Breaking News: GSK patents challenged: IPAB revokes one, upholds another

The IPAB recently decided upon revocation petitions of two GSK patents, applications for which were filed by Fresenius Kabi Oncology Limited, an Indian pharma company. The IPAB pronounced orders for both revocation petitions on the same day.

The first revocation petition was filed for Patent No. IN221171 titled Quinazoline Ditosylate Salt Compounds[Patent 1], and the second one was for Patent No. IN221017 titled Bicyclic Heteroaromatic Compounds[Patent 2]. The IPAB revoked Patent 1, and dismissed the revocation petition for Patent 2. These decisions are a testament to a healthy Indian IP regime and snub US’s repeated assertions that Indian IPR policies are detrimental to granting patents.

GSK disclosed Patent 2 as prior art in the complete specifications for Patent 1. Further, there were parallel revocation proceedings for Patent 2 also. The essential subject matter of the patents was Lapatinib and its compounds. These inventions were marketed as a product under the trademark TYKERB in the US and international markets, including India, and under the trademark TYVERB in Europe.

The petitioner filed a revocation application on the grounds of of obviousness, S. 3(d) and, non-disclosure under S. 8 of the Patents Act, 1970. It argued that it did not require great skill to expect that the new crystalline form would have better stability. The invention was merely a result of routine testing. They submitted that the impugned invention was obvious to try with reasonable expectation of success in view of the combined teachings of the Exhibits read together. According to the petitioners Exhibit-B which was an admitted prior art, teaches the claimed compound (Lapotinib ditosylate salt) itself. Further, the use of tosylate salts has increased manifold( Sorafenib, the first CL drug in India is a tosylate salt). Thus, there existed a clear direction towards choice of tosylate.

Then, the petitioners raised an objection under S. 3(d) stating that the only improvement that invention had was that it provided superior moisture sorbing properties and enhanced stability. The two qualities were physicochemical and not related to therapeutic efficacy. Both these qualities can be expected by a person skilled in the art. Further, they argued that the respondents made no efforts to disclose the grants, rejection, abandonment of patent application in relation to the same subject matter in foreign jurisdictions, as required by law under S. 8. Thus, they were in clear violation of S. 8.

The respondents pointed out that the petitioners did not file any evidence to support their revocation petition, and on this ground alone the revocation application deserved to be dismissed. Further, the matter of selection of salts was very unpredictable and the choice cannot be made merely by trial and error. The invention was not the result of routine experimentation, there was an inventive step. In conclusion they submitted that the ditosylate salt of Lapatinib being thermodynamically more stable and less hygroscopic did not attract S. 3(d).

Also, the respondent’s defence was that it had complied with S.8, and that it had made divisional applications in respect of these patents in foreign jurisdictions. The records placed showed that the respondent submitted Form 3(details of only 3 applications) which were for the same/substantially the same invention.

The IPAB held that regarding the S.3(d) bar, the respondent’s own statements and the expert’s affidavit demonstrated that this invention cannot be held to have enhanced therapeutic efficacy. Thus, the patent was revoked at the outset.

However, the Board made pertinent observations on the issues of obviousness and S.8. Regarding obviousness, the Board held that the prior arts filed were clues sufficient enough for any person skilled in the art to arrive at these results.

With respect to S.8, the Board indicated the principles behind the S.8 objection- how it should be raised, defended and decided. The Board observed that the petitioners did a shoddy job of making out a case of S.8. The petitioner’s objection was rejected due to their failure to plead the facts and, state how the particular undisclosed application was for the same or substantially the same invention. It was not enough to just file the documents along with an affidavit. In the present case the IPAB rejected the S.8 objection only because the petitioner failed to make out the grounds of attack by stating the facts.

It came down heavily on the respondents for non-compliance of S.8. It observed that the object behind introducing S.8 was that the applicant should disclose all foreign applications so that the Indian examiner may know if it contained obviousness objections or any amendments and so on. The application outside India must be for the same invention or for substantially the same invention. Thus, the subject matter of the invention must be the same or almost the same. The IPAB has in its decisions clearly held that it is the duty of the Patentee to furnish the particulars under S.8.. A S.8 violation has severe consequences and may be a potential ground for a challenge to a patent grant. It cannot be said that the omission to comply with the requirement of Section 8 was not serious enough to affect the decision of the Controller to grant patents. The Board expressed its indignation at the Controller taking liberties to ignore and ‘settle’ non-compliance of S. 8 in this particular case( GSK and Asst. Controller settled that GSK will be required to submit the ‘prosecution‘ details of any one of the major Patent offices in respect of which Form 3 were to be submitted). Reiterating the Ayyangar Committee Report, the IPAB was of the opinion that if in any of the foreign offices the patentee had made a division or was required to make a division, in respect of the same or substantially the same invention or had amended or was required to amend in respect of the same invention or substantially the same invention such information regarding division or amendment would also be information required to be furnished under Section 8.

Ultimately, the IPAB allowed the petition with costs of Rs. 50,000.

In the second revocation petition, the application was made on similar grounds – S. 3(d), non-obviousness and S. 8. The Board upheld the respondent’s pleadings with respect to S. 3(d) because the petitioners failed to show a known compound with equivalent therapeutic efficacy. With respect to obviousness, the Board after elaborate scientific examination of the prior arts concluded that the invention was non-obvious. Thus, the claimed New Chemical Entity was upheld as an invention. The IPAB expressed a similar opinion ( as in the petition discussed above) regarding S. 8 and held that violation of S. 8 was not proved by the petitioners, hence rejected this ground.

In this case, the IPAB noted that there were substantial discrepancies between the PCT application relating to this invention, and the complete specifications placed before the Board due to deletions made by the Controller, without specifying the reasons thereof. It observed that such sweeping and large scale deletions and changes when allowed must be cautiously done and not casually.

The petition was dismissed with costs of Rs. 50,000.