Ibrutinib – India

Ibrutinib – India

On Sep 29, 2020, Intellectual Property Appellate Board (IPAB) set aside the order of Learned Controller finding compound patent invalid.

Brief background of the case is like this. Appellant, Pharmacyclics Inc. filed patent application – IN 1642/DELNP/2009 on Mar. 12, 2009. This application claims compound, Ibrutinib as Bruton Tyrosine Kinase inhibitor. This application was granted as IN 262968 on Oct 03, 2014. Post grant opposition was filed by Laurus labs on Sep. 24, 2015. Patentee & opponent then filed their respective written submissions.  Hearing was rescheduled few times & finally it was held on Nov 22, 2019. During this period additional  documents were also filed after the announcement of date of hearing. Parties filed post hearing submissions & on Mar 04, 2020, the Learned Controller by its order revoked the patent under lack of inventive step.

Appellant filed appeal to IPAB on many grounds under procedural & technical aspects. IPAB come heavily on these two aspects & found that Learned Controller did not follow the proper procedure of law. IPAB citing the judgment of High Court (W.P.(C) No. 12105/2019; decided on 20/11/2019) provided important pointers while dealing with the post grant opposition.

Let’s see the IPAB findings in summary:

Technical aspects (Inventive step)

1The prior arts should be analogus to the claimed invention.

[The prior art relied upon by the opponent pertains to LCK inhibitors, whereas, the invention pertains to BTK inhibitors.]

2. Reasoning of substitution of one group by another group should be justified properly.

[Here, IPAB said that Learned Controller made not only legal error but also scientific errors when deciding the issue of inventive step which is neither based on the arguments of the Appellant/Respondent, written submissions or the evidence filed by their experts.]

3. There should be proper motivation to combine the references.

[IPAB said that Motivation to attach a Michael acceptor from prior art to hypothetical compound has not even referred in the impugned order.]

4. There should not be any hindsight analysis in inventive step inquiry.

[IPAB said that the substitutions are somehow trying to trace back to the invention by keeping the invention in forefront and it amounts to “hindsight analysis”.]

Procedural aspects:

1. Trend of filing additional evidences under Rule 60 after the hearing being fixed by the Controller or place documents having evidentiary value in guise of “publication” under Rule 62(4).

[IPAB said that these actions do not find proper basis in the Rules and need to be addressed so as to smoothen the process of post–grant oppositions and reduced the timelines being consumed unduly. It should be ensured that the provisions of Rules 60 and 62 should be followed strictly.]

2. Learned Controller should provide reasons for his findings.

[IPAB said that it is well within his powers as provided in the law to disagree with the opinion of the opposition Board, but while he disagreed on this ground should have annotated the reasons thereof properly.]

3. Inventive step is mixed question of law & facts.

[Here, Learned Controller ignored the legal aspects from the determination of the “inventive step” & focused only on factual aspects.]

4. There is no concept of “ordinary” person skilled in the art in the Indian Patent Act, 1970.

[IPAB said that the determination of “inventive step” as envisaged in the Patents Act under section 2(1)(ja) clearly stipulates “person skilled in the art” & not “ordinary” person skilled in the art. Therefore, inquiry should be made in view of the person skilled in the art when dealing with inventive step attack.]

IPAB, therefore, set aside the impugned order of the Learned Controller.

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