API and IP Newsletter
Contents
UPC says public need legal representation to access court files
Lenovo accelerates Ericsson dispute with unusual UPC and UK claims
Paragraph IV filings
We follow P-IV filings. On 05 February 2024, FDA updated list of recent P-IV filings. Here
OB listed patents for Lumateperone Tosylate are as below:
Lumateperone Tosylate is expected to become a top-three anti-psychotic drug and hit $1.2 billion in global sales across various indications by the financial year 2030-31. Here
Lumateperone type compounds are very old compounds. These compounds are disclosed in prior art WO 2000/77010; WO 2000/77002; WO 2000/77001; US 6,713,471; US 6,552,017; US 7,081,455; US 6,548,493, 7,071,186; USRE 39,680; USRE 39,679. These compounds have been found to be useful as 5-HT2 receptor agonists and antagonists used in treating disorders of the central nervous system. So broadly, the compound and its use were known in prior art.
The equivalents of WO2009114181A2 family are listed in Orange book. Mostly all the patents which would have an expiration date in 2029 as per OB listing above. Since the compound are use were not relatively unknown, the key OB listed patents, hence, mainly relate to crystalline form of Lumateperone Tosylate with an X-ray powder diffraction pattern consisting peaks at 5.68°, 12.11°, 16.04°, 17.03°, 18.16°, 19.00°, 21.67°, 22.55°, 23.48° and 24.30°±0.2° 2θ.
This perhaps offered an opportunity for generics to challenge innovator (Intra-Cellular Therapies Inc) by filing ANDAs with different crystalline form/with amorphous material.
Zydus, DRL and two others have filed Drug Master Files.
Zydus and DRL could be one among these 7 ANDA filers on NCE-1 date.
As per import export database DRL exported API to Teva. Hence, Teva could be one of the ANDA filer.
Intas, Zydus, Sun, MSN, Hetero, Aurobindo had imported innovator samples Caplyta. These companies either should have filed ANDA or could be in the process of ANDA development.
General information
UPC says public need legal representation to access court files
Transparency at the Unified Patent Court has hit another stumbling block after the Court of Appeal decreed that members of the public may not access court documents without legal representation. While the case is not yet over, the decision comes amid a legal tug-of-war regarding accessibility of court proceedings.
News here.
Lenovo accelerates Ericsson dispute with unusual UPC and UK claims
Lenovo and its subsidiary Motorola have taken the global dispute with Ericsson over 5G patents to the Unified Patent Court. In doing so, the Chinese mobile phone manufacturer is pursuing an unusual defence against Ericsson that centres in the UK.
News here
Intellectual Property
T 1339/21 (Spray-Drying/P & G) 29-01-2024
The Procter & Gamble Company Vs UNILEVER N.V. / UNILEVER PLC
EP 2406363 issued to P & G.
This matter was before Appellate Board at European Patent Office (EPO). The appeal was filed by Unilever.
The appeal from Unilever is directed against the decision of the opposition division to reject the opposition against EP2406363, claim 1 thereof reading as follows:
A spray-drying process to prepare a spray-dried powder comprising:
(a) anionic detersive surfactant;
(b) 0 wt% zeolite builder;
(c) 0 wt% phosphate builder;
(d) 0 wt% silicate salt;
(e) optionally carbonate salt;
(f) optionally polymeric material; and
(g) optionally from 0 wt% to 10 wt% water,
wherein, the process comprises the steps of:
(i) spraying an aqueous slurry comprising from
(a) anionic detersive surfactant;
(b) 0wt% zeolite builder;
(c) 0wt% phosphate builder;
(d) 0wt% silicate salt;
(e) optionally carbonate salt;
(f) optionally polymeric material; and
(g) water,
into a spray-drying zone, wherein the spray-drying zone is under negative pressure and wherein the air inlet air temperature into the spray-drying zone is greater than 150°C; and
(ii) drying the aqueous slurry to form a spray-dried powder,
wherein the spray-drying zone is under a pressure of at least -50Nm-2.
In the statement of grounds of appeal, Unilever argued that the claims as granted were not inventive in view of D8 (EP 1 914 297 A1) as closest prior art combined with the teachings of D3 (The Manufacture of Modern Detergent Powders, De Groot et al, 1995, pages 60-71), D4 (Manufacture of Consumer Products, Adler et al, 1987, pages 399-439), D5 (US 3,849,327),
With its reply dated 11 March 2022, P&G defended the patent as granted.
According to the opposed patent, the alleged invention relates to a spray-drying process intended to prevent overheating of spray-dried detergent powders. This problem is said to be specifically related to low-built highly soluble detergents, i.e. compositions including no phosphates, zeolites and silicates.
The parties agreed that document D8 represented the closest prior art. The inventive step argumentation will therefore be formulated starting from this document.
Problem solved by the invention
According to the patent, the object of the invention is to prevent overheating of a low-built detergent composition, a concept which is associated with detergents including no zeolite builders, phosphate builders or silicate salts. This problem is said to be specific to this type of detergents and is solved by operating the spray-drying tower under a vacuum.
In view of the above and in the absence of evidence to the contrary, the board agrees with the respondent (P&G) that the problem solved by the invention is to propose a process that prevents overheating in a spray-drying process for low-built detergent compositions.
Obviousness of the solution
Document D3 ((The Manufacture of Modern Detergent Powders, De Groot et al, 1995, pages 60-71)- a handbook for the production of detergent powders - teaches (on page 66) that the design and operation of spray-drying towers must take into account the thermal efficiency and the heat sensitivity of the product. This document states (on page 70) that the spray-drying towers should be operated at a slight negative pressure, such as 10 mm water column (equivalent to approximately -98 N/m-2), to draw air into the base of the tower and cool the detergent powder to about 80ºC.
Document D6 similarly discloses that the spray-drying of detergents should be carried out under vacuum conditions to draw cold air and prevent thermal damage of the detergent powder. These documents therefore teach the same solution as claim 1 at issue for solving the technical problem of the invention.
P&G argued that the problem of overheating was specific to low-built detergents (i.e. containing no phosphates, zeolites or silicates). Since none of the above cited documents concerned such detergents, there was no reason to consult their teachings to solve the underlying technical problem.
At the oral proceedings, P&G argued that there was a fundamental difference between detergents with no zeolites, phosphates and silicates as defined in claim 1 and other detergent compositions. Zeolites, phosphates and silicates had relatively high surface areas, which played a key role in dispersing and drying the liquid components. Without zeolite, phosphate and silicate, liquid surfactants were not well dispersed and, due to their water affinity, formed sticky agglomerates that were difficult to dry.
Notably, in 2004, there was a significant change in regulations where phosphates were first limited and then banned, resulting in consequences for the handling of compositions.
Documents D3 and D6 were published before those regulatory changes, so their teachings likely related to detergents containing phosphates and/or silicates. Such detergents could be easily dried, so working under negative pressure to cool down the air inlet of the spray-drying tower did not represent a problem.
The situation was however different for detergent compositions with no zeolites, phosphates or silicates, as in D8. In such cases, the skilled person would have a prejudice to implement a solution involving the cooling of the air in the spray-drying tower, because this would be expected to further hinder the drying of a detergent composition which was known to form sticky agglomerates which were difficult to dry.
These issues were furthermore implicitly addressed in document D3, which indicated (page 64) that the formulation of the composition greatly influenced the structure of the particles and the speed of drying. A skilled person starting from the process in D8 would therefore have a disincentive to implement the solution proposed in D3 or D6.
The Board disagreed with the above argumentation by P&G for the following reasons:
As argued by Unilever, low phosphate detergents were not only known but relatively common by the end of the 80s, i.e. several years before D3 was published, so it is not apparent why the teachings in this document should be considered to be limited to detergent compositions including phosphates.
No evidence has been presented that the above discussed problems would indeed occur when drying the detergent composition of D8. These problems are not even disclosed or hinted in the patent.
All in all, the Board concludes that a skilled person starting from D8 and seeking a solution to prevent overheating of the detergent composition would contemplate the one proposed in D3 or D6, and in doing so would arrive at the subject-matter of claim 1 in an obvious manner.
The subject-matter of claim 1 at issue is therefore not inventive in view of the combination of D8 with the teachings of D3 or D6.
The patent was revoked.
Decision here
