API and IP Newsletter
Contents
Recent Paragraph-IV filings.
We follow Paragraph-IV filings at the USFDA website. On 13 May 2024, the FDA published a new list of P-IV filings. The complete list can be found here.
Below three are the new P-IV submissions.
General information
Delhi High Court Awards ₹217 Crore In Lost Profits Damages To CCAI In Patent
Infringement Suit Against Mobi Antenna Technologies
The patent, titled “Asymmetrical Beams for Spectrum Efficiency,” was issued to Communication Component Antenna Inc. It allows a larger number of subscribers to use the same spectrum and connect without distorting the quality of a call. The granted patent number is IN 240893, and the priority date is 17 March 2026.
One famous IP blog, Spicy IP, commented that it is a true embodiment of the globalized world—US/Canadian company Communication Component Antenna Inc (CCAI) battling against a Chinese defendant, Mobi Antenna Technologies, in an Indian Court.
USFDA gives nod to first interchangeable biosimilar for two rare diseases
Bkemv is the 53rd approved biosimilar in the U.S. The FDA has approved 13 of these as interchangeable biosimilars.
News here
Intellectual Property
T 2209/21- Aflofarm Vs Straw Man
European patent EP 2957280 was granted with a set of 13 claims and was issued to Aflofarm Farmacja Polska Sp. z o.o.
Aflofarm is one of the largest pharmaceutical companies in Poland.
The patent was related to solid pharmaceutical composition of cytisine and process for preparation thereof.
Sopharma AD and Adamson Jones IP Limited opposed this patent. Opponent 1 did not present any requests, and opponent 2 continued the appeal proceeding.
Adamson Jones, i.e. Opponent 2, is a dedicated patent and trademark practice firm in the UK. This could be a straw-man opposition filed by one of the leading pharmaceutical companies, that did not want to file opposition by the name of the company. A "straw man" enables a party to oppose a European patent while maintaining anonymity.
Claim 1 reads as follows:
1. Solid pharmaceutical composition comprising cytisine as an active substance, characterized in that said composition does not contain lactose and comprises from 20% to 75% by weight of microcrystalline cellulose, glidant and at least one pharmaceutically acceptable excipient chosen from the group comprising: mannitol, colloidal silicon dioxide, calcium hydrogen phosphate, whereby at least 60% of cytisine particles have size from 10 µm to 200 µm, and the pharmaceutical composition is in a form of tablet manufactured by direct compression method.
The patent was opposed under Article 100(a), (b) and (c) EPC on the grounds that the claimed subject-matter lacked an inventive step, was not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, and extended beyond the content of the application as filed.
In this write-up we would discuss about inventive step.
Following prior art documents were cited.
The inventive step was assessed starting from the disclosure of, inter alia, document D1 i.e. EP 1586320. At first instance, the Opposition Division held that Auxiliary Request (AR) 1 involves an Inventive step.
Opponent 2, ie Adamson Jones (Straw man?), appealed against this decision.
The patentee submitted a new set of claims entitled "Auxiliary Request 2".
Claim 1, according to the new main request, is identical to claim 1 as granted.
Claim 1 of auxiliary request 2 is identical to claim 1 of the main request, except that it additionally specifies that a single tablet contains 1.5 mg of cytisine.
D1, i.e., EP 1586320 B1 describes cytisine tablets containing lactose and microcrystalline cellulose in a specified ratio. The rationale behind these technical features is not explained.
However, a commonly known drawback of using lactose as a tableting excipient is that the resulting tablets are unsuitable for patients with lactose intolerance (D6: Table 2).
In light of common general knowledge, it would thus have appeared obvious to the person skilled in the art seeking to solve the objective technical problem to consider developing modified lactose-free formulations, in order to provide cytisine tablets that could also be administered to patients with lactose intolerance.
The function of lactose in tablet formulations is that of a diluent (or filler). If lactose was to be omitted, it would have appeared obvious to replace it with another widely-used diluent, such as mannitol.
The mere fact that D1 ie EP 1586320 happens to rely on lactose is not a technical reason why it cannot be replaced by an equivalent diluent if there is an incentive for doing so.
There was no technical prejudice against combining mannitol with cytisine, and it would not have been surprising that mannitol, which has the advantage of not being a reducing sugar, proved to be compatible with cytisine.
D1 ie EP 1586320 does not teach any particular tableting process. Since direct compression has the advantages of simplicity and economy and avoids exposure of the active agent to heat and moisture, the skilled person would have envisaged and sought formulations that can be tableted by direct compression as the method of choice.
In this context, it was known that both mannitol and microcrystalline cellulose can be used in both granulated and directly compressed tablet formulations. This is taught in D8 on page 132, point 7, page 449, point 7 and in D10 on page 3656, Table 1, page 3664, Table 6.
Optimizing the ratios and particle sizes of tablet components is part of a pharmaceutical formulator's routine actions.
The particle size of cytisine as defined in claim 1 is not unusual, overlaps with particle sizes taught in D1 i.e. EP 1586320, and has not been associated with any particular technical effect.
Thus, the incentive for changing the formulation taught in EP 1586320 (D1) would have been the known lactose intolerance problem in certain patients. The person skilled in the art would have had no reason to doubt the suitability of mannitol as a diluent and of direct compression as the method for preparing the tablets. They would have implemented these features as a matter of routine, without using inventive skill, and without being dissuaded by the teaching of the prior-art documents on file.
Consequently, the Appeal Board decided that the subject matter of claim 1 of the main request does not involve an inventive step within the meaning of Article 56 EPC.
The patent was revoked.
Decision here
