Category Archives: Pharma/Biotech Patent Litigations

Blogs in this Category would include all Patent Litigation’s in Pharmaceutical/Biotech Domain with focus on IIPRD’s analysis and key take away strategies from the Litigation.

U.S. District Court Confirms Validity of Patent For UCB Pharma’s Vimpat®

UCB Pharma, a Belgian pharmaceutical company, announced on 14th August 2016 that the U.S. District Court for the District of Delaware confirmed the validity of its U.S. reissued patent RE38551 related to anti-epileptic drug Vimpat® (lacosamide). The patent challenge was brought by generic drug makers who had questioned the validity of the UCB’s patent which is scheduled to expire in March 2022.

Vimpat®, one of four key products for UCB Pharma, generated net sales of 379 million euros ($423.7 million) in the first half of 2016. Vimpat® is indicated for use alone or as add-on therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years of age or older.

In 2013, UCB had sued numerous generic drug companies, including New York-based generics maker Argentum Pharmaceuticals, after they applied ANDA application to market a generic version of Vimpat® in the United States. In late May, Argentum Pharmaceuticals won an inter partes review of UCB’s patent by the USPTO’s Patent Trial and Appeal Board (PTAB).

The Delaware district court has ruled that UCB’s patent covering the epilepsy drug Vimpat® is valid. The Court upheld the validity of the UCB’s patent after issuing a sealed opinion on the patent. The court’s favorable decision for UCB now guarantees patent protection for Vimpat® until 2022.

Anna S. Richo, executive vice president and general counsel for UCB stated “We are pleased with Delaware Chief Judge Stark’s decision”. “This confirms the strength of our intellectual property for Vimpat®”.

The decision is currently under seal and will be released following an order from the court.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:antony@khuranaandkhurana.com.

Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation

In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § 262(l)(2)(A) notice of USFDA review.

            In Amgen v. Apotex, the Federal Circuit rejected Apotex’s contention that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” procedure of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that the 180 days notice provision under § 262(l)(8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.

Background:

            The biologic product at issue is Amgen’s Neulasta® (pegfilgrastim). Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. Pegfilgrastim treatment that can help patients make white blood cells after receiving cancer treatment. After Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Neulasta® (pegfilgrastim), the parties began the BPCIA’s patent information exchange process, known as the “patent dance”, and as a result, Amgen concluded that two patents U.S. Patent Nos. 8,952,138 and 5,824,784 will be infringed by Apotex’s biosimilar version of Neulasta®. Those infringement claims are being litigated in the U.S. District Court for the Southern District of Florida, although the ‘784 patent has been dropped since it expired.

            Apotex sent Amgen a letter on April 17, 2015, stating that it was “providing notice of future commercial marketing pursuant to § 262(l)(8)(A), though Apotex lacked an FDA license.” Amgen sought a preliminary injunction to “require Apotex to provide … notice if and when it receives a marketing license from FDA and to delay any commercial marketing for 180 days from that notice.” The district court granted that motion, citing the Federal Circuit’s decision in Amgen v. Sandoz that notice cannot be given before the biosimilar product is approved. Apotex appealed.

What is Biosimilar Patent Dance:

            The US Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information for resolving any patent disputes before a biosimilar product can enter the US market.  This procedure has strict timing and sequencing requirements and involves several rounds of information exchanges between the reference product sponsor and the biosimilar applicant. Some of the key steps of this process include:

  • Within 20 days after the FDA has accepted its abbreviated application, the biosimilar applicant must provide the reference product sponsor with confidential access to the biosimilar application and relevant manufacturing information for the proposed biologic.
  • Within 60 days of receiving these materials, the reference product sponsor must provide to the biosimilar applicant: (1) a list of patents it believes are infringed, and (2) identify which, if any, of these patents it would be willing to license to the biosimilar applicant.
  • Within 60 days of receipt of the patent list, the biosimilar applicant must provide the reference product sponsor a statement describing, on a claim-by-claim basis, the factual and legal basis as to why each patent is invalid, unenforceable, and/or not infringed. Within this same 60 day period, the biosimilar applicant may provide to the reference product sponsor a counter list of patents that the biosimilar applicant believes could be subject to a claim of patent infringement.
  • Within 60 days of receiving these materials, the reference product sponsor must provide a reciprocal statement describing, on a claim-by-claim basis, the factual and legal basis that each patent will be infringed, as well as a response to any statement regarding validity and enforceability.
  • The parties then have up to 15 days to negotiate in good faith to arrive at a list of patents, if any, that should be subject to a patent infringement action.

– If the parties reach agreement, then the reference product sponsor must bring an infringement action within 30 days for each patent on the negotiated list.

– If the parties do not reach agreement, the biosimilar applicant must notify the reference product sponsor of the number of patents it will provide in a second list, and the parties then simultaneously exchange within 5 days of this notice a list of patents that each party believes should be the subject of the infringement litigation. Within 30 days after this exchange, the reference product sponsor must bring an infringement action on all the patents on the simultaneously exchanged lists.

The Federal Circuit’s decision in the Amgen v. Apotex case:

            Two provisions of the BPCIA were at play in the Federal Circuit’s decision.  First, under § 262(l)(2)(A), the biosimilar applicant initiates the statutory “patent dance” by providing a copy of its biosimilar application and information about how its product is manufactured.  Second, under § 262(l)(8)(A), the applicant must provide a notice to the innovator 180 days before the first commercial marketing of the biosimilar product.

            In Amgen v. Apotex, Apotex argued that it had followed the patent dance procedure and made its (2)(A) disclosures to Amgen, and that the (8)(A) notice of commercial marketing is only mandatory if the applicant failed to provide the information required by (2)(A).

            The Federal Circuit rejected this argument and upheld the district court’s grant of an injunction to Amgen.  The court held that (8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.

            The Federal Circuit looked to the text of the law, finding that the “language of (8)(A) is categorical”, and there is “no other statutory language that effectively compels a treatment of (8)(A) as non-mandatory.”  The court further noted that § 262(l)(8)(A) “contains no words that make the applicability of its notice rule turn on whether the applicant took the earlier step of giving the § 262(l)](2)(A) notice that begins the patent dance (i.e. information-exchange) process,” and stood by its holding in Amgen v. Sandoz that the statute is “‘a standalone notice provision’ not dependent on the information-exchange processes that begin with (2)(A).” The court held that “the (8)(A) notice must be a notice given after FDA licensure of the biosimilar product, not before, and that pre-licensure notices are of no legal effect for purposes of (8)(A)”. The court explained that the 180 days period gives the reference product sponsor a period of time to assess and act upon its patent rights.

            In sum, the Federal Circuit concluded that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.

The Federal Circuit’s order can be found at the following link:

http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1308.Opinion.6-30-2016.1.PDF

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com.

Revocation of Valganciclovir patent by Controller of Patents, Chennai

Recently in a matter remanded from IPAB to Controller of Patents, Chennai, a decision of revoking Roche’s patent IN207232 for Valganciclovir was delivered after hearing both the parties. The subject patent was granted on January, 2009 followed which post grant oppositions were separately filed by CIPLA, Matrix, Ranbaxy and Bakul Pharma along with two NGOs Delhi Network of Positive People and lndian Network for People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS (hereinafter INP+ and TNNP+), wherein INP+ and TNNP+ were allowed by the Apex court to raise all contentions in the form of an intervention cum affidavit before the Assistant Controller and the parties agreed to be heard along with CIPLA, Matrix, Ranbaxy and Bakul Pharma. In the opposition proceedings, the patent was revoked limiting it to single process claim by the Controller of Patents on 30.04.2010 and being aggrieved by this decision, Roche filed an appeal at IPAB challenging the decision. IPAB on 30.01.2014 set aside the Patent Controller’s decision to revoke the patent on technical grounds and remanded it to the Controller for re-consideration.

Issues before the controller:

  • Determining whether the expert evidence was prior art publication or disclosure

Answering the issue, controller observes that the expert evidence is not a prior art document to be relied upon for deciding a case, but it may be considered for understanding the prior art documents, if the evidence covers such prior art documents. The opinion of the expert evidence, if it is based on further laboratory or animal study of a given subject matter, it cannot be considered for concluding such invention because it is later acquired knowledge, but it can be used for understanding the present invention. Therefore, expert evidences cannot be considered as prior publications/disclosures, but it can be taken as opinion on the prior arts.

  • Deciding upon the obviousness of the present invention

The next issue which the controller addressed was whether the present invention was obvious with respect to prior art references. The controller observes that the present invention is obvious against two prior arts US 4957924 and EP 0375329A2.

Claim 1 of the present invention recites,

  1. The compound 2-{2-amino-1, 6-dihydro-6-oxo-purin-9-yl} methoxy-3-hydroxy-1-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R) or (S)- diastereomers, on in the form of mixtures of the two diastereomers.

Regarding this , the controller states that the monovaline ester of ganciclovir is disclosed in the form of Markush formula in EP ‘329, which covers both monovaline and di-valine ester of ganciclovir where support for the both mono and di-valine ester of gancicloviris is provided in the specification. Thus the disclosure of EP ‘329 is clear and unmistakable direction to the mono valine ester of ganciclovir. Hence, a skilled person working in the synthetic chemistry field can easily arrive at the present invention without further experimentation. Therefore mono valine ester of present invention is anticipated by EP’329. Controller further emphasizes that claim 1 of EP ‘329 clearly and unambiguously discloses as at least one of the substituents is valine residue which indicate the presence of mono valine ester. Therefore, EP’329 undoubtedly disclosed mono valine ester of ganciclovir.

With respect to process claim, controller observes that the synthetic method for preparing mono valine ester of ganciclovir as claimed in independent claim 12 of present invention may not be explicitly disclosed in EP ‘329, but said method is just a general method for coupling acid group in the amino acid with hydroxyl group, which can be adopted for any type of alcohols. Therefore, using EP’329, a person working in the synthetic chemistry can easily prepare ester of ganciclovir with lysine without undue burden.

Further the controller observes that the object of the present invention is to provide a prodrug of ganciclovir with improved oral bioavailability. Controller notes that the solution for poor absorption in the gastrointestinal tract for acyclovir is disclosed in US ‘924 patent. Therefore a person skilled in the art can perceive to prepare mono valine ester of ganciclovir from the teachings of both EP’329 and US’924 references. Thus all the claims including process claim are obvious to a skilled person in the art.

  • Deciding upon the efficacy of substance under the subject patent under section 3 (d)

Deciding upon the efficacy of substance under the subject patent, the Controller observes that the new form L-monovaline ester of ganciclovir molecule has shown improvement in oral bioavailability than bis-valine ester of ganciclovir and ganciclovir, whereas there is no support in the specification pertaining to efficacy. Controller observes that the ester modification of the present invention was made to protect the substance from destruction in the gastrointestinal tract and make the molecule more bioavailable. Thus the controller has ruled that while bioavailability is one of the factors affecting efficacy, it cannot be directly equated to efficacy. Citing Hon’ble Supreme Court of India’s decision on Novartis case, the Controller rules that: “lmprovement in bioavailability of the new form cannot be considered directly related to efficacy. Even any unforeseen property observed in new form, unless such property directly relate to efficacy, it will be considered as inherent property of such substance. Since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, and therefore such a new form shall be considered as a same substance. Thus new form of the present case Monovaline ester of ganciclovir is considered as a same substance i.e. ganciclovir because,the difference in enhanced efficacy is not shown in the complete specification.” According to the controller, since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, therefore such a new form shall be considered as a same substance. Further regarding process used for preparing present invention, the controller held that the process used to prepare new form is a conventional process as it is already known process as disclosed in EP ‘329. Thus, the Controller rules that the present patent was a ‘mere use of a known process’ which was not patentable under S. 3(d), Patents Act.

  • Locus standi of the two NGOs as “person interested” under section 2(1)(t)

Deciding the locus standi of the two NGOs, as person interested under section 2 (1)(t) of patent act, Controller notes that NGOs would fall under the ambit of persons interested as the criteria of locus standi in post grant opposition is to be viewed in broader perspective to grant quality patent. According to the Controller, the two NGOs are the end users or directly affecting parties, if the patent is granted. Thus it is held by the controller that viewing in to the broader prospective, the two NGOs falls under the purview of under section 2 (1)(t) of the patent act and hence the parties have locus standi to oppose the patent.

Thus hearing all the parties and considering all facts and relevant arguments, the Controller revoked the patent granted for the drug Valganciclovir under section 25(4) of Indian Patent act.

About the Author: Mr. Sitanshu Singh, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: sitanshu@khuranaandkhurana.com.

Division Bench of Delhi High Court passed an interim order in Glenmark v. Symed (July 2015)

The High Court of Delhi has passed an interim order wherein the  Justices have made it clear that the appellant (Glenmark) may use any other process which may be a development of Glenmark process / Upjohn process so long as it does not infringe the patented processes of the respondent (Symed).

Background:

Symed Laboratories Ltd. is an Indian bulk drug manufacturer based in Hyderabad. Among other drug products, it manufactures Linezolid, an antibacterial used to treat skin and blood infection including pneumonia. Symed owns two process patents (IN213062 and IN213063) for the manufacture of intermediates for linezolid. The product patent for the drug is owned by Pfizer. Symed has sued a number of Indian manufacturers of Linezolid for patent infringement including Glenmark, Optimus Pharma, Alkem Laboratories Limited (Symed has now entered into a settlement with Alkem), Mankind Pharma Limited and Sharon Bio-Medicine Ltd.

The Delhi High Court had granted an ad interim injunction on 19 January 2015 restraining the Defendants, through their officers, directors, agents and distributors from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Symed’s registered Patents IN213062 and IN213063 till the disposal of the suit.

The grant of interim injunction had been predicated on four criteria:

  • That there is a prima facie case in favour of the plaintiff;
  • That the plaintiff is likely to suffer an irreparable injury if the defendant is not restrained;
  • That the balance of convenience lies in favour of the plaintiff; and
  • That public interest would not be dis-serviced by the grant of the injunction.

However, the injunction against Glenmark was vacated by the Delhi High Court consisting of Justice Badar Durrez Ahmed and Justice Sanjeev Sachdeva within 2 weeks of the Single Judge’s decision. The other defendants in this case have not been as lucky and continue to suffer the injunction.

While setting aside the January 19 order, the court noted: “It was incumbent upon the single judge to prima facie come to a finding that the active pharmaceutical ingredient (API) of both Glenmark and Symed were identical.”

“This (prima facie finding) does not appear to have been done. In these circumstances, we are vacating the interim order and modifying the same by directing appellant (Glenmark) to maintain accounts and file same in court..,” the Bench said and listed the matter for further hearing on 16 March 2015.

It was also noted by the Court that the single judge did not go into the point regarding applicability of section 104A of the Patents Act 1970 as per which in suits alleging infringement of process patents, the defendant (Glenmark) has to prove that its process is different from that of the plaintiff.

Symed Labs Ltd. vs Glenmark Pharmaceuticals Ltd. on 17 July 2015

In the very recent decision, the Delhi High Court has ordered that Glenmark shall use its process which is virtually identical to the Ujohn process as indicated in the expert report of Prof. Steven W. Baldwin (filed by Glenmark). The Court noted that the expert report indicates that the appellant (Glenmark) process and the Uphohn process are different from the process of preparation of Linezolid, which is employed by the respondent (Symed).

It has been agreed by both the parties that the appellant (Glenmark) shall manufacture Lineolid through its process indicated in the expert report which does not infringe upon the patented process of Symed as indicated in the report. The learned counsel for the respondent (Symed) has accepted the report to the extent that the process shown as the Glenmark process which is virtually identical to the Upjohn process does not infringe the patented process of Symed for production of Linezolid. The learned counsel for the appellant has also stated that they have not and shall not use the patented process of Symed numbered as IN213062 and IN213063.

Paragraph 24 of the report of Prof. Stephen W. Baldwin reads as under:

24. The two claimed intermediate compounds discussed above (PHPFMA and CHFA) do not appear in the Glenmark process for making Linezolid. Moreover, the reaction conditions involved in the various Glenmark process steps would not produce either of these claimed comounds, even as trace inpurities

[CHFA (N-[3-Chloro-2-(R)-hydroxprophy1]-3-fluoro-4-morpholinyl-anlaniline) : PHPFMA (N-3 [Phthalimido-2-(R)-hydroxprophyl]-3-fluoro-4 (morpholinyl) aniline]

While both the parties have accepted the above extracted paragraph No.24 of the report, the Justices have made it clear that the appellant (Glenmark) may use any other process which may be a development of Glenmark process / Upjohn process so long as it does not infringe the said patented processes of the respondent.

Dr. Singhvi, the learned senior Advocate stated on behalf of appellant (Glenmark) that the appellant has already been and will continue to take declarations from sellers of Linezolid to the effect that the seller does not violate anybody’s registered patent and will also in future specify in the declaration b the seller that he does not violate Symed’s aforesaid two patented processed, adding that in the event the respondent initiates legal proceedings against a seller for infringement of the aforesaid two patents, the appellant, on a request being made, would supply the aforementioned declaration.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com

Supreme Court stayed the Delhi High Court order of injunction against Glenmark over the Generic drug “Sitagliptin”

Reportedly, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. The Delhi high court on dated 20th March 2015 set aside an order of single judge bench of Delhi High Court which rejected the injunction application by MSD against Glenmark. This article aims to analyze the Delhi High Court judgment by the Division bench in detail. The detailed judgment can be found here.

Facts of the case:

Merck Sharp & Dohme (hereafter “MSD”) aggrieved by the dismissal of its application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals (hereafter “Glenmark”) from using its patented product Sitagliptin (Indian Patent No. 209816) filed an appeal. MSD filed an application before single bench Delhi High Court for permanent injunction, restraining infringement of the patent, damages, rendition of accounts and delivery up. The suit patent relates to a drug which lowers blood sugar levels in Type 2 Diabetes Mellitus (“T2DM”) patients. Glenmark opposed the application for ad interim injunction and relied on documents produced during the hearing. The learned Single Judge rejected the injunction application. Aggrieved by the dismissal of interim injunction Merck sought to obtain an interim injunction against Glenmark seeking to restrain Glenmark from selling its Generic products Zita (generic version of Januvia) and Zitamet (generic version of Janumet, combination of sitagliptin+metmorphin).

Argument advanced by the Appellant (MSD): 

The learned Senior Counsel, Mr. T.R. Andhyarujina for MSD argues, that its drug Sitagliptin is the first in its class of compounds that inhibits the enzyme Di Peptidyl Peptidase-IV (“DPP-IV”). The learned counsel argued that the suit patent is infringed because Sitagliptin and any of its acceptable salts are covered by its claims, thus resulting in the making, using or offering for sale, importing into India etc. of Sitagliptin or any of its salts or any form amounting to infringement of the suit patent. It was further argued that Glenmark, by manufacturing, selling, offering for sale and advertising the pharmaceutical combinations Sitagliptin Phosphate Monohydrate under the brand Zita and Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride under the brand name Zitamet infringes the suit patent and all its claims. It was underlined that Sitagliptin Phosphate Monohydrate cannot be prepared without manufacturing the active ingredient Sitagliptin molecule. Therefore, the use of Sitagliptin claimed by IN 209816 to prepare Sitagliptin Phosphate Monohydrate by Glenmark infringes the suit patent. MSD argued that its non-disclosure of applications (which were not pursued by it) was an inessential detail which should not have clouded the debate on whether Glenmark infringed its suit patent. It was submitted that the subject of the European Patent, and the application No. 5948/DELNP/2005 (filed on 18.06.2004 – in respect of the Phosphoric Acid Salt of a DPP-IV inhibitor that claimed Dihydrogenphosphate salt of Sitagliptin and was abandoned under Section 21(1) on 23.08.2010) could not have been the basis for refusing ad interim injunction. In India, on account of Section 3(d) and the interpretation of the expression “efficacy” by courts, MSD abandoned the phosphate salt application.

The learned counsel for MSD argued that Glenmark’s US Process Patent No. US8334385 is for “Process for the preparation of R. Sitagliptin and its pharmaceutical salts”. It was further contended that this patent clearly admits that Sitagliptin is developed for the treatment of T2DM and is the active free base. It also gives the full description of the process for preparing Sitagliptin freebase in the patent specification which is Scheme 6 in Merck’s patent. The claim of Glenmark’s patent is for a crystalline salt of Sitagliptin. The learned counsel relied upon the disclosures made to the suit patent IN 209816 to state that the basic invention for which patent protection was sought was Sitagliptin “with pharmaceutically acceptable salts thereof”. It is submitted that this is clearly stated in claims 1, 15, 17 and 19. Thus learned counsel stressed that Glenmark”s ZITA (Sitagliptin Phosphate Monohydrate) and ZITA-MET (Sitagliptin Phosphate Monohydrate and Metformin) infringe the suit patent because Sitagliptin is made and used by Glenmark in ZITA and ZITA-MET when it makes salt Sitagliptin Phosphate Monohydrate. It was underlined that the phosphoric acid salt of Sitagliptin was disclosed in the suit patent itself as one of the pharmaceutically acceptable salts.

Arguments advanced by the Respondent:

 The counsel for the respondent argued that the suit patent is obvious and does not involve an inventive step over and above previous disclosures in the prior art. It was further argued that the suit patent is anticipated by prior arts European Patent 1406622 and WO/01/34594.

Further it was argued by the Counsel for the respondent that the suit patent drug Sitagliptin as well as Sitagliptin Hydrochloride are unstable compounds possessing incapability of commercial production and industrial use.

The respondent argued that the claim goes much beyond the limited disclosures in the specification, and thus the claim is overbroad or an impermissible Markush claim that creates a false monopoly. It was also contended that the patent monopoly is too broad to be workable as it includes possibly 4.9 billion compounds and such elastic claims cannot be sustained.

It was argued that the complete specification of the suit patent does not sufficiently and fairly describe the invention and the method by which it is to be performed, since the patent does not describe the preparation of the Sitagliptin free base or Sitagliptin phosphate monohydrate, but only its hydrochloride salt.

Further it was argued that MSD did not comply with its obligation under Section 8 of the Act to disclose patent applications made for the “same or substantially the same invention” – it did not disclose 5948/DELNP/2005 (for Sitagliptin Phosphate Monohydrate), 1130/DELNP/2006 (Sitagliptin Phosphate Anhydrate), 2710/DELNP/2008 (Sitagliptin plus Metformin) or subsequent international applications for these compounds either. It was also argued that such suppression and concealment – contrary to statutory obligations – results in the invalidity of the patent, and at any rate, militates against the grant of an interim injunction that is premised on good faith and complete disclosure.

It was argued by the respondent that the suit patent by the plaintiff’s own admission is different from its product. The only exemplified salt being Sitagliptin Hydrochloride, no other salt can be claimed or covered in the impugned salt patent and the plaintiff, by its own admission equivocally, through several documents admitted that the suit patent is distinct and different from the Sitagliptin Phosphate Monohydrate (SPM) as well as its combinations with Metformin Hydrochloride. Urging that the latter two products are the subjects of separate patents, Glenmark highlighted that this is clear admission that they are not covered by the suit patent. In this respect, the details of the plaintiff’s application, i.e. 5148/DELNP/2005, especially, Claim no.1 and International Patent US 2004027983, again claim no.1 are relied upon. The said salt, i.e. SPM was also claimed to possess tremendous advantages over free base and previously disclosed hydrochloride salt. MSD‟s said patent application no. 5948/DELNP/2005 for SPM was specifically abandoned.

Conclusion:

Considering the arguments advanced by both the parties, the court evaluated the three grounds Prima facie case, irreparable injury and balance of convenience for passing interim injunction as below:

1) The court on the first ingredient held that prima facie case had been established by MSD for the fact that Glenmark uses Sitagliptin free base as the active component in its chemical formulation.

2) The court on the issue of whether the claimant would suffer irreparable injury in the absence of interim injunction or not, held in affirmative. The court rejected the argument of Glenmark that injunction should not be granted as the monetary compensation may be granted. On the contrary court opined that prices may not recover after the patentee ultimately prevails, even if it is able to survive the financial setback (or “hit”) during the interim, which may take some time.

3) On the issue of balance of convenience the court held in favor of MSD. On the issue of price difference between the commercial products by MSD and Glenmark is not so startling as to compel the court to infer that allowing Glenmark to sell the drug, at lower prices would result in increased access. However, the court observed that Permitting Glenmark to operate would not necessarily result in lowering of market prices. Hence according to court the balance of convenience lies in favor of MSD.

The court conclusively held that all the three ingredients for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

About the Author: Meenakshi Khurana, Partner at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: meenakshi@khuranaandkhurana.com

CIPLA’s plea for revocation of Novartis Patents for Onbrez may face major set back by the Government

As reported in TOI, the Indian Government has found very little merit in Cipla’s plea for waiver and cancellation of Patent rights for chronic obstructive pulmonary disease (COPD) drug over which Novartis has exclusive rights. We have reported on Cipla’s plea here.

Background:

Cipla, previously approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol and is currently selling under the brand name Onbrez. The said drug is one of the preferred medications for COPD.

The relevant sections 66 and 92 of the Indian Patents Act are as follows:

  1. Revocation under section 66:

Section 66 states “Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked”.

  1. Special provision for compulsory licences on notifications by Central Government

Section 92 (3) states Notwithstanding anything contained in sub-section (2), where the Controller is satisfied on consideration of the application referred to in clause (i) of sub-section (1) that it is necessary in—

(i) a circumstance of national emergency; or

(ii) a circumstance of extreme urgency; or

(iii) a case of public non-commercial use,

which may arise or is required, as the case may be, including public health crises, relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics, he shall not apply any procedure specified in section 87 in relation to that application for grant of licence under this section:

 Provided that the Controller shall, as soon as may be practicable, inform the patentee of the patent relating to the application for such non-application of section 87.”

Cipla’s Contention in the Representation:

  • Cipla argued that the causes of COPD are several and the sheer magnitude of the disease as per the publicly available data which is sufficient for the Central Government to invoke the provisions of Section 92 and to treat it as an “epidemic” or a “public health crisis”. Such exercise of power in the present case would be in consonance with the avowed purpose for which Section 92 has been enacted.
  • Cipla also contended that Novartis has been granted these patents since 2008-09 but has chosen not to manufacture the same in India. However, Novartis merely imports a negligible quantity of these products manufactured in Switzerland through its licensee Lupin Pharma as per its own data filed before the Patent office. As submitted by Novartis in IPO in Form 27, the import for the year 2013 is a meagre 53,844 units which do not satisfy even 4,500 patients annually which is a shortage is more than 99.97 percent.
  • Further Cipla contended that cost of the drug is also very high for a patient in India. The estimated cost of the drug Indacaterol as imported and sold by Lupin Limited, under the trademark Onbrez is about Rs.2000/- per month per patient. On the contrary, the proposed drug of Cipla under name UNIBREZ would be costing approximately Rs. 400 per month.

 It is pertinent to note that Section 66 has been invoked only on two occasions earlier. Firstly it was invoked for the case of a process patent granted to Agracetus, an American company for genetically engineered cotton cell lines. The said patent was revoked by the Central Government in the year 1994 keeping in mind public interest and the fact that genetically engineered cotton, being a product of concern for the national economy, particularly for agriculturists, ought not to be the subject matter of a patent monopoly. Secondly in 2012, a patent granted to Avesthagan Limited for a “synergistic ayurvedic/ functional food bioactive composition” i.e. the composition consisting of Jamun, Lavangpatti and Chandan to be used for treatment of Diabetes. In light of the public interest in using traditional knowledge for curing and treating Diabetes, the said patent was also revoked under Section 66 of the Act. However pertinently, both the patents were revoked due to cloud over patentable subject matter.

It would be prejudiced to comment on the fate of the matter at this stage. However as per TOI the Govt. may turn down the plea of Cipla for revocation of Novartis patent.

About the Author: Mr Sitanshu Singh, Patent Associate, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: sitanshu@khuranaandkhurana.com

Cipla Files Representation with Govt. Seeking Revocation of Novartis’ Patents

It has been recently reported in Economic times that Cipla has filed representation with the government (Department of Industrial Policy & Promotion) seeking revocation of five patents of Novartis on indacaterol, a respiratory drug for the treatment of chronic obstructive pulmonary disease (COPD) and marketed as Onbrez by Novartis. The central government, under section 66 of the Indian Patent Act, has the power to revoke patent in public interest, after giving patentee an opportunity to be heard.

According to section 66,

“Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”

Cipla has launched its generic version of indacaterol and alleged that Novartis held patents on indacaterol since 2008-09 without manufacturing in India and importing only in negligible amounts, as a result of which there is an urgent and unmet need to provide this drug to patients at affordable prices. According to Cipla, it has potential to manufacture adequate quantities of the drug to make available in the country.  Cipla’s launched generic version of indaceterol is reported to be 1/5th of the price of Novartis’ Onbrez.

This is the first time that an Indian generic company has asked the government to revoke patents on the ground of public interest under section 66. Otherwise, the revocation has always been sought on grounds under section 64 (for example obviousness, anticipation, insufficient disclosure, violation of section 8, 3d etc.), whether an Indian company has filed a revocation petition or a counter claim in an infringement suit. However, public health and drug price play significant role in deciding a patent’s fate in India especially in context of Compulsory Licensing of patent as it happened in Natco’s case. Even in Roche v. Cipla, public health and pricing issues were considered by the India courts, although the decision at the High Court was based on merits of the case and not in public interest.

It is highly expected that Novartis will take a legal course to challenge Cipla’s launch. Novartis has been very active to protect patents for its one of the blockbuster anti-diabetic drugs vildaglipton in India. Novartis has sought, just a few months ago, quia timet interim injunctions against several Indian generic companies including Glenmark generics, Bajaj healthcare, Cadila healthcare, Alembic pharmaceuticals against alleged patent infringement of vildaglipton even before they actually launched their generic versions and after they obtained marketing approvals from DCGI.

Thus Novartis will most likely file patent infringement suits seeking interim/permanent injunctions restraining Cipla from manufacturing and selling generic version of indacaterol in India.

On another note, Cipla could also have applied to obtain a compulsory license to manufacture and sell indacaterol before launching the drug. All three grounds of granting compulsory license under section 84(1) viz. reasonable requirements of public not being met, drug non-affordability and non-working of patent in India could have been proved by Cipla. According to Cipla, Novartis declared import of meagre 53,844 units for the year 2013 which do not satisfy even 4500 patients annually where there are more than 1.5 crore patients in need of the drug. Cipla also urged the government to consider COPD as an epidemic worthy of being qualified as a “public health crisis” as it claims 50 lakh lives annually in India, which is more than the toll from HIV-AIDS, malaria, cancer and tuberculosis.

Till now, we are not aware of any case in India wherein the government has revoked the patent in public interest under section 66. The outcome of government opinion to revoke said patents is thus eagerly awaited. This would act as precedent for all similar future cases. And if the government decides to revoke the patent under this section, the ongoing conflict between multinational innovator companies and Indian generic companies is going to intensify. Innovator companies criticize that India has weak patent laws not in compliance with international standards, whereas Indian government takes a stand that its patent laws are in compliance with TRIPs standards and are designed to meet the objectives of drug availability, affordability and accessibility.

 About the Author: Meenakshi Khurana, Partner at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: meenakshi@khuranaandkhurana.com

Why Protecting Patents in India is Giving Hard Time to Drug Patent Holders

Introduction

A lot has been discussed on the Novartis ruling indicating much higher standards of patentability under Indian law under section 3d. The ruling decided that any new form of known compound (in medicine) would be patentable only if there is enhanced ‘therapeutic efficacy’ over the known compound. Post Novartis ruling, a couple of patent revocation decisions at Intellectual Property Appellate Board (IPAB) ruled on section 3d giving precedent of Novartis. In addition, these decisions also seem to be setting higher standards of non-obviousness as compared to countries such as United States.

Case I: Fresenius Kabi Oncology Limited v. Glaxo Group Limited, decided in July 2013

a)     Case Facts:

Fresenius Kabi filed a revocation petition against Glaxo’s patent IN221171 (referred to us ‘171 hereinafter) claiming di-tosylate salts of Lapatinib on grounds of obviousness, section 3d and section 8. Fresenius alleged that the ‘171 patent was obvious to a person skilled in the art with reasonable expectation of success in view of the combined teachings of  D1  read along with D2 to D4.  D1 was a basic product patent of Glaxo (IN221017) disclosing Lapatinib free base and its various salts. Amongst salts, hydrochloride (HCl) salts were the ones selected and exemplified, however D1 also disclosed ditosylate salts as one example. Furthermore, background section of D1 discussed problems of hygroscopicity and instabity of HCl salts.  D2 was a prior patent disclosing ditosylate salts of different compounds disclosing the problems solved by the ditosylate salts such as better moisture sorption and better stability. D3 and D4 were general prior art literature articles disclosing pharmaceutical salts and selection of salts for basic drugs. Fresenius also alleged that the ditosylate salts of the said patent are new forms of known HCl salts of Lapatinib showing no enhancement in therapeutic efficacy and hence not patentable under section 3d as well. b)     Decision:  i. On Obviousness: IPAB, first of all, reinforced that under Indian law, it is the “person skilled in the art” (referred to as Ms. P. SITA) who would decide obviousness of the invention, rather than person having ordinary skill in the art as in United States and other geographies. It was held that Ms. P.SITA was not a dumb person who was ignorant of happenings in her field of art, but had skill to perform experiments with the knowledge of state of the art. It would be obvious for Ms. SITA to solve the problem of hygroscopicity and instability by combined teachings of D1 to D4. She already knew the problems being faced with HCl salts and the said prior art would give her motivation to prepare the ditosylate salts to arrive at the invention of the ‘171 patent with reasonable expectation of success. ii. On Section 3d: Citing precedent of Novartis ruling, it was held that the salts were shown not to have enhanced ‘therapeutic efficacy’. Better stability, better moisture sorption properties and other physicochemical properties exhibited by di-tosylate salts were rejected as proof of better ‘therapeutic efficacy’ over known HCl salts. Note: Fresenius also filed another patent revocation application against the basic product patent IN221017 claiming Lapatinib, which was dismissed by IPAB. Case II: Ajanta Pharma Limited v. Allergan Inc., Allergan India Private Limited and The Controller of Patents and Designs, decided in August 2013  a) Case Facts: Two Revocation Petitions were filed by Ajanta Pharma against Allegan’s two patents, one claiming fixed dose combination of Timolol and Bimatoprost (IN212695, referred to as IN‘695 hereinafter) marketed as Ganfort® and the other claiming fixed dose combination of Brimonidine and Timolol (IN219504, referred to as IN‘504 hereinafter) marketed as Combigan®. Both drug combinations are for treatment of ocular hypertension. Both patents were revoked by IPAB on ground of obviousness and section 8.

b)Decision:

i.On obviousness:

· IN‘695 Patent:

IPAB held that it was obvious for Ms SITA to arrive at the fixed dose combination of Timolo and Bimatoprost for the treatment of ocular hypertension in view of the combined teachings of known serial (five minute gap) administration of these two drugs further in view of Diestelhorst M. et al disclosing fixed dose combination of Latanoprost and TImolol for treatment of glaucoma, and two other prior art documents teaching better efficacy and potency of Bimatoprost over Latanoprost. Latanoprost was a predecessor of Bimatoprost, both belonging to the same class of Prostaglandin Analogs. The fixed dose combination of Latanoprost and TImolol was known to reduce side effects and increase potency to treat glaucoma as compared to individual drugs. IPAB rejected Allergan’s contentions that both drugs were structurally different or acted on different receptors. IPAB further rejected Allergan’s contentions of achieving unexpected effects of reduced side-effects and increased potency. Secondary considerations were not considered relevant in determining obviousness. IPAB held that Ms. P. SITA would find the drugs closely related and be motivated by teachings of Diestelhorst M. et al to produce fixed dose combination of Timolol and Bimatoprost with reasonable expectation of reduced side-effects and increased potency. She would know the trend going from monotherapy to adjunct therapy to fixed dose combination in order to optimize the convenience and the patient compliance. ·IN ‘504 Patent IPAB held that it was obvious for Ms. P.SITA to arrive at the fixed dose combination of Brimonidine and Timolol in view of the combined teachings of known topical administration of Brimonidine in combination with Timolol spaced 5 minutes further in view of Desantis disclosing fixed dose combination of Timolol and alpha 2 agonists. It was held that both Timolol and Brimonidine were commercially available. It was known that serial administration of Brimonidine and Timolol reduced intraocular pressure better than TImolol and Brimonidine alone. It was held that DeSantis expressly provided motivation for fixed combination to increase patience compliance.  It was held that when viewed under a proper standard, the evidence establishes a motivation to combine since it was common at that time to provide Brimonidine and Timolol sequentially and DeSantis taught fixed combination. IPAB also cited the US Court of Appeals judgement in respect of the US equivalent patent in Allergan Inc vs. Sandoz wherein the US equivalent patent was held invalid as obvious. Key take-aways:

a)Prepare to clear a higher bar: Ms. P Sita has more than ordinary skill

Obviousness standards in India are higher as compared to countries such as US, in such a manner that the skilled person in US is a “person having ordinary skill in the art”, called as PHOSITA whereas in India she is a “person skilled in the art” called as Ms. P.SITA. The level of skill of Ms. SITA looks to be higher than PHOSITA. IPAB, in above cases, cited Roche v Cipla wherein the judge highlighted in context of obviousness that Ms. P.SITA is a not a dumb person who is ignorant of happenings in her field of art, but has skill to perform experiments with the knowledge of state of the art.  Glaxo (the respondent in the above first case) cited various foreign decisions to show how obviousness is decided, who is the person Skilled in the Art, what is the Common General Knowledge and so on, however, IPAB citing Roche v. Cipla highlighted that observations made in foreign judgements would not be guiding factors. May be that is a reason that the US counterpart of the IN‘171 patent is a granted and unopposed patent whereas its Indian equivalent patent is held to be obvious and revoked. Not only US, even the corresponding EP granted patent passed EPO’s obviousness standards. Again for the combination therapy patents in India, as seen in the above Ajanta v. Allergan IPAB decision, standards of obviousness seem to be stricter. Both the patents of Allergan covering ophthalmic compositions were revoked. Ganfront®, for example, in US and EP is protected as EP and US patents, but here in India the patent is revoked. For combination therapy of A and B, if serial administration of A and B is known to alleviate the condition better than monotherapy and a fixed dose combination of A or B with C is known for alleviating the same condition, it seems that it will be difficult to pass the obviousness challenge in India, owing to Ms. P. SITA who would be knowing the happenings in her field and would know the trend going from monotherapy to adjunct therapy to fixed dose combination in order to optimize the convenience and the patient compliance. Furthermore, it seems that secondary considerations in India have not been considered relevant in India in determining non-obviousness. Unexpected effects are generally accepted in US as a means to rebut obviousness rejection. Thus, person skilled in the art in India is considered to be having more skill, more creative imagination as compared to the person having ordinary skill in the art in other important geographies such as US, and hence clearing obviousness challenge is tougher. For patent holders around the globe, to clear these higher standards of obviousness is becoming problematic. b)3d after Novartis: Physico-chemical properties are not enough This is clear that after Novartis case, salts (or other new forms) of known compounds would always be hit by section 3d unless enhancement of therapeutic efficacy is not proven. Physico-chemical properties would not be considered to impart therapeutic efficacy. The “therapeutic efficacy” test as laid down by Supreme Court (SC) in Novartis will be cited as precedent in all such cases. Again, patent holders around the globe would have hard time pursuing their salts (or other new forms) patent applications in India unless enhancement in therapeutic efficacy is proven. Considering that the pharmacophore remains the same in developing these new forms, proving enhancement in therapeutic efficacy would be very difficult. The enhancement in physico-chemical properties, which impart inventive step over the known compounds, would not generally be able to comply with “enhancement in efficacy” clause in section 3d till Novartis precedent prevails. Even though SC clearly laid down that physico-chemical properties such as increased stability, absorption, lower hygroscopicity etc. could not be said to enhanced therapeutic efficacy, regarding bioavailability, SC pointed that increased bioavailability may or may not lead to enhanced therapeutic properties and would be dependent on case to case basis. But again, proving enhanced bioavailability leading to enhanced therapeutic efficacy would be difficult. No matter how enhanced bioavailablity has helped the drug to perform better, the test relied by India is to prove therapeutic efficacy enhancement over the known compound.

The law of the land

The Indian Patent Office has been receiving criticism from the US and other developed countries for following such stricter standards of patentability in refusing applications and revoking patents. The intention behind section 3(d) and setting higher standards of obviousness is to prevent evergreening and frivolous pharmaceutical patents in India, so that the public access to medicines is ensured. Such provisions are necessary for protecting public interest and ensuring public access to medicines in developing countries like India. However, steps should be taken to ensure that genuine innovative inventions should not be rejected so that the right balance between patent protection and public access is maintained to further research and development of newer medicines.

About the Author: Meenakshi Khurana, Partner at Khurana and Khurana and can be reached at: meenakshi@khuranaandkhurana.com

Note: This Article was first published in a premier Managing IP magazine in March 2014 here

GSK’s patent on lapatinib ditosylate revoked by IPAB

GSK’s granted patent IN221171 (‘171) on lapatinib ditosylate (marketed as Tykerb), a tyrosine kinase inhibitor for treating breast cancer, was revoked by IPAB by its order of 27th July, 2013.

A revocation application was filed by Fresenius Kabi Oncology Limited. The patent is revoked on ground of non-compliance with S.3d alone on basis of no proof of enhanced therapeutic efficacy vis-a-vis lapatinib di-HCl salt (known compound). Still IPAB discusses the grounds of obviousness and non-compliance with S.8 in detail as it considers these grounds important.

Section 3d

IPAB very straight forwardly failed the test of section 3d for the ‘171 patent. Taking precedent of Novartis Glivec case, it was held that there was no enhancement in therapeutic efficacy of the ditosylate salt as compared to the di-HCl salt and thus “the patent deserves to be revoked”. The only enhancement w.r.t the di-HCl salts was the increase in moisture absorption property and the increase in stability which are physico-chemical properties.

Next IPAB discussed the grounds of obviousness and Section 8, though it considers that non-compliance with Section 3d itself revokes the patent.

Obviousness

GSK’s basic patent (IN221017) on lapatinib was cited as prior art (D1) in view of three other prior art documents D2 to D4. It was argued that D1 describes a list of acid addition salts which exemplify 19 acid addition salts among which p-toluene sulphonic acid salts were one of them and even one Example 29 is a tosylate salt.

It was held that at the time of invention of ‘171 patent, the inventors knew that the HCl salts of lapatinib were hygroscopic and thus having stability issues (described in background section of the ‘171 patent). D3 and D4 are non-patent basic literature articles describing selection of salts and pharmaceutical salts respectively. D2 is a prior patent WO 98/25920 disclosing tosylate salts of 3-pyridoxyl alkylene azetidine-2-yl compound and that these are less hygroscopic, more crystalline, more stable, have a higher melting point and are readily purifiable as compared to hydrochloride salts. It was argued that D3 discloses that aryl groups are said to minimize hygroscopicity as opposed to the poorly stable hydrochloride and sulphate salts which teaches towards tosylate or ditosylate salt with reasonable expectation of success in combination with D1, D2 and D4. D2 further teaches tosylate salts to sorb less moisture, are more stable and crystalline.

IPAB clarified that the skilled person in obviousness analysis in Indian law is the person skilled in the art (Ms. SITA) rather than the person having ordinary skill in the art (PHOSITA) as used in US law, in reply to the Respondent’s citing of US case laws and description of skilled person as PHOSITA. IPAB held that the skilled person (Ms. SITA) would know at the time of the invention of the problem of the hygroscopicity and stability of HCl salts and it would be obvious to try for her to select ditosylate salt as taught by D1 in view of D2 to D4. IPAB further held that whether D2 belonged to another class of compounds (read analgesics) would be immaterial. IPAB asserts that:

“Salt selection especially if there is a wide range is not a matter of routine, according to the respondent. Even if we accept this as correct, it does not help the respondent. Ex D is about salt selection and it shows that aryl groups present a hydrophobic barrier to minimize hygroscopicity. The Person Skilled in the Art would look at Ex.C  and find that the tosylate salt of such 3-pyridoxyl alkylene azetidine-2-yl compound shows exactly the same qualities that the persons in this field are looking for in relation to Lapotinib. She knows that tosylate compound is a preferred compound from Ex B and that it can be prepared by Procedure D. She is not a dullard she can do experiments with skill. She is more likely to think “Let me try a tosylate first. If it demonstrates the same improvements as it has in Ex-C then I need not search further.” She would have tried a tosylate with a reasonable expectation of success.”

                                                                              Ex D = D3, Ex C = D2 and Ex B = D1

IPAB finally held that if the salt selection were to be made from a vast variety of salts by testing each compound with no clue available, then selection of one particular salt is not easy but in this case the clue is provided by D2 to D4 which makes the invention obvious.

Section 8

IPAB rejects the ground of Section 8 in the absence of pleading and proof of violation. IPAB stated that:

“It is not enough to merely reproduce the language of the section. A S.8 violation has severe consequences and the case for it has to be made out. The facts have to be pleaded and the applicant must state how the particular undisclosed application was for the same or substantially the same invention. It is also not enough to just file the documents along with an affidavit. The least that the deponent shall state is how each application mentioned therein is for the same or substantially the same invention”

On another note, IPAB stressed the importance of compliance with S. 8 in a number of ways as shown below. In the opening sentence under the S. 8 heading itself, IPAB states that

S.8 destroys a patent which is otherwise patentable on grounds which have nothing to do with the invention, but only with the Inventor’s lapse during the grant proceedings”.

Further excerpts of IPAB are as below:

“The Controllers cannot ignore it and condone the breach. The patentee cannot  tell the Examiners, ” We are filing applications nineteen to the dozen, compliance is very difficult, and in any case there is the Super Kamadhenu the Internet which will give you what you want.”

In view of what is stated in the Ayyangar Committee Report, we are of the opinion 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.”

Patentees must comply with S.8 (1) provision however inconvenient it is.”

Fresenius Kabi also filed revocation petition against GSK’s basic patent IN 221017 claiming Markush structure encompassing lapatinib and pharmaceutically acceptable salts (discussed as D1 hereinabove) on grounds of obviousness, non-compliance with S.3d and S.8. This revocation petition however was dismissed by IPAB. We would discuss this in detail in an upcoming article.

About the Author: Ms. Meenakshi Khurana, Patent Attorney at Khurana & Khurana and can be reached at: Meenakshi@khuranaandkhurana.com

Follow us on Twitter: @KnKIPLaw.

Monsanto’s Patent on Method of Producing Transgenic Plants refused by IPAB

Monsanto’s Indian patent application 2407/DEL/NP/2006 on transgenic plants with heat/salt/draught tolerant plants is rejected by IPAB.  The subject patent application is directed to a method of producing a draught/stress/heat/salt/drug tolerant transgenic plants by inserting a recombinant DNA molecule that expresses a cold shock protein CspA or CspB. The subject patent application was rejected by the Controller of Patents on lack of inventive step under 2(1)(ja) in view of three prior art references and under section 3d.

The final set of amended claims contain four claims, the independent claim is as follows:

1.  A method of producing a transgenic plant comprising the steps of:

 (a) inserting into the genome of plant cells a recombinant DNA molecule comprising a DNA encoding a cold shock protein, wherein said DNA encoding said cold shock protein is operably linked to a promoter and operably linked to a 3′ transcription termination DNA polynucleotide;

(b) obtaining transformed plant cell containing said recombinant DNA;

(c) regenerating plants from said plant cells; and

(d) selecting a plant for increased heat tolerance, salt tolerance, or drought tolerance.

In the IPAB decision, it was held that the cited prior art discloses structure and function of cold shock protein CspA and CspB and thus would be obvious to a person skilled in the art to make transgenic plants using the same. Further, under section 3(d), it was held that the subject patent’s invention is just a new application of the already known cold shock protein in producing stress/draught/heat/salt tolerant transgenic plant.

It was held that it was already known in the prior art  to use cold shock protein for expression in E.coli, yeast cell, vertebrate cells, human cell Hela, Rat cell BLAB/c 3T3,NIH 3T3 and Rat embryo fiberblasts. It is also further disclosed in prior art: “additional vectors and sources ………….including …….yeast cloning vectors , plant vectors …………[page 23 and 24 ]”

It was thus held that there is sufficient suggestion in cited prior art documents that the method would work for plants with reasonable success, hence rendering the subject patent obvious.

When the structure and function of cold shock protein was already known in cited prior art and it is obvious to person skilled in plant to make transgenic plant which is heat or drought tolerance by inserting the recombinant DNA molecule in its genome.”

Similarly under section 3d objection, it was held that: “Mere use of admittedly known substance is not permitted under section 3(d).The argument of surprising result will not change the position as it will be still be a new use of known even if it produces better results.” It was already known to use CspA, CspB protein of the ‘cold shock domain’ for expression of cold shock protein in E.coli, yeast cell, vertebrate cells, human cell Hela, Rat cell BLAB/c 3T3,NIH 3T3 and Rat embryo fiberblasts. But it was not previously used to achieve that specific results in plants. The selection of specific proteins from ‘cold shock domain’ to achieve better result in plants contributes merely to a new use of such substance.

It was thus finally concluded that the subject patent claim is a new use of known cold shock protein for expression in plants to produce heat/salt/drought tolerant plants and is merely a discovery of new property of known substance and not an invention.

Implications

The refusal of grant of this Monsanto’s patent will definitely by applauded by farmers community throughout India as they will be free to develop and reproduce such draught/salt/heat tolerant plants without infringement of any third party’s patent on the same. Had this patent been granted, Monsanto would have controlled the production and sale of their patented climate resilient plants/seeds and kept the much higher prices causing much plight to the farmers in India. In calamities like the recent Uttarakhand floods, such salt tolerant crop varieties are needed in large amounts by the farmers of such areas who otherwise cannot produce crops because of sea salt deposition on their farms in such conditions. If this patent would have been granted, the farmers would have to buy such plants/seeds from Monsanto or undergo licensing agreements to use the patented method, which now they will be able to use and produce themselves freely.

Also, after this decision came out, Navdanya** publishes as below:

We applaud the decision of the Patent Office and Appellate Board and will disseminate it world wide the so other countries can use it to protect farmers, biodiversity and seed sovereignty. We will also be ready to intervene in case Monsanto brings the case to the Supreme Court.”

On another hand, such decision will be condemned by such seed and plant innovators like Monsanto in the developed markets like US and EP, especially when this patent has been successfully granted in US and EP. According to them, refusal of patent protections diminishes motivation for further innovation and that the rewards for innovation should be paid so that more innovative products and processes keep arriving in the markets. For pharmaceutical inventions too India is already on the priority watch list of US for refusing/ revoking patents u/s 3d which have been successfully granted in other countries.

** Navdanya is a network of seed keepers and organic producers spread across 16 states in India. It has its 54 seed banks across the country and organic farm spread over an area of 20 acres in Uttranchal, north India.

About the Author: Ms. Meenakshi Khurana, Patent Attorney at Khurana & Khurana and can be reached at: Meenakshi@khuranaandkhurana.com

Follow us on Twitter: @KnKIPLaw.