“A Declaration pursuant toCPR 40.20 and/or the inherent jurisdiction of the Court that importing into the United Kingdom and offering to sell and dispose of, and to sell and dispose of, and to keep for such sale or disposal in the United Kingdom, the Claimant's products containing their biosimilar monoclonal antibody to the antibody adalimumab (Humira) for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every other week by subcutaneous injection for: (a) rheumatoid arthritis would, in so far as the dosing regimen is concerned, have been obvious and/or anticipated at the date from which EP (UK) 1 406 656 was entitled to claim priority, whether or not co-administered with methotrexate (as would administration of 40 mg by subcutaneous injection every week in the case of monotherapy in rheumatoid arthritis); and (b) psoriasis and/or psoriatic arthritis would, in so far as the dosing regimen is concerned, have been obvious and/or anticipated at18 July 2003 (as would administration of 40 mg by subcutaneous injection every week) (whether as an initial or continuing dosing regimen).”
"Preliminary results of early clinical trials with the fully human anti-TNFα monoclonal antibody D2E7" by Joachim Kempeni published in Annals of Rheumatic Diseases (Ann. Rheum. Dis., 1999, 58 (Suppl 1), I70-I72) ("
“A person who has duly filed in or for any State party to the Paris Convention for the Protection of Industrial Property, an application for a patent or the registration of a utility model or for a utility certificate or for an inventor’s certificate, or his successors in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application.”
“Any person who has duly filed an application for a patent, or for the registration of a utility model, or of an industrial design, or of a trademark, in one of the countries of the Union, or his successor in title, shall enjoy, for the purpose of filing in the other countries, a right of priority during the periods hereinafter fixed.”
“93 So art.4 [of the Paris Convention] specifies a person is to enjoy a right of priority if he has filed a relevant application for a patent or if he is the successor in title to such a person. Further, any person wishing to take advantage of the priority of such a filing must be required to make an appropriate declaration. … 95 In my judgment the effect of art.4 of the Paris Convention and s.5 of the Act is clear. A person who files a patent application for an invention is afforded the privilege of claiming priority only if he himself filed the earlier application from which priority is claimed or if he is the successor in title to the person who filed that earlier application. If he is neither the person who filed the earlier application nor his successor in title then he is denied the privilege. Moreover, his position is not improved if he subsequently acquires title to the invention. It remains the case that he was not entitled to the privilege when he filed the later application and made his claim. Any other interpretation would introduce uncertainty and the risk of unfairness to third parties. In reaching this conclusion I derive a measure of comfort from the fact that the Board of Appeal of the EPO has adopted the same approach to the interpretation of art.87 EPC in two cases: J-0019/87 and T-0062/05.”
“69 I would add that, even if it was not effective to convey the legal title to the invention, para.3 of the Confidentiality Agreement was plainly effective to transfer the entire beneficial interest in the invention, including the right to file patent applications in respect of it, from Mr Lina to KC Inc. KC Inc would have been entitled to demand that Mr Lina convey the bare legal title to the invention to itself at any time, and to compel Mr Lina to do so if he failed or refused to do it. If necessary, I would hold that that was sufficient to make KC Inc Mr Lina’s "successor in title" for the purposes of a claim to priority under art.87(1) of the EPC and art.4(A)(1) of the Paris Convention even if KC Inc had not acquired the bare legal title at the relevant date. … 71... Article 4(A) of the Paris Convention and art.87(1) of the EPC are provisions in international treaties whose operation cannot depend upon the distinction drawn by English law, but not most other laws, between legal and equitable title. When determining whether a person is a "successor in title" for the purposes of the provisions, it must be the substantive rights of that person, and not his compliance with legal formalities, that matter.”
“84 Counsel for S & N submitted that it did not matter whether Mediscus was a co-applicant only for a GB national patent or also for a European patent (UK) since at that stage it was not yet known which of the regional/national phases would be pursued by the applicants. He argued that KC Inc and Mediscus were co-applicants for the PCT Application, and accordingly priority could only be validly claimed in respect of the PCT Application if both co-applicants had the right to claim priority under Article 4(A)(1) of the Paris Convention. 85 I do not accept that submission. What matters for the purposes of this litigation is whether priority has been validly claimed for the Patents, both of which are European patents (UK), in accordance with Article 87(1) EPC. The PCT is simply a mechanism for the central filing of multiple patent applications. Once an international patent application enters the regional/national phase, it is treated as a regular regional or national application. Accordingly, the only part of the PCT Application that is material to the entitlement of the Patents to priority is the part that relates to the European patent. Provided that priority has been validly claimed in respect of the European patent, it does not matter whether priority was validly claimed in respect of the United Kingdom national patent, if any.”
“I, the undersigned employee, in consideration of my employment by BASF Corporation or any of its affiliates (“BASF”), and of the salary and wages paid for my services in the course of my employment, agree as follows”
“6. All inventions, improvements, conceptions, or developments relating to the business, affairs, or fields of interest of BASF which I conceive, make, develop, or complete, either solely or jointly with others, during my employment shall be the property of BASF whether patented or not. Upon request of BASF I will execute such (a) patent applications (including divisional, continuing, reissue and extension applications) desired by BASF, and (b) all other documents deemed necessary by BASF to transfer to BASF, its nominees or assigns, all my right, title, and interest in and to such inventions, improvements, conceptions or developments and patent applications and any patents granted thereon including extensions, renewals, and reissues thereof. I will testify in legal proceedings, sign papers, make all lawful oaths and otherwise assist BASF to perfect, maintain, and enforce the same in any country.”
“33. Accordingly, an equitable interest in a patent, patent application or any interest there is freely assignable. There is no requirement in US law that an agreement assigning equitable title to any interest in a US patent or patent application must be in writing, or must satisfy any other specific formalities. 34. The United States Supreme Court’s decision in Standard Parts Co. v. Peck, 264 U.S. 52 (1924) strongly supports treating this type of equitable title as assignable “by conduct,” such as a general transfer of interests in a business. On the facts in Standard Parts, an employee working for a first company made an invention and obtained a patent on it. Later, the former employee sued a second company that had acquired the entire assets of the first company. The second company successfully claimed equitable title, which defeated the former employee's suit based on the patent. The Court made no reference to an express written agreement transferring rights from the inventor’s employer to the employer’s successor (who was a party to an infringement suit and gained an order requiring transfer of legal title to the patent).”
“Of course, my view is that if there was the policy equals an implied in fact contract, that will be sufficient. I tried to indicate earlier in my unfortunately lecture-based answer that I look at the equitable title as being linked into the court of equities [sic] power to shape the remedy. The equity is already involved because we hypothetically assume the inventors have refused to transfer legal title. We have equity involved. The question is, "What would be the remedy to whom they order the employee to transfer?" I think even absent under the facts and circumstances here -- I will give you up-front my opinion. Even absent what you might call an agreement, the facts and circumstances indicate that KPC designated or nominated Knoll, the German company, and these facts all support the view that there was a nomination, whether or not there was an agreement, between KPC and Knoll.”
“WHEREAS in furtherance of its tax planning and other strategies, Abbott determined to transfer to Abbott Biotech Bermuda all US intellectual property rights related to D2E7 Antibody including all US patent rights, and to transfer to Abbott Labs Bermuda all non-US intellectual property rights related to D2E7 including all non-US patent rights and…executed [the APAs] which provided for the assignment to, respectively, Abbott Biotech Bermuda and Abbott Labs Bermuda, of certain patents and patent applications listed on Schedules to the respective agreements but through inadvertence failed to include the ‘961 Provisional Application on such Schedule and failed to include KPC as a seller;”
“(1) Any employee making a service invention shall be under a duty to report the invention to his employer immediately in a special written notice indicating that said writing constitutes the report of an invention. Where two or more employees have contributed to making the invention, a joint notice may be filed. The employer shall inform his employee without delay and in writing of the date the report was received.”
“(1) An employer may claim a service invention by means of an unlimited or a limited claim. (2) Such claim shall be made in a written statement, addressed to the employee. It shall be made as soon as possible, and no later than four months from the receipt of a proper report (Section 5(2) and (3)).”
“Sellers desire to sell the rights and assets related to a recombinant fully human therapeutic antibody (hereinafter called D2E7) …”
“Subject to the terms and conditions of this Agreement Sellers hereby agree to sell and deliver to Purchaser at the Closing (as hereinafter defined) all of their interest in the assets relating to D2E7 listed on Schedule 1 and Schedule 2 (the “D2E7 assets”). Purchaser hereby agrees to purchase and accept at the Closing the D2E7 assets.”
“A. Abbott Biotechnology has acquired from [Abbott GmbH & Co KG]… all rights in the United States to a pharmaceutical compound commonly referred to as D2E7 (the "Compound") B. [Abbott Laboratories (Bermuda) Ltd] has acquired from [Abbott GmbH & Co KG] all rights to the Compound in territories outside the United States.” territories outside the United States.”
“… the legal effect of a claim to the invention (s. 6, 7 ArbEG old version) only relates to the right in the invention, and the assignment of property rights themselves is not covered by it. The transfer of property rights requires a separate act of assignment, as Prof. Leistner correctly notes (loc. cit. 6.12 of his report). This assignment is made according to the provisions of s. 298 ff. of the Civil Code (“BGB”) which concern the assignment of claims. The same applies to the right of priority which arises due to a property right application and which accrues to the applicant. The right of priority itself is independent of the substantive-law entitlement of the applicant, and can be assigned informally (and also implicitly), independent of the property right. The Federal Supreme Court explicitly stated this in its Fahrzeugscheibe decision of16 April 2013 – X ZR 49/12 and this is undisputed.”
“When I am advising people about developing a drug, what we are trying to do in a chronic disease like rheumatoid arthritis is we are trying to get a dose that will be effective but is not necessarily the maximum dose. It will not necessarily be effective in all patients. The idea is to get an effective dose that is going to be used to begin therapy and of course if there is failure of therapy, you then have the option of increasing the dose. If you give everyone the maximum dose that you have got side effects or adverse events, you cannot cut back in the same way. What you need to do is start low and work up, and you have that option. That is what you are trying to do; you are trying to get an effective dose that will look at the majority of patients, but will not be effective in all patients.”
“It follows that, even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge.”
“There is a point P here I have drawn of interest, which I call the point of plateau, or the onset of plateau, which is not a point, as you can see. It is a curve. One has to make a pragmatic decision as to whether you go for right up on to the plateau, which is a bit expensive and potentially toxic, or you take somewhere about here and, if you do that, you may want to think that most of the patients will get a good result, but you might want to increase the dose for a proportion of patients …”
“.....Of course, point P …is an area and if you are a little bit low on point P, you still would be expecting to get a substantial number of patients well and have a good therapeutic effect. You would have the standard option that we have in rheumatology of giving a double dose or a one and a half dose to some patients if you thought they were getting suboptimal responses”
“The Rheumatologist would of course be conscious that patients at the extremes of the size spectrum might need a modified dose (although this is an issue of volume of distribution, not clearance). However, most adult RA patients fall within a reasonably narrow lean body mass range, which means fixed dosing is a practical option. Moreover, the Rheumatologist would be aware that fixed dosing was used without problems with many drugs and experience with etanercept had confirmed that this was likely to be practical for TNF inhibitors.”
“ACR20 was recognised at the Priority Date as a minimum threshold for distinguishing active drug from placebo. However, for an RA patient with moderate to severe disease, achieving no more than an ACR20 would represent a minimal clinical improvement. It would not have been a clinical target for a rheumatologist (or a patient) at the Priority Date.”
“…the ACR20 grade is not a minimal improvement. As explained in my First Report at paragraph 41, although ACR20 sounds modest, it represents a significant improvement for patients, especially for those patients with moderate to severe RA who may have failed to respond to a number of DMARDs. To obtain ACR20 requires complete reversal of swelling and tenderness in at least some joints. The ACR50 and ACR70 response rates have a significant disadvantage in early studies because the numbers of patients achieving those responses are relatively small and therefore likely to be subject to more variation from trial to trial. Since the rates for ACR20, ACR50 and ACR70 tend to follow similar relations when considered across drugs in the same class the ACR20 rate is a practical primary outcome measure. In 2001, ACR20 was generally regarded as the primary efficacy measure on the ACR scale for trials of new drugs.”
“....... ACR20 should continue to be the primary measure of efficacy in RA trials, with higher thresholds for improvement being determined and reported as secondary efficacy measures.”
“There should be sufficient evidence that the primary variable can provide a valid and reliable measure of some clinically relevant and important treatment benefit in the patient population described by the inclusion and exclusion criteria”
“A considerable portion of these patients, even if you gave them the very best drug you could get your hands on, would only achieve ACR50. Some of them might only achieve ACR20 because, in reality, they had achieved ACR49 and you are not allowed to have anything except ACR20 and ACR50. I do not think that the implication here is at all that an ACR20 or 50 improvement is not something that the patient might be extremely grateful for.”
“So that is where I think the difference is. It is a very relevant end point. Is it the most clinically relevant to me or to treating physicians? No.”
“Patients on the key clinical trials of these therapies were achieving ACR50 responses in around 20-40% of patients after around six months. The better non-biologic therapies available were known to produce ACR50 responses in around 30% of patients (see for example studies comparing the then new DMARD leflunomide with sulfasalazine and methotrexate, where ACR50 responses were seen in between 22% to 34% patients on each of these DMARDs in various different studies). The Skilled Clinician would therefore be looking to achieve at least as good results in clinical trials for a new biologic therapy.”
“The Rheumatologist's preference would have been to administer D2E7 in fixed doses (a fixed mg amount), rather than variable (mg/kg) dosing, because it is much easier and cheaper to prepare and distribute fixed s.c. doses, rather than preparing syringes with variable doses on a patient-by-patient basis. Individually tailored dosing is more prevalent in early drug development when solutions are made up on site and administered i.v., or if there are toxicity concerns which require the administration of only the exact amount of drug required. As D2E7 has a wide therapeutic window, a fixed dose could be used (as was the case with etanercept).”
"the Rheumatologist would have wanted to administer the minimum amount of drug capable of producing the maximum therapeutic effect"
“In patients with persistently active RA, the combination of anakinra and MTX was safe and well tolerated and provided significantly greater clinical benefit than MTX alone.”
“The results of this trial demonstrate that the combination of anakinra and MTX offers a new alternative for patients with ongoing active disease despite MTX therapy. Long-term follow-up and evaluation of the effects of this combination on retarding radiographic progression will determine the place for this therapy in the treatment area for patients with RA”
“Yes, it could have been in but I do not think there is any significance to me at least, having it in there or not. I am not trying to [be] extensive as you already have my CV. It is just highlighting some of the clinical trials.”
“In 2001, and still now, it was generally understood that with repeated dosing once a half-life, this accumulation will mean that each dose is effectively equivalent to double a single dose (i.e. 0.5 mg/kg every half-life would accumulate to be equivalent to a single dose of 1mg/kg).”
“The more promising of [innovative] treatments seem to be those that block the effects of tumour necrosis factor (TNF)α because this proinflammatory cytokine seems to play a central part in the immunopathogenesis of RA.”
“Treatment was tolerated very well. No clinically relevant and dose related adverse drug reactions were observed. The therapeutic effects became evident within 24 hours after study drug administration and peaked at week 1-2. 19, 41, 72, 67, 56, 78% of the patients achieved response status at any time after treatment with placebo or 0.5, 1, 3, 5, 10 mg/kg D2E7. Response on day 29 after dosing was 0,6, 28, 33, 44, 39% respectively. Some responses were observed up to week 12.”
“The data from this first therapeutic trial in humans were very encouraging. In the three highest dose groups, 40-70% of patients achieved DAS and ACR20 response status at 24 hours to 29 days of treatment. The therapeutic effects became evident within 24 hours to one week after D2E7 administration and reached the maximum effect after 1-2 weeks, with dose response reaching a plateau at 1 mg/kg D2E7. In contrast, only 19% of patients taking placebo achieved response status. Single doses of D2E7 were well tolerated and the dose increment scheme was followed as planned reaching the maximum dose of 10 mg/kg without any evidence of clinically relevant or dose related adverse effects.”
“Use of Dose Response Information in Choosing Doses What is most helpful in choosing the starting dose for a drug is knowing the shape and location of the population (group) average dose-response curve for both desirable and undesirable effects. Selection of dose is best based on that information, together with a judgment about the relative importance of desirable and undesirable effects. For example, a relatively high starting dose (on or near the plateau of the effectiveness doseresponse curve) might be recommended for a drug with a large demonstrated separation between its useful and undesirable ranges.”
“Pharmacokinetic parameters were calculated for a total of 89 patients from all dose groups. The systemic drug exposure (AUC) increased proportionally with increased dose. The mean total serum clearance was 0.180 to 0.271 ml/min, and the steady state volume of distribution ranged from 0.063 to 0.076 l/kg indicating that distribution of D2E7 was mostly in the intravascular space. The estimated mean terminal half life was 11.6 to 13.7 days.”
“With distribution, what you typically see with a onecompartment system is that you have tissues that are highly perfused and with red blood cells they are not even perfused. They are sitting in the plasma so they are actually there. I would not expect it to act as a compartment. I know of no drug where the red cells act as a compartment. The fact that we have a five litre volume of distribution to me says that the drug is in blood.”
“Response rates of more than 80% have been achieved with a mean dosing interval of 2.5 weeks. After six months, 86% of patients continued to receive treatment with D2E7 indicating that long term intravenous treatment with D2E7 in the dose range from 0.5 to 10 mg/kg was well tolerated.”
“A.I would agree that it suggests that two weeks is on the threshold of what you would need. I think it is very difficult to interpret precisely beyond that. Q.If you have a large proportion of patients requiring dosing at two weeks because their disease has flared, that suggests you should be dosing them more frequently otherwise you lose control of the disease which, as we discussed earlier, is what you want to avoid. A.I think -- no, I agree that it would tend to point that one might think in that direction, yes.”
“Q. Looking at this all in the round, professor, surely you would agree that there is nothing here to indicate that 0.5 mg per kg as a repeated two weekly regimen is efficacious? A. I would not attempt to draw that information from DE003 at all, no, because we do not have any dose-related information from DE003”
“Based on preliminary data, plasma concentrations of D2E7 after multiple subcutaneous doses were comparable to those achieved ·with intravenous administration. Up to 78% of patients achieved a DAS/ACR 20 response after three months of treatment with subcutaneous D2E7. With the exception of mild and transient injection site reactions, adverse events occurred with the same frequency and distribution in the D2E7 and placebo groups. The investigators concluded that D2E7 given subcutaneously was safe and as effective as when administered intravenously demonstrating that subcutaneous self adminis- tration is a promising approach for D2E7 delivery.”
“D2E7 (1mg/kg as a single subcutaneous or intravenous injection) was evaluated in a randomized, double blind, placebo controlled trial in patients whose stable dose of methotrexate was insufficient to control symptoms. An ACR20 response was seen in 67% and 72% of patients receiving D2E7 by subcutaneous and intravenous injection, respectively. The safety profile of D2E7 administration was comparable to that of placebo. Collectively, these early data suggest that the fully human anti TNFα mAb D2E7 is safe and effective as Fujifilm & Others-v-Abbvie 260. monotherapy or in combination with methotrexate when administered by single and multiple intravenous and subcutaneous injections.”
“Collectively, these early data suggest that the fully human anti- TNFAE mAb D2E7 is safe and effective as monotherapy or in combination with methotrexate when administered by single and multiple intravenous and subcutaneous injections. Additional studies are underway to further define optimal use of this novel treatment.”
“Based on Kempeni 1999, the skilled team would have been interested in D2E7 being taken forward as a subcutaneous treatment. Based on my reasoning above, I believe 40mg given every two weeks would have been an obvious dose to choose. The Rheumatologist would also have been keen to see D2E7 with MTX. The skilled team would have had a very high expectation that this regimen, being a variation on the regimen already reported as effective by Kempeni, would be efficacious in the treatment of RA. The skilled team may have also been interested in a two week dosing interval with a dose of 80mg and a lower dose, perhaps 20mg, to confirm 40mg is at or near the point of plateau of the dose response curve.”
“Q. You certainly cannot draw the conclusion, can you, professor, from this data that 14 days the concentration of drug following a 1 mg dose is sufficient to maintain beyond the plateau of the concentration response curve? A. I do not think you can be absolutely sure of that on the basis of assuming the simplest default model that would explain the data, and we are told about one to two weeks, so maybe ten days, so I would work on the model that these responses told us something about the efficacy of the level of drug that was still around at about ten days, which is a little bit less than a half-life.”
“Prof Johnston sets out his calculations in Exhibit ACJ-3. The skilled pharmacologist would not have considered these calculations to be at all meaningful because they are based on assumptions as to the pharmacokinetics and pharmacodynamics of D2E7 that are not supported by the Cited Art (or for that matter the Additional Art). In particular: ….. 31.3 Prof Johnston assumes that an appropriate target trough concentration is the concentration that would be produced by a single 1 mg/kg dose after 2.5 weeks. The purported basis for this assumption (see paragraph 7 of ACJ-3) is that “the ascending dose study indicated that on average symptoms returned after 2.5 weeks”
“Professor, what I have here is I have taken your figure 2 and put another line on it, as you will see. If the pharmacologist was told by the rheumatologist that the concentration at about day 10 was the key one, instead of that at two and a half weeks then obviously you would end up drawing a line on our model for C min, as shown in this diagram, X5, that I have just handed up. If that were the right conclusion, then the pharmacologist would have to say that the 40 mg every other week dose was too low.”
“I will also add this. One of the vices of raising a point like this in cross-examination when it is not foreshadowed in the expert evidence is that it can become a test of how quickly people can think. That is not helpful.”
“My best guess would be somewhere between 1 and 2, so that is 10-11 days. We might say that may be a little bit shy of a half-life, but I actually think that if they say that these responses have peaked at 1-2, from my experience of this situation I would have expected most patients really to be maintaining that at two weeks, but that is arbitrary. I am working on the assumption that this is somewhere around 1012 days, on the basis of being one to two weeks. So, it is the least biased interpretation, if you like, from what we have.”
“Prof Johnston assumes that response status is lost immediately after the plasma concentration drops below an effective level. The skilled pharmacologist would not assume that to be the case. There is no information available about the relationship between declining plasma concentration and loss of response. Among a number of potential scenarios, the skilled pharmacologist would consider that there would be some lagtime between concentrations falling below the effective level and the loss of clinical response.”
"It is a dose which would correspond to a point on the plateau."
"Your position was that on the basis of the DE001 study that we were looking at in van de Putte and Kempeni 1999, the concentration at the plateau response curve is that produced by a single 1 mg/kg dose after ten days"
“27 Patentability is justified because the prior idea which was thought not to work must, as a piece of prior art, be taken as it would be understood by the person skilled in the art. He will read it with the prejudice of such a person. So that which forms part of the state of the art really consists of two things in combination, the idea and the prejudice that it would not work or be impractical. A patentee who contributes something new by showing that, contrary to the mistaken prejudice, the idea will work or is practical has shown something new. He has shown that an apparent “lion in the path” is merely a paper tiger. Then his contribution is novel and non-obvious and he deserves his patent. 28 Where, however, the patentee merely patents an old idea thought not to work or to be practical and does not explain how or why, contrary to the prejudice, that it does work or is practical, things are different. Then his patent contributes nothing to human knowledge. The lion remains at least apparent (it may even be real) and the patent cannot be justified.”
“It was known at the Priority Date that humanisation of a nonhuman antibody would not fully eliminate the risk of an immune response, and it would have been anticipated that even completely human biologics could be immunogenic. By way of example, it was widely known that recombinant human insulin (i.e. insulin made from a human gene expressed in cells grown in a laboratory) could induce ADAs. Therefore, a Skilled Clinician reading about a fully human antibody at the Priority Date would have been concerned about the possibility of an ADA response and would have had that in mind when considering a dosing regimen for such an antibody.” considering a dosing regimen for such an antibody.”
“… that there will be a motivation for the patients to put down a score on their global health which we have reason to believe will mean that they have a slightly higher dose because they are not necessarily feeling absolutely as well as they might want to. So when you have an option of moving up and not moving down in this sort of study, I personally would not take any notice at all of how many people moved up or what was going on because we are in a situation where there is room for systematic bias and systematic bias always creeps into this sort of study.”
“In my opinion the obvious regimens for the Skilled Clinician to test in a further clinical trial, in a larger group of patients, would have been intravenous doses of adalimumab in the range of 3-10 mg/kg at a dosing interval of roughly every 2 weeks, given that doses in that range appeared from the data available to have the best efficacy without significant adverse effects. The alternative would have been to conduct a dose ranging study for subcutaneous administration of adalimumab, starting with 1 mg/kg adalimumab (as the lowest dose) administered at weekly dosing intervals. These would be the obvious regimens to test whether or not given in combination with MTX.”
“Subcutaneously and intravenously administered D2E7 provided similar D2E7 plasma levels and comparable ACR20 response rates. At a dose of l mg/kg, subcutaneous and intravenous administrations were safe and efficaceous when given with standard, stable doses of MTX. In the long term open label extensions, a high percentage of patients continued to receive treatment with D2E7 indicating that long term treatment with D2E7 in the dose range from 0.5 to 10 mg/kg was well tolerated.”
“All three doses of D2E7 were efficacious (49% to 57% of patients received ACR20 responder status compared with 10% placebo, p<0.0001) and no dose response relation was apparent at month 3. ”
“there are no patent applications in the same family as, or claiming the same priority date as, EP 656 that relate to the treatment of rheumatoid arthritis by the administration of 40 mg every other week of adalimumab by subcutaneous injection as monotherapy”
“Back in October, we outlined in detail the extensive portfolio of IP that we have for HUMIRA and our confidence in that IP and it goes beyond any one single patent. And I can tell you that we remain confident in that IP portfolio and we’ve made it very clear that we intend to vigorously defend all of our IP against anyone that potentially infringes it. … I think we have a strategy that we have developed that we will put in place at the point at which we see biosimilar competition in any market around the world. We will obviously implement that strategy outside the US potentially earlier, in an earlier timeframe.”
“Yeah, I mean, based on the long-term expectations, as we've communicated to the market before, we don't anticipate biosimilar competition in the U.S. market for quite some time. And so I think we have a strategy that we have developed that we will put in place at the point at which we see biosimilar competition in any market around the world. We'll obviously implement that strategy outside the U.S. potentially earlier, in an earlier timeframe.”
“there is a public interest in commercial certainty in patent matters as in any others. Business needs to know where it stands. I believe this court should assist in providing that certainty where it properly can”
“8. The Patents Court judge is entitled to refuse a stay of the national proceedings where the evidence is that some commercial certainty would be achieved at a considerably earlier date in the case of the UK proceedings than in the EPO. It is true that it will not be possible to attain certainty everywhere until the EPO proceedings are finally resolved, but some certainty, sooner rather than later, and somewhere, such as in the UK, rather than nowhere, is, in general, preferable to continuing uncertainty everywhere.”
“93 The eventual existence of the statutory remedy of revocation is, in our judgment, of relevance to the question of whether a declaration should be granted in the exercise of the court's discretion. A claimant cannot seek an Arrow declaration simply because it would like to know whether a patent application in the course of prosecution will result in a valid patent. The course envisaged by the statute is that he should wait and see what, if any, patent is granted. The statutory remedy does not constitute a bar in principle to the granting of declaratory relief in appropriate cases, however. Where, for example, it appears that the statutory remedy is being frustrated by shielding subject matter from scrutiny in the national court, it should be open to the court to intervene. Just as in Nokia , the statutory remedy does not provide, in practical terms, the relief which the claimant needs.”
“In my judgment, those authorities demonstrate that it is perfectly legitimate for the claimant to seek to obtain a judgment of this Court on the validity of the patent in suit in the hope that it will lead to a settlement of the dispute between the parties throughout Europe. Nor, in my judgment, would it be in any way illegitimate for the claimant, absent such a settlement being achieved, to seek to rely upon the judgment of the English court in proceedings before the courts of other contracting states or the European Patent Office. It is commonplace for parties litigating on the same European patent in a number of contracting states to put before the courts of one contracting state decisions arrived at in one or more other contracting states.”
“Broadly speaking we think the principle in our courts – and indeed that in the courts of other member states – should be to try to follow the reasoning of an important decision in another country. Only if the court of one state is convinced that the reasoning of the court in another member state is erroneous should it depart from a point that has been authoritatively decided there. Increasingly that has become the practice in a number of countries, particularly in the important patent countries of France, Germany, Holland and England and Wales. Nowadays we refer to each other’s decisions with a frequency which would have been hardly imaginable even years ago. And we do try to be consistent where possible.”
"The plaintiffs are forum shoppers in the most literal sense. They have weighed up the advantages to them of the various jurisdictions that might be available and decided that England is the best place in which to vindicate their international reputations. They want English law, English judicial integrity and the international publicity which would attend success in an English libel action. … My Lords, I would not deny that in some respects an English court would be admirably suitable for this purpose. But that does not mean that we should always put ourselves forward as the most appropriate forum in which any foreign publisher who has distributed copies in this country, or whose publications have been downloaded here from the Internet, can be required to answer the complaint of any public figure with an international reputation, however little the dispute has to do with England. In Airbus Industrie G.I.E. v Patel[1991] 1 AC 119 your Lordships’ House declined the role of "international policeman" in adjudicating upon jurisdictional disputes between foreign countries. Likewise in this case, the judge was in my view entitled to decide that the English court should not be an international libel tribunal for a dispute between foreigners which had no connection with this country."
"So far as concerns the issue currently under consideration there is no conflict between the view of Lord Hoffmann and the view of the majority. This action falls to be considered as relating exclusively to an independent tort, or series of torts, in this country. It is thus not legitimate for the claimant to seek to justify the pursuit of these proceedings by praying in aid the effect that they may have in vindicating him in relation to the wide publication."
“the existence of the divisional applications gives rise to the need and justification for seeking declaratory relief. AbbVie could withdraw the “GB” designations of the divisional applications or acknowledge that it can have no claim under them in this country in respect of a product having the specified characteristics of FKB’s product. If it did so then the commercial purpose of the declarations sought would fall away”
“Mr Nomura, CEO of FKB, has informed me that FKB’s plans for launching FKB-327 will involve certain aspects of manufacture and supply taking place within Europe (outside of the UK). In particular, FKB’s current intention is that its European supply chain will involve at least three unconnected third party suppliers and activities in at least two other jurisdictions.”