Janssen Inc and Actelion Pharmaceuticals Ltd. Vs Saodoz Canada Inc

DATE OF JUDGEMENT: 31.05.2022:
CASE NO: T-549-20 [2022 FC 715]
CASE TITLE: Janssen Inc and Actelion Pharmaceuticals Ltd. Vs Saodoz Canada Inc
NAME OF HON'BLE COURT: Hon'ble Federal Court of Canada
NAME OF HON'BLE JUDGE: Hon'ble Madam Justice Pallotta

Brief Note on the case: 1. Plaintiff namely Jassen sought relief against the Defendant namely Sandoz for infringement of claim 21 to 31 of the subject matter Patent no. 2,659,770 titled “Therapeutic Compositions Comprising a Specific Endothelin Receptor Antagonist and a PDE5 Inhibitor” (770 Patent).Para 5

2.The Defendant Sandoz seeks Health Canada’s approval to sell a generic prescription medication containing 10mg of macitentan as the active ingredient. Para 5

3.It is claimed that this product of Respondent is infringing the subject matter Patent. Now question was this whether product of Respondent fell within claims of the subject matter Patent no. 2,659,770. Para 5

4.770 Patent specification describes the invention as relating to a product containing a compound of formula known as macitentan. Para 17

5.The issues in this action relate to claim construction and validity of the Asserted Claims. Para 29

6.the claims be read in an informed and purposive way, from the perspective of a notional person of ordinary skill in the art or science to whom the patent is addressed (skilled person): Free World Trust v Électro Santé Inc, 2000 SCC 66 at para 44 [Free World]. Para 30

7.Claim construction is a matter of law for the Court to decide: Whirlpool at para 61; Zero Spill Systems (Int'l) Inc v Heide, 2015 FCA 115 at para 41: Para 32.

8.Plaintiff alleged that Defendant's expert conducted his test of obviousness review with hindsight, which is not accepted in law.

9. The Defendant alleged because of prior publication of WO 395, the subject matter Patent is obvious.

10. The Court held that WO 395 contains large number of compounds. It does not indicated as to how a skilled person would select a group of compound fro large number of compounds. Para 197-199

11.The court also held that defendant failed to show that process involved in WO 395 would motivate person skilled in the art to focus on subject matter patented compound namely MACITENTAN. Para 204.

12.The utility of a claimed invention must either be demonstrated or soundly predicted based on the information and expertise available at the material date, which is no later than the filing date: Patent. Para 204.

13.Defendant argued that result conducted on rats may not be translated to human. Hence the impugned Patent does not proved utility. Para 246.

14. The court rejected this argument after observing that that the line between sound prediction and demonstrated utility is vague, however there is a point where the cumulative weight of evidence supporting a sound prediction can reach a sufficient level to establish demonstrated utility: Para 246.

15.The Defendant pleaded that the specification does not enable the skilled person to practice the subject matter of the claims 21-25 in order to treat the disease. The insufficiency of disclosure in specification was not explained by the Defendant as to what was missing in the specification. Hence this argument was rejected. Para 255

16.Hence Plaintiff was granted the relief of declaration of Patent Infringement against the Defendant.

Ajay Amitabh Suman, IPR Advocate,
Hon’ble Delhi High Court,
ajayamitabh7@gmail.com,
9990389529