Pfizer falls prey to Section 3(d)

India’s patent office had rejected Pfizer’s application to patent ‘Tofacitinib’ in 2011, but was ordered to reconsider the decision by the Intellectual Property Appellate Board, after Pfizer appealed. On 3rd September, 2015, the Controller of Patents issued a decision again in respect of Pfizer’s application number, 991/MUMNP/2003 which sought to patent an invention titled “CHIRAL SALT RESOLUTION”. Pfizer’s patent application claimed “a pharmaceutical composition for treating or preventing a disorder or condition selected from organ transplant rejection, xeno transplantation or conditions like lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, Type I diabetes and complications from diabetes, cancer, asthma, atopic dermatitis, autoimmune thyroid disorders, ulcerative colitis, Chron’s disease, Alzheimer’s disease, leukemia and other autoimmune diseases”.

Pfizer discovered and developed a drug of the janus kinase (JAK) inhibitor class, which is currently approved for the treatment of rheumatoid arthritis (RA) in the United States, Russia, Japan and many other countries and is being studied for treatment of psoriasis, inflammatory bowel disease, and other immunological diseases, as well as for the prevention of organ transplant rejection. In November 2012, the U.S. Food and Drug Administration (FDA) approved “Tofacitinib” for the treatment of rheumatoid arthritis. Once on the market, rheumatologists in the United States however complained that the $2,055 a month wholesale price on the drug was too expensive.

In India, however the picture is different. The question before the controller was not whether the drug is expensive or not, the question instead was whether Tofacitinib was worthy of a patent grant and the controller has answered the question in negative.

The observations made by the patent office during examination of the application were as follows:

  • Subject-matter claimed in claims 1-2 was not novel in view of the prior documents as cited in the international search report of the application and further citation WO0142246.
  • Subject matter of claim 1 falls within the scope of sub clause (d) of section 3 of the Patents Act, 1970 as amended.
  • Claim 2 does not sufficiently define the composition with respect to its ingredients with their percentage. Further, it appears to be an intended use of a claimed compound. Therefore, claim 2 does not constitute an invention under section 2 (1) (j) of the Patents Act, 1970 as Amended.

Claim 1 of the application claims a compound 3-{(3R,4R)-4-Methyl-3-[methyl-7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amio]-piperidin-1-yl}-3-oxo-propionitrile or a pharmaceutically acceptable salt thereof. And Claim 2 claims the pharmaceutical composition for treating or preventing disorders as quoted earlier.

The applicant was offered a hearing by the Patent Office based on its findings. The applicants then made oral submissions and proposed one amended claim on record. The applicant at the hearing handed over a set of documents that outlined the technology explaining stereo-chemistry in general and in particular the importance of stereo-chemistry in the drug-receptor binding activity which has a direct co-relation with the efficacy/effectiveness of the drug molecule and revisions made to the patent application.

The Controller noted that claim 2 of the application had been deleted by the applicant and hence objection no. 3, that Claim 2 did not sufficiently define the composition with respect to its ingredients with their percentage and that the claim appeared to be an intended use of a claimed compound, could be set aside.

With respect to objection 1 of the hearing letter, the applicant submitted that document D1 did not discloses or identify any known substance with known therapeutic efficacy for the application of Section 3(d) because the document D1 was published after the priority date of the present application.

The Controller in respect of this argument by the applicant noted that the cited document D1 (WO 0142246) disclosed the inhibitors of JAK3 as agents for the treatment of a variety of diseases and also that a claim of the cited document discloses a compound “3-{4-Methyl-3-[methyl-(7H-pyrrolo [2, 3-d] pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxopropionitrile”

This cited document was filed as a national phase application on 10-06-2002 which was granted the Indian patent number 241773. The Controller suggested that the claim and compound would obviously be known to the applicant (Pfizer) because Pfizer itself was one of the applicants named in the cited document. Further, the Controller stated the fact that, for the purpose of determining novelty, a patent application filed at the Indian Patent Office before the date of filing of complete specification of a later filed application but published after the same is considered for the purposes of prior claiming. The Controller cited section 46(2) of the Patents Act, 1970 which reads that “a patent shall be granted for one invention only”. This means that two patents cannot be granted for one invention and since the compound had been granted earlier, the present application did not deserve to be granted.

The Controller did not find any distinctive difference between the compound being claimed by the application 991/MUMNP/2003 and the priorly claimed compound in document D1, except the fact that the former was an enantiomer of the latter. The Controller found it disappointing that the applicant had failed in their duty to reveal the facts of the document D1 and its grant in India. The suppression of facts by the applicant was not appreciated.

With respect to objection 2, the Controller found that Pfizer did not submit any experimental data to show the enhanced efficacy over the base compound claimed in document D1. Further, the Controller cited the judgment of the Supreme Court in NOVARTIS AG V/S UNION OF INDIA (CIVIL APPEAL Nos. 2706-2716 OF 2013). Where it was held that the applicant would have to establish the therapeutic enhanced efficacy of the claimed compound over the base compound.

In the absence of disclosure of any test result and comparative data over the base compound, the Controller remarked that he could not admit that the claimed compound had enhanced efficacy over the base compound in D1 and hence was not patentable under section 3(d) of the Patents Act. The patent application also failed to satisfy the criteria of novelty and inventive step based on the documents and data made available to the Controller.

Section 3(d) has been the subject matter of intense debate for years now, and this was reiterated in this decision by the Controller when he referred to the provision of section 3(d) and stressed on the fact that “…derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

Many of the world major pharmaceutical companies including Pfizer, Bayer and Roche have in recent years struggled to retain exclusivity on drugs in India, and have blamed section 3 (d) and the patent laws in the country, which they say are designed to favor the local industry.

Note– Also read Dr. Kalyan’s post on the topic.

Authored by Gaurav Mishra

Read other relevant articles on section 3(d) here, here, here, here and here.

References – here

Image Source/ Attribution- this image is in the public domain.