Pfizer granted a patent for Tofacitinib and its salts

The IPAB  has recently allowed an appeal and granted a patent to Pfizer for its application 991/MUMNP/2003.

This application claimed the compound 3-{(3R, 4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile and pharmaceutically acceptable salts thereof (Tofacitinib and its salts) and was refused by the patent office on various grounds, including anticipation by prior claiming and section 3(d).

The main prior art cited by the controller for novelty was Document WO 0142246(D1) that claimed and disclosed the compound 3-(4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl)-3-oxo- propionitrile. The ground of anticipation by prior claiming was not raised in the hearing notice and for section 3(d) no known substance was identified.

The appeal was filed on various grounds including  that the order was against pprinciples of natural justice as the objection of anticipation by prior claiming was never raised, and “known substance” was not identified for section 3(d) but also on various substantive grounds like non applicability of such grounds to the present invention.

It was also submitted that during the prosecution of present invention, before the hearing in 2015 the Appellant submitted comparative data to support the surprising efficacy of the compound claimed in the present application, Tofacitinib monocitrate, compared to the compound disclosed in the alleged prior art document D1.

The appeal was allowed by the Hon’ble IPAB and the main findings in the decision are as follows: –

Section 3(d):

  • it is against the principles of natural justice that an application is rejected without clearly communicating an objection to the Appellant.
  • The applicant must be aware as to what the known substance is, and against which an enhancement of efficacy is to be shown to show patentability.
  • As D1 is not a prior published documents, the hon’ble IPAB held that for section 3(d), prior art has to be known to the public and not the inventor/ applicant of the patent specification. Inventor’s knowledge is immaterial in patentability analysis.
  • The document cited- D1 was filed earlier, however, was not published before the priority date, it was not a prior public document and therefore the compound disclosed therein, in particular compound of Example 14 was published after the priority date of the present application and is not a “known compound”.
  • The controller admits that a data comparing Tofacitinib and example 14 of prior art can overcome section 3(d), however, still rejects the application on grounds of section 3(d), even in the presence of such data.

The board therefore held that Section 3(d) is not applicable to the present case as there is no “Known compound”. D1 was not publically available at the priority date of the present application. Further, even if Section 3(d) is applied without prejudice, the applicant by evidence has established the superiority of claimed form over 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)amino]-piperidin-1-yl}-3-oxopropionitrile, and other enantiopure forms of compound of D1.

Anticipation by prior claiming

  • It is settled law and principle of anticipation that a generic disclosure does not take away the novelty of a claim of a specific disclosure, or else several provisions of the Indian Patents Act including section 3(d) would be rendered otiose
  • The party/ applicant is to only establish that 3R, 4R has not been specifically claimed in the cited art.
  • It is a legally established principle that no data, establishing superiority of unexpected results is required to overcome the objection of anticipation be it anticipation by prior claiming or anticipation by prior publication.

After the order in the appeal was reserved, a third party filed a pre grant opposition and made representation of the opposition before the Board. The board also dismissed the representation and held that in the present case the application for registration was rejected though no opposition was filed.

Once the application was rejected, the question of filing opposition in the rejected application does not arise. The board also discouraged the filing of oppositions to delay grant of the application and held that:

  • Once the infringers become aware that it is a valid, genuine and commercially successful invention/patent and if any action is taken or likely to be taken before the Court for infringement, they make all efforts and see that the life of the genuine patentee must become miserable by raising all types of false and frivolous objections.
  • the practice of filing of Benami opposition by the Benami opponent and crooked imposter has to be stopped.
  • It is the duty of the respondent/controller of patents that such person(s) may not be allowed to take the advantage of multiple layers of opposition.
  • If any opposition is filed either under Section 25(1) or 25(2), which is bogus and without any merit, the same is to be thrown out at the earliest with heavy costs and penalty. Only the genuine oppositions are to be entertained.

Filing of additional documents, data and evidence in support of the invention is allowed under the Patent Law

The IPAB has recently allowed an appeal and granted a patent to the University of Miami.

The application claims were directed to pharmaceutical composition comprising coenzyme Q10 and the method of using co-enzyme Q10 for treatment of cancer. A composition of co-enzyme Q10 comprising a lipid has also been exemplified in the specification. During prosecution of the application, the claims were revised and the method of treatment claims were deleted in response to the objection of the Controller, the composition claims were revised and limited to be directed to liposomal composition for the treatment of cancer comprising 0.01 to 30% w/w co-enzyme Q10 and a liposome for topical and intravenous administration. The applicant also relied upon post published data confirming and further supporting results provided in specification. The application was refused on various grounds including that the use of liposomes is known, and that post filing data cannot be considered. The application was also considered to be a method of treatment.

 The IPAB allowed the appeal, granted the patent and held that:-

  • Controller failed to consider the facts and evidence produced by the appellant, merely vague order has been passed.
  • Controller is wrong in rejecting the application as the same is a breakthrough invention for treatment of cancer, an embodiment of which is being studied at the clinical stage for treatment of cancer.
  • The claims are novel and also inventive in view of the cited documents and completely supported by the specification as originally filed.
  • Filing of additional documents, data and evidence in support of the invention, to overcome the objection raised and to attack a specific objection is something which is allowed under the Patent Law of not only India but also other foreign jurisdictions.

Patent for Delgocitinib granted to Japan Tobacco

Dismissing the Pre-grant filed by Mr. Tapan Shah, the Indian Patent Office has granted a patent bearing Patent Application No. 640/CHENP/2012 entitled “Nitrogen containing spiro-ring compound and medicinal use of same” covering the commercial product, Delgocitinib.

The claims of the application were directed to nitrogen containing spiro-ring compounds represented by the Markush Formula (I) in claim-1 as inhibitors of Janus Kinase 3 (JAK3) for its therapeutic applications in conditions associated with it. The main grounds of opposition relied by the opponent were obviousness and non-patentable. The opponent in the opposition relied on 4 documents for obviousness. The Applicant argued non-obviousness, emphasizing, on the structural dissimilarity of present invention compared to prior art documents and its contrast teaching. Moreover, heavy reliance was placed on the specification which is replete with exemplified compounds of formula (I) along with its method of preparation, biological activity and formulation.

Importance of Opposition Board and Opposition Board recommendation reinstated by the IPAB

The Hon’ble IPAB, has maintained the stay granted on the order of the Controller revoking Indian Patent IN262968 covering the product Ibrutinib.

Some facts of the case are provided below:-

  • Patentee Pharmacyclics LLC was granted Indian Patent No.262968. The publication of the grant took place on 3rd October, 2014.
  • On 24th September, 2015, the Opponent – M/s. Laurus Lab Pvt. Ltd. filed a post-grant opposition under Section 25(2) of the Patents Act, 1970. The Patentee filed its response to the said opposition
  • The report/recommendation of the Opposition Board was submitted on 23.02.2017. On the basis of report, on 14.09.2017, the ld. controller appointed hearing for 16.11.2017.
  •  When the date of 16.11.2017 was fixed, none of the parties has availed the option of rule 60 (to file further evidence) or Rule 62(4) of the Act. However, after adjournment when the matter was fixed again for 25.09.2019, the opponent, filed seven additional documents, as further evidence by way of affidavit of Dr. B.M. Chaudhery. The controller has heavily relied upon the said affidavit in the impugned order.
  • Vide order dated 6th November, 2019, the Controller came to the conclusion that the documents and evidence filed by the Opponent, Natco would be taken on record, and would be considered at the time of final adjudication.
  • A Writ petition was filed challenging the impugned order dated 6th November, 2019, passed by the Controller of Patents and Designs Controller. In said petition the court held that 62(4) is to be treated as exception and not a rule. The Hon’ble High Court of Delhi also allowed the additional and rebuttal evidence.
  • After the hearing, the patent was revoked and appeal filed by Pharmacyclics LLC.

Two issues which the Board thought were necessary and argued by both sides to decide the stay application till the pendency of the appeal are :-

  • firstly, as to whether the deputy controller of patents has ignored the mandatory provisions of Act as raised on behalf of the appellant by not sending the additional and rebuttal evidence to the Opposition Board and
  • secondly, as to whether the deputy controller of patents has ignored the order of the Hon’ble High Court relating to attendance of Opposition Board Members in the hearing.

The Hon’ble Board held that mandatory provisions of the Special Act are not be ignored. The controller of patents was to follow the provisions of the Act strictly and to follow the High Court order.

The board held that the finding of the controller in the impugned order where the controller has held that he has not sent the additional and rebuttal evidence to the Opposition Board as this would take another six months and delay the proceedings is not acceptable.

The said findings are against the law and direction of the High Court. The Delhi High Court in its order clearly observed that in case any further evidence is filed under Rule 60 and publication under Section 62(4),the presence of Opposition Board member is permitted to ensure that the documents are discussed in Opposition Board. However, the Board noted that the same has not happened in the case.

It is noted that, at the time of hearing, all members of the Opposition Board were not present, except one Examiner, ShriProful Kumar Manwatkar.

In view of the above, the Hon’ble Board held that the stay on the order should be maintained as the balance of convenience is in favour of the appellant. As far as principles of injury is concerned, it was held that if the interim order is not continued, the proceedings in all suits for infringement filed by the appellant would not continue.

Shri. B.P. Singh appointed as a technical member at the IPAB

A writ petition was filed by the Indian Drug Manufacturers Association before the Delhi High Court. The main grievance of the petitioner was that a technical member who is qualified in the patents Act has not been appointed to the IPAB.

In the writ, it has been confirmed that vide a notification dated 21.7.2020 Shri B.P. Singh, Joint Controller of Patents and Design has been appointed as the technical member.

In view of the appointment, the writ has been disposed off.

Invention cannot be denied patent protection only because it also employs a computer program

The Hon’ble IPAB has allowed the Indian patent application IN/PCT/2002/00705/DEL titled “METHOD AND DEVICE FOR ACCESSING INFORMATION SOURCES AND SERVIC ES OF THE WEB”, of ALLANI FERID by setting aside the impugned order of Indian Patent Office dated 7th February, 2020.

The invention of appellant provided a forward looking solution in the form of an ‘Efficient Search Strategy’ to overcome the problems encountered in the traditional search engines which existed in 1999. Accordingly, the invention in consideration drastically reduces the mean time duration for accessing the searched information, because the user does not spend time in selecting and reviewing multiple search results as returned by the other prevalent technologies in 1999.

The hon’ble IPAB on examining the application held that while rejecting said patent application, the Respondent failed to appreciate the guidance provided by Hon’ble High court of Delhi in order passed in W.P. (C) 7/2014 & CM APPL. 40736/2019 dated December 12th, 2019 as how to deal with inventions relating to computer related inventions (CRI). The IPAB maintained that the Hon’ble High court of Delhi in said order clearly stated that if the invention demonstrates a “technical effect” or a “technical contribution”, it is patentable even though it may be based on a computer program. The mere fact that a computer program is used for effectuating a part of the present invention, does not provide a bar to patentability.

The hon’ble board continued to hold that an invention must be examined as whole and the following factors are to be considered while deciding upon the patentability of such (computer related) inventions – i.e. (i) technical effect achieved by it, and its (ii) technical contribution. The hon’ble board categorically held that “..the CRI Guidelines, 2013 [issued by Indian Patent Office] provide cogent and coherent guidance in terms of the indicators of “technical effect”, as follows:

  • Higher speed
  • Reduced hard-disk access time
  • More economical use of memory
  • More efficient data base search strategy
  • More effective data compression techniques
  • Improved user interface
  • Better control of robotic arm
  • Improved reception/transmission of a radio signal

The technical solution provided by the appellant invention is to retrieve the detailed information about the result which the user is looking for in a localized manner (without using any bandwidth resources), and thereafter taking the user directly to the desired internet resource (utilising the said detailed information) e.g. to a website, rather than providing a list of results for user to choose from which was common in that era. As the user has accurately specified the required resource, the bandwidth so consumed is guaranteed to assure a successful result to the user. Thus, the present invention delays emitting of a final request to the internet by locally implementing preliminary selection steps to form a well construed query, which is finally emitted to the internet.

The present invention therefore falls under at least the following indicators of technical effect i.e. Higher speed, more economical use of memory and a more efficient data base search strategy, and is patentable .

Further, hon’ble IPAB board acknowledged that controller incorrectly identified relevant prior art with respect to the present invention as said prior art and present invention have different objectives and they therefore provide different solutions.

The Hon’ble IPAB board concluded that in light of the Hon’ble Delhi High Court’s direction that the Guidelines for grant of patents relating to the Computer Related Inventions are to be considered, along with the settled judicial precedents for granting the patent, as well as the fact that the present invention provides at least the aforesaid technical effects, the Patent ought to be granted in favour of the Appellant.

Thus, as long as an invention exhibits technical contribution to the state of the art and possesses a technical effect, the same shall not be denied patent protection only because it also employs a computer program.

IPAB stays order of the controller revoking Novartis’s patent for Ceritinib

The Intellectual Property Appellate Board (IPAB) has stayed the order of the controller dated 16.08.2019 revoking Novartis’s patent covering the commercial product Ceritinib.

Novartis had filed an appeal against the impugned  order dated 16.08.2019 passed in the post grant opposition proceeding under Section 25(2) filed by Natco against Novartis’s patent 276026 . Due to the delay in appeal proceeding, the appellant had also requested for stay of the operation of the impugned order until the final appeal is decided.

In the stay application, and in the hearing two main issues were raised:-

Issue No.1: Whether the impugned order passed by controller was contrary to the order/direction passed by the Hon’ble Delhi High Court.

In the present case, parties admittedly completed their respective evidence under rules 57 to 61 of the Act. After the completion of pleadings, there is no provision or rule to produce new evidence once the hearing is sppointed. There is a window of sub rule 4 of Rule 62 where either party is allowed to rely on any publication at the hearing by giving notice to the other party and to the controller of not less than five days.

As per the hon’ble board, it is not denied that Natco filed an evidence along with rule 138 application prior to the hearing, i.e., has produced documents other than publication.

Novartis also raised this issue in a writ petition before the Hon’ble Delhi High Court, the Hon’ble Court clearly observed that order shall be passed by the controller hearing the post grant opposition on all the documents placed on record as on 11/07/2019 and no further documents shall be filed by the parties. The reply to additional evidence of Natco was already filed by Novartis on 9.7.2019.

The controller having been made aware of the order of the Delhi high court disregarded the evidence filed by Novartis while passing the impugned order. In fact it is admitted by the counsel appearing on behalf of Natco that rebuttal evidences filed by the appellant have not been considered

In view of above, the Hon’ble IPAB held that, prime facie, it is clear that such important issue raised in the appeal requires consideration.

Issue 2: Whether the Controller was misled by Natco in its pleadings.

In Natco’s pleadings, certain examples are reproduced which are the example taken from impugned Patent 276026 and are cited as example of WO “980 ( IN 653) which is a cited document.

The Hon’ble IPAB agreed that as far as pleading of misleading facts by any party, is concerned, it is no doubt, a serious matter.

The Hon’ble IPAB held that they do not wish to decide the two issues finally, but held that the appellant has made a strong case of stay of the operation of impugned order dated 16.8.2019.

Nivolumab patent granted in India

The Indian Patent Office (IPO) has dismissed 4 pre-grant oppositions filed by Indian Pharmaceutical Alliance, Pankaj Kumar Singh, Restech Pharmaceuticals, and Dr. Reddy’s Laboratories Ltd. and has granted a patent to Indian Patent Application 5057/CHENP/2007 covering the commercial product Nivolumab. Nivolumab, sold under the brand name Opdivo, is a medication used for treatment types of cancers.

The claims of the application were directed to an isolated monoclonal antibody or an antigen-binding portion thereof that binds specifically to human Programmed Death (PD-1) wherein the 6 CDR’S (SEQ ID No. 18, 25, 32, 39, 46 and 53) of the antibody were defined in the main claim. The main grounds raised in the oppositions were lack of novelty, obviousness and non patentability under section 3(c).

The cited prior art document for lack of novelty was EP1537878 B1. As per the controller, the prior art document cited does not disclose the isolated monoclonal antibody or antigen binding portion thereof that specifically binds to human Programmed Death (PD-1), comprising SEQ ID No. 18, 25, 32, 39, 46 and 53 as claimed in claim 1 of the present invention, hence the claims of the present invention are new or novel over the cited prior art.

The opponents also argued inherent anticipation by cited document EP1537878B1 as said document disclosed use of anti-PD-1 antibody for the treatment of cancer and while applying for the SPC based on EP1537878, the Applicant submitted that the product is Nivolumab, thus conceding that the antibody was inherently disclosed. Also, reliance was placed by the opponents on the complaints that were filed in the USA based on US equivalents of EP1537878B1 (US8728474, US9073994 and US9067999) and in said complaints it was stated that said  patents were put into practice by developing an anti-PD-1 antibody called Nivolumab. However, the controller held that the disclosure of cited art cannot be forming basis for the lack of novelty in the absence of disclosure of the monoclonal antibody as claimed in claim 1 with six CDR sequences in cited document.

As far as obviousness is concerned, the controller agreed with the applicants assertion that it is not obvious for a person skilled in the art to arrive at the claimed antibodies with unique sequence and such unexpected properties with reasonable expectation of success from the teachings of prior art even if the method of manufacture of antibodies is known. The Controller agreed that the method of making monoclonal antibodies have been known for a long time, still patents have been granted to antibodies, if they cannot be arrived by a person skilled in the art during normal course of action and considering the unexpected superior properties of claimed antibody over the reference antibodies in tighter binding activity, higher binding specificity along with the therapeutic efficacy.

For section 3(c), the controller held that the claims and the claimed antibody cannot be considered as isolated from nature. The controller held that the sequence listing clearly identifies the sequences of the antibody as being artificial and the artificiality is well explained by the Applicant. The controller therefore also rejected this ground.

Order revoking Pharmacyclics patent for Ibrutinib stayed by the IPAB

Vide an order dated 12th June 2020, the Hon’ble Intellectual Property Appellate (IPAB) has stayed the order of the Deputy Controller revoking Indian Patent IN262968 covering the product Ibrutinib.

The Hon’ble Board held that as per material available on record, the appellant has made a strong prima facie case in its favour. The balance of convenience is also in favour of the appellant and if interim order is not passed, the appellant will suffer irreparable loss and injury. The main arguments of the appellant considered by the Board are as follows:

  • In case interim orders are not passed, appellants suit for infringement of Patent being CS(COMM) 709/2019 may be dismissed on.

  • The controller while deciding the opposition disregarded the order of the Hon’ble High Court wherein it was directed to ensure that the members of Opposition Board be present so that new documents and evidences are discussed in the presence of the Opposition Board. The said documents/ additional evidences were not sent mainly on the reasons as given in the impugned order that it will cause further delay of six months and there is no procedure.

  • All other issues including novelty have been decided in favour of the Appellant except the issue of obviousness which is a mix question of law and fact as per settled law.

INTELLECTUAL PROPERTY APPELLATE BOARD PRESENTLY FUNCTIONAL

With the retirement of the last Chairman in May 2016, and shortly thereafter, the Technical Member, the Intellectual Property Appellate Board (IPAB), had been non-functional for a couple of years. The IPAB is the body responsible for dealing with appeals arising from orders of the Controller of Patents and revocation of patents filed u/s 64 of the Patents Act. The Board of the IPAB for hearing patent matters, is required to be composed of the Chairman and a Technical Member.

While a new Chairman of the IPAB, Hon’ble Justice Manmohan Singh, was appointed on 1st January 2018, the post of Technical Member was still lying vacant and in the absence of the requisite quorum for the Board to be functional, hearings, in appeals against orders under the Patents Act could not be conducted. While the post of Technical Member under the Patents Act was vacant, the Technical Member under the Plant Varieties Protection Act was available.

A series of writ petitions filed at the Delhi High Court urging the Court to intervene in appeals in matters of urgent nature, prompted the Court to issue directions to the Government for the immediate appointment of a Technical Member and to prolong the tenure of the existing Chairman. Following said directions, the Government of India issued a notice to prolong the tenure of the existing Chairman, Hon’ble Justice Manmohan Singh, till 21st September 2020.

The Court also found that the Chairman and Technical Member under the Plant Varieties Protection Act were competent to hear urgent matters relating to patents till the vacancies of the Technical Member under the Patents Act is filled up and that such orders will not be invalid for lack of coram.

As a result of the foregoing developments, the IPAB is currently functional with Justice Manmohan Singh as Chairman and the Technical Member of the Plant Varieties Protection Act acting as Technical Member in patent matters.

Thus the filing of appeals against orders of the Controller of Patents, is very much a viable option for applicants. In fact, even amidst the COVID-19 lockdown in India, the IPAB has taken steps to ensure its functioning and the following steps have been directed through office order dated 6th May 2020:

  1. The proceedings of the IPAB will continue through video conferencing.
  2. E-filing of urgent matters is permitted but physical filing is currently on hold.
  3. The parties are permitted to request for listing or make urgent mentioning of their matters by sending an e-mail to the IPAB.
  4. All communication with the IPAB, including filing of hearing submissions, audio of oral submissions, listing of cases, filing of documents etc., has to be done through e-mail.

The aforesaid protocol regarding communication, filing and hearing will continue till further orders of the IPAB.

Thus even at this point of time, cases requiring immediate attention can be mentioned as urgent matters before the IPAB and can be heard on priority basis.