API and IP Newsletter
Contents
505 (b) (2) NDA approvals in November 2024
We follow 505(b)(2) approvals.
Generally, 505(b)(2) NDAs relate to changes compared to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details 505 (b) (2) FDA approvals can be found here.
In November 2024, there were four such 505 (b) (2) NDA approvals. Details are as follows:
General information
Update on Pending Denosumab BPCIA Litigations
Amgen brings four pending BPCIA litigations against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the District of New Jersey.
Fact discovery is to be completed by February 21, 2025, and expert discovery to be completed by March 7, 2025.
News here
Court approves export of undiluted amount for research purposes Next-generation vaccine development is likely to gain momentum.
SK Bioscience won an appeal trial over whether to infringe patents with Pfizer over the pneumococcal undiluted solution exported to Russia.
SK Bioscience received permission from the Ministry of Food and Drug Safety for the first time in Korea in 2016. However, the following year, Pfizer filed a lawsuit for infringing on the composition patent of its product.
News here
Intellectual Property
Coca-Cola Company vs Acapo AS
This opposition at the European Patent Office is regarding EP2993990. It was issued to The Coca-Cola Company.
The patent relates to beverages containing rare sugar and a natural high-potency sweetener in specific weight ratios. The beverages of the present invention are asserted to possess improved flavour and temporal profiles.
This patent was opposed by Acapo AS and by Compagnie Gervais Danone.
Acapo AS appealed against the opposition division's decision, holding the then auxiliary request 2 allowable.
With their notices of opposition, Opponents 1 and 2 (Acapo AS and Compagnie Gervais Danone) requested that the patent be revoked because, among other things, it did not involve an inventive step under Article 100(a) EPC.
The opposition division decided that the subject matter of claim 1 of the then auxiliary request 2 involved an inventive step in view of D1 as the closest prior art.
Claim 1 of the main request (which is identical to claim 1 of the then auxiliary request 2) reads as follows:
"A beverage comprising the rare sugar D-psicose and the high potency sweetener Rebaudioside M; wherein the Rebaudioside M is greater than 95% pure; the D-psicose is present in an amount from 0.1% to 2% by weight; and the weight ratio of Rebaudioside M to D-psicose is from 1:25 to 1:100."
Claim 1 of auxiliary request 1 differs from claim 1 of the main request in that the feature "wherein the beverage does not comprise allose" has been added to the end of the claim.
Claim 1 of auxiliary request 2 differs from claim 1 of the main request in that the feature "wherein the beverage does not comprise erythritol" has been added to the end of the claim.
Claim 1 of auxiliary request 3 differs from claim 1 of the main request in that the feature "wherein the beverage does not comprise a polyol" has been added to the end of the claim.
The following documents are cited as prior art.
D1: WO 2013/096420 A9
D6: GRAS exemption claim for D-psicose as an ingredient in foods, 18 August 2011
D19: GRAS Notice for D-allulose, 01 April 2016
D1 discloses a beverage comprising Rebaudioside X (Reb X) and at least one additive, and it may further contain at least one additional sweetener (see claim 40 of D1).
In this context, it is noted that Reb X is a synonym of Rebaudioside M (Reb M). D1 describes that the additional sweetener may be a carbohydrate sweetener such as D-psicose (see page 34, lines 13 to 15, of D1), a synthetic sweetener (see page 34, lines 21 to 32, of D1) or a natural high-potency sweetener such as Reb A, Reb B, Reb D, mogroside V, etc. (see page 34, line 33, to page 35, line 14, of D1).
Reb X and carbohydrate sweetener may be present in any weight ratio, from about 0.001:14 to about 1:0.01, for example, about 0.06:6.
The sweetener composition contains carbohydrates that effectively provide a concentration of approximately 100 ppm to approximately 140,000 ppm when included in a sweetened composition, such as a beverage (see page 34, lines 16 to 20 of D1).
Example 10 of D1 discloses blends of Reb X with other non-caloric sweeteners, such as Reb B, Reb D, Reb A, or mogroside V.
The subject matter of claim 1 differs from D1 due to the combination of Reb M with D-psicose in an amount ranging from 0.1 to 2 wt.%.
D1 discloses a beverage comprising Reb X, namely Reb M, at least one additive, and an additional sweetener (see claim 40 of D1). As mentioned in example 10 of D1, the additional sweetener may be Reb X, Reb B, Reb D, Reb A, or mogroside V.
The Board said there is no evidence on file of the impugned patent that the claimed beverage improves upon the results disclosed in Example 10 of D1, where the improvement originates from the distinguishing feature.
In light of this, the objective technical problem to be solved is to provide an alternative beverage.
The board opined,
Regarding the question of obviousness, D1 teaches D-psicose as an additional sweetener.
As can be understood from paragraph [0004] of the patent, "D-psicose is self-GRAS, with a letter of no objection from the US FDA. It is approved at a maximum level of 2.1% (w/w) in a non-alcoholic beverage."
As D6 shows, this is considered general knowledge in the present technical field.
Even if the post-published document D19 could demonstrate that the U.S. FDA has now approved D-psicose in higher amounts of up to 3.75 wt.%, this does not influence how a skilled person would assess this in the priority date.
Given the above, the subject matter of claim 1 of the main request does not involve an inventive step because of D1 alone.
The patent is revoked.
Decision here.
