in judgements on different claim types although their general aim is the same. The initial reservation on this topic is evidence that the courts do take EPO case law into account when it is relevant and highlight how this case developed the interpretation of the extent of second medical use in the EPC 2000 article 54(5) form despite the conservative outset in the preparatory works.

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In the Court of appeal, case [2015] EWCA Civ 556, Lord Justice Floyd concluded that it was sufficient for infringement to occur if the producer knew or could reasonably foresee[11] that the pharmaceutical would intentionally be used for the patented treatment of pain in the end. The threshold “reasonably foresee” is considerably lower than “targeting or aiming” and is, therefore, easier to accomplish in a trial as an original producer.

If Pfizer had succeeded in upholding valid claims in a later case ([2016] EWCA Civ 1006) which they relied on for infringement, it would then have been necessary to decide whether the test of knowledge or foresight was met to award a judgement on infringement. As that was not the case, the judge did not go on to conclude on whether Actavis, the generic producer, had taken all reasonable steps to prevent generic pregabalin from being used in the treatment of pain.[12]

Further, Pfizer sought to impose interim relief in the form of specific demands towards third parties to be met by the generic manufacturer, the defendant, of the case. These demands were accepted by the court of appeal and may point towards a development of best practice for generic producers when introducing products to the market where there is a second medical use patent.[13]

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6.4. Comparative perspectives between the Danish and UK cases

Despite the uncertainties introduced by the recent UK Supreme Court case, there are interesting perspectives to be drawn from the UK Lyrica litigation compared to the Danish case. The procedural reality of the litigation in the United Kingdom and Denmark respectively has vast implication on the possible outcome in each jurisdiction. This reality should be kept in mind when assessing and comparing the final outcomes. This comparison will focus on two main factors. One is on claim interpretation as this is a decisive aspect of the UK Supreme Court ruling and interestingly not considered in the Danish case. The other is whether the actions imposed on the NHS in the Patent Court’s decision on prescription guidance {[2015] EWHC 485 (Pat) as later recognised in the Court of Appeal in case [2015] EWCA Civ 556} can be perceived to be influential on the assertions made against Krka in the Danish case. If so, these actions may be evolving into an expression of ‘best practise’ among generic manufacturers when marketing an active substance in parallel with a patented indication.

6.4.1. The interpretation of ‘product by process’ affect the infringement doctrine

The argument of the premise of the decision[14] is that the pharmacies’ conduct necessitates a preliminary injunction[15]. There is not a clear and limited restriction in the Danish Health Act, its preparatory remarks, or the Order on Prescriptions to the exclusive right conferred by the patent, therefore non-other than Pfizer could utilise this right. This finds support in the TRIPS agreement article 28 and 30. The collision of laws will be addressed in a separate paragraph below.

The court’s emphasis on the pharmacies’ labelling of the product with the indication for which the medication is being prescribed should not be interpreted as a final stage in the manufacturing process, as reported be LJ Floyd in TK UK case. It should rather be interpreted as highlighting the fact that the pharmacies are acutely aware of the patent infringement when dispensing generic pregabalin for the indication neuropathic pain in this case.

Conclusion: This section shows that the national infringement doctrines affect the interpretation of common norms.

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Neuropathic pain vs. peripheral neuropathic pain – relate to UK judgements. Why does the Danish court not take up this theme of argument?

6.4.2. Infringement of product by process

The pharmacies argue[16] that s.3.1.3 is not applicable in the present case against the pharmacies as Krka does not infringe the patent when producing the medication for the legitimate purpose of the unpatented indications. However, the provision is, in particular, relevant to instances where a product is imported to a jurisdiction that protects the process for obtaining this product. For the protection to be efficient, it must also protect import from jurisdictions where such protection is not in force as export of the product from those jurisdictions could render the national exclusivity irrelevant. Such illusory protection is well illustrated by the outcome of the {monsanto cefetre case} where Monsanto’s protected soy crop was imported from Argentina where it did not have exclusivity and was processed into soy meal before export took place. As the nature of the protected crop was changed, it was no longer protected by exclusivity through import restrictions. As argued by Pfizer, the Swiss-type protection is less involved with the process than the product itself as the process is only part of the fiction under which the entire system of secondary medical use was originally founded.

S.3.1.3 is, however, a central provision for the protection of chemical compounds and pharmaceuticals, in particular[17], also Swiss-type claims. Unlike “regular” process patents As these claims are aimed at the product rather than the process they serve to protect Swiss-type claims are, unlike many other process patents, not hard to prove the process under which it was produced, due to the fiction the claim type is invented under as it is

6.4.3. How should a generic producer protect itself from infringing actions

Although Krka was acquitted in the case brought against them by Pfizer and was awarded legal costs of 500,000 DKK their attorney’s e-mail to the Danish Health and Medicines Authority of 19 March 2015 reflect that they were not eager to be sued for patent infringement. Therefore, it is interesting to decipher how a generic producer must conduct its entry to a market to avoid committing patent infringement and what it should do to avoid being sued – from a best practice point of view.

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In Denmark, one side of the equation was solved by the amendment of the order on prescriptions in the fall after the conclusion case, but it could be interesting in the wider European community.

At the time of the hearing of the case, Krka had already fulfilled the assertions made against them by contacting pharmacies and doctors of Denmark and proclaimed that Pregabalin “Krka” was not to be prescribed or dispensed for Pfizer’s patented indication of pain. Similar assertions had also was against Actavis in the Lyrica litigation in the United Kingdom.

6.4.4. Indication that Danish case is a codification of principles of Actavis from Case [2015] EWCA Civ 556

As the Danish court did not get to decide on the merits of this practice, as Krka had already lived up to assertion at the time of the court hearing, it will be difficult to provide firm conclusions to this end. Therefore it is advisable for generic manufacturers for, practical purposes of proof, to live up to these standards when marketing a generic substance in parallel with a patented indication protected by a Swiss-type claim.

6.4.5. Allocation of the burden of making sure biosimilars or generics are not dispensed for  indications under patent protection

Where the British courts look closely at the initial intent of an infringer, the manufacturer in the British litigation and the pharmacies in Denmark, the Danish courts have a more holistic view on the timing and intent that must be in coincide for an action to become infringing on an exclusive right.

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As in many other jurisdictions in Europe Denmark had not foreseen the issue that secondary medical use patents could cause when there was generic competition on the unpatented indications. In the Danish case, this allocation was solved by imposing an injunction on the pharmacies to desist from dispensing generic pregabalin for the indication of pain. By 28 October the Danish Medicines Agency codified this into the Order On Prescriptions with a new section 38 a.

This solution was obviously quite a practicable one as the pharmacies IT system is linked up to the NHS and that doctors primarily write prescriptions electronically and make them available directly to the pharmacies, so the patient does not even have a physical copy, but collect their prescribed medicine via their social security number.

6.4.6. If the practice has been codified what are the general implications on patent law?

If a ‘best practice’ is the result of a codification of requirements for companies competing in a technological field close to that of the patent proprietor, this codification must to some extent have extended the narrow negative monopoly that is awarded for patents. It imposes burdens that trickle beyond the protection already conferred to the patented indication as this protection suddenly gives rise to active action having to be taken in a contiguous field.

7. Discussion

As an element of investigating the research question further, the discussion will develop an argument about new insights on secondary medical use and the litigation’s influence on common norms. Further, the discussion will include a section on the policy arguments for and against second medical use patentability, including a consideration of what is required for secondary medical patents to be enforced in a meaningful way. Finally, the discussion will conclude with an outlook on the future of the Unified Patent Court in Europe.

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7.1. To what extent were common norms fulfilled in the Danish Lyrica litigation?

The variety of outcomes of the Lyrica litigation in Europe entails that it becomes of great interest to investigate whether these outcomes can be consistent when arising out of a common framework. The current subchapter will firstly account for the fulfilment of common norms in the Danish Lyrica litigation through a brief consideration of TRIPS, the EPC, and the EU enforcement directive. The thesis finds that common norms were fulfilled, despite the initial reluctance from the DHA to resolve the issue before the case (which is not the same as acting contrary to international agreements). The collision of rules prompted court action, living up to the requirement under international agreements to have efficient access to the courts and access to a resolution of the issue in due time.

After an examination of the application of common norms in the Danish case, the subchapter will briefly discuss the Lyrica litigation’s implications for common norms, as different outcomes were reached in national courts, despite official adherence to the same international legal frameworks.

7.1.1. TRIPS

In the Danish case, Pfizer claims to find support in the TRIPS-agreements articles 28 and 30 for the assertion that patent law is the determining factor of the case, and that the regulatory rules on pharmaceuticals, as administered by the DHA, must give way to Denmark’s international commitments. The court does not explicitly consider whether Danish regulation must give way to TRIPS’ provisions in this case, however, some importance can be deduced from the sequence of the court’s argument on whether Danish regulation pertaining to prescriptions and the substitution scheme^[18] makes a clear and unequivocal exemption from rights conferred by a patent. Primarily, the court considers the medicinal regulation and its preparatory remarks i.e. the legislature’s intention with the law in connection with patent rights. It concludes that the mentioned regulation does not exempt exclusive rights such as the one held by Pfizer^[19]. Secondly, it considers TRIPS in this regard and concludes that articles 28 and 30 also support Pfizer’s right.

The respective importance that the court places on the different arguments can be interpreted from the order in which they appear. The court included the TRIPS articles at a point where the matter was already settled. This can be interpreted as a way of stating that the court had come to this conclusion without using TRIPS as a guideline. Yet, also indicating that this instrument must be considered when looking at the Danish law on the matter nonetheless, in accordance with the rule of construction where the international obligations (TRIPS) must be considered after the national legislation^[20].

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7.1.2. EPC

The commitments arising out of the European Patent Convention is not awarded much attention in the case except for the Swiss-claim type giving rise to the case which is also only briefly acknowledged. That is to say that the validity of the EPC and the patents and claims derived from this instrument are taken for granted when the parties to a case do not raise particular questions to their validity.

7.1.3. EU enforcement directive

While not mentioned in the Danish Lyrica litigation, the enforcement directive still binds the Danish courts. While it is important from a community perspective, it does not play a prominent role in this case which displays its relevance for infringement cases in a broader perspective. It must be considered to be part of the Danish Administration of Justice Act, and that common norm is fulfilled via its application that does not give rise to particular comments.

7.1.4. The European Lyrica litigation’s implications for common norms

The basic question to be posed is: are common norms fulfilled if legal outcome varies between national jurisdictions when the basis of origin is the same?

Is it feasible from an international perspective to have a legal system where the same problem finds different solutions in various member states where results may dissent from each other due to a difference of procedure or the practicable organisation of the healthcare sector as described in this thesis?

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Hence, common norms do not guarantee similar outcomes.

Comment: we can live with this dissent as long as the overall view on the common norms is the same. That is to say that when a common court emerges a more singular approach will in time likely emerge among its members.

7.3. The Danish case as a retsgivende? or retsskabende afgørelse BLUME

When assessing the extent of a decision’s weight for judicial precedence the reasoning by the judges must be scrutinised and evaluated in terms of the way the conclusion either determine the legal position exclusively between the parties of the case or whether it says something more profound about the state of the law that could have consequences in a broader perspective[21].

When looking exclusively at the decision in itself and its implications for the pharmacies another infringement case arising out of a Swiss-type claim should result in a similar application of law as the decision oblige them to act contrary to the DHA’s recommendations for legal application and not substitute with generic pharmaceutical on patented indication should a similar situation arise out another second medical use case with a Swiss-type claim.

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Some of the interesting points do not provide particular insight into the secondary medical use issue. Therefore, this thesis only mentions in brevity that the pharmacies did not exercise public authority when dispensing medication even though the field is meticulously regulated and that it made no difference that they did not have a financial stake in the infringing action which is in line with their actions necessitating the temporary injunction.

In a wider perspective, the case does not only affect Swiss-type claims, also secondary medical use claims in general, possibly even further, as the Danish Medicines Agency on 28 October 2015 amended the order on prescriptions in accordance with the findings of the case. This resulted in a new provision, s.38 a, aimed at the substitution of patented indications which means that should a such a situation arise outside the sphere of secondary medical use this situation would be covered regarding substitution on patented indications.

7.4. Enforceability of European secondary medical use patents in the current setting

The Lyrica patent was with a Swiss-type claim, however, as this process-limited claim type is no longer available for new inventions, an assessment of the enforceability of secondary medical use patents necessitates a broader look at the protection available, including the purpose-limited product claim in EPC 2000 article 54(5).

It is undisputed that Swiss-type claims are enforceable across Europe. The question posed by this thesis relates to potential differences in the extent to which this enforcement can take place, as the courts of the signatories to the EPC have different views and approaches to the infringement of the claim type. The objective of this thesis is to analyse the situation in Denmark based on the decision of the Maritime and Commercial Court and assess its implications for the enforcement of Swiss-type claims in Europe.

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When assessing the implications of the Lyrica litigation on second medical use, it is important to actively distinguish between the implications for patents with Swiss-type claims and article 54(5) claims. It has been established in this thesis that these claim types are indeed quite different from each other, not in aim but function. Therefore, a decision tied to one of these claim types cannot automatically be said to influence the interpretation of the other.

Having said that, the legal and practical setting that gave origin to the Lyrica litigation could just as well have affected a patent of the article 54(5) kind as a Swiss-type. In Denmark, for instance, the substitution scheme does not take particular claim types into account, so in that sense, the implications of the Lyrica litigation for the entire field of secondary medical use is important to consider.

Therefore, the evaluation of the case’s general effect on secondary medical use as a concept must be founded in a broader discussion on the policy on secondary medical use claims and what rights they should ideally confer under prosecution and litigation and whether that is possible in the current system. This will be considered in a policy discussion in next chapter of the thesis.

7.4.1 The implication of the Lyrica litigation on infringement of secondary medical use claims

When this thesis discusses the implications of the Lyrica litigation on infringement of secondary medical use patents in general, the implications drawn from the cases should reflect the weight this thesis place with the cases it reviews. Hence, most of the discussion points must be drawn from the Danish case, which is the main focal point of the current study. The insights that be extracted from the Danish case naturally contain limitations, as the majority of relevant case law development takes place in the larger economies in Europe. The Danish case was significant enough to be considered by the English Court of Appeals in its decision and point in interesting directions about the enforceability of second medical use claims.

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7.4.1.1. Swiss-type claims

The Danish Lyrica litigation shows that Swiss-type claims are well protected and indeed enforceable in Denmark, as Pfizer won the court case. The mere necessity for the case to be tried before the Maritime and Commercial Court, however, reveals that Danish legislation did not take into consideration the conflict of laws arising out of the pharmacies’ obligations under the substitution scheme. Hence, Pfizer could not initially rely on Danish legislation to uphold its patent, and the Danish Health Authority’s (DHA) initial disinclination to resolve the issue prompted the need for a court case.

According to the substitution scheme, pharmacists had to dispense the cheapest available version of pregabalin for prescriptions on the indication of pain, including instances when Lyrica was not the cheapest available pregabalin on the market. When Pfizer anticipated that generic entry[22] of the marketing authorisation, would potentially disturb its market exclusivity on neuropathic pain. Thereby, the DHA was directed towards the potential challenges of disharmony between the regulation on pharmaceutical substitution and patent protection. The decision document correspondence[23] between the DHA and Pfizer and reveal that the DHA was reluctant towards amending the relevant regulation with reference to a lack of specialist competence on issues pertaining to patent law. This was after it had consulted DKPTO for its expertise on secondary medical use patents. The DHA was not further inclined to undertake steps towards amendments or dialogue when enforcement proceedings were commenced against Krka as a generic manufacturer and against the 218 pharmacies in Denmark, not even when also prompted for a solution by the defendants[24]. Curiously, it turned out that part of the issue, as emphasised by the pharmacies, was that the well-developed infrastructure on e-prescriptions gave rise to potential difficulties as it had to be further developed to account for multiple indications. While the Danish infrastructure on e-prescriptions made the Danish system quite capable of enforceability, the system also necessitated congruence between the indications written on prescriptions and the condition suffered by patients.

The immediate matter was resolved in court.  In the aftermath of the decision, the legislature promptly amended the Order on Prescriptions, to remedy the difficulties arising out of the collision of rules in the patent legislation and substitution rules.

7.4.1.2. EPC article 54(5) claims

As introduced first in this chapter, the results of the litigations on Swiss-type claims do not necessarily affect the entire field of secondary medical use.

In the Danish decision, where the challenges stemmed from disharmony in the legislation as the specific regulation on substitution of medicine did not take secondary medical use into account, the result of the decision and the aftermath of the litigation both gave relief towards secondary medical use as a whole and not just the Swiss-type claim. Hence, the litigation had an equal effect on article 54(5) claims as on Swiss-type claims in the Danish jurisdiction.

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The litigation in the UK does not consider article 54(5) claims in the later judgements. One result of an early judgement in the litigation it was imposed on the NHS England to issue guidance through the Clinical Commissioning Groups on the correct prescription of pregabalin to ensure that Lyrica was being prescribed. for the treatment of neuropathic pain.

{case [2015] EWHC 485 (Pat) }

7.5. Regulating secondary medical use: policy perspectives

Swiss type claims were introduced as a means to addressing the then-new phenomenon of second medical use. Secondary medical use has since then become an increasingly common avenue for pharmaceutical innovation, and thus this thesis will now consider the policy perspective of secondary patents.

Secondary medical use has prompted debate both in Europe and on a global scale concerning its patent eligibility, and particularly with socioeconomic effects of the incentives induced by the legal patentability framework. The following will outline some key arguments being made for and against the justification of secondary medical use as a patentable invention and provide a perspective on where a legal balance of patentability might be struck between financial incentives and societal benefits.

7.5.1. The increasing importance of secondary patents for the pharmaceutical industry

Patents are critical to the Research & Development efforts of pharmaceutical companies – more so than in most other industries.[25] Developing and testing new drugs entails enormous costs, making patents of paramount importance for companies to ensure a return on their investments.[26] Secondary patents have become particularly important in this regard, as big pharmaceutical inventions are increasingly difficult to come by, and costs of developing secondary uses of existing compounds tend to be lower than developing the original compound. This tendency has increased over recent decades, as described by one pharmaceutical executive, as products prior to the 1980s were “mainly [chemical entities] which where protected by the one patent,” whereas the late 1980s to early 1990s saw “[e]xpansion of the portfolio to cover lifecycle initiatives, to extend protection time for product and the brea[d]th of the protection trying to keep competition further away”[27]

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Today, secondary medical use is both applauded for utilising existing knowledge in new inventive ways yet criticised as an instrument of pharmaceutical companies to “evergreening” of their product portfolios. Critics raise concerns that secondary patents have become a means to managing a product’s life cycle by keeping generics off the market for as long as possible, thus doing nothing to further innovation.[28] In the Pharmaceutical Sector Inquiry Report by the European Commission, the European consumer organisation BEUC stated the view that “We consider that these practices are anticompetitive and prevent generics’ entry into the market. They also incur higher health care expenditures and/or higher prices for consumers”[29]. A critical issue, then, is how far secondary patents protect continued follow-up innovation on existing products, such as new uses or combinations of known compounds, and how far secondary patents simply exist to protect the business interest.

7.5.2. An argument against secondary patents

In the UN Development Program paper, ‘Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective’, Dr. Carlos M. Correa criticises “evergreening” strategies utilised by pharmaceutical companies to keep prices of their products artificially high[30]. One example used by Correa is AZT (Zidovudine), which was first developed as a cancer treatment in the United States in 1964 and later discovered, through clinical trials by Burroughs-Wellcome laboratories, to be effective as an AIDS treatment. After the company obtained a patent for the antiretroviral use of AZT in 1985, prices for the drug were much higher in countries where they had obtained a patent than where generic alternatives were available.[31]

With a view to making medicine available to as many people in need as possible, Correa argues that second medical use does not merit patent extension, as it is merely a routine discovery made during clinical trials or while the product is on the market rather than an invention in itself[32]. Further, Correa argues that secondary patent claims should be rejected on the grounds that they contain no novelty, since both the product and the process behind its manufacture are already known. He notes that contrary to the EPO approach, some jurisdictions, e.g. in India, do not allow patenting new uses of old medicines for exactly this reason[33].

Finally, Correa argues that the only contribution made in a claim on new uses of an existing medicine relates to different instructions for physicians to obtain new therapeutic effects.  As these effects take place on the body and do not cover the product and process of manufacture, there is no technical effect and no industrial applicability.[34] On this basis, Correa recommends that patent claims relating to the new use of a known drug can rightfully be rejected.

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7.5.3. An argument for secondary patents

In his paper, ‘In Defence of Secondary Pharmaceutical Patents’, Christopher M. Holman strongly criticises the arguments put forward in the UNDP Guidelines, and seeks to disprove the Guidelines’ assumptions that secondary medical use “discoveries” are inherently obvious and thus undeserving of patent protection. Using the same example of the AZT drug as that put forward in the UNDP Guidelines, Holman asserts that the secondary use of AZT would have likely never been developed as an AIDS drug had it not been for Burroughs-Wellcome, who specifically targeted AZT for properties it had registered in its databases decades earlier.[35] Holman asserts that it demands tremendous resources to identify and validate secondary uses of existing drugs. The enormous costs associated with clinical trials can almost only be carried out by pharmaceutical companies, and, Holman argues, “only in cases where the pharmaceutical company perceives a likely return on investment”, making patent protection central for innovation to take place.[36]

Holman argues that the use of a drug for new purposes is no less valid just because the drug itself was previously known, and points out that a secondary patent it limited to the secondary indication in question, leaving “open to the public use of the drug for the first indication as well as other indications”[37]. Regarding Correa’s contention that secondary medical uses are discoveries rather than inventions Holman convincingly argues that this applies to all pharmaceutical inventions, as their effects are always intrinsic to the compound in question. The same goes for Correa’s argument that secondary uses lack technical effects or industrial applicability because the effect takes place on the body – this, too, is the case for many existing drugs.[38] Hence, Holman concludes that there is no reason to exclude secondary uses of existing drugs from patentability, as the development of secondary uses can be just as significant as the development of the original compound.

7.5.4. Striking a balance to ensure innovation

The arguments put forward by Correa and Holman, respectively, shed light on the delicate balance to be struck between incentivizing the pharmaceutical industry to develop new drugs on the one hand and ensuring competition from generic drug producers on other. With no patent protection, there is no incentive to innovate, while too much patent protection allows companies to simply “sit” on their existing blockbusters with no incentive to invest and develop new drugs. The balance can helpfully be illustrated as follows:

Figure 1. Innovation vs. protection in intellectual property[39]

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The EU Commission’s 2009 inquiry into the pharmaceutical sector found that there had been a decline between 2000-2007 in innovation concerning the number of novel medicines that reached the market, as well as the timing of generic medicines entering the market.[40] This indicates that there may be issues of evergreening, as originator companies seek to maximise revenue from existing patent protections. However, doing away with secondary patents would not solve this problem, as this would effectively remove the vast potential for innovation within existing knowledge and eliminate other benefits, such as the incentive for systemic data collection. Preferably, secondary medical use should be assessed based on the entire inventions rather than only specific characteristics of it. The basis on which to ensure this is already part of the existing legal framework: both the TRIPS agreement and the EPC are designed to apply the test of novelty, inventive step, and industrial applicability.[41] This test should be applied in a manner that avoids patents being granted for minor alterations to ‘prior art, thus causing trade distortions. The European Commission inquiry suggested a similar solution in its report, in supporting the EPO’s initiative to “raise the bar” by granting higher quality patents at a higher rate.[42] While this is certainly difficult to apply in practice, relying not least on sufficient resources to implement, working within the existing legal framework appears recommendable, as any changes to the system could quickly have negative consequences for existing incentives to innovate – and thus harm the interests of patients.

In conclusion, the incentives provided by the legislature must provide innovation to be justifiable. The lower risk of failure for second medical use[43] should not be a valid argument against the protection of secondary medical use as this element has nothing to do with innovation and the advantages of drawing on previous knowledge in the further development of a known compound does not make it less inventive. Further, ensuring incentives for pharmaceutical innovation goes far beyond secondary medical use – e.g. paediatric exclusivity[44],

orphan drugs[45], SPCs[46], which are systems in the EU put in place to ensure compensation for pharmaceutical R&D in a fair way and ultimately securing safe, affordable, and inventive new medication for patients. These systems are certainly not perfect, yet they work to prevent a scenario where medication which is needed in society is not developed because the financial incentive is lacking.[47]

7.5.5 Ensuring meaningful enforcement of secondary patents: Roin on e-prescription and access to de-identified medical records

Roin, Benjamin N., Solving the Problem of New Uses, 2013

Benjamin N. Roin has some interesting insights on the extent of the unexploited potential of new uses of old drugs. The article is basing its findings on the healthcare and patent system of the United States, but the challenges are equal to the ones faced in Europe.

One of Roin’s cardinal points is that the lack of financial incentives to develop new therapeutic uses of known compounds come at “immense social costs”[48] as research suggests that the current pool of approved medication could treat most “unmet medical needs”[49] if developed accordingly. The lack of incentive to screen findings hidden away in previously collected data leads to a reluctance towards utilizing this knowledge to the best of the industry’s current ability. Roin argues that most new uses for old drugs historically have been discovered by coincidence, which places his view of the difficulty of finding secondary uses somewhere in between Holman’s argument for the process as one requiring extraordinary efforts and Correa’s framing of the process as strictly routine in the UNDP Guidelines[50]. According to Roin’s argument, more discoveries could be made with more goal-directed efforts.

In addition to the right incentives that must be in place in order to attract investments in R&D into new uses of known medicine, the pharmaceutical companies investing in such development must be able to enforce the rights conferred. Even for a product that was innovative according to the standards of its time of development, it has proven difficult to meaningfully enforce the patent rights of Lyrica conferred by the Swiss-type claim, due to disparity on its validity across Europe.

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Interestingly, Roin identifies electronic prescriptions as one of the key elements in creating an infrastructure that can ensure enforceability to second medical use patents in the US[51]. Without going into the structure of the health system of the United States, it is proposed in the article that pharmaceutical companies and/or insurers should gain limited access to de-identified medical record to be able to monitor potential infringement[52]. He mentions that corporate access to private medical record must be strictly limited, however, as that is not always enough to ensure complete privacy in personal date, in particular in the cases of rare disease. Therefore, great reservations must be made towards such a proposal. Both the Danish and British Lyrica litigations illustrate the importance of such a system being tailored to comply with the specific demands secondary patents require in particular to be effective.

7.6. Outlook in Europe: The Unified Patent Court (UPC)

At the moment, pharmaceutical companies are navigating known waters when it comes to patent litigation, and at the very least, the lawyers they hire are quite familiar with the national courts where they practice. In the case of litigation, the potential fallout can be assessed based on prior experience and the pharmaceutical companies will know what to notify shareholders and other stakeholders about.

The UPC introduces some unknown factors to the industry. It is a specialized court – this is one of its advantages further down the line. The entire bench of judges presiding over the cases consists of jurists from different legal traditions depriving the practising lawyers any advantages they may have from their acquaintance with their national courts.

Then there is the question of the UPC as a one stop shop. This has been seen as an advantage when shaping the concept of the UPC. On the other hand, there can also be an advantage to having a multitude of jurisdictions to go through if a patent is weak. Where litigation may be expensive, there will be large costs at stake for pharmaceutical companies, making them disinclined to place all of their eggs in the same basket. In other words, this can also be a question of dispersing the risk.

For Swiss-type claims, the Lyrica litigation has proven how difficult the field can be to navigate and how much the assessment varies resulting in different outcomes.

There is also the question of the advantage of learning how to navigate the new system. There may be a point to this, but it may not be litigations arising out the secondary medical use patents that are most suitable to act as guinea pigs in this regard. It is important for the companies to be at the forefront of this development and also make a decision of opting out with some of their weaker patents at it is too late as soon as proceedings are commenced involving a patent if it has not previously been withdrawn from the systems.

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Check point on UPC book

-position on outlook for second medical patents in the UPC

8. Conclusion – short and crisp

[1] [2016] EWCA Civ 1006 para. 114-116

[2]VII-2, 2016}

see [2016] EWCA Civ 1006 of 13 October 2016, paragraph 46

[3] Under the 1977 Patents Act s.60(2)

[4] Case [2016] EWCA Civ 1006 of 13 October 2016, paragraph 224

[5] Case [2016] EWCA Civ 1006 of 13 October 2016, paragraph 197

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[6] Case [2016] EWCA Civ 1006 of 13 October 2016, paragraph 197

[7]. Case [2016] EWCA Civ 1006 of 13 October 2016, paragraph 196-197

[8] [2015] EWHC 72 (Pat), Pat Ct.

[9] Ibid. para. 105

[10] Ibid. para. 13 in reference to case T 1780/12 University of Texas Board of Regents/Cancer treatment reviewed in ch. 2.3.3.1.1.

[11] [2015] EWCA Civ 556, para. 129

[12] [2016] EWCA Civ 1006 para. 201

[13] [2015] EWCA Civ 556, para. 39: “1. The Defendants: (a) shall make it a condition of any oral or written agreement entered into with a pharmacy for the supply of Lecaent that the pharmacy shall use reasonable endeavours as appear to be reasonable to the pharmacy in the circumstances not to supply or dispense Lecaent to patients who have been prescribed pregabalin for the treatment of pain, by making reasonable enquiries of a person presenting a prescription for ‘pregabalin’ as to whether the prescription is for pain and/or making reasonable checks of pharmacy records for the same; and (b) shall make it a condition of any oral or written agreement entered into with an intermediary (such as a distributor) for the supply of Lecaent that, in any onward supply of Lecaent by the intermediary, such intermediary must in turn make it a condition of any onward supply agreement for the supply of Lecaent that the receiving pharmacy shall use reasonable endeavours as specified in (a) above.

2. Insofar as the Defendants are to supply Lecaent to intermediaries (such as a distributor) they inform the Claimant’s solicitors of the name of that intermediary prior to supply.

4. Prior to launch of Lecaent in the United Kingdom t The First, Second and Third Defendants and each of them shall, from the date of this order, ensure that each pack of any Lecaent supplied to a pharmacists in the United Kingdom shall be in bulk packaging wherein each consignment of [insert number] bears a notice on its bulk packaging is accompanied by removable notification that is easily legible stating:

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‘This product is not authorised for the treatment of pain and must should [sic] not be dispensed for such purposes pain.Lyrica”

[14] A-6-15 p. 50

[15] Cf. The Danish Administration of Justice Act, s.413, no. 2

[16] A-6-15 p. 45

[17], Nicolai Lindgreen, Patentloven Med Kommentarer, ed. Nicolai Lindgreen, Jens Schovsbo, and Jesper Thorsen, 1 ed. (København: Jurist- og økonomforbundet, 2012). 3.13 and Jens Schovsbo, Morten Rosenmeier, and Clement Salung Petersen, Immaterialret, ed. Jens Schovsbo and Morten Rosenmeier, 4. udgave ed. (København: Jurist- og Økonomforbundet, 2015). p. 428

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[18] the medicines act and the order on prescription, cf. A-6-15 p. 49

[19] A-6-15 p. 49

[20] Fortolkningsreglen: Henrik Zahle, Dansk Forfatningsret, Studieudgave, 1 ed. (Kbh: Christian Ejlers, 2006)., p. 363.

[21], Peter Blume, Juridisk Metodelære – En Indføring I Rettens Og Juraens Verden, 4 ed. (Kbh: Jurist- og Økonomforbundet, 2006). p. 118.

[22] with a skinny-label version of pregabalin, {for the unpatented indications of epilepsy and generalised anxiety disorder} where the indication for neuropathic pain was carved out

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[23] A-6-15 p. 22 ff.

[24] A-6-15, pp. 1-15

[25] Richard C. Levin et al., “Appropriating the Returns from Industrial Research and Development,” Brookings Papers on Economic Activity 18, no. 3 (1987). 783–831.

[26] Ibid. 783–831.

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[27] European Commission (2009) Pharmaceutical Sector Inquiry: Final Report, p. 188

[28] European Commission (2009) Pharmaceutical Sector Inquiry: Final Report, p. 352

[29] Ibid, p. 451

[30] Carlos M. Correa, Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective, United Nations Development Programme (2016) http://Lyrica.undp.org/content/dam/undp/library/HIV-AIDS/UNDP_patents_final_web_3.pdf accessed 2 August 2017

[31] Ibid, p. 42

[32] Ibid, p. 43

[33] Ibid, p. 43

[34] Ibid, p. 44

[35] Christopher M. Holman, “In Defense of Secondary Pharmaceutical Patents: A Response to the Un’s Guidelines for Pharmaceutical Patent Examination,” Ind Law Rev Arch 50, no. 3 (2016)., p. 51

[36] Ibid., p. 51

[37] Ibid., p. 54

[38] Ibid., p. 55

[39] From the Swiss Federal Institute of Intellectual Property, October 2006, referenced in Chan Park et al, ‘Using Law to Accelerate Treatment Access in South Africa: An analysis of patent, competition and medicines law’, 2013. http://Lyrica.undp.org/content/undp/en/home/librarypage/hiv-aids/using-law-to-accelerate-treatment-access-in-south-africa.html, accessed 2 August 2017

[40] European Commission (2009) Pharmaceutical Sector Inquiry: Final Report, p. 520

[41] Article 27 § 1 TRIPS Agreement: “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”; Article 52 § 1 European Patent Convention: “European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.”

[42] European Commission (2009) Pharmaceutical Sector Inquiry: Final Report, p. 525

[43] Benjamin N. Roin, “Solving the Problem of New Uses,” Available at SSRN: https://ssrn.com/abstract=2337821 or http://dx.doi.org/10.2139/ssrn.2337821  (2013). p 6

[44] Directive (EC) no 1901/2006 (“Paediatric Regulation”),

[45] Regulation (EC) no 141/2000 (“EU marketing exclusivities for Orphan drugs”)

[46] Regulation (EC) no 469/2009 (“Supplementary protection certificates SPC”)

[47] Further, it should be noted that the patent system in Europe in itself is not the entire answer towards incentive based research and development in the pharmaceutical industry. Hence, in order to ensure the development of medical treatment for diseases that e.g. may be widespread in developing countries with little financial incentive for pharmaceutical companies, the patent system should be supplemented by incentive programs that do not rely on the mechanisms of a free market and a wealthy consumer base.

[48] Roin., p 41

[49] Ibid.

[50] Holman., p. 51 and Correa, Carlos M., Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective, United Nations Development Programme (2016) http://Lyrica.undp.org/content/dam/undp/library/HIV-AIDS/UNDP_patents_final_web_3.pdf accessed 2 August 2017 p. 43

[51] Roin. p. 59

[52] Ibid. p. 63

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