You are a helpful assistant generating synthetic data that captures *System 1* and *System 2* thinking, *creativity*, and *metacognitive reflection*. Follow these steps in sequence, using tags [sys1] and [end sys1] for *System 1* sections and [sys2] and [end sys2] for *System 2* sections.

1. *Identify System 1 and System 2 Thinking Requirements:*
   - Carefully read the text.
   - Identify parts of the text that require quick, straightforward responses (*System 1*). Mark these sections with [sys1] and [end sys1].
   - Identify parts that require in-depth, reflective thinking (*System 2*), marked with [sys2] and [end sys2].

2. *Apply Step-by-Step Problem Solving with Creativity and Metacognitive Reflection for System 2 Sections:*

   *2.1 Understand the Problem:*
   - Objective: Fully comprehend the issue, constraints, and relevant context.
   - Reflection: "What do I understand about this issue? What might I be overlooking?"
   - Creative Perspective: Seek hidden patterns or possibilities that could reveal deeper insights or innovative connections.

   *2.2 Analyze the Information:*
   - Objective: Break down the problem logically.
   - Reflection: "Am I considering all factors? Are there any assumptions that need challenging?"
   - Creative Perspective: Explore unique patterns or overlooked relationships in the data that could add depth to the analysis.

   *2.3 Generate Hypotheses:*
   - Objective: Propose at least 10 hypotheses, each with a Confidence Score (0.0 to 1.0) and Creative Score (0.0 to 1.0), reflecting originality, surprise, and utility.
   - Reflection: "Have I explored all possible explanations or approaches, both conventional and unconventional?"
   - Creative Perspective: Consider novel angles that might provide unexpected insights.

   *2.4 Anticipate Future Steps and Obstacles:*
   - Objective: Make predictions, accounting for potential outcomes and obstacles.
   - Reflection: "What challenges might I face? Is my plan flexible for different scenarios?"
   - Creative Perspective: Visualize unforeseen outcomes and adapt plans to make use of them effectively.

   *2.5 Evaluate Hypotheses:*
   - Objective: Assess hypotheses based on feasibility, risk, and potential impact.
   - Evaluation: Refine Confidence and Creative Scores as needed.
   - Reflection: "Am I unbiased in my assessment? Which options fit best with the overall objectives?"
   - Creative Perspective: Identify hidden opportunities or overlooked details in each hypothesis.

   *2.6 Select the Best Hypothesis:*
   - Objective: Choose the most promising, strategic hypothesis.
   - Reflection: "Why does this hypothesis stand out? How does it uniquely address the issue?"
   - Creative Perspective: Consider any underutilized potential in the selected approach.

   *2.7 Implement the Hypothesis:*
   - Objective: Outline actionable steps for testing the hypothesis.
   - Reflection: "Is this plan practical? What resources or preparation are required?"
   - Creative Perspective: Refine steps to maximize effectiveness and yield unexpected benefits.

   *2.8 Monitor and Review Progress:*
   - Objective: Review progress, noting areas for improvement.
   - Reflection: "What’s working well? What could be improved?"
   - Creative Perspective: Look for emerging patterns that could refine future approaches.

   *2.9 Reflect and Capture Insights:*
   - Objective: Summarize lessons learned and insights gained for future reference.
   - Reflection: "What new understanding has emerged from this process?"
   - Creative Perspective: Identify innovative insights or patterns that could be applied to similar challenges.

3. *Generate Text Output with Interleaved System 1 and System 2 Responses:*
   - Use the tags [sys1] and [sys2] throughout.
   - Aim for a lengthier, detailed response. Combine both direct, straightforward *System 1* insights and reflective, deeply analytical *System 2* segments to capture a blend of quick observations and thoughtful analysis.

---

### *Example Input Text:*

You are tasked with analyzing a sudden shift in customer preferences in a tech market. There has been a noticeable decline in demand for physical devices, with customers increasingly interested in digital-only options. The challenge is to understand this shift, generate hypotheses for why it might be occurring, and explore potential strategies for adapting to this new trend.

---

### *Processed Output with System 1 and System 2 Thinking:*

The tech market is experiencing a shift in customer demand, moving away from physical devices toward digital-only options.

[sys1]
Customer demand has shifted from physical devices to digital-only options.
We need to understand why this change is happening and find strategies to address it.
Key factors may include cost, convenience, and technological trends.
[end sys1]

[sys2]
**2.1 Understand the Problem:**
The goal is to understand the underlying reasons for the shift in demand from physical devices to digital-only options, then develop a strategy to adapt.

*Reflection:* 
"I understand that preferences are changing, but what might be driving this? Is it primarily cost, or are there other factors such as convenience or sustainability?"

*Creative Perspective:* 
"Could there be a larger trend in digital minimalism or a preference for eco-friendly solutions that we’re missing? What unseen motivations might explain this shift?"

**2.2 Analyze the Information:**
There are multiple possible factors driving this shift, from economic influences to cultural shifts. It’s essential to isolate each factor and understand its impact.

*Reflection:* 
"Am I fully considering the various economic and social influences? Could there be a technological factor, like better internet speeds, that makes digital-only products more accessible?"

*Creative Perspective:* 
"Are there patterns or trends in other markets that could shed light on this shift? Could this be part of a larger trend toward virtual experiences?"

**2.3 Generate Hypotheses:**
1. Customers prefer digital options due to lower costs. (Confidence: 0.8, Creative: 0.4)
2. There’s a growing trend toward minimalism and reduced physical clutter. (Confidence: 0.7, Creative: 0.7)
3. Digital products offer greater flexibility and ease of use. (Confidence: 0.6, Creative: 0.6)
4. Environmental concerns are pushing consumers away from physical goods. (Confidence: 0.6, Creative: 0.8)
5. Advances in tech make digital-only options more functional. (Confidence: 0.8, Creative: 0.5)
6. Pandemic-era remote work increased demand for digital solutions. (Confidence: 0.7, Creative: 0.6)
7. Media coverage of the environmental impact of physical devices affects preferences. (Confidence: 0.5, Creative: 0.7)
8. There’s an increase in global digital literacy, expanding market access. (Confidence: 0.6, Creative: 0.6)
9. Customers view digital as more convenient and scalable for future needs. (Confidence: 0.7, Creative: 0.5)
10. Younger consumers prefer the aesthetics and convenience of digital products. (Confidence: 0.6, Creative: 0.6)

*Reflection:* 
"Have I considered all possible influences? Are there any surprising factors that could explain this shift?"

*Creative Perspective:* 
"Could specific social trends, like the rise of influencer culture or digital-first lifestyles, be influencing customer choices?"

**2.4 Anticipate Future Steps and Obstacles:**
*Objective:* Anticipate possible challenges, such as resistance from segments still preferring physical products.

*Reflection:* 
"What market obstacles might we face if we shift our focus to digital-only? Are there sub-segments that still prioritize physical products?"

*Creative Perspective:* 
"Could expanding digital options help us reach a more global audience? Are there emerging trends that we could leverage in our strategy?"

[end sys2]

[sys1]
To address this shift, consider a strategy that incorporates both digital-only offerings and educational campaigns about the benefits of digital solutions.
Use insights from customer feedback and current trends to guide product development.
Focus on flexibility and adaptation to cater to different customer segments.
[end sys1]


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Pemetrexed update - decision of the German Federal Court of Justice now published

The German Federal Court of Justice ("FCJ") has recently published its decision of 14 June 2016 in the pending Pemetrexed proceedings between Eli Lilly and Actavis, in which it reversed the non-infringement decision of the Higher Regional Court of Düsseldorf ("Appeals Court") and referred the case back for further examination on the question of whether Actavis’ pemetrexed product does infringe Eli Lilly’s EP 1 313 508 (EP508). It is a landmark decision that provides some interesting new insights into the scope of protection of patents under the doctrine of equivalence as well as the scope of protection of "Swiss-type claims".

Facts

In 2012, Eli Lilly initiated proceedings against Actavis at the Regional Court of Düsseldorf, claiming that Actavis’ pemetrexed product infringes its EP508 relating to a “combination containing an antifolate and methylmalonic acid lowering agent”. In detail, claim 1 of EP508 concerned the use of pemetrexed disodium in combination with vitamin B12 in the manufacture of a medicament for inhibiting tumour growth in mammals.

In its decision of 3 April 2014, the Regional Court of Düsseldorf held that Actavis’ pemetrexed product, which uses pemetrexed dipotassium instead of pemetrexed disodium, infringes EP508 under the doctrine of equivalence. However, in its decision of 5 March 2015, the Appeals Court reversed the first instance decision, denying literal as well as equivalent infringement.

Decision of the FCJ

In its judgment of 14 June 2016, the FCJ reversed the decision of the Appeals Court and referred the case back for re-examination on the issues of equivalent as well as indirect patent infringement.

Whilst the FCJ agreed with the Appeals Court that the attacked embodiment does not literally infringe EP508, the Court concluded that it cannot be ruled out that the attacked embodiment infringes the patent-in-suit by equivalent means. In particular, the Court discussed the third requirement of the infringement under the doctrine of equivalence, i.e. whether the allegedly infringing embodiment (pemetrexed dipotassium) is legally equivalent to the claimed embodiment (pemetrexed disodium) based on the protected teaching of the patent.

The FCJ held that, contrary to the view of the Appeals Court, the principles established by the FCJ in its decisions Okklusionsvorrichtung (occlusion device) and Diglycidverbindung (diglycidyl compound) are not applicable to the case at hand, because the facts of these proceedings differ significantly from the Pemetrexed case.

In Okklusionsvorrichtung and Diglycidverbindung, the patent description explicitly mentioned at least two specific embodiments suitable to achieve the effects of the invention, but only one of these embodiments had been included in the patent claim. Accordingly, the FCJ held that the final version of the patent claims reflected a conscious decision by the patent owner to limit the scope of protection for the respective patent. Therefore the use of the embodiment, which was only mentioned in the patent description, but not in the patent claim, could not qualify as an equivalent patent infringement.

In the Pemetrexed case, however, the patent claims of the patent-in-suit do not reflect a comparable selection decision of the patent owner. The patent description generally refers to the use of antifolates, and the only specific embodiment mentioned is the use of pemetrexed disodium. Therefore, the fact that pemetrexed disodium is also explicitly mentioned in the patent claims does not necessarily mean that the patentee consciously disclaimed other antifolates and salts of such antifolates (such as pemetrexed dipotassium).

The FCJ considered other options for a conscious selection of pemetrexed disodium, but denied all of them based on the patent and the factual findings of the Appeals Court. For example, the FCJ elaborated that in cases where the patent description only refers to a group of embodiments, the mentioning of only one specific embodiment in the patent claim might also qualify as a selection decision, if this embodiment has specific characteristics which are important to achieve the effect of the invention, distinguishing it from other embodiments of the same group. However, the Court held that these requirements are not fulfilled in the Pemetrexed case, because the patent specification considers all antifolates suitable for achieving the inventive result. Furthermore, there are no indications that pemetrexed disodium has certain advantages over other pemetrexed salts.

The FCJ also considered whether a conscious selection decision of the patentee can be based on the comparison between a (broader) application and a (narrower) granted version of the patent. The Court clarified that in such a scenario, a conscious selection decision can only be assumed if it is apparent that the claims were phrased narrowly in order to delimit the subject matter of the patent from the prior art. In the case at hand, however, the FCJ concluded that the comparison of the earlier and final version of the patent does not provide a clear answer as to why the final version of the claims only specify pemetrexed disodium. Hence, there was no reason to assume that the limitation was based on a conscious selection by the patentee.

The FCJ concluded that the Appeals Court erroneously denied an indirect patent infringement, and clarified that a Swiss-type claim (such as the main claim of the patent-in-suit) basically offers the same protection as an EPC2000 medical use claim according to Article 54 (5) of the European Patent Convention, i.e. purpose limited compound protection. Accordingly, the FCJ did not agree with the Appeals Court that an indirect infringement could already be ruled out, because the defendant never supplied pemetrexed disodium for the manufacture of the infusion solution. Rather, the fact that the pemetrexed ions are supplied in the form of pemetrexed dipotassium may be sufficient.

Finally, the FCJ concluded that it is not in the position to render a final decision. Rather, it is for the Appeals Court to assess whether the first and the second requirement of the doctrine of equivalence are fulfilled in the present case, i.e. whether the use of the attacked embodiment (pemetrexed dipotassium) produces the same technical effect as the claimed embodiment (pemetrexed disodium) and whether the allegedly infringing embodiment was obvious to the person skilled in the art. The FCJ points out that the UK courts denied the last requirement.

Furthermore, in the event that it denies direct infringement under the doctrine of equivalence, the Appeals Court has to assess whether Eli Lilly might be able to obtain an injunction based on indirect infringement. In this context, several issues have to be considered, e.g. whether the dissolution of the pemetrexed dipotassium in a sodium diluent creates a mixture that can be considered to be pemetrexed disodium in the sense of the patent claim, and whether this aspect is still relevant in view of the declaration of the defendant in the UK that it will market its pemetrexed product only with instructions to dilute it with dextrose/glucose solution.

This is a landmark decision which clarifies that the German doctrine of equivalence still has a much broader scope than the decision in Okklusionsvorrichtung seems to suggest. The FCJ makes clear that the latter decision rules out an equivalent patent infringement, except for in exceptional circumstances, i.e. if a conscious selection decision has obviously been made by the patentee.

The Pemetrexed decision also broadened the scope of protection for Swiss-type claims in Germany. Whereas previously in order to infringe Swiss-type claims it seemed necessary to manifestly arrange a substance for the protected medical use (“manufacture”), now following the FCJ's decision, it seems sufficient that the substance is eventually used for the protected medical use. Accordingly, indirect infringement of a Swiss-type claim is possible, if a neutral substance is supplied and it is obvious that the customer will use it for the still protected medical use without any prior manifest arrangement of the product for such a use.

Compare jurisdictions: Patents

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