Karapapa & McDonagh, Intellectual Property Law

Suggested Answers to the Questions in Chapter 18

1. Why is the definition of ‘making’ in patent infringement not as straightforward as it

The good answer will:

• Demonstrate knowledge of direct patent infringement under s.60 Patents Act 1977,
which refers to a number of different ways that an infringer can infringe, including by
‘making’. Note that although it might be thought the word ‘makes’ is a common term
and needs no further explanation, in fact this not the case - as noted by the UK
Supreme Court in Schütz v Werit.

• Discuss the fact that in Schütz the defendant supplied replacement plastic bottles to fit
the patented cages of the claimant intermediate bulk carriers — yet it was held not to
amount to infringement under s.60 because the bottles were a subsidiary part of the
patented item. Therefore, what amounts to ‘making’ does not have a precise meaning
— whether an activity amounts to ‘making’ is a matter of fact and degree.

• Conclude by reflecting on whether the ambiguity inherent in this term and its analysis
by the courts is likely to benefit the patentee or the alleged infringer.

© Karapapa & McDonagh 2019. All rights reserved.

Suggested Answers to the Questions in Chapter 18

2. Does the UKSC Actavis v Eli Lilly case present a useful clarification of the law on
equivalents or a needless complication?

The good answer will:

• Begin by discussing Actavis v Eli Lilly. This case concerned whether drugs
manufactured by Actavis infringed a European Patent owned by Eli Lilly. The case
began when Actavis sought declarations of non-infringement under s. 71 of the
Patents Act 1977 that its products did not infringe Eli Lilly’s patent. Eli Lilly counter-
claimed that Actavis’ products infringed their patent directly and indirectly.

• Relate the fact that Eli Lilly’s central argument was that Actavis’ products infringed
their patent, reasoning that the Actavis product—a pemetrexed salt (or the free acid)
with vitamin B12— represented the key essence of the invention within the claims of
the patent. Actavis argued that their acts were not infringing because the claims of
the patent were limited to a specific pemetrexed salt, i.e. the one named in the
patent: pemetrexed disodium. (Actavis’ drug contained different pemetrexed salts e.g.
the dipotassium salt.)

• Note that the UK Supreme Court held for Lilly, dismissing Actavis’ cross-appeal. The
reasoning of the UKSC is worth considering in detail. First, the SC had to construe the
meaning of the patent’s claims. The SC stated that ‘as a matter of ordinary language’
the claims only covered the disodium salt. Nonetheless, the SC stressed the need to
take into account the Protocol on the Interpretation of Art. 69 (as amended in EPC
2000).

• In light of the Protocol, the UKSC decided that it had a duty to take account of non-
literal infringement – in this case an infringing product that did not fall under the
scope of the claims as written but was nonetheless ‘equivalent’ to the invention
covered by the patent. The UKSC was satisfied that the Actavis products infringed the
Eli Lilly patent, holding that Actavis’ products achieved: (i) substantially the same
result in substantially the same way as the patented invention, and (ii) this would have
been obvious to the person skilled in the art at the priority date.

• Finally, conclude by noting that the UKSC held that in light of the Protocol the
interpretation of the claims is not the same task as assessing the scope of protection—
in the present case, this meant that although the patent’s claims were limited to the
disodium salt, this did not mean that the patentee did not intend other pemetrexed
salts to infringe. This moves the UK away from the purposive approach stated in Kirin-
Amgen, and towards the ‘doctrine of equivalents’. We do not know as yet the full
consequences of the ruling—there appears to be some confusion about the impact of

© Karapapa & McDonagh 2019. All rights reserved.

the decision on novelty, as shown by recent orbiter comments in the High Court case
of Mylan v Yeda—but on infringement UK patent law is now more in line with the
German and wider European approach. Here reference to academic commentary
(Fisher, Laddie, etc.) would be welcome.

© Karapapa & McDonagh 2019. All rights reserved.

Suggested Answers to the Questions in Chapter 18

3. What are the positives and negatives of the territorial scope of patent infringement in
European jurisdictions such as the UK? Will the proposed Unified Patent Court system
provide a better option for patentees?

The good answer will:

• Focus on the fact that although the (non-EU) European Patent Office grants patents
centrally, such patents do not have unitary effect and must be validated nationally,
which means that patentees must decide which European jurisdictions to protect their
inventions in. These validations often come at a price – indeed, in some countries this
can be quite costly for the patentee as the (required) translation of the patent into e.g.
Spanish or Italian can be expensive. For this reason, patent holders typically decide to
validate their patents strategically – thus, many European Patents do not cover the
entire EU: the majority are validated only in the major EU markets (Germany, France,
the UK, Italy, the Netherlands, etc.).

• Explain that there are further complexities inherent in the current system – although
the EPO has the final say on validity via its patent opposition service, it can take
several years to get to a final decision on validity. In the meantime, national courts in
the UK, Germany, France, etc. will often make decisions on validity of those patents as
part of national litigation. Furthermore, questions of patent infringement are
territorial, and thus national courts in the UK, Germany, France, etc. can make
decisions that contrast with one another. The end result is fragmentation of litigation
outcomes concerning the same essential patent, in different European jurisdictions.

• Discuss the fact that the EU has since 2012 been making preparations for reform of
the European patent system. Along with the new European patent with unitary effect
(‘UP’), the most important reform is the setting up of a new Unified Patent Court
(‘UPC’), common to participating EU member states. The UPC will have jurisdiction to
hear patent disputes and issue remedies to litigants that are binding within an area
covering almost the entire EU single market (Spain, Poland and Croatia are at present
not taking part). Refer to academic commentary (e.g. McDonagh) on topic.

• Conclude by noting that the ongoing Brexit process has put the entire package of
reforms in doubt – will the UK be able to participate, post-Brexit? An ongoing German
constitutional challenge could also derail the entire project. So for the moment, the
current, fragmented system, remains in place.

© Karapapa & McDonagh 2019. All rights reserved.