Opposition to IL 190827 to Pfizer – A request to delete paragraphs from Expert Opinion as Widening Front of Attack

In evidence submissions, parties can support contentions made in statements of case, but are not allowed to widen their position by introducing new matter. When evidence relating to allegedly new issues is submitted by an Opposer, the Applicant can be expected to oppose the submission. Opposition proceedings are typically characterized by skirmishes regarding the admissibility of evidence, that are discussed in interim rulings. This is one such ruling.

Opposition to IL 190827 to Pfizer

Lyrica

IL 190827 to Pfizer relates to a pharmaceutical composition prescribed for once a day dosage comprising Pregablin and a matrix forming agent of PVP or PVA and CPVP as a swelling agent.

Teva opposed the patent.

This interim ruling relates to a request by Pfizer to remove paragraphs 13-15, 16, 94, 105 and 130 from the Opposer’s Counter-Evidence in Response of Professor Golomb, acting as an expert witness for Teva.

Pfizer claimed that paragraphs 13-15 of the Opposer’s Counter-Evidence in Response stress gelling agents which are not mentioned on the Opposition or in Professor Golomb’s main Opinion. In paragraph 15 of the Opposer’s Counter-Evidence in Response, Professor Golomb alleges that selective reporting on stability, swelling and hardness is arbitrary and they claim that these paragraphs should be struck as they were not submitted in answer to anything in their response.

Pfizer alleged that Paragraph 16 of Teva’s Counter-Evidence in Response raises issues not previously raised: that there is no comparison between the claimed invention and known formulations and no indication of any advantage thereover.
Pfizer requested that paragraph 94 be struck since it makes allegations not found in the original evidence submission. Similarly, paragraphs 105 of the Opposer’s Counter-Evidence in Response relates to Cmin values in the simulation summarized in table 15, and paragraph 130 thereof, are not by way of response and should be struck from the record.
Teva responded that the request to have these paragraphs in their Opposer’s Counter-Evidence in Response cancelled was submitted for improper reasons. Paragraphs 13 and 15 are supported by the patent application itself and do not raise new subject matter. They come in response to paragraph 9 of Dr. Tomber’s opinion. That mentioned in paragraph 15 regarding swelling, stability and harness comes in direct response to Dr. Tomber’s claim that these characteristics are advantageous. The claim that this is an advantage of the claimed invention was first raised in Dr. Tomber’s opinion as expert witness of the Applicant and so the first opportunity for the Opposer to refute this allegation is in their Counter-Evidence in Response.
Teva further submitted that Section 16, when read in context, is a response to Dr. Tomber’s claim that there is an advantage in the claimed formulation of the application. Professor Golomb considers that without comparison to other formulations, one cannot claim the present invention provides an advantage thereover. Similarly that stated in Section 95 of the opinion; that the application does not provide stability data, comes in response to Dr. Tomber’s claims regarding the efficacy of the formulation. The Opposer adds that the application and the Applicant’s claims in the Statement of Case do not relate to any advantage provided by the swelling or the hardness.
Section 105 deals with the Cmin value in table 15 and comes in response to Dr. Tomber’s claim that tablets having a 6 hour release window are not appropriate for once-a-day dosage. Teva claims that when reading this paragraph in the Opposer’s Counter-Evidence in Response together with the previous paragraphs one can only conclude that they come in response to Dr. Tomber’s claim.

As to paragraph 130, the Opposer claims that the expert opinion cited comes in response to the Applicant’s claim that formulation is resistant to the compaction pressure which is based on experimental evidence first submitted by Dr. Tomber.

The Applicant considers that the Opposer’s Counter-Evidence in Response was not a fair response to their counter statement of case and the Opposer allegations that Dr. Tomber’s statements went further than required to respond to the Opposition, whereas the Applicant claims that Professor Golomb simply expanded on statements made in the original Opposition, that could have been made in the original opposition.

Discussion

The parties are in no disagreement regarding the Law, but only in how it should be applied in this instance. Consequently, the relevant case law regarding the application of Regulation 62 is only summarized briefly.

This regulation orders that evidence in response must fulfill one of the following conditions: They should relate to the issues that are specifically denied by the Applicant in their counter-evidence, or are raised for the first time in their counter-evidence. In the response to the Applicant’s evidence, the Opposer may not submit evidence that should have been part of their main submission of evidence (See Opposition to IL 178141 Unipharm vs. Bristol Myers Squibb Company, 12 January 2015 following the ruling of the then Deputy Commissioner in the opposition to IL 127833 Teva vs. Abbott, 12 February 2007 (Oppositions to IL 177724 and 205606, request to delete sections from the Opposer’s Counter-Evidence in Response DSM IP Assets B.V. vs. Refine Technology LLC, 16 March 2015).  

The Deputy Commissioner, Ms Jacqueline Bracha considers that, on examining the paragraphs in question, Pfizer’s request to have them struck from Teva’s Counter-Evidence in Response should be rejected.

In Paragraphs 13 and 14 of the Opposer’s Counter-Evidence in Response, Professor Golomb relates to Dr. Tomber’s examples. Most of the criticism is directed to Dr. Tomber not relating to the fact that the examples include additional ingredients that are not claimed, and which could affect the release of the active ingredients.

In paragraph 15 of the Opposer’s Counter-Evidence in Response, Professor Golomb alleges that there is nothing in Dr. Tomber’s Opinion to explain why examples 24, 25 and 40 of the Application were chosen to show stability, swelling and hardness of the formulations claimed. Professor Golomb further claims that the Opinion does not relate to the other components of the examples, apart from those that are likely to affect the hardness and swelling of the tablets. The additional components are defined in the specification as gelling agents. From this, Professor Golomb deduces that the chosen examples do not exemplify formulations that only include the elements of claim 1.

In these examples, Professor Golomb relates to things mentioned in Dr. Tomber’s opinion. However, this is not a new issue first raised in the Response Opinion. In fact, a similar statement to that of paragraph 15 of the Response Opinion is found in paragraph 81-83 of Professor Golomb’s first opinion where he explains why, in his opinion, none of the Examples of the patent match that claimed. The difference is the switching of the words “additional assistive materials” in the first Opinion, with the phrase “gelling agents” in the second opinion. Professor Golomb also explains in paragraph 15 of the Opinion that the additional materials are defined as “gelling agents” in the patent application itself.

From that stated, it is clear that paragraphs 13-15 of the Response Opinion do not raise any new issue but rather come in response to that said previously, and so the request to delete these paragraphs is rejected.

In paragraph 16 of the Response Opinion, Professor Golomb relates to the claim in Dr. Tomber’s Opinion, that the claimed invention is advantageous in terms of stability, swelling and hardness of the tablets as compared to those formulated by the standard methods for obtaining delayed release in the stomach that is described in example 29. In the Opinion of the expert, the comparative data provided is insufficient to prove this advantage. The Applicant claims that Dr. Tomber did not make this claim and so this response comes to reject a claim not made.

Examination of Dr. Tomber’s Opinion shows that in part 9.4 of his Opinion, the expert relates to example 29 of the Application as a comparative example. Dr. Tomber explains that the release of the active ingredient in example 29 after 12 hours is 65%, compared to 80% for formulations of the invention, and so some of the active ingredient in the formulation of example 29 is wasted. It appears that paragraph 16 of the Opinion is an attempt to respond to this contention of Dr. Tomber and is thus a response to an issue raised by the Applicant. To the extent that the Applicant considers that Dr. Tomber’s opinion was not properly understood by the Opposer, they can relate to the alleged misunderstanding in cross-examination. In light of this, the request to delete paragraph 16 is rejected.

Paragraph 94 of the Opinion in Response by Professor Golomb raised the issue that Examples 15-23 which look at Lactam formation over time does not indicate the efficiency of the claimed formulation. In this paragraph, Professor Golomb responds to Dr. Tomber’s claim that was raised in paragraph 30 of his opinion, that “the results demonstrate the efficacy of the claimed invention.” Dr. Tomber continues that the examples show the efficacy of the invention under various conditions. In Paragraph 95, Professor Golomb adds that the Application lacks stability data for Example 29 which also does not include all the elements of the invention. According to Professor Golomb, without stability data, Example 29 cannot be used for comparative purposes as Dr. Tomber had suggested in Section 9.4 of his Opinion. The Deputy Commissioner does not think that Paragraph 95 goes beyond the issues under discussion, since it specifically relates to Dr. Tomber’s Opinion which related to Professor Golomb’s original Opinion. In light of this, the request to cancel section 95 is refused.

In paragraph 104 of the Expert Opinion in Response, Professor Golomb summarizes that stated in paragraph 32 of Dr. Tomber’s opinion regarding adapting the formulation for once-a-day dosage, with reference to the release duration and the amount of active ingredient in the blood over the period of release by the tablet. In paragraph 105, Professor Golomb explains why he disagrees with that stated by Dr. Tomber in Paragraph 32 of his opinion, and supports this with reference to publications cited in his original Opinion. This is sufficient to show that Paragraph 105 of the Response Opinion relates to matters raised by the Applicant and is in accordance with Regulation 62 of the Patent Regulations.

In paragraph 104 of the Expert Opinion in Response, Professor Golomb summarizes that stated in paragraph 32 of Dr. Tomber’s opinion regarding adapting the formulation for once-a-day dosage, with reference to the release duration and the amount of active ingredient in the blood over the period of release by the tablet. In paragraph 105, Professor Golomb explains why he disagrees with that stated by Dr. Tomber in Paragraph 32 of his opinion, and supports this with reference to publications cited in his original Opinion. This is sufficient to show that Paragraph 105 of the Response Opinion relates to matters raised by the Applicant and is in accordance with Regulation 62 of the Patent Regulations.

In Section 130 of the Response Opinion, Professor Golomb claims that the Application emphasizes the wear data and hardness of the formulation as ways to optimize the release rate of the active ingredient, but he disagrees that the evidence supports this contention. Here again, the Deputy Commissioner accepts the Opposer’s argument that this paragraph comes in response to Dr. Tomber’s statement in paragraph 26 of his Opinion, that CPVP manufacturing provides a significant advantage. In fact, Dr. Tomber dedicated a number of paragraphs to the stability of the tablets, and so the Deputy Commissioner does not consider that Paragraph 130 goes beyond Regulation 62 of the Patent Regulations.

In Section 130 of the Response Opinion, Professor Golomb claims that the Application emphasizes the wear data and hardness of the formulation as ways to optimize the release rate of the active ingredient, but he disagrees that the evidence supports this contention. Here again, the Deputy Commissioner accepts the Opposer’s argument that this paragraph comes in response to Dr. Tomber’s statement in paragraph 26 of his Opinion, that CPVP manufacturing provides a significant advantage. In fact, Dr. Tomber dedicated a number of paragraphs to the stability of the tablets, and so the Deputy Commissioner does not consider that Paragraph 130 goes beyond Regulation 62 of the Patent Regulations.

In light of this, the request to cancel the various paragraphs is refused.

Since the parties informed the Patent Office a few days ago that they are negotiating a way to end this Opposition procedure, no costs are awarded at this time.

Interim ruling re admissibility of various paragraphs in a Response by Opposer to Applicant’s Opinion concerning IL 190827 to Pfizer, opposed by Teva, ruling by Deputy Commissioner Jacqueline Bracha,  6 June 2018.     

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