API and IP Newsletter
Contents
Recent P-IV filings by generic companies
General information
AG Rayfield Secures $9,250,000 Dollar Settlement Against Pharmaceutical Giants AbbVie and Besins
Big Pharma Fails to Warn Women About Risks of Birth Control Injection
Intellectual Property
T 1870/22 -Solid Compositions Comprising a GLP-1 Agonist
Recent P-IV filings by generic companies
We follow P-IV filings from generic companies. While predicting who might have filed an ANDA is challenging, secondary information can help us make an educated guess.
Our analysis and comments are as follows:
General information
AG Rayfield Secures $9,250,000 Dollar Settlement Against Pharmaceutical Giants AbbVie and Besins
In a groundbreaking case, Oregon Attorney General Dan Rayfield reached a settlement involving a monopoly on testosterone replacement gels. The $9.25 million settlement includes $6,197,500 in disgorged profits and penalties along with attorney fees and costs.
The drug companies, AbbVie and Besins, were gaming the system – preventing competitors from manufacturing generic versions of the gels, by filing lawsuits to extend the amount of time they could charge customers high prices.
News here
Big Pharma Fails to Warn Women About Risks of Birth Control Injection
For decades, women have trusted Depo-Provera, a birth control injection manufactured by Pfizer, as a convenient and effective contraceptive option. However, recent research has uncovered alarming health risks associated with prolonged use of this medication, particularly an increased likelihood of developing brain tumors called meningiomas.
Now, patients and their families are taking legal action against Pfizer, accusing the pharmaceutical giant of failing to adequately warn women of these dangers.
News here
Intellectual Property
T 1870/22 -Solid Compositions Comprising a GLP-1 Agonist
EP 3 326 620 B1 was granted based on a set of 25 claims issued to Novo Nordisk. This patent is a divisional application of EP 11 805 824.7, with the publication number EP 2651398. The parent patent is the subject of decision T 1404/21.
Independent claim 1, as granted, read as follows:
"1. A solid composition for oral administration comprising semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein said composition comprises at least 60%(w/w) of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid."
The patent was opposed under Article 100 (a), (b), and (c) EPC on the grounds that its subject matter lacked an inventive step, was not sufficiently disclosed, and extended beyond the content of the application as filed.
The appeal lies from the decision of the opposition division to revoke the patent.
The document cited during the opposition proceedings included the following:
D20: WO 2012/080471 (parent application).
The opposition division determined that the parent application did not indicate that at least 60% (w/w) of the salt of N-(8-(2-hydroxybenzoyl)amino) caprylic acid (NAC) could be used instead of at least 0.6 mmol, and that the patent as a whole required this minimum amount of 0.6 mmol of the salt of NAC.
The opposition division, at first instance, opined that the main request did not comply with the requirements of Article 76(1) EPC in view of the claimed amount percentage of the salt of NAC acid in claim 1.
The proprietor, Novo Nordisk (appellant), filed an appeal against said decision.
Hexal and Generic (UK) responded to the statement of grounds of appeal.
This decision by the Boards of Appeals is related to 76 (1).
What is Article 76(1) EPC?
This Article 76 (1) of the EPC pertains to divisional applications, stating that a European divisional application must be filed directly with the European Patent Office in accordance with the Implementing Regulations. It can only be filed concerning subject matter that does not extend beyond the content of the earlier application as filed. If this requirement is met, the divisional application will be considered to have been filed on the date of the earlier application's filing and will enjoy any right of priority.
In this case, EP 3 326 620 B1, the subject matter of claim 1 has been objected to under Article 76(1) EPC for two reasons:
a) The claimed amount of "at least 60% (w/w) of said salt of NAC has replaced the originally claimed amounts of the salt of NAC of "at least 0.6, or at least 0.8 mmol", and there was no indication in the parent application that an amount of "at least 60% (w/w)" could be used instead of "at least 0.6 mmol". The opposition division concluded that an amendment replacing or removing a feature presented as essential contravened the requirements of Article 76(1) EPC.
b) Generic UK also believes that the subject matter of claim 1 represents a selection from a threefold selection from lists concerning the claimed amount, semaglutide, and oral administration.
The Board could not follow the line of argumentation developed by the respondents (Hexal and Generic UK) and by the opposition division in its decision regarding the feature "at least 60% (w/w) of said salt of NAC in claim 1 for the following reasons.
Hexal and Generic UK argued that the amounts of 0.6 mmol or 175 mg of the delivery agent are essential features of the disclosure of the parent application, especially in light of the technical problem to be solved, and that it is not possible to consider single statements in the application in isolation, said statements involving the presence of less than said 0.6 mmol or 175 mg of the delivery agent; the deletion of such essential features contravened Article 76(1). This argumentation was followed by the opposition division in its decision.
In more detail, Hexal and Generic UK argue that replacing the absolute amounts of 0.6 mmol or 175 mg of the delivery agent with a relative amount of 60% (w/w) is not feasible. This is because the skilled person is informed by the parent application that a specific and minimal absolute amount of NAC is necessary to ensure the bioavailability of the GLP-1 agonist. This is demonstrated by the results in Table 1 of the patent, where 300 mg of SNAC (compositions B, D, E, F) resulted in better bioavailability compared to 150 mg of SNAC (composition A). Furthermore, the bioavailability was unaffected by the relative amounts, which exceeded 60% (w/w) in all examples.
In the same context, the opposition division concludes in its decision that the skilled person recognises that the only difference between the background art cited in the description of the contested patent and the proposed solution is the absolute amount of the salt of NAC, indicating that this feature represents the contribution to the state of the art.
This standard requires that the subject matter of a claim in a divisional application or patent stays within the bounds of what a skilled person would derive directly and unambiguously using common general knowledge, viewed objectively and relative to the filing date, from the entirety of the earlier application as filed. Furthermore, the skilled person should not encounter new technical information.
While the points raised by Hexal and Generic UK, as well as those from the opposition division, may be valid, these considerations are irrelevant to the assessment of added matter under Articles 76(1) or 123(2) EPC. Instead, they relate to the evaluation of sufficiency of disclosure or inventive step. According to Articles 76(1) and 123(2) EPC, it is sufficient for a feature to be derivable directly and unambiguously from the parent patent application, which is the case here.
Furthermore, the parent application does not specify that a minimum of 0.6 mmol of NAC salt is required. D20 mentions in several places that "certain amounts" of NAC salt are necessary (e.g., page 1, line 33). However, other sections of the description do not indicate any minimum amount.
The board said the main request's subject matter meets the requirements of Article 76(1) EPC. However, the main request has not yet been examined regarding other grounds of opposition, such as inventive step, sufficiency of disclosure, or even Article 123(2) EPC.
As discussed above, in the present case, the opposition division decided only on Article 76(1) EPC and did not consider the additional grounds of opposition. Under these circumstances, the Board finds it appropriate to exercise its discretion under Article 111(1) EPC and remit the case to the Department of First Instance for further prosecution.
So, the case is referred back to the first instance to decide on other grounds of opposition.
In a previous decision, Novo successfully defended EP2651398 B1, a parent patent that was the subject of decision T 1404/21. Given these two decisions regarding oral semaglutide in Europe, generics should wait until the expiration of these formulation patents in 2031 or find ways to circumvent them. Since circumvention without SNAC would be challenging, it is likely that generics will wait until 2031 for oral solid dosage forms in Europe.
Decision here
