The validity of a species patent can be challenged based on grounds of prior claiming and lack of inventive step, particularly if the genus patent has expired.

JUDGMENT

Rajiv Shakdher, J.

Table of Contents

Preface:

Background:

Submissions of the parties:

On behalf of the plaintiffs:

On behalf of the defendants:

Rejoinder arguments on behalf of the plaintiffs:

Analysis and reasons:

ARE THE SUIT PATENTS VULNERABLE?

PUBLIC INTEREST:

Conclusion:

Preface:

1. The captioned actions concern, principally, two patents. These being:

a) Indian Patent No. 205147 [hereinafter referred to as: IN 147]

b) Indian Patent No. 235625 [hereinafter referred to as: IN 625]

2. IN 147, as per the averments made in the plaint, is the genus patent while IN 625 is claimed to be the species patent. The moot point, which arises for consideration in the instant actions, is: whether the compound-in-issue i.e. Dapagliflozin [in short "DAPA"] which, according to the plaintiffs, is covered in IN 147 stands disclosed both, in law as well as on facts?

2.1. I must also state, at the very outset, that there are various shades and limbs to this broad frame which is the essence of the dispute obtaining between the parties.

2.2. Furthermore, for the sake of convenience, I would be referring to plaintiff no. 1 i.e. AstraZeneca AB as "Astra Sweden" and plaintiff no. 2 i.e. AstraZeneca Pharma India Limited as "Astra India". The defendant in CS (COMM) 410/2020 i.e. Intas Pharmaceuticals Limited will be referred to as "Intas"; while the defendant in CS (COMM) 411/2020 i.e. Alkem Laboratories Limited will be referred to as "Alkem".

2.3. Besides this, wherever the context requires, Astra Sweden and Astra India will collectively be referred to as the plaintiffs and likewise, Intas and Alkem will be collectively referred to as the defendants.

Background:

3. Before I proceed further, the following broad contours of the case are required to be noticed.

3.1. The first registered patent holder i.e. the grantee of these two patents is an entity going by the name Bristol Myers Squibb Company [in short "Bristol"]. Bristol, it appears, via an assignment deed dated 01.02.2014, assigned the rights in the aforementioned patents in favour of Astra Sweden. It is claimed that this assignment deed was placed on record of the patent's office by Astra Sweden via its application dated 02.06.2014 and that as a result of this step having been taken, it was registered as the patent holder qua the aforementioned patents.

3.2. Insofar as Astra India is concerned, it is averred in the plaint that it is the only company in the country which has obtained the necessary statutory approvals for importing and marketing DAPA in India.

3.3. The plaintiffs claim that DAPA is used worldwide to treat people suffering from type-II diabetes mellitus. According to the plaintiffs, this is achieved by DAPA acting as an inhibitor of sodium-dependant glucose transporter i.e. SGLT2 in the kidneys.

3.4. It is, thus, claimed that DAPA aids in normalisation of plasma glucose levels and perhaps, body weight by enhancing glucose excretion. It is averred, hyperglycaemia is a hallmark of type-II diabetes and the challenge, therefore, is to control plasma glucose levels so as to prevent complications which arise when the disease reaches an advance stage.

3.5. It is stated that plasma glucose is normally filtered in the kidneys in the glomerulus which is then actively reabsorbed in the proximal tubule. SGLT2, according to the plaintiffs, is a major transporter which is responsible for the reuptake of glucose in the glomerulus. The SGLT2 inhibitors such as phlorizin and other closely related analogues inhibit the re-uptake process. The selective inhibition of SGLT2 normalises plasma glucose by enhancing excretion of glucose in the urine, thereby, improving insulin sensitivity and, thus, delaying the development of diabetic complications such as neuropathy, nephropathy and retinopathy, wound healing and other related diseases.

3.6. It is also averred by the plaintiffs that the main claim in IN 147 is a Markush structure, in other words, a patent covering a group of compoun