तिमिरातुनी तेजाकडे- from ZP to IIT

08/03/2024

नुकतेच शिवाजीराव एस. जोंधळे इन्स्टिट्यूट ऑफ लॉ अँड रिसर्च, मुंबई येथे वेबिनार द्वारे "overview of Patent Law- India "या विषयावरील सत्रात भाग घेण्याची संधी मिळाली. मी संस्थेच्या प्राचार्या "डॉ. नुसरत हाश्मी" मॅडम आणि "ज्येष्ठ प्राध्यापक (ॲड.) कुणाल मनकाणी" सरांचे मनःपूर्वक आभार व्यक्त करते, त्यांनी मला लॉ स्टूडेंटशी संवाद साधण्याची ही संधी उपलब्ध करून दिली, त्याबद्दल मनःपूर्वक धन्यवाद 🙏🏻
आणि, सर्वांना जागतिक महिला दिनानिमित्त खूप खुप शुभेच्छा!

28/04/2023

Novartis A.G. v. Union of India (SC Civil Appeal No. 2706-2761 of 2013)

Facts:
This is landmark judgment with regard to defining the term “efficacy”. In 1997, Novartis, a Swiss based pharmaceutical giant filed an application to grant patent to an anticancer drug Glivec which is used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST) on the basis that it invented the beta crystalline salt form (imatinib mesylate) of the free base, imatinib. In this case, the Swiss pharma company got rejection for its patent application filed in India for the Imatinib. The patent application was objected on the ground of Sec. 3 (d) when application was examined post 2005. In May 2006, Novartis filed two writ petitions under Article 226 of the Indian Constitution before the High Court of Madras – one appealing against the order of Madras Patent Office rejecting its patent request and the other contesting that Section 3(d) of the Indian Patents Act is not in compliance with TRIPS and is vague, arbitrary and violative of Article 14 of the Constitution. The Madras High Court refused the Writ Petitions of Novartis holding that it did not have jurisdiction to determine whether a domestic law is in contrary to international treaty, so it cannot decide whether Section 3(d) is in compliance with TRIPS. The new phase of litigation stated in IPAB. The board considered the beta-crystalline form of imatinib mesylate as new and an inventive step but refused to grant a patent to the drug of Novartis since it was hit by Section 3(d) of the Act. Novartis challenged the said order by filing Special Leave Petition before the Supreme Court.
Issue raised:
• Whether the invention is in consistent with Section 3(d) of the patent act?
• Interpretation of Section 3(d) of the patent act?
• Whether the invention qualifies for the test of novelty and inventive for the alleged product?
Held:
The case finally made it to the Apex Court which delivered the landmark judgment on 1st April, 2013 and rejected Novartis patent application.
In this case, the Apex Court interpreted the term “efficacy” which is not defined under the said Act. The Supreme Court referred the oxford dictionary and observed a desired or intended result. Accordingly Supreme Court observed that, the test of efficacy depends upon the function, utility or the purpose of the product under consideration. Therefore, the court held that, in case of medicine, whose function is to cure disease, the test of efficacy can only be the “therapeutic efficacy.”

27/04/2023

Milliken & Company v Union of India (OA/61/2012/PT/MUM)

Facts:

In this case, Milliken filed a voluntary second divisional application after certain claims were rejected by the patent office in the first divisional application. The second divisional application was filed by the applicant during the prosecution of the first divisional application. The patent office rejected the second divisional application filed by the applicant. The further divisional application was rejected for being directed towards the same invention despite the objection to the first filed parent application for lack of unity in the FER as submitted by the Indian Patent Office. To get the claims patented, the applicant referred second divisional to IPAB. IPAB after looking into the facts and circumstances of the Patent application set aside the impugned order passed by Indian Patent Office and it granted the patent to the applicant.

Held:
The first divisional application was carved out from the parent application and then a subsequent divisional application was carved out from the first divisional application which is well within the terms and tunes of the provision under Sec. 16 of the act. The affected party should not be left in the lurch mainly on the basis of the objection raised by the office which necessitated the appellant to take resort to file the divisional application as the subject application in the instant case without any remedial measures available in accordance with the law.
There is no bar for filing the second divisional application on the basis of objection raised by the patent office in respect of the first divisional application relating to certain claims necessitating the aggrieved party to prefer a second divisional application. The impugned orders by the assistant controller of patents are set aside and he is directed to reconsider the application by giving the appellant reasonable opportunity to the appellant by sufficient materials and objections and after giving the opportunity the assistant controller shall pass orders in accordance with the law.
[Note: The provision of divisional application derives its nexus from the concept of 'Unity of Invention' which is an administrative requirement present in various forms in the Patent Act)

26/04/2023

Happy World Intellectual Property Day!

Natco Pharma Ltd. v. Bayer Corporation IPAB, 2012

Facts:

This is the only case where the Compulsory license granted so far in India. Natco, Generic Pharma company applied for Compulsory License on NEXAVAR which is a cancer drug used tto treat Liver Cancer and Kidney cancer drug. So Natco relied on all three grounds mentioned under Sec. 84 of the Patents Act, 2007. And compulsory licenses were granted by the Controller General of Patents on the following grounds:

a. Reasonable requirement of public not met. Because of the facts that number of bottles of drug supplied abysmally low considering number of patients requiring drug.

b. Patented drug not available at reasonably affordable price. Bayer’s drug priced at INR 2.8 Lakh/month as opposed to Natco’s price of INR 8.8K/month.

c. Patented Invention not worked in the territory of India- Natco argued that drug was being imported and not locally manufactured.

d. Importation has not been considered as working of invention.

Held:

The Controller agreed with the above grounds and grant compulsory license in favour of Natco Pharma for Nexavar i.e. Sorafenib Tosylate. A royalty rate of 6% also set by the Controller for the compulsory License. Appeal was filed by the patentee against this decision. IPAB upheld the decision of grant of compulsory license. However, it clarified that the term “working” could encompass importation as well and thus there is no requirement as such to locally manufacture the patented article in India provided that there is reasonable explanation for the same. But in this case, Bayer had no plausible explanation for not manufacturing the drug locally.

[Note: Compulsory license is an authorization granted by the Government to someone else i. e. third party to produce a patented product without the consent of the patent owner who has been taking undue advantage of exclusive rights granted by the patent.]

24/04/2023

Dhaval Diyora v. Union of India [Writ Petition (L) No. 3718 of 2020, Bombay High Court, 05 November, 2020)

Issue raised: Whether the pre-grant opposition filed by the Petitioner is maintainable?
Held: The Court observed that, the Controller shall give his/her decision in a pre-grant opposition proceeding after hearing the parties. The Court further states that, “The Rules lays down on consideration of the statement and evidence filed by the applicant, the representation including the statement and evidence filed by the opponent, submissions made by the parties, and after hearing the parties, the controller may either reject the representation or require the complete specification and other documents to be amended to his satisfaction before the patent is granted or refuse to grant a patent on the application, by passing speaking order. Most crucially it directs that the application and the opposition are to be simultaneously decided…
….. Therefore, scheme of section 25(1) read with Rule 55 postulates that both the applications seeking patent and pre-grant opposition are to be heard by the Controller simultaneously. The language and intent are clear. There is no separate hearing on the pre-grant application. The right under section 25(1) of pre-grant opposition starts when the patent is published and continues till the matter is decided by the controller but no further.”
[Note: As per Section 25(1), any person can file an opposition against patent application before the grant of patent by the Controller. Rule 55 of Patents Rules, 2003 provides for the appointment of a hearing in a pre-grant opposition proceeding, if the same is requested by the parties.]

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21/04/2023

Syntonix Pharmaceuticals, Inc. v. Controller Of Patents IPAB (27 June, 2014)

Judges: K.N Basha, Chairman

In this case, appeal filed against the order passed by the Assistant Controller of Patents & Designs dated 21st March, 2013, that dismissed the divisional application preferred by the appellant for seeking for the relief of patent in respect of Group-1 claim consisting of 1 to 28 claims.

Issue raised: Once a “lack of unity” objection is made, can the Controller reverse its position on the objection and refuse to entertain the divisional?

Held: The IPAB states that, “On the perusal of the impugned order, it is crystal clear that the Assistant Controller has given a finding to the effect that the inventions under Group-1 are similar and identical to that of the patent granted in respect of Group-IV claims 61-84 which is self-contradictory to the findings and objections raised in the FER. Therefore, we have no hesitation to hold that the appellant filed the divisional application only on the basis of the objection and on the basis of the finding given in the First Examination Report and there is absolutely no fault on the side of the appellant….”

Hence, The Board held that, if a divisional application is filed on the basis of a lack of unity objection raised in FER of the parent application, the controller cannot directly refuse the divisional application by adopting the position that its earlier opinion on lack of unity of invention in the parent application was erroneous

[Note: Section 16 deals with power of controller to make orders respecting divisional application of patents.]

20/04/2023

Neon Laboratories Pvt. Ltd. v. Troikaa Pharma Ltd & Ors. [2011 (45) PTC 357 (Bom)] Writ Petition No.: 211 of 2010

Issue raised: If the person opposing the grant of patent, files his opposition and also prays that he should be heard on the amended claims as well, then, whether it is incumbent upon the authorities to grant a personal hearing to the opponent?

Held: The Bombay High Court states that “When the law consciously confers a right on a person that right must be protected in the way it has been granted.” Section 25(1) of Patents Act and Rule 55 of Patent Rules contemplate that, if the original claim/application for grant of patent is amended and the amendments are opposed, then, a personal hearing to the objector (opponent) on the amended claims is required to be given if specifically requested.”

The Court held that, the controller has not given the Petitioner any chance of hearing even though the Petitioner admittedly requested for the same. Hence, the Petitioner’s statutory right of making submission during the hearing was denied. But the patent was granted to the Respondent by denying the Petitioner any chance to make a submission on his representation. The High Court finally set aside the grant of patent and directed the Controller to give hearing to the Petitioner with respect to amended claims filed as well.

[Note: Sec 25(1) deals with grounds of pre-grant opposition and Rules 55 deals with pre-grant opposition proceedings.]

19/04/2023

Hindustan Unilever Limited v. Controller of Patents & Designs (OA/14/2009/PT/MUM) (2013)
CASE NO - OA/14/2009/PT/MUM
ADVOCATES- (By Advocate Shri S. Majumdar)
JUDGES- Smt. Prabha Sridevan, Chairman
Shri D.P.S Parmar, Technical Member (Patents)

In this case, the appeal is filed against the rejection of a divisional application on the ground that it does not conform to Section 16 of the Patents Act, 1970.
In the instant case, the patent was applied for an invention entitled “ANTIPERSPIRANT COMPOSITIONS”. The First Examination Report (FER) was issued on 11/11/2005 raising certain objections. The appellant gave their explanation. Then, a Second Examination Report was sent which was received by the inventor almost at the end of the 12-month period that is given to them under law for putting an order to the application. The learned counsel submitted that since the time for putting the application in order had lapsed and since the appellant desired to get a patent for invention, a divisional application was made.
The time for putting an application in order for grant under Sec. 21 is given in Rule 24B(4). It says that it shall be 12 months from the date on which the first statement of objection is issued to the applicant to comply with the requirement. The applicant has twelve months to put his application in order for grant of patent. His application will not be examined unless he makes a request in the prescribed manner for such examination within the prescribed period (Section 11(B) of the Patents Act, 1970). The examination of the application is mentioned in Sec. 12.
IPAB told that, it was because of the paucity of time that the inventor had to re-submit the same invention as a divisional application. If time had been given by a prompt Second Examination Report, the inventor may have succeeded in putting the application in order. Hence, the board can’t treat this application as a divisional application in the absence of plurality of invention.
However, to ensure the fairness in the proceedings, the IPAB made below suggestions-
• When the First Examination Report is sent, the patentee may be required to respond within four months.
• Within two months, thereafter, the Patent Office if satisfied shall grant the patent, if not it will issue the second gist of objections within the said two months.
• Therefore, after the patentee will still have six months of the time allowed by Law.
• If the Patent Office feels that Second Examination Report must be sent, it may require the applicant to respond the objections within three months.
• This takes us to the 9 months. If objections are still unresolved, in an extreme situation, it is open to the Patent Office to issue one more Examination Report if the objections appear to be capable of resolution.
• The applicant will still have two months more to set it right and if even now, the Controller is unable to accept the application, hearing may be given after the expiry of twelve months.
The said appeal is dismissed with these directions.

17/04/2023

Sphaera Pharma Pte. Ltd. And Anr. V. Union Of India & Anr. (2018)

In this case, Delhi High Court decided upon the issue of limitation period for the examination of a patent application prescribed under the Patent Act, 1970 and The Patents Rules, 2003.
The Delhi High Court held that, any request for extension of time prescribed has to be made before the expiry of such time as prescribed in the Rules. Therefore, even if the express language of Rule 138 of the Rules is ignored, the benefit of Rule 138 would not be available to the petitioner (who requested for extension of time under Rule 138 to file are request for examination in Form 18), as no such application for extension of time was made prior to expiry of the prescribed time.
The Court further states that, the time limit of 48 months is mandatory and must be adhered to regardless of the delay caused due to any reason whatsoever. The time limits are there for a purpose and must be strictly followed by the applicant. However, if any problem arises because of the technical reason there must be some alternate method for the applicant for filing the request for examination of patent application after the completion of the time specified in the act.
(Note: Rule 138- Power to extend time prescribed. Under Rule 138(2), any request for extension to do any act or to take any proceedings shall be made before expiry of such time prescribed as per the Rules.)

15/04/2023

Nippon Steel Corporation v. Union of India (UOI)- W.P. (C) 801 of 2011: Manu/De/07/12/2011

In this case, the Petitioner is a corporation organized under the laws of Japan. It is stated that, the Petitioner has the world’s top-class technology and involved in intensive research and development in relation to it. On 9th February 2007, the Petitioner filed an application being PCT/JP2007/052796 under the Patent Cooperative Treaty (PCT) that designates India as a member.
The Delhi High Court held that, once application is deemed to have been withdrawn by applicant in terms of Section 11B (4) of Act, the Controller of Patents cannot entertain application for amending any portion of such application. It is not possible to accept submission of petitioner that Controller of Patents is bound to allow amendment at any time, even after deemed withdrawal of such application. The Court also noted that the Petitioner missed the deadline for filing Request for examination accordingly.
Hence, the Court concluded by clarifying that, the time-limit prescribed under the Act for filing a patent examination request is not directory but mandatory and it cannot be relaxed in any event.

14/04/2023

Seoul Semiconductor Co., Ltd., et al. v. Enplas Corp., IPR2014-00605 (PTAB, Nov. 5, 2014)

In this case, while addressing the issue of whether a patent owner’s motion for additional discovery was justified based on a newly-filed exhibit, the Patent Trial and Appeal Board (PTAB) denied the request for failing to demonstrate the requirement for additional discovery in view of the Garmin factors.
• With respect to the original exhibit, the Patent Trial and Appeal Board applied the factors set forth in “Garmin v. Cuozzo Speed Tech “ in determining whether the additional discovery was needed to satisfy the interests of justice. In doing so, the Board considered several Garmin factors.
• The first Garmin factor requires that the party requesting discovery should already be in possession of evidence showing, beyond mere speculation, that something useful will be uncovered by the discovery requests. Here, the patent owner had only established the “mere possibility” that something useful would be found, which was not enough.
• The next factor considered which is the third Garmin factor, provides that it is not in the interest of justice to require a party to produce information the other party can reasonably figure out or assemble on its own without additional discovery of the opposite party.
• The Board concluded that the expert’s declaration disclosed all of the information necessary for the patent owner to figure out or assemble the information being sought without additional discovery and that the patent owner had failed to show that the information provided in the declaration was incomplete or inaccurate.
• Finally, the Board applied the fifth Garmin factor, which provides that any additional discovery should be “sensible and responsibly tailored according to a genuine need.” The Board determined the patent owner’s additional discovery requests seeking “any and all experiments and work . . . , or any similar documents referring to [Parkyn] . . .” was too broad and overly burdensome and was not properly tailored to demonstrate the need for additional discovery.

13/04/2023

Ravi Kamal Bali v Kala Tech and Others [2008] (38) PTC435 (Bom)
Brief Facts:
In this case, docrine of Equivalence (DOE) first time applied in India. The plaintiff Ravikumar Bali had filed a suit seeking damages and an injunction from the court to prohibits the defendant (Kala Tech & Others) from manufacturing, using, selling & distributing tamper locks. Court issued a patent & certificate of registration (CoR)- 29-Feb-1994 for tamper locks/seal. Patent of addition issued- 12-03-1994 (for improvement made on the tamper proof lock/seal under name “TechLock”. Plaintiff alleges that the defendant no.1 manufacturing & selling a same product with a different name “ SEAL Tech” with the aid of Defendant no.3 who were employee of the plaintiff till 2002.
Contentions:
Plaintiff pleaded the docrine of Equivalence (DOE) i.e. it is not necessitated that goods have to be similar in all aspects in order to considered as an infringement on the patented product. In alleging so, the plaintiff put forward the similarities between the two products .The defendants considered that the goods sold by them under the name “seal tech” is distinct by stating that it is rectangular in shape & not in ‘V’ shape & does not require compress pressure among others. Also number of “Vanes “ used in the two products are different.
Issue:
Whether the product of the defendant “ Seal Tech” infringes upon the patented product of the plaintiff?
Sections applied:
Section 54, Section 10 of the Patent Act, 1970, DOE
Held:
• At the initial stage, the defendant was not present and the plaintiff procured an ex parte (ad interim) order injuncting the defendant.
• Upon hearing of the ex parte injunction, the defendant approaches the court and prays that the injunction order be vacated. The court vacates the ex parte order and sets a date for a detailed hearing of the interim application. After hearing both parties, the court reserves judgment. In the meantime, the Defendant moves an application to bring on record further documents and to raise a new defense. This application was heard by the judge on 3.6.2008, who then proceeded to reject the application.
• Tulzapurkar (counsel for defendant) argued that “the Defendants device, even if held to perform the same function, to obtain the same result, did not function in substantially the same way as the Plaintiffs device”. Surprisingly, Tulzapurkar did not deny the application of the “doctrine of equivalents” in this case, a doctrine that has, to the best of my knowledge, never ever been endorsed by any Indian court.
• The Hon’ble Court ruled in favour of the plaintiffs and opined that the built, functionality and shape of the product has to be considered. Moreover, the court stated that the usage or non-usage of force in the process and the shape of the product are a marginal difference and thus cannot be considered differences.
• The court took notice of Section 54 of the Patents Act, 1970 and held that “only the patentee of the main invention is entitled to improve or modify the main invention and claim patent for such or else it would permit anybody to benefit from it by exploiting the main invention”. Thus, in order to prevent fraud, the court applied the Doctrine of Equivalents opined that the defendant’s product is an infringement on the patent of the plaintiff.
• Court was view that; product of the defendant did infringe the patent of plaintiff. The final reasoning was there was no substantial difference between the two products.
• The slight additions made to the product of the defendant would not constitute a new product. If it was recognized as a new product then the potential for misuse would be very high as people would just change trivial aspects of patented product & would claim a new patent on it.