Division Bench of the Delhi High Court stays the order of the Single bench setting aside the grant of Novartis application

Vide an order dated 14th December 2022, the Controller of Patents and Designs, allowed Indian Patent Application no. 4412/DELNP/2007, filed by Novartis AG covering its heart failure drug Vymada. Ten Pre grant Oppositions were filed during the pendency of the said application. One of the Opponents was Natco Pharma Ltd. (Natco).

A writ petition under Article 226 of the Constitution of India, filed by Natco against the order dated 14th December 2022, was allowed by the Delhi High Court.

On 25th November 2022, the Controller addressed a notice, only to Novartis. Following the issuance of the aforesaid notice and as envisaged therein, Novartis presented itself before the Controller on 2nd December 2022, and was heard. Natco was never issued notice of the said hearing appointed under Section 14 (examination proceeding) and was, therefore, unrepresented. This was one of the grounds of the Writ.

The main reason for allowing the Writ was that the Court held that Rule 55(5) does, as it is enacted, envisage participation by both sides (applicant and opponent) in the entire exercise, from the point of submission, by the patent applicant, of a reply under Rule 55(4) to the notice under Rule 55(3), till the final decision to grant or refuse the patent or require the patent specification applications to be amended. The Court held that the objector objecting to the application cannot be excluded from the examination proceedings at any point. The order of grant was set aside and matter was remanded back.

An appeal was filed by Novartis against said order of the Single bench of the Delhi High Court, setting aside of grant of patent. The Division Bench till the next date of hearing, has stayed the impugned judgment of the Single bench of the Delhi High Court and therefore the Patent reinforced.

The main issues to be decided in the appeal is whether once the pre-grant opposition is filed both examination and opposition proceedings stand merged and whether any examination of the application can be undertaken by the Controller without issuance of a Notice to the opponent, arise for consideration in the present appeal.

Chemtura’s Patent restored

The Bombay High Court’s division bench has set aside the order of the IPAB revoking Chemtura’s patent IN213608 and has directed the Controller of Patents to restore the patent on the e-register.

IPAB had earlier revoked Chemtura’s Patent for non compliance of section 8 and lack of inventive step. Chemtura filed a writ against the decision in the Bombay High Court.

Stay tuned for details!

Trastuzumab “can” be sold as a bio similar to Roche’s Trastuzumab

The division bench of the Delhi High Court, of Badar Durrez Ahmed and Sanjiv Sachdeva, has permitted Biocon and Mylan to use Roche’s product data for Trastuzumab. Roche had challenged the approval mechanism adopted by the central drug standards controller (CDSCO) in giving Biocon and Mylan approval for its biosimilar drug and their product inserts containing product data before the single judge.

 Earlier, the Delhi High Court, in a single bench order, had allowed Biocon and Mylan to market their product without any reference to Roche’s product or biosimilarity.

 Stay tuned for a fuller report!

Delhi DB raises the bar of burden of proof on the Defendant to establish a credible challenge

A bench comprising of Justice BD Ahmed and Justice Sanjeev Sachdeva recently passed an order granting an injunction in a patent matter. The DB reversed an order of Justice Manmohan Singh who had denied the injunction.

The Court has also hinted at a presumption of validity of the patents holding that the grant of the patent by the IPO and the USPTO heightens the burden for establishing a credible challenge (see point IV. below)

The principles laid down by the Division Bench are culled out below:

1. The principles governing patentability of an invention have been summarized as under:
   • it must be the inventor’s own discovery;
   • it should not be a mere verification of what was already known before the date of the patent;
   • it is a manner of new manufacture and includes an improvement and an allied invention;
   • must also be useful;
   • not only the art, process or manner of providing, preparing or making an article but also the article prepared or produced by the manufacture can be patented;
   • should be more than a mere workshop improvement;
   • the improvement or the combination must produce a new result, or a new article or a better or cheaper article than before;
   • a combination of old, known integers may be so combined that by their working inter-relation they produce a new process or improved result;
   • mere collection of more than one integer or things, not involving the exercise of any inventive faculty, would not qualify for the grant of a patent;
   • there must be novelty in the mode of application and the novelty must show invention;
   • the new subject-matter must involve “invention” over what is old;
   • must involve something which is outside the probable capacity of a craftsman;
   • it must not be the obvious to a skilled worker, in the field concerned,
   • it must not be a natural suggestion of what was previously known;
   • Prior public knowledge of the alleged invention would disqualify the grant of a patent and prior public knowledge can be by word of mouth or by publication through books or other media;

    

2. Merely because the prior art and the subject patent use the same term for a feature does not necessarily mean that the feature is the same. The said term may have two different meanings in the prior art reference and the subject patent. For the invention to be anticipated, the feature disclosed in the prior art must pertain to the same concept as claimed in the patent.
3. The entire specification and teaching of the prior art must be considered while determining patentability. Mere reference to the abstracts of the prior art documents without considering the teaching of the prior art in the detailed description is erroneous.
4. The Indian Patent Office and the United States Patent Office have granted the patent and have not found that the patent is obvious in view of the cited prior art. Since these expert bodies have found the patent to be non – obvious, the burden of proof on the Defendant to establish a credible challenge is even greater.

F. Hoffmann La Roche vs CIPLA- A Digest

The long pending patent dispute ensuing between CIPLA and F. Hoffmann La Roche over Roche’s lung cancer drug Erlotinib hydrochloride (sold under the name of Tarceva) has been resolved after the Division bench of the Delhi High Court pronounced in its judgement that CIPLA  infringes Roche’s patent.

This judgement has contributed in establishing Indian jurisprudence with regard to various legal principles relating to not only the validity of a patent, but also in extending the scope of a composition of matter patent.

The History so far:

1. Roche sued Cipla in early 2008 for infringement of their Patent IN ‘774, claiming [6, 7-bis(2- methoxyethoxy) quinazolin-4-yl]- (3-ethynylphenyl) amine hydrochloride’ also known as ‘Erlotinib Hydrochloride’.
2. No interim relief granted to Roche in the early stages of the suit and the main matter was decided after the trial vide an order dated 7th September 2012.
3. The Single Judge’s decision was that while Roche’s patent IN ‘774 was valid (the counter claim for revocation could not be proved), there was no evidence that the alleged infringing product does, in fact, infringe their patent.
4. An appeal was filed before the Division Bench by Roche challenging the non-infringement aspect of the order of the Single Judge and a cross appeal was filed by CIPLA in respect of primarily the validity aspect of 774.
5. The main issues decided by the Division Bench are:

1. Whether Roche’s compound patent, i.e. IN ‘774, is valid; and
2. Whether CIPLA’s product, Erlocip which is polymorphs B of the compound Erlotinib, infringes Roche’s patent for the compound Erlotinib;

The Division Bench held that CIPLA’s product Erlocip, which is claimed to be a polymorph B form of the compound Erlotinib, infringes the compound patent IN ‘774 and affirmed the validity of the patent as well. The Division Bench set the correct legal principle for establishing infringement  i.e  mapping the infringer product with the patented claims.

The Bench held that “an infringement analysis involves comparison of each and every limitation of the claim with the allegedly infringing product/device. The analysis cannot be performed by comparing the product manufactured by the patentee with the allegedly infringing product.

The Defendant alleged that their product Erlocip is a polymorph B form of the compound Erlotinib Hydrochloride and since patent application for the polymorphs B of Erlotinib Hydrochloride is rejected, and hence Cipla is free to make polymorph B form.

The Division Bench of the Delhi High Court held that Indian Patent IN ‘774 claimed the compound, [6,7-bis (2-methoxyethoxy) quinazolin-4-y1]-(3-ethynylphenyl) amine hydrochloride], is clearly not limited to any polymorphic form of Erlotinib Hydrochloride, but to Erlotinib Hydrochloride itself. “This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent. Therefore as Cipla’s Erlocip is admittedly one particular polymorphic form of the Erlotinib Hydrochloride compound (Polymorph B), it will clearly infringe the IN’774 patent”.

The Division Bench while interpreting claims of the Suit Patent also summarizes principals of claims construction as follows:-

1. Claims define the territory or scope of protection.
2. There is no limit to the number of claims.
3. The broad structure of set of claims is an inverted pyramid with the broadest at the top and the narrowest at the bottom (Manual of Patents Office – Practice and procedure). An independent Claim can be the broadest scope claim. It has fewer limitations than any dependent claim which is dependent upon it’.
4. Where claims are ‘dependent’, they incorporates by reference ‘everything in the parent claim, and adds some further statement, limitations or restrictions’.
5. Where claims are ‘independent’ although relating to the same inventive concept this implies that the ‘independent claim stands alone, includes all its necessary limitations, and is not dependent upon and does not include limitations from any other claim to make it complete.
6. Different claims define different embodiments of the same inventive concept.
7. If subsidiary claims contain an independent inventive concept different from the main claim then the Patent office will insist on the filing of a divisional application.
8. Subject matter of claims can be product, substances, apparatus or articles; alternatively methods or process for producing said products etc. They may be formulations, mixtures of various substance including recipes. Dosage regimes or in some countries methods of use or treatment may also be claimed.
9. To invalidate a patent, the challenger must invalidate each claim separately and independently as it is quite likely that some claims may be valid even while some are invalid.
10. In an infringement action, first define the scope and meaning of the claims including its terms. Herbert Markman Vs. Westview 52 F.3d 967 also 517 US 370), the Courts held that an infringement analysis entails two steps:-

1. to determine the meaning and scope of the patent claims asserted to be infringed.
2. to compare the properly construed claim with the device accused of infringing.

Each claim has a priority date and hence a group of claims in a specification may have multiple priority dates. This only means that if a patent application with certain priority date and claims was followed by another application with different claims and different priority dates, then if they were consolidated or cognate with another application, each claim would retain the original priority date [Section 11(1)].

On the question of obviousness, the Division Bench held that “to test obviousness” the first test required to be applied is to see who is an ordinary person skilled in art (POSA) and its characteristics. The features of a person skilled in the art are;

1. that of a person who practices in the field of endeavour,
2. belongs to the same industry as the invention,
3. possesses average knowledge and ability, and
4. is aware of what was common general knowledge at the relevant date.

The Division Bench crafted the steps to determine obviousness/lack of inventive step in the nature of following queries:-

1. To identify an ordinary person skilled in the art,
2. To identify the inventive concept embodied in the patent,
3. To impute to a normal skilled but unimaginative ordinary person skilled in the art what was common general knowledge in the art at the priority date.
4. To identify the differences, if any, between the matter cited and the alleged invention and ascertain whether the differences are ordinary application of law or involve various different steps requiring multiple, theoretical and practical applications, and
5. To decide whether those differences, viewed in the knowledge of alleged invention, constituted steps which would have been obvious to the ordinary person skilled in the art and rule out a hindsight approach.

The Division bench held that the teaching of the prior art document should be considered as a whole and that similarity of structure alone was insufficient for prima facie unpatentability. To show obviousness besides structural similarity, there should be a reason or motivation shown in the prior art to make the particular structural change in order to achieve the properties that the applicant was seeking. CIPLA’s expert witness who was presented as a Person Skilled in the Arts (POSA), was not a medicinal Chemist and could not be considered as a POSA and the court held that CIPLA has been unsuccessful in satisfying the tests laid down above to establish prima facie that the suit patent was obvious.

CIPLA also sought revocation of the suit patent for violation of Section 8 of the Patents Act and contented that if Polymorph B of Erlotinib Hydrochloride is presumed to have been covered in the suit patent, this would imply Polymorph B of Erlotinib Hydrochloride to be same and substantially the same as the suit patent. Roche was then under an obligation to have disclosed before the patent office while prosecuting its application resulting in IN `774 that it had filed an application for grant of patent for Polymorph B of Erlotinib Hydrochloride resulting in US `221 which fact was not disclosed.

The Division Bench rejected this ground as well as it held that CIPLA did not prove that inventions in IN774 and US 221 are same and substantially the same.

Further the Bench held that, when Roche was prosecuting its application for grant of Suit Patent IN `774 separate application for grant of patent for Polymorph B form of Erlotinib Hydrochloride was filed on February 06, 2002. The Suit Patent was a product patent relating to the new molecule Erlotinib Hydrochloride whereas US`221 was an improvement patent application relating to certain polymorphic structure. The Court attributed the non-filling of the details of the application resulting in grant of patent US ‘221 by Roche to the bona-fide belief of Roche that the application resulting in patent US’221 is not same or substantially the same compound.

To conclude, the Division Bench affirmed the validity of Roche patent, IN ‘774, and set aside the single judge decision dismissing suit for injunction filed by Roche. However, keeping in view the fact that the IN ‘774 patent would expire in March, 2016, the Bench did not grant injunction against CIPLA. Importantly, the Division Bench of the Delhi High Court directed CIPLA to render accounts concerning manufacture and sale of Erlocip for the calculation of damages.

AD-INTERIM RELIEF TO SERGI: ALLOWED TO MANUFACTURE AND DEAL IN TRANSFORMERS

In the patent battle raging between Sergi India and CTR in the Bombay High Court, a Division Bench order provides some respite for the former and allowed Sergi to continue manufacture and deal in transformers.

Sergi had appealed the injunction reinstated against it by a Single Judge bench on the 23^rd day of October, 2015. The Division Bench order stayed the order of the single judge in view of the judgement of the Apex court in the Case of Dr. Aloys Wobben & anr. v/s Yogesh Mehra & ors [2014 SCC Online SC 482] which states, “only the culmination of procedure contemplated under Section 25(2) of the Patents Act, bestows the final approval of the patent. Therefore, it is unlikely and quite impossible, that an “infringement suit” would be filed, while the proceedings under Section 25(2) are pending, or within a year of the date of publication of the grant of a patent.” 

Hence, the bench ordered the Controller General of Patents to expeditiously dispose off the post-grant proceedings initiated under Section 25 (2) of the Patents Act , 1970 by Sergi India.