Showing posts with label validity. Show all posts
Showing posts with label validity. Show all posts

‘Redskins’ marks cancelled: offensive to Native Americans

Author: Mira T. Sundara Rajan (Professor of Intellectual Property Law, CREATe and Glasgow Law School and Honorary Member, Magdalen College, Oxford)

Blackhorse v Pro Football, Inc, TTAB Cancellation No 92046185, 18 June 2014, available at http://pub.bna.com/ptcj/TTABBlackhorseJune18.pdf

Journal of Intellectual Property Law & Practice (2014) doi: 10.1093/jiplp/jpu199

The US Patent & Trademark Office's Trademark Trial and Appeal Board (TTAB) cancelled six registrations of trade marks incorporating the word ‘Redskins’, used by the Washington Redskins football team. While the team is not barred from using the marks, it will be denied legal recourse under trade mark law in cases of infringement, depriving the marks of much of their commercial value.

Legal context The Lanham Act 15 USC s 1052(a) is responsible for the legal regulation of trade marks in the United States. Section 2(a) of the Act prohibits the registration of any word that is disparaging of ‘persons’, providing as follows:
No trademark by which the goods of the applicant may be distinguished from the goods of others shall be refused registration on the principal register on account of its nature unless it—

(a) Consists of or comprises immoral, deceptive, or scandalous matter; or matter which may disparage or falsely suggest a connection with persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute. …
Facts

A group of six Native American plaintiffs brought an action against the Washington Redskins football team, arguing that the use of the name ‘Redskins’ was disparaging to Native Americans, and that trade mark registrations held by the team should be cancelled. The marks registered by the team in relation to ‘professional football services’ included various presentations of the terms ‘Redskins’, ‘Washington Redskins’ and ‘Redskinettes’, sometimes in combination with a picture of a Native American man, seen in profile and wearing a traditional headdress. The plaintiffs were Native American individuals with no claim to an interest in the marks except their Native American ancestry.

The Redskins case considered the validity of marks registered between 1967 and 1990. Its history is properly traced to 10 September 1992, when a case on this issue was first initiated by Suzan Harjo and six other Native Americans, who filed a petition seeking the cancellation of the marks (Pro-Football, Inc v Harjo, 415 F 3d 44 (DC Cir 2005)). After seven years of litigation, the TTAB cancelled the registrations. This decision was appealed, and eventually dismissed, on the grounds of laches: the Native American plaintiffs, the court said, had waited too long to bring the action. An issue regarding the evidence presented in the case also arose, with a suggestion that it might be insufficient to show that the term ‘Redskins’ was derogatory; but no ruling was made on the merits, and it never received a response (TTAB decision, pp. 4–6, ‘Prior Litigation’). Harjo was controversial and, in the case before it, the TTAB had emphasized that laches should not apply to claims involving public interest issues. It also allowed the plaintiffs to resubmit the evidence first put forward in Harjo in support of their claim.

Analysis

The TTAB's examination of the case was closely tied to the earlier disposal of Harjo's case. The Board noted the continuity between the earlier litigation and the present case, and, in the interest of efficiency, it allowed the re-submission of the ‘voluminous’ documentation from the previous case as evidence in the current dispute. Indeed, the majority effectively attempted to correct what it perceived as errors in the Harjo decision. In contrast, the lone dissenting voice on the Board argued that the evidence amounted to ‘a database dump’, and that it was insufficient to establish that the term ‘Redskins’ was disparaging to Native Americans at the relevant time when the registrations were made.

In determining the validity of the marks using the Redskins name, the majority outlined a two-step analysis:

(i) What was the meaning of the term ‘Redskins’?

(ii) Was that term disparaging to Native Americans?

In response to the first issue, the Board was able to demonstrate, with ease, that the term Redskins was used by the football team to designate Native Americans. In doing so, it was sufficient to look at the team's own practice surrounding the name. The team not only used the name ‘Redskins’, but it also had an associated image that often appeared with the word—a picture of a Native American man wearing traditional, feathered headgear. The team's cheerleaders, called the ‘Redskinettes’, had also appeared in Native American costumes during games. On one sample occasion, their pictures appeared with the caption ‘Dancing Indians’, and the notation, ‘Here are the Redskinettes all decked out in their Indian garb and carrying Burgundy and Gold pom-poms’. Press guides for the team displayed Native American imagery on their covers. Accordingly, there could be no doubt that the name represented anything else.

In dealing with the more complex issue of whether the term was disparaging, the Board attempted to determine not only whether the term itself was at fault but also how the use of the term by the team might affect its derogatory character. It pointed out that the character of the term could be altered by the use, which could either infuse a derogatory flavour into a neutral term, or neutralize an offensive term. It concluded that the use of the term did not have an impact on its objective meaning—and, in particular, that the team's ‘honorable intent’ or otherwise non-derogatory use of the term—was essentially irrelevant to the issue facing the Board.

The Board then examined what exactly the character of the term ‘Redskins’ might be. In this regard, it was confronted with substantial evidence on both sides, as each party, in typical style, tendered its own expert witness on the nature of the word. The experts traced the evolution of ‘Redskins’ through the decades of the 20th century, examining dictionary definitions of the term and whether it was designated in dictionaries as a ‘disparaging’ or ‘offensive’ word, as opposed to a standard one. Predictably, some dictionaries identified the term as offensive, while others did not. The experts argued about the significance of these designations or omissions, in some cases pointing out the political pressures operating on the compilers of dictionaries. But the Board pointed out that much of the analysis was ‘not from the viewpoint of Native Americans’ which, in its view, was what really mattered. This simple remark represents a crucial insight from a Western legal perspective—subtle, but seismic nevertheless—in the overt admission that the point of view that matters may be one that is inherently difficult for both court and plaintiff to grasp, representing a non-Western worldview. The Board then considered the use of the term in different media, drawing an interesting inference from the fact that the term ‘Redskins’ was generally used, at times disparagingly, to refer to a group of people, but rarely if at all to an individual.

The Board considered the position of the National Congress of American Indians (NCAI), which had adopted a resolution in favor of the cancellation of the marks back in 1993. It also accepted evidence in the form of nineteen letters from Native Americans across the United States, which complained of the derogatory nature of the team's name.

The team was also able to offer evidence from Native American groups that the term ‘Redskins’ was not derogatory. A number of tribal councils from the states of Oklahoma, Washington and California had all submitted letters in the early 1990s, affirming that they did not find the use of the Redskins name by the Washington team to be offensive. Chief Taylor of the Eastern Band of Cherokee Indians in North Carolina wrote that the use of the Redskins name by a school in Naperville, Illinois was ‘a great honor for all Native Americans’.

In the end, the Board identified the key question, crucially, as whether the term disparaged ‘a substantial composite, which need not be a majority, of Native Americans at the times of the registrations’. In this regard, the majority of the Board considered the position of the NCAI to be determinative; in its view, evidence showed that it was the largest and most established body representing Native Americans in the United States and, as such, its position had to be accorded the value that was its due. The dissent, however, disagreed strongly with this approach, calling efforts to include evidence about NCAI membership ‘gyrations’: There was no order or structure to petitioners' evidence that told a compelling story or presented a coherent case. One need look no further than gyrations the majority employed to establish membership of the National Council of American Indians. It is astounding that the petitioners did not submit any evidence regarding the Native American population during the relevant time frame, nor did they introduce any evidence or argument as to what comprises a substantial composite of that population thereby leaving it to the majority to make petitioners' case have some semblance of meaning (p. 84).

Practical significance

The ruling of the Board effectively accepts the idea that the possibility of offence to some Native Americans is sufficient reason to cancel the registration of the Redskins' trade marks. The objections of the minority are well reasoned, but the strength of the majority's viewpoint lies in its ultimately credible suggestion that the standard of proof required in a case such as this should be somewhat lenient. Arguably, where the use of potentially derogatory racial epithets is concerned, this approach is appropriate enough. The evidence offered on both sides shows the potential absurdity of trying to establish the offensiveness of a racially-motivated term—in this case, by looking at the history of its treatment in dictionaries compiled by non-Natives—through evidence offered by non-Native linguistic experts about how non-Natives might perceive the term. The search for certainty may lead us from indeterminacy to absurdity.

From a purely legal standpoint, the approach of the Board to this conflict is an interesting one. Both majority and minority show a striking level of sensitivity towards non-mainstream points of view when it comes to the recognition and ownership of intellectual property. Where the claims of aboriginal peoples around the world are concerned, courts in countries like the United States, Canada and Australia have had the greatest difficulty accommodating the possibility of an alternate worldview (see eg the well-known Australian case of Yumbulul v Reserve Bank of Australia [1991] 21 IPR 481). No one can accuse the Board of failing to stretch its imagination in that direction. It did so in spite of an evidently clumsy and disorganized approach to the presentation of the case, perhaps with the greater goal of recognizing a principle that was, in its view, in need of support. In this sense, notwithstanding the imperfect fact scenario, the case represents a benchmark for a new understanding of the relationship between intellectual property and traditional perspectives and, indeed, traditional knowledge.

The Board's decision does not mean that the Redskins team needs to change its name; what it does is limit, if not destroy, the ability of the Redskins to fight the production of counterfeit merchandising or other infringements of its marks. But this begs the question, why wouldn′t the Redskins want to consider changing their name? As a matter of public relations, the Redskins name seems like more of a liability than an asset: not only has it cost the team money to defend it, but it has also led to years of controversy, ugly accusations, and animosity from at least some interested parties. On the other hand, a change of name, and a corresponding change of strategy, could open the doors wide to a new opportunity. As Jeremy Phillips notes,
‘[h]eritage is history, but it is not the same as goodwill and it cannot of itself create or preserve conditions of profitability for a brand’. 
The gesture could generate immense positive publicity and widespread goodwill by representing the team's broader support for non-discrimination and human rights.

A win–win situation? Apparently, the Redskins don′t think so. Their owner has filed an appeal, arguing that the name is a ‘badge of honor’ that ‘celebrates Native Americans’.

Disk brakes, hockey sticks and added matter

Author: Paul England (Taylor Wessing LLP)

AP Racing Ltd v Alcon Components [2014] EWCA Civ 40, Court of Appeal, England and Wales, 28 January 2014

Journal of Intellectual Property Law & Practice (2014) doi: 10.1093/jiplp/jpu052, first published online: April 25, 2014

The Court of Appeal has overturned the first instance decision to hold that a disk brake caliper patent does not disclose added matter.

Legal context

The rule on added matter, as summarized by the Court of Appeal in AP Racing Ltd v Alcon Components, is ‘the rule that a patent application or patent may not be amended in such a way that it contains subject matter which extends beyond the content of the application as filed. If it has been so amended, and the added matter is not or cannot be removed, the patent will be invalid.’ A particular issue when assessing whether there has been added matter in a granted patent specification, is the relationship between the breadth of the granted claim, and what is disclosed in both the specification of the granted patent and its corresponding application.

Facts

In AP Racing, the patent application and granted patent in question are for disk brake calipers used in motor vehicles, and particularly the asymmetrical peripheral stiffening bands (PSBs) associated with the caliper body embodied in the application as having a ‘J’ or hockey stick shape. The granted patent contains materially the same disclosure as the application, but the following feature of claim 1 of the granted patent is not disclosed in the application ‘in which each of the stiffening bands has a profile that is asymmetric about a lateral axis of the body when viewed in plan’.

This feature of the claim gave rise to two points of dispute:

* Is there a clear and ambiguous disclosure in the application of PSBs asymmetric about the lateral axis of the caliper body?

* Nonetheless, if only a class of generally hockey stick shaped PSBs is disclosed in the application, does the claimed feature contain added matter?

Analysis

On issue 1, the Court of Appeal has held that, although not expressly stated in the application, it would be abundantly clear to the skilled reader that the PSBs were, individually, asymmetric about a lateral axis of the caliper body, and the presence of the PSBs had the effect of giving the overall shape of the caliper body an asymmetric appearance.

Answering issue 2, the Court of Appeal says, depends on whether it is legitimate to add to a claim features that describe the invention in more general terms than a specific embodiment. Summarizing authorities from the English courts and the European Patent Office's Technical Boards of Appeal, the Court of Appeal concludes that it is clear that the law ‘does not prohibit the addition of claim features which state in more general terms that which is described in the specification’.

In this case, the application would be understood by the skilled person as disclosing that the asymmetrical design of the PSBs is significant in imparting stiffness to the caliper, and that the hockey-stick shaped PSBs are ‘necessarily asymmetrical’. It must then be asked whether any disclosure has been added to this in the granted specification. The description of the PSBs in claim 1 as ‘asymmetric’ has to be read as part of that disclosure. From this, the skilled person would understand that the claim covers asymmetric PSBs generally. The skilled person would also understand that the PSBs are exemplified by the hockey-stick shapes described in the specific embodiments. The skilled person would not, therefore, learn any new information about the invention from the granted patent.

Practical significance

The Court of Appeal appears to say in A P Racing that the skilled person would understand the breadth of the claim in question to be supported by a coextensively broad disclosure in the application. Although the Court of Appeal does not say so, the case invites comparison with sufficiency cases in which the principle of an inventive concept derived from the specification can have a general application across a claim.

Malaria combination patent invalidated for obviousness

Author: Keo Shaw (McDermott Will & Emery UK LLP)

Glenmark Generics (Europe) Limited & others v The Wellcome Foundation Limited & Glaxo Group Ltd [2013] EWHC 148 (Pat), Patents Court, England and Wales, 7 February 2013

Journal of Intellectual Property Law & Practice (2013) doi: 10.1093/jiplp/jpt101, first published online: June 25, 2013

The Patents Court, England and Wales, has held that a patent for the 5:2 ratio combination of two anti-malarial drugs (atovaquone and proguanil) was obvious, based on prior art that disclosed the two drugs in combination, but not at the claimed ratio.

Legal context

The claimants, Glenmark and Mylan, sought revocation of European Patent (UK) No 0 670 719, protecting the invention of a combination anti-malarial drug, in order to clear the way for the launch of their own generic versions of the drug. The defendants were both part of the GlaxoSmithKline group of companies. The Wellcome Foundation Limited was the registered proprietor of the patent, and Glaxo Group Ltd was the patent's beneficial owner and exclusive licensee.

Facts

The patent related to an anti-malarial medication with a priority date of 26 November 1992, comprising a combination of atovaquone and proguanil in the ratio 5:2. The only ground on which the claimants contended that the patent was invalid was obviousness in relation to two pieces of prior art: a presentation by Dr David Hutchinson, one of inventors named in the patent, and an abstract from a plenary lecture by Dr A T Hudson, who also worked for the defendants.

The defendants sold a pharmaceutical composition consisting of a 5:2 combination of atovaquone and proguanil under the trade mark Malarone. The claimants wanted to launch a generic version of Malarone, resulting in the defendants counterclaiming against both for infringement. There was no dispute that the proposed products would infringe the patent if it was valid. Notably, the defendants made an unconditional application to amend the patent by deleting Claim 1 (a claim to a method of treatment using a combination of atovaquone and proguanil in any ratio), which was granted.

Analysis

There were certain areas of dispute as to what fell within the common general knowledge, the most interesting of which related to combinations. One of the claimants' experts, Professor Molyneux, gave evidence as to the benefit of additive combinations of drugs where there is some resistance to one or both drugs and an absence of any synergy, arguing that it was rational to use an additive combination in the appropriate circumstances. Arnold J agreed with this, commenting that he found a combination that was shown to be significantly synergistic in vitro (experimentation ‘within the glass’, ie in a test tube or petri dish) would encourage the skilled team to go forward to in vivo (experimentation using a whole, living organism) trials.

Arnold J continued by setting out the law on obviousness by reference to consideration of the ‘Windsurfing’ test in Pozzoli v BDMA SA [2007] EWCA Civ 588 and in MedImmune Ltd v Novartis Pharmaceuticals Ltd [2012] EWCA Civ 1234.

Arnold J then applied the test to the patent's claims. He found that there was no technical significance in the 5:2 ratio set out in the claims. The correct question therefore was whether or not it would be obvious to proceed with the development of a medication consisting of atovaquone and proguanil in combination. As the prior art disclosed the combination for the treatment of malaria and set out promising clinical trials results, the defendants needed to show that the skilled team would not proceed with the development of the combination of atovaquone and proguanil in order to be successful. Arnold J rejected the defendants' arguments that critical comments made about the findings would have deterred the team of skilled persons from investigating the combination further. He also rejected arguments claiming that the invention was not obvious because at the time few pharmaceutical companies supported such investigation on account of a perception of limited profit in anti-malarial drugs; he stated that commercial factors are irrelevant in determining obviousness. Arnold J concluded that, against the backdrop of a pressing need for new anti-malarial drugs, the skilled team would have reached the conclusion that the combination merited further investigation and that this would, in turn, have led to a formulation based on suitable proportions of the two drugs. As such, the invention was obvious.

Practical significance

This judgment is another adverse decision for combination patents at the hand of the courts of England and Wales and, once again, highlights the dangers of inventors publicly disclosing the findings of their research before a related patent application has been filed. While this is not a welcome decision for pharmaceutical combination patent owners, especially where their combination product has no other patent protection, the issue of a combination patent where the patent discloses a synergy that was not disclosed in any prior art remains to be tackled by the courts.

Enantiomers are obvious even though they have unpredictable properties

Author: Suleman Ali (Holly IP, London)

Novartis AG v Generics (UK) Limited (t/a Mylan) [2012] EWCA Civ 1623, Court of Appeal for England and Wales, 12 December 2012

Journal of Intellectual Property Law & Practice (2013), doi: 10.1093/jiplp/jpt049, first published online: April 14, 2013

The Court of Appeal has upheld the finding of the High Court that an enantiomer and its use in therapy were obvious from disclosure of the racemate mixture, given that at the priority date it was standard practice in the art to resolve racemate mixtures and there was no difficulty in doing so.

Legal context

This case concerns inventive step of an enantiomer which has been resolved from a racemate mixture. Previously in H Lundbeck A/S v Generics (UK) Ltd [2008] EWCA Civ 311 and Generics (UK) Ltd v Daiichi Pharmaceutical [2009] EWCA Civ 646 the courts decided that enantiomers which had been resolved from racemate mixtures were inventive, essentially based on the difficulty of obtaining the relevant enantiomer. However, in the present case there was no difficulty in resolving the enantiomer at the priority date, and so the previous cases on enantiomers were not considered relevant. Instead the court assessed inventive step based on the criteria developed in case law for assessing inventive step of a new therapeutic molecule.

Inventive step in chemical and pharmaceutical cases will often depend on the route used to identify and characterize the relevant substance. It is also dependent on the properties the substance is found to have, though arguably the UK approach places less emphasis on this than the European Patent Office problem–solution approach to inventive step. The courts have recognized the difficulty in deriving a specific test for inventive step where the invention concerns substances that have been identified based on a series of tests in a research program, especially where the results of the tests are unpredictable. When faced with inventions where a specific substance is provided for a given use, the courts have tended to assess whether it was ‘obvious to try’ that specific substance, with ‘expectation of success’ sometimes also contributing to the analysis. The present state of the case law is expressed in the following passage from Generics (IK) Ltd v H Lundbeck A/S [2007] EWHC 1040 (Pat) which is quoted in the present judgment:
The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort in pursuing them and the expectation of success.
Facts

This is an appeal from a High Court decision in which Novartis's SPC certificate SPC/GB98/038 and the basis patent, UK Patent No 2,203,040, were found to be invalid due to lack of inventive step. The claims of the patent cover rivastigmine and its use in the treatment of Alzheimer's disease. Rivastigmine is one of the enantiomers of a compound that occurs in chiral forms, ie the compound has two distinct forms (called ‘enantiomers’) which are mirror images of each other. When such chiral compounds are first synthesized it is usually as a mixture of the two mirror forms and such mixtures are called ‘racemates’. At the priority date the racemate form of the compound was known and its use to treat Alzheimer's had been suggested. Thus the contribution made by the invention could on the face of it be seen simply as resolving the racemate to separate the chiral forms before using one of them, rivastigmine, in therapy. However, Novartis argued that selection of the racemate compound from the prior art was also an important part of the contribution.

At the priority date (4 March 1987) the resolving of racemic mixtures into enantiomers was common practice in the art and in the present case there was no difficulty in doing so. Novartis argued that the disclosure of the racemate in the prior art was in the context of a very early stage in the research, and at that stage the skilled person would not have chosen to resolve the racemate into enantiomers. Instead they would have investigated other compounds with similar structures and so it was not obvious to choose this particular racemate. Novartis further argued that extensive testing of the compound would still need to be done to determine whether it would be suitable for therapy, and there would not have been a fair expectation of the compound surviving such testing. In terms of the enantiomer itself, Novartis argued that the resolution of the racemate could not be deemed to be obvious because the properties of the enantiomers could not be predicted.

Analysis

In the judgment, Justice Kitchin discusses the relevant case law on how to approach inventive step for a therapeutic substance, and in particular discusses whether to apply a simple ‘was it obvious to try?’ approach to the steps of choosing the racemate compound and then choosing to resolve it into enantiomers. He also discusses how to consider the ‘degree of expectation of success’ that is required, but in line with the case law decides to reject using any particular test saying that ‘obvious to try’ and ‘fair expectation of success’ are not the same as the statutory question of whether the invention was obvious. He thus decides that it is more appropriate to judge obviousness based on the facts. However, his subsequent analysis of inventive step essentially amounts to an ‘obvious to try’ approach, at least in as far as selection of the racemate compound is concerned.

When looking at whether the skilled person would focus on the racemate compound, Mr Justice Kitchin's position was that the possibility of investigating other compounds did not preclude further testing of the racemate compound, which was presented as promising candidate in the prior art. When assessing the decision to resolve the racemate into enantiomers, he acknowledged that the properties of rivastigmine were not predictable, but that in itself did not make it inventive since the ‘experimentation is driven by rational technical considerations’. Further, there were good reasons for resolving the racemate into enantiomers since there was the possibility that one of them may have lower toxicity.

Novartis also ran the argument that the High Court had chosen the wrong technical effect when considering the problem–solution approach. In its view it was wrong to see the technical effect as what ‘one would expect from resolution of a chiral compound’. Instead it was use of rivastigmine for treatment of Alzheimer's disease. Mr Justice Kitchin dealt with this very briefly, essentially believing that this point added little to the previous arguments.

Practical significance

Given the facts of the case it is difficult to see how the court could have come to any other conclusion. However, taking the approach of deciding obviousness on the basis of ‘the facts of each case’ will inevitably lead to more uncertainty. In particular it is not clear when ‘fair expectation of success’ should form part of the assessment of inventive step, and for many chemical and pharmaceutical cases that will be the determining factor. Mr Justice Kitchin did not explain in his judgment why he did not consider ‘expectation of success’ when assessing choice of the racemate compound.

Clearly the judgment will have an impact on inventions concerning resolution of enantiomers, making it less likely that mere resolution of a racemate into enantiomers will be considered inventive if there are no difficulties in doing so. In particular it seems that inventive step arguments based on the advantageous properties of the resultant enantiomers will not succeed if the advantages are of the type that enantiomers could be expected to have, even though which advantage a specific enantiomer would have could not be predicted.

British court finds rivastigmine patent obvious

Author: Christopher Hayes (Atlantic Chambers, Liverpool)

Generics UK Limited (t/a Mylan) v Novartis [2011] EWHC 2403 (Pat), (Floyd J), 30 September 2011

Journal of Intellectual Property Law & Practice (2011), doi: 10.1093/jiplp/jpr191, first published online: December 6, 2011

A court has invalidated Novartis' patent and SPC for rivastigmine as being obvious in light of prior art.

Legal context

The analysis of the inventive step of a patent requires a multifactorial assessment of technical subject area. The British courts and the EPO use slightly different frameworks to assess the inventive step. In this case, the Patents Court for England and Wales has stated that the same conclusion would be used using the EPO approach. The current case looks at the validity of a pharmaceutical patent, for the enantiomeric drug rivastigmine.

Facts

Rivastigmine is sold under the brand name ‘Exelon’, for the treatment of Alzheimer's disease (AD). Rivastigmine is an enantiomer: it contains a carbon atom which forms chemical bonds with four different chemical groups. Such enantiomers can exist in a right-handed or left-handed form. Often the first time such molecules are synthesized, the product will contain a mix of equal amounts of both enantiomers. Such mixtures containing an equal amount of both enantiomers are called racemates. The racemic mixtures can then be resolved into their individual enantiomers, for subsequent testing of their pharmacological properties.

Novartis held a patent for rivastigmine, UK 2,203,040 (the '040 patent) which had a priority date of 4 March 1987, which expired on 29 February 2008. The '040 had the benefit of supplementary protection certificate (SPC) which extended the period of protection until 30 July 2012. Generics UK commenced proceedings for the revocation of the '040 and the SPC on 3 March 2011. Given the proximity of the expiration date of the SPC, this matter proceeded to trial very quickly. In a little over six months, the matter was heard at trial on 5–7 September 2011.

The only attack brought forward by Generics UK was that the '040 patent was invalid for lack of inventive step. In consequence, the SPC for rivastigmine would also be invalid for failing to be covered by a basic patent. The obviousness case was based on the state of the current general knowledge (CGK) at the priority date and two publications.

Turning to the prior art publications, the first was a patent application by Weinstock (EPA 193,926) which disclosed the racemic mixture. The second publication was also by Weinstock from 1986 and was entitled ‘Pharmacological activity of anticholinesterases of potential use in the treatment of Alzheimer's disease’.

Floyd J found that, at the priority date, the clinical features of AD were known. Acetylcholine was a known neurotransmitter, and it was understood how acetylcholine was synthesized and acted on synaptic receptors. It was also known that there was a link between the pathology seen in AD and the acetylcholine system and it was postulated that the enhancement of the acetylcholine signalling system might be of therapeutic benefit in AD disease. This hypothesis was supported by some reported clinical data using the drugs physostigmine and tacrine.

Physostigmine was known to counteract the effect of overdoses of anticholinergic drugs and had also been shown some efficacy in AD. Physostigmine had severe limitations as a potential treatment; it caused intolerable side effects of therapeutic doses (or doses close to therapeutic) and has duration of action of typically 30 minutes. Although there were other hypotheses, the cholinergic was regarded as the most promising to yield potential drugs to treat AD.

Analysis

For the purposes of the obviousness analysis, it did not matter whether one started with the Weinstock publication or with the application. The necessary steps were to start with choosing the racemate, resolving the racemate into its constituent enantiomers, and then finally preparing a medicinal compound containing rivastigmine for the treatment of AD.

The Weinstock articles showed that the racemate was the most promising candidate disclosed from the other compounds taught to choose for further research. Therefore it would be obvious to choose the racemate to start from.

It was further agreed that this racemate could be easily separated and that the skilled team would consider resolving a racemate into its enantiomers at the priority date. The evidence was that, since the advantages of an enantiomer cannot be predicted in advance, the skilled team would resolve the racemate to test the properties of the enantiomers. The judge therefore concluded that there was nothing inventive in deciding to resolve the racemate into the enantiomers, although it was noted that the absence of evidence from Novartis on the invention history assisted Generics UK in this regard. Once rivastigmine has been resolved, Floyd J considered it would be obvious to formulate it into a pharmaceutical composition.

Floyd J concluded that using rivastigmine for the treatment of AD was conceptually obvious from the Weinstock articles. It would also be obvious to resolve the enantiomers, and the chemistry involved in the resolution would be found to be unproblematic to the skilled team. Formulating a pharmaceutical composition of rivastigmine would be entirely obvious.

Although Floyd J applied the Windsurfing formulation to determine whether the '040 contained an inventive step, he said that his result was consistent with the problem–solution approach employed by the EPO. The problem was how to achieve the desired effect from an enantiomer starting with the racemate taught by the Weinstock articles, and the solution could be found in the common general knowledge.

In conclusion, the '040 patent was obvious and as a result the rivastigmine SPC was also invalid.

Practical significance

In the two most recent UK cases involving the obviousness of pharmaceutical enantiomer patents, Lundbeck (House of Lords) and Daiichi (Court of Appeal), the patents were held to be inventive, although the priority dates were later than in these cases.

Floyd J pointed out that an obviousness analysis will always turn on the facts of the individual case. In this case, the evidence was that the chemistry involved in the resolution of the enantiomers was straightforward and posed no problems to the skilled team to produce the enantiomers from the racemate, whereas, in Lundbeck and Daiichi, the chemistry involved in resolving the individual enantiomers from their respective racemates was not straightforward.

Although the judge reached a different conclusion regarding the validity of the rivastigmine enantiomer patent when compared with the enantiomer patents at issue in Lundbeck and Daiichi, he distinguished the cases based on their respective facts. It appears that a key difference was that the resolution of the enantiomer in this case did not involve any invention. Indeed, the resolution of the racemates into the single enantiomers in Lundbeck and Daiichi required invention.

Novartis's case on obviousness was not aided by the fact that it did not lead evidence on the history of its invention. Although the patentee is not obliged to bring forward such evidence, this case illustrates the importance of this type of evidence, particularly where validity is at stake. This case shows that patentees should be reluctant not to lead evidence of their invention story when resisting an obviousness attack.