API and IP Newsletter

 Contents

• Paragraph-IV filings in recent past

• General information

• BMW takes Avanci licence after patent pool launches 5G vehicle programme

• AARP backs HHS: Keep Medicare drug price negotiations on track, dismiss lawsuit

• Intellectual Property

• Patent listing in Orange Book will be vetted by FTC.

Paragraph-IV filings in the recent past

We follow Paragraph-IV filings by generic companies at USFDA website.

Paragraph-IV filing certificate list as of 18 September 2023 is updated at FDA website and attached here

Two new P-IV certificates are filed as per the list. 

Drug Name	Details	Sidvim comments
Fedratinib Hydrochloride	Dosage  Capsules Strength: 100 mg RLD : Inrebic Submission date 16 August 2023	Q2 2023 sale of Inrebic is about USD 27 mio. (Here) This is small product, second line treatment, approved for myelofibrosis previously treated with Ruxolitinib. There is only one DMF filed and that is by Teva. There is high likelihood that Teva could have filed this ANDA on NCE-1 date and secured First to File (F2F) status.
Ruxolitinib Phosphate	Dosage Cream Strength:  1.50% RLD:  Opzelura Submission 31 July 2023	Opzelura rose to $80.23 million in the second quarter of 2023.  It seems sales of Opzelura started picking up as per hyperlinked news article. There are only two DMFs. MSN and one Chinese company had filed DMF. Overall API volume requirement is low.  ANDA filer must have either invalidity or non-infringing argument for US11571425B2, US10758543B2, US11219624 and couple of others. These patents would expire in 2031.  Some of these are listed in Orange Book and ANDA filer must have P-IVed against these OB listed patents.  It seems lot of Indian companies working on FDF development. One could notice, Hetero, Cipla, Glenmark, Aurobindo, EnCube and Zydus have imported innovator samples. Cipla and Glenmark imported samples several times and could be ahead of the competition in the ANDA development.  It would very difficult to predict though which company had filed ANDA. It would be possible that ANDA could have been filed by any non-Indian company too. Unless generic company is sued, it is very difficult to know who had filed the ANDA. It would be only guess work.

General information

BMW takes Avanci licence after patent pool launches 5G vehicle programme

Luxury auto manufacturer BMW has taken a licence from Avanci, after the patent pool officially launched its new 5G vehicle licensing programme last month. This latest development comes as the connected cars market becomes increasingly popular, with at least 25 global automakers committed to deploying the technology in their vehicles.

News here.

AARP backs HHS: Keep Medicare drug price negotiations on track, dismiss lawsuit

The AARP and AARP Foundation on Monday filed an amicus brief urging the U.S. District Court for the District of Columbia to dismiss Merck & Co.’s lawsuit challenging the program. The brief supports the U.S. Department of Health and Human Services against Merck, the manufacturer of type 2 diabetes medicine Januvia. It said the drug’s list price has jumped more than 275% since entering the market in 2006 and has accounted for $21.6 billion in Medicare Part D spending between 2017 and May 2023.

News here

Intellectual Property 

Patent listing in Orange Book will be vetted by FTC. 

FTC issues policy statement on patent listing on 14 September 2023.  Under the Hatch-Waxman Act, drug manufacturers while submitting a New Drug Application (NDA) must submit a list of patents that claim the drug or a method of using the drug to the FDA for inclusion in the Orange Book. 

Orange book is FDA’s catalogue of Approved Drug Products with Therapeutic Equivalence Evaluations. One can find an electronic Orange Book here. 

About 20 years ago, on 18 June 2003, FDA issued rules on patent listing requirements (Listing Rules). 

Some of the key highlights of the rules are as below. 

1. The FDA listing rules prohibit the submission of patents claiming packaging, intermediates, or metabolites.

2. FDA requires the submission of certain patents claiming a different polymorphic form of the active ingredient described in the NDA. However, while submission of polymorph patents, the NDA holder must have test data demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the NDA. 

3. Patents claiming devices or containers that are “integral” to the drug product or require prior FDA approval should be listed. 

4. The FDA distinguished between packaging and devices such as metered dose inhalers and transdermal patches, drug delivery systems used and approved in combination with a drug. 

5. FDA agreed that patents claiming a package or container must not be submitted and clarified that such packaging and containers are distinct from the drug product and thus fall outside the requirements for patent listing.

6. FDA did not expressly address device-related patents associated with NDAs but clarified the rule to list the patents that claim the drug product as defined in FDA’s regulation, which defines a drug product as a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. 

7. FDA explained that the key factor in determining whether the patent must or must not be submitted for listing is whether the patent claims the finished dosage form of the approved drug product. 

8. Patents must not be submitted for bottles or containers and other packaging, as these are not dosage forms.

In Short, FDA had set rules to list the patent/(s) in the Orange Book for NDA holder/Brand manufacturer. This informs manufacturers of generic drug products of patents which the brand manufacturer believes are likely to cover the generic products. 

Certification by generics:

1. If a generic company filing an Abbreviated New Drug Application (ANDA) seeks FDA approval prior to the expiration of an Orange Book listed patent covering the branded drug product and contends that the patent is invalid, not infringed, or unenforceable, it must file a certification to that effect with the FDA. It is popularly known as P-IV (Paragraph IV) Certification. 

2. The generic company serves notice of that certification, along with a detailed description of the basis for the contention, on the NDA holder and patentee.  This is known as “P-IV Notice”. 

3. The Hatch-Waxman Act provides a process under which a patent holder can file an infringement action upon receiving a P-IV Notice. 

4. If the patent holder files an infringement action within 45 days of receipt of the PIV Notice, the statute provides a presumptive 30-month stay on the approval of the ANDA. 

This is the Statute. There were incidences where such system is misused. Brand companies listed many patents which made life of generic companies difficult. The 30 months stay statutory provision then started delaying generic entries. 

The Federal Trade Commission (FTC) on 14 September 2023 issued a policy statement, supported by the USFDA, warning pharmaceutical companies that make and sell brand-name drugs that they could face legal action if they improperly list patents in the Orange Book.

Improperly listing patents in the Orange Book may harm competition from less expensive generic alternatives and keep prices artificially high, according to the policy statement. 

Henceforth, the FTC will scrutinize improper Orange Book patent listings as potential unfair methods of competition in violation of Section 5 of the FTC Act.

Policy here