API and IP Newsletter
Contents
DMFs filed in December 2022
We monitor DMFs filed by Indian companies. FDA publishes list of DMF filers every quarter, the new list of DMF filers in last quarter of year 2022 was published recently.
This week we analysed DMFs filed in the month of December 2022. About 95 DMFs filed in the month of December.
Some of our observations are as below.
General information
China adds 111 new drugs to NRDL, focus on innovation
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
News here.
Single-Arm Versus Randomized Trials for FDA Approvals of Cancer Drugs
The use of single-arm trials, in which all patients receive the same investigational drug, has been increasing over the past to evaluate and potentially support an approval from the Food and Drug Administration (FDA), although randomized-controlled trials continue to be the preferred approach, an expert said.
“Single-arm trial designs have been a common development strategy to support regulatory approval for anti-cancer therapies and have allowed for transformative therapies to be made available to patients expeditiously,” said Dr. Sundeep Agrawal, acting supervisory associate director of the Division of Oncology 1 and acting clinical director of project renewal for the Oncology Center of Excellence at the FDA, in an interview with CURE®. “While single-arm trials will continue to play an important role, the randomized clinical trial remains the preferred approach to support the approval of new drugs, when feasible.”
Agrawal and colleagues recently published a study in JAMA Oncology, which analyzed the use of single-arm trials in supporting FDA approvals of anti-cancer drugs from 2002 to 2021.
The findings demonstrated that 176 new cancer indications for drugs approved by the FDA were based on single-arm trials, which included 116 accelerated approvals and 60 traditional approvals.
News here.
Intellectual Property
Valsartan and Sacubitril: Natco Pharma Limited vs Assistant Controller Of Patents
This is a writ petition at Delhi High Court under Article 226 of the Constitution of India.
Natco challenged order dated 14th December 2022, passed by the Learned Assistant Controller of Patents and Designs, allowing Indian Patent Application no. 4412/DELNP/2007 (`4412), filed by Novartis AG (Novartis) on 8th June 2007.
This `4412 application was issued as patent IN 414518.
There was one earlier application 1538/CHENP/2004, titled ―Pharmaceutical Compositions comprising Valsartan and NEP inhibitors which was granted by the Controller of Patents on 13th February 2009 as IN 229051 (IN'051).
In `4412 case the examiner issued a first examination report (FER) on 30th January 2015.
Novartis filed its response to the aforesaid FER on 27th November 2015. By the said report, Novartis amended its claims. As amended, only 17 claims.
Novartis further amended claims on 30th May 2016 to eight claims.
Of the said eight claims, the objections of Natco are essentially relatable to Claims 1, 3 and 4.
On 6th September 2016, Natco filed a pre-grant opposition to Application `4412
While things stood thus, on 4th/5th February 2019, Novartis instituted law suit before Delhi High Court (this Court), alleging infringement, by Natco, of IN'051, by manufacturing and marketing a product consisting of a combination of Valsartan and Sacubitril.
On 6th January 2020, Natco filed an application before the learned Controller in Application `4412 of Novartis, seeking to place the entire record of the court case before the learned Controller.
On 6th June 2020, Novartis filed a new claim set before the learned Controller, along with three expert affidavits.
Natco contends that Claim 4 in the new set of eight claims included the compound claimed in Claim 4 by Novartis in crystalline form which, according to Natco was originally claimed as Claim 3 in `4412 and was subsequently deleted in the eight claims which were filed on 30th May 2016, consequent on Natco's objection.
On 7th May 2021, Natco applied to the learned Controller for permission to cross examine the three experts whose affidavits had been filed by Novartis on 8th June 2020.
The request was disallowed by the learned Controller on 16th September 2021.
As regards to Writ Petition filed by Natco, one of the contentions that was advanced by Novartis was that Natco has not really suffered any prejudice in the present case, as would justify interference by this Court especially under Article 226 of the Constitution of India.
The Hon. Court disagreed with Novartis. The aspect of prejudice cannot be viewed merely by referring to Claims 4 and 5 of the claim set filed by Novartis before the learned Controller.
It has to be borne in mind that, prior to 14th December 2022, there was no decision either on `4412 filed by Novartis, or the pre-grant objections filed by Natco thereto. It was for the first time, therefore, that a decision was taken by the learned Assistant Controller, on any aspect of controversy before him, on 14th December 2022.
According to Natco, the objections raised by Natco against the patentability of Claim 4, in the claim set filed by Novartis on 6th June 2020 did not stand entirely answered by merely deleting Claim 4.
Natco’s submission was that the crystalline form of the Valsartan-Sacubitril composition was also subsumed in Claim 1 of the Claim Set filed by Novartis on 6th June 2020.
Prior to 2nd December 2022, both Claims 4 and Claim 1 were claimed by Novartis before the learned Assistant Controller.
Even if the submission of Novartis that the proceedings on 2nd December 2022 were restricted only to the allowability of Claims 4 and 5 of the claim set filed by Novartis is to be accepted, the fact of the matter remains that, as Natco was kept out of the proceedings on 2nd December 2022, Natco lost the opportunity to point out to the learned Controller that, in fact, the crystalline form of the Valsartan-Sacubitril formulation was also subsumed in Claim 1 of the claim set filed by Novartis.
This Court, in any manner, not intended to examine the correctness of this objection. Please note, the Hon. Court had not examined the merits of the objections raised by Natco either.
All that the Hon. Court intend to point out is that the opportunity to demonstrate, to the learned Assistant Controller, that what was claimed in Claim 4 was also claimed in Claim 1, was lost to Natco, as it was kept out of the proceedings on 2nd December 2022.
In that background, given the fact that it was for the first time on 14 th December 2022, that the learned Assistant Controller pronounced on any of the aspects of the controversy, including the patentability of Claim 1 of the claim set filed by Novartis on 6th June 2020, the unilateral proceedings, which took place on 2nd December 2022, in which Novartis was heard and Natco was kept out of the proceedings, in the Court’s view, this seriously prejudices Natco's interest.
The Delhi High Court Single judge bench allowed the writ and set aside the impugned order, granting a patent to Novartis on pharmaceutical combinations of “an Angiotensin Receptor Antagonist and an NEP Inhibitor”. Decision here.
However, this order has been stayed by divisional bench. Novartis moved the Divisional bench in Delhi HC.
Novartis emphasised that the impugned order was passed without directing and/or giving an opportunity to the Controller to file a counter affidavit.
The division bench is of the prima facie view that issues as to whether
once the pre-grant opposition is filed both examination and opposition proceedings stand merged and
any examination of the application can be undertaken by the Controller without issuance of a notice to the opponent.
The contesting parties shall file their written submissions not exceeding five pages before the next date of hearing.
The Court ordered to list the matter for hearing and disposal on 01st February 2023. Till the next date of hearing, there shall be stay of the impugned judgment. However, Natco shall maintain accounts of its expenses and sales. Decision here.
