T 2082/19 - Complete case on prior use / submitting sales data

Key points

• The patent has a filing date of 16.02.2005. A notice of opposition was filed in 2010, the first decision in appeal was issued in 2017, and in the present decision notified in March 2023, the Board decides on the patentability of the claims. 
• The opponent alleges lack of novelty over public prior use of a product by the patentee itself. Part of the evidence is "a video commercial shown [relating to "Extra Strength Tylenol Rapid Release Gels"] to the public on 6th February 2005 during the Super Bowl pre-program advertisements."
• Documents A30-A36 were filed by the opponent/appellant with its statement of grounds. The Board does not admit them.
• "The Board notes first that the prior use objection was raised in the notice of opposition on 10 March 2010 and that the main request is on file since 2 November 2011. It is established case-law that where lack of novelty is alleged over a public prior use, the burden of proof lies with the party claiming that the claimed features were disclosed in the alleged public prior use before the relevant date. This requires a provision of a complete chain of evidence that the product "Tylenol Extra Strength - Rapid release gels" disclosed all the claim features and was made available to the public before the filing date of the contested patent. Yet, for the first-time in appeal the appellant files a document (A30) relating to the composition of the Tylenol gelcaps, in particular to the presence of a sub-coating and to the width of the gap. These features were at the heart of the substantive discussion in the opposition proceedings."
• "Documents A31, A32 and A34-A36 are intended to demonstrate the public availability of the Tylenol product before the priority date. The content of documents A31, A32 and A34 was available already in 2005, while A35 and A36 are declarations relating to the purchase and the receipt of the Tylenol product in 2005. As they relate to the prior use objection raised in the notice of opposition, the Board could not find any reason why these documents could not have been filed earlier."
• "In the present case, the crucial document appears to be D20, which is supposed to make the link between the product "Extra Strength Tylenol Rapid Release Gels" seen in D29 or in the video commercial and proving that the same product was effectively sold before the effective date of the contested patent, namely 16 February 2005. "
• "According to the appellant [opponent] [D20]  is a sales report from the AC Nielsen database indicating a summary of sales of Tylenol product for the period ending 29 January 2005. For the product code 030045048824 there were specifically 158.975 units sold by the week ending 29 January 2005. "
• The Board: "document D20 merely discloses a table of undefined provenance, without any evidence or certificate of authenticity. As observed by the respondent, the appellant has offered no substantiation of exactly what the data of D20 demonstrate or any further explanation to corroborate the alleged sales. In the Board's view, D20 cannot provide any evidence in relation to the questions that need to be answered to substantiate an allegation of prior use, here to the occurrence of a public use in the form of the sale of the product, since its authenticity cannot be certified and it does not mentions inter alia where, how or to or by whom the product was indeed sold."
• D 20 is here. 
• As a comment, the Board apparently wants more information and a certification of authenticity. The document seems to mention a grocery shop chain, I understand that AC Nielsen is a company buying sales information from groceries and supermarkets (based on point-of-sale data) and selling the information to other companies. However, D20 itself does not identify the document as coming from an AC Nielsen database.
• "Referring to T 55/01, the appellant [opponent] argued that in case of mass-produced and distributed consumer products there were no need to prove that the product was sold to specific customer. However, this decision is not relevant to the present case since there is no convincing evidence that the product Tylenol Rapid Release Gels was massively distributed before the filing date of the patent."
• The public prior use is considered to be not proven.

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t192082eu1.html

Reasons for the Decision

1. Admission of documents A30-A36 into the appeal proceedings

1.1 Documents A30-A36 were filed for the first time with the appellant's statement of grounds of appeal on 25 September 2019. The respondent objected to the admittance of these documents into the appeal proceedings. In view of their date of filing, i.e. before the entry into force of the revised Rules of procedure of the Boards of Appeal (RPBA 2020, OJ EPO 2019, A63), the admittance of these documents is to be decided under Article 12(4) RPBA 2007 (Article 25 RPBA 2020). Pursuant to Article 12(4) RPBA 2007, the Board has discretion to hold inadmissible facts, evidence or requests which could have been presented in the first instance proceedings.

A30 is an experimental report established by Capsugel Lonza - R&D department in September 2019 on "Tylenol Extra Strength - Rapid release gels" allegedly received in Colmar, France, on 7 February 2005. It comprises pictures of bottles and tablets of Tylenol product, coating and subcoating identification, gap size calculation, coating and subcoating weight gain calculation, pictures of Tylenol product before and after coating and subcoating removal and results of dissolution tests conducted in February 2005 and February 2006.

A31 is an e-mail dated 7 February 2005 from Dominique Cade to Ewart Cole, confirming the reception of "Tylenol RR samples".

A32 is an e-mail dated 8 February 2005 from William Checkan to Dominique Cade relating to the sending of additional acetaminophen samples.

A33 is a dissolution test of Tylenol RR Gelcaps dated 3 March 2005.

A34 is an advert for Tylenol Rapid Release Gels allegedly published in "USA Today" on 21 January 2005.

A35 is an Declaration of Delphine Nombret relating to the reception on 7 February 2015 of tylenol gelcaps and the testing of this product shown in document D29, D30 and D33.

A36 is a declaration of William Chekan relating to the purchase of a Tylenol "extra strengh rapid release Gels" gelcap in a retail store in new jersey, USA prior to 16 February 2005.

1.2 The appellant argued that these documents relate to evidence already on file, particularly to D20, D21, D28 and D29, that they were filed at the very beginning of the appeal proceedings and are very straightforward. According to the appellant, they were filed directly in response to points made in the decision of the opposition division, which confirmed that there had been a prior disclosure of the Tylenol product but surprisingly considered that D29 was not enough to confirm the presence of all the claim features. They are prima facie highly relevant for the discussion of lack of novelty in light of public prior use and for inventive-step. They relate to a product massively sold by the respondent by the beginning of February 2015 and of which they were already aware for over 15 years, so that there are no reasons why the respondent could not review these straightforward documents.

1.3 The respondent considers that these documents should have been filed during the opposition proceedings since they relate to a prior use objection which was raised by the appellant with their notice of opposition on 10 March 2010 and to a product which was in possession of the appellant since 2005. They alleged that the appellant made a tactical decision to delay submitting the documents until the appeal stage, forcing the Board of Appeal to investigate their relevance for the first time and depriving the respondent the opportunity of having two instances on them. They further contest their prima-facie relevance in particular in terms of whether the newly filed experiments are actually reflective of knowledge that could be gained by the skilled person using their general technical knowledge to discover the internal structure of the product at the filing date.

1.4 The Board takes the view that documents A30-A36 could and should have been filed in the opposition proceedings.

The Board notes first that the prior use objection was raised in the notice of opposition on 10 March 2010 and that the main request is on file since 2 November 2011. It is established case-law that where lack of novelty is alleged over a public prior use, the burden of proof lies with the party claiming that the claimed features were disclosed in the alleged public prior use before the relevant date. This requires a provision of a complete chain of evidence that the product "Tylenol Extra Strength - Rapid release gels" disclosed all the claim features and was made available to the public before the filing date of the contested patent.

Yet, for the first-time in appeal the appellant files a document (A30) relating to the composition of the Tylenol gelcaps, in particular to the presence of a sub-coating and to the width of the gap. These features were at the heart of the substantive discussion in the opposition proceedings. During the opposition proceedings, the appellant relied on D29 only in support to its allegation that all claimed features were present in the Tylenol gelcaps (see decision point 3.3). The decision of the opposition division that the figure of D29 did not allow the skilled person to determine the presence of a sub-coating nor the presence of a gap width having 3% to 33% of the elongated tablet did not come as a surprise since it was based on the arguments of the respondent (see for instance their letter of 20 March 2018) and already presented in the annex to the summons to attend opposition oral proceedings dated 6 June 2018 (see point 1.10). Furthermore, the appellant claims that they are in possession of the Tylenol Tablets since 2005. This means that they had ample time to test the product in the course of the opposition proceedings to support their allegation that it disclosed all the claimed features. The same holds true for the dissolution tests of A33 that were performed in 2005.

Documents A31, A32 and A34-A36 are intended to demonstrate the public availability of the Tylenol product before the priority date. The content of documents A31, A32 and A34 was available already in 2005, while A35 and A36 are declarations relating to the purchase and the receipt of the Tylenol product in 2005. As they relate to the prior use objection raised in the notice of opposition, the Board could not find any reason why these documents could not have been filed earlier. The appellant had several opportunity during the opposition proceedings to provide evidence regarding the public availability of this product. In particular, after receipt of the annex to the summons to attend the opposition oral proceedings of 6 June 2018, which expressed doubts as to the public availability of the claimed prior use before the relevant date (see point 1.9), the appellant filed documents D26-D29. If the appellant wanted to complete their case on this, they could and should have filed documents A31, A32, A34-A36 at the same time. The circumstances of the case do not justify that these documents were submitted only in appeal.

The alleged prima facie relevance of documents A30-A36 cannot justify their late-filing. In this regard the Board notes that the criterion under Article 12(4) RPBA 2007 is whether the documents in question could and should have been filed in the first-instance proceedings.

Accordingly, the Board exercises its discretion not to admit A30-A36 into the appeal proceedings (Article 12(4) RPBA 2007).

2. Request to hear Ms Nombret during oral proceedings

In view of the decision to not admit documents A30 and A35 into the appeal proceedings, the request to hear Ms Delphine Nombret on these documents must also be rejected.

3. Main request - Sufficiency of disclosure

The appellant objected to claim 7 of the main request.

Dependent claim 7 of the main request includes a technical effect, i.e. that "at least about 40%, preferably about 60%, of at least one active ingredient dissolves within 3 minutes in 900 mLs water when tested using USP dissolution apparatus with a paddle speed of 50 rpm".

The Board concurs with the appellant that the gelcaps of examples 6A, 2C and 3B contain all the features of claim 1 of the main request, yet they do not show the dissolution profile of dependent claim 7. Hence example 6A shows 0% dissolution within 3 minutes, while examples 2C and 3B show 4% and 17% respectively after the first 3 minutes.

The Board notes however that claim 7 is a dependent claim relating to more restricted specific embodiments of the invention. Independent claim 1 of the main request relates to a broader subject-matter, and the presence of alleged "non-working embodiments", such as examples 6A, 2C or 3B as mentioned by the appellant, does not lead to an insufficient disclosure, as long as the description as a whole provides also all technical information to realize more specific embodiments, which is the case in the contested patent.

The opposition division mentions in particular example 7 and paragraphs [0042] and [0068] of the opposed patent as providing the relevant information to achieve the claimed technical effect.

In example 7, several dosage forms present the claimed dissolution profile of dependent claim 7, such as at least examples 6B and 5B. The invention claimed in dependent claim 7 is therefore specifically illustrated in these specific examples. Moreover, paragraphs [0042] and [0068] provide sufficient teaching regarding the openings and the gap width to adapt the claimed dosage form to the dissolution profile of dependent claim 7.

Consequently, the subject-matter of the main request is sufficiency disclosed.

4. Main request - Lack of novelty in view of the alleged prior use

4.1 The appellant based its allegation on public prior use on documents D29, D20, D21 and D28 and on a video commercial shown to the public on 6th February 2005 during the Super Bowl pre-program advertisements.

4.2 The video commercial was shown to the public on 6th February 2005 during the Super Bowl pre-program advertisements (Cf. D11 and screenshots of D12, D14-D19). D11 comprises screen grabs of a commercial that has been broadcast on 6 February 2005 relating to "Extra Strength Tylenol Rapid Release Gels". Page 10 shows a dosage form in form of a caplet that has different colours and holes in the middle.

FORMULA/TABLE/GRAPHIC

4.3 D29 is a photograph of the box and bottle of Tylenol Rapid Release Gels product allegedly received on 7 February 2005 in Colmar, France, which lists a product code number 3-0045-0488-24, a limit date of 10/06, and a batch number JSA246; it also shows a Tylenol gelcap aside the box as following:

FORMULA/TABLE/GRAPHIC

According to the appellant, the product of D29 known as "Extra Strength Tylenol Rapid Release Gels" was publicly sold prior to the effective date of the patent and was purchased by the appellant before 7 February 2005 with a proof of public sales given by D20. The purchased product has been analyzed as shown by D21 and D28.

Both parties agreed that the sample of Tylenol product brought by the appellant at the oral proceedings for inspection corresponded to the one showed in D29. The parties also agreed that for this reason an inspection of the sample was not necessary.

D20 is a table comprising several columns, showing aside from a product code 030045048824 two different numbered results namely 158.975 for the week ending 29 January 2005 and 1.149.126 for the week ending 26 February 2005. This is shown on the second page, last line as follows: FORMULA/TABLE/GRAPHIC

According to the appellant, the table is a sales report from the AC Nielsen database indicating a summary of sales of Tylenol product for the period ending 29 January 2005. For the product code 030045048824 there were specifically 158.975 units sold by the week ending 29 January 2005. Said product code 3-0045-0488-24 mentioned in D20 is also visible on the picture of document D29, which shows also the batch number JSA246 on the medicament box of Tylenol Rapid Release Gels.

D21 shows a Table and a figure disclosing the in vitro release profile of Tylenol rapid release gels of batch JSA246 received on 7 February 2005.

D28 is an extract from a laboratory book dated 24 February 2005. According to this document, the product tested in a dissolution test is Tylenol Rapid Release Gels with batch number JSA246, received on 7 February 2005. The results of said tests are shown in D21.

4.4 Under established case law, when determining whether an invention has been made available to the public by prior use, the following has to be clarified: (i) when the prior use occurred, (ii) what was made available to the public through that use and (iii) the circumstances of the use, i.e. where, how and by whom the subject-matter was made public through that use (see Case Law of the Boards of Appeal, I.C.3.2.4, 10th edition).

In the present case, the crucial document appears to be D20, which is supposed to make the link between the product "Extra Strength Tylenol Rapid Release Gels" seen in D29 or in the video commercial and proving that the same product was effectively sold before the effective date of the contested patent, namely 16 February 2005. However, document D20 merely discloses a table of undefined provenance, without any evidence or certificate of authenticity. As observed by the respondent, the appellant has offered no substantiation of exactly what the data of D20 demonstrate or any further explanation to corroborate the alleged sales. In the Board's view, D20 cannot provide any evidence in relation to the questions that need to be answered to substantiate an allegation of prior use, here to the occurrence of a public use in the form of the sale of the product, since its authenticity cannot be certified and it does not mentions inter alia where, how or to or by whom the product was indeed sold.

Moreover, the medicament box of the batch number JSA246 has been reported in documents D21 and D28 for its reception on 7 February 2005 and for the dissolution experiments performed on 24 February 2005, i.e. after the filing date of the contested patent. The Board concurs with the respondent that neither D21 nor D28 provides details or evidence in relation to the circumstances surrounding the tested samples. It is therefore not clear how the medicament box with the code number 3-0045-0488-24 and the batch number JSA246 has been acquired and there is in particular no evidence that it has been purchased.

Referring to T 55/01, the appellant argued that in case of mass-produced and distributed consumer products there were no need to prove that the product was sold to specific customer. However, this decision is not relevant to the present case since there is no convincing evidence that the product Tylenol Rapid Release Gels was massively distributed before the filing date of the patent.

Consequently, the circumstances relating to the alleged prior use are not shown by document D20 and by any other cited documents, in particular D21 or D28. Thus, the evidence submitted fails to support the appellant's allegation of public prior use.

It follows that the main request complies with the requirements of novelty.