alertmeipp
14 hours ago
FWIW - Here is ChatGPT's appeal strategy:
To build a stronger appeal strategy for Enanta in **Enanta Pharmaceuticals, Inc. v. Pfizer, Inc.**, here’s an improved and more tailored approach that targets the Federal Circuit's standards and tendencies, with an emphasis on presenting compelling legal and factual arguments.
---
### **1. STRATEGIC FOCUS AREAS**
#### a. **Reframing the "New Matter" Decision**
- **Core Argument**: The court misapplied the law regarding what constitutes "new matter," particularly in distinguishing typographical corrections from substantive claim broadening.
- **How to Attack**:
1. **Typographical Error Doctrine**: Argue that the addition of "C1-C12 alkyl" merely clarified an inherent part of the claim, supported by the consistent use of broader language like “including but not limited to.”
- Use expert testimony to show that **C1-C12 alkyl** is scientifically and logically encompassed by the original genus of **C2-C12 alkyl**, as even C2-C12 alkyl implicitly includes smaller ranges.
- Highlight the alignment between the claim's chemical definitions and how a POSA would interpret it.
2. **Case Law**: Focus on precedents like *Novo Industries, L.P. v. Micro Molds Corp.* and *In re Oda* to argue that courts and patent offices routinely allow corrections for drafting inconsistencies that do not add substantive new matter.
3. **Practicality**: Emphasize that requiring perfect consistency between provisional patents and final patents sets an impossible standard for innovators and risks chilling innovation.
#### b. **Anticipation Defense**
- **Core Argument**: The court incorrectly concluded that Pfizer’s disclosures (e.g., conference presentations) constituted enabling prior art.
- **How to Attack**:
1. **Enablement Standard**: Argue that Pfizer's conference disclosure and patent filings failed to meet the enablement threshold under 35 U.S.C. § 102.
- Pfizer’s disclosures did not provide sufficient details for a POSA to replicate **nirmatrelvir** without undue experimentation. Highlight gaps or ambiguities in Pfizer’s presentations and press reports.
2. **Public Accessibility**: Question whether the public disclosures (e.g., conference presentations) were sufficiently accessible to qualify as prior art.
3. **Case Law**: Rely on cases like *Amgen Inc. v. Sanofi* to emphasize the importance of enablement in prior art analysis and challenge the completeness of Pfizer's disclosures.
#### c. **Priority Date Misinterpretation**
- **Core Argument**: The court improperly demanded overly strict alignment between the written description in the provisional patent and the issued patent.
- **How to Attack**:
1. **Written Description Compliance**: Argue that the provisional patent described the invention broadly enough to support claims for **C1-C12 alkyls**.
2. **Flexibility in Claim Construction**: Emphasize that minor variations between provisional and final filings are common and permissible under 35 U.S.C. § 112 if they are reasonably supported by the original disclosure.
3. **Case Law**: Use *Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.* to argue that the written description requirement should not penalize innovators for drafting flexibility.
---
### **2. PROCEDURAL AND TACTICAL MOVES**
#### a. **Request En Banc Review at the Federal Circuit**
- If unsuccessful at the panel level, consider requesting an en banc review to argue the broader implications for pharmaceutical innovators.
- **Argument**: The district court's ruling imposes an overly rigid interpretation of provisional patents, which could stifle innovation and harm public health.
#### b. **File Amicus Briefs from Industry Leaders**
- Collaborate with organizations like BIO (Biotechnology Innovation Organization) and other industry stakeholders to file amicus briefs emphasizing the importance of flexibility in patent drafting for drug development.
#### c. **Highlight Public Policy Concerns**
- Argue that invalidating Enanta’s patent sets a dangerous precedent for biotechnology and pharmaceutical innovation, particularly for small companies competing with larger corporations like Pfizer.
---
### **3. CHANCES OF SUCCESS**
Appeals in patent cases are challenging, especially when the district court ruling aligns with precedent. However, by sharpening the focus on critical legal missteps and public policy concerns, Enanta could substantially improve its odds.
- **New Matter Argument**: ~40-50%
- Success depends on convincing the Federal Circuit that the C1-C12 adjustment clarified inherent scope without adding substantive new matter.
- **Anticipation Argument**: ~30-40%
- Focus on enablement gaps in Pfizer’s disclosures and argue they were incomplete as prior art.
- **Overall Appeal Success**: ~35-45%
- Combining these arguments, Enanta’s odds improve if it can convince the Federal Circuit of significant procedural or substantive errors in the district court's ruling.
---
### **4. FINAL STRATEGY**
The appeal should focus on reshaping the narrative:
- Position the case as a battle between encouraging innovation and penalizing minor drafting errors.
- Use expert testimony and industry support to reinforce the argument that the district court misunderstood the science and misapplied legal standards.
- Push the Federal Circuit to consider the broader implications of its decision for the pharmaceutical industry.
This strategy maximizes Enanta’s chances while reframing the debate in its favor.
alertmeipp
3 days ago
I agree, at this point, we might as well keep pushing.
Why District Court Decisions Are Often Appealed in Patent Cases
- Patent cases are complex and require interpretation of intricate technical details and legal principles, which district courts may not always get right.
- The CAFC provides a more consistent and specialized review, ensuring uniformity in how patent laws are applied across the U.S.
If Enanta Pharmaceuticals appeals to the CAFC, its arguments will focus on the district court's legal errors (e.g., claim construction or invalidity determination), leveraging the CAFC's expertise in patent law.
floblu14
3 days ago
I tend to disagree with those stating NOT to appeal. Actually, it should be a piece of cake -
Read footnote #9 -
Even assuming arguendo that the error was an obvious typographical error, the Court would have no power to correct this type of error because the correction of the error remains subject to reasonable debate, particularly here, where the prosecution history adds ambiguity because Enanta did not correct the internal inconsistency in the definition of "alkyl." See Bella Summit LLC v. Gamebreaker, Inc., No. 21-cv-06007JAKMAR, 2022 U.S. Dist. LEXIS 233720 , 2022 WL 17882138 , at *7-8 (C.D. Cal. Oct. 17, 2022) (reasoning that error was obvious as it rendered an impossibility but correction of error in patent was subject to reasonable debate in part because of the repetition of the error and because plaintiff corrected the error in one place but "[p]laintiff's failure to correct the error in the disputed term" supported the determination that plaintiffs proposed correction was subject to reasonable debate).
https://www.bloomberglaw.com/public/desktop/document/ENANTAPHARMACEUTICALSINCPlaintiffvPFIZERINCDefendantNo22cv10967DJ?doc_id=X1686UDMG000N
Suggest Foley Hoag LLP | Law Firm & Barbara Fiacco take the appeal pro bono since they did NOT correct the error after receiving multi-millions from ENTA.
alertmeipp
3 days ago
FWIW - ChatGPT on appeal chances - quick summary is it would be a uphill battle.
Enanta’s chances on appeal will depend on its ability to challenge the district court’s key rulings regarding **priority date determination** and **anticipation**. Here’s an analysis of its prospects:
---
### **1. Priority Date Determination**
The district court ruled that Enanta could not claim the benefit of the July 2020 provisional application because the change from "C2-C12 alkyl" to "C1-C12 alkyl" constituted **new matter**. To succeed on appeal, Enanta will need to convince the appellate court that:
- **The change was a permissible correction**:
- Enanta argued that the change was an "obvious typographical error." However, the district court found that it broadened the scope of the patent, disqualifying the correction as minor.
- If Enanta can demonstrate that the change was consistent with the intent and understanding of a person of ordinary skill in the art (POSA) and that it was indeed a correction rather than an expansion, it may have a chance to overturn this ruling.
- **Standard of Review**:
- The appellate court will likely review the district court’s legal interpretation **de novo**, while factual findings will be reviewed for **clear error**. If there is room for a reasonable difference in interpretation, the appellate court could side with Enanta.
---
### **2. Anticipation**
The district court found the ‘953 Patent invalid for anticipation, citing Pfizer’s earlier disclosures of nirmatrelvir. For Enanta to prevail on appeal, it must challenge this finding by arguing that:
- **Pfizer’s disclosures were insufficient to anticipate the patent**:
- Enanta could argue that Pfizer’s disclosures lacked essential details or were not enabling (i.e., not sufficient for a POSA to practice the invention).
- If Enanta can show that there were key differences between its claimed invention and Pfizer’s disclosures, it might persuade the court.
- **Precedent on Anticipation**:
- Anticipation is often considered a question of fact, meaning the appellate court will review the district court’s findings under the **clear error** standard. This can make it harder for Enanta to succeed unless it can identify significant flaws in the lower court’s reasoning or evidence.
---
### **3. Broader Context and Challenges**
- **Burden of Proof**:
- Enanta must overcome the presumption of validity that favors the district court’s findings. Courts generally avoid overturning decisions unless there is a clear legal error or misapplication of the law.
- **Technical Complexity**:
- Patent cases involving complex chemical definitions and priority claims are inherently challenging on appeal. Enanta must effectively argue that the district court misunderstood the interplay between its claims and the prior art.
- **Pfizer’s Strong Position**:
- Pfizer’s disclosures predate Enanta’s effective filing date, and the ruling on priority weakens Enanta’s position significantly. Unless Enanta can restore its earlier priority date, anticipation is likely to stand.
---
### **Conclusion**
Enanta faces an **uphill battle** on appeal. While it has a plausible argument regarding the correction of "C2-C12 alkyl" to "C1-C12 alkyl," the district court’s findings on anticipation are well-supported by Pfizer’s robust prior art disclosures. The appellate court is unlikely to overturn the lower court’s decision unless Enanta can present compelling evidence of clear legal or factual errors.
floblu14
4 days ago
AI's "thought process" which appears relevant to conflict of interest:
A "conflict of interest" refers to a legal situation where a court decision is reversed on appeal because a lawyer or judge involved in the original case had a conflict of interest that could have unfairly influenced the outcome, potentially impacting the fairness of the proceedings and causing a miscarriage of justice.
Key points about conflict of interest overturn cases:
What constitutes a conflict:
This could include situations where a lawyer represents multiple clients with opposing interests, has a personal relationship with someone involved in the case, or has a financial stake in the outcome.
How to raise a conflict of interest claim:
A party in a case can typically raise a conflict of interest claim by filing a motion to disqualify the lawyer or judge involved, arguing that the conflict could compromise their ability to act impartially.
Factors considered by courts:
When deciding if a conflict of interest is significant enough to overturn a decision, courts will consider the nature of the conflict, whether it was disclosed, and whether it could have affected the outcome of the case. {Might be that ENANTA did NOT know that her husband had corporate dealings with PFIZER. In today's world - anything is possible.}
Example scenarios:
A lawyer representing both the plaintiff and defendant in a lawsuit:
If a lawyer is representing both parties in a case, they might be unable to effectively advocate for each client's interests, leading to a potential conflict of interest.
A judge with a personal relationship with a party in a case:
If a judge has a close personal relationship with someone involved in a case, their impartiality could be questioned, potentially warranting a recusal.
A lawyer with a financial interest in the outcome of a case:
If a lawyer stands to gain financially from a specific decision in a case, this could create a conflict of interest.
floblu14
4 days ago
Monday, December 23, 2024
394 order Order Mon 12/23 4:12 PM
Judge Denise J. Casper: ELECTRONIC ORDER entered. In light of the Court's Memorandum and Order entered today, D.393 , the Court is prepared to enter judgment in favor of Defendant Pfizer Inc. ("Pfizer") on the only count in Plaintiff Enanta Pharmaceuticals, Inc.'s complaint (for infringement of the '953 patent), D.1 ; and in favor of Pfizer on its Counterclaim II (declaration of invalidity for the '953 patent), D.22 at 12. Pfizer's proposed order, D.269 -1, is silent as to the only other remaining claim, its Counterclaim I (declaration of non-infringement of the '953 patent). If, in light of the rulings today, Pfizer is not pressing Counterclaim I and the parties seek to have the Court enter judgment as to Enanta's claim and Pfizer's Counterclaim II resolved in today's Memorandum and Order, the parties shall confer and file a joint statement to that effect by January 10, 2025. (Cook, Savannah)
393 order Memorandum & Order Mon 12/23 4:07 PM
Judge Denise J. Casper: ORDER entered. MEMORANDUM AND ORDER - the Court ALLOWS Pfizer's motion for summary judgment as to invalidity, D.269 , and DENIES Enanta's motion for summary judgment as to infringement as moot, D.266 . In light of these rulings, the Court DENIES the parties' respective motions to exclude expert testimony, D.264 ,265 ,267 ,268 , as moot. (Cook, Savannah)
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
Even under these negative circumstances, I agree with Dew's POSITIVE statements on X - $ENTA is oversold. Break-up cash value—including NPV of retained Mavyret royalties—is ~$20/sh.
Biowatch
5 days ago
Big pharma acquisitions are almost always 100% cash
Unless they have lots of other ideas that they are working on. Otherwise, it’s more along the lines of:
The experimental research project you managed while going it alone that worked out means that you are completely under our control now. We bought you out. We fully expect that the founders will take the money to the bank then move on, or they, and all the employees, will just become another cog in our very large machine.
If you enjoyed the perks of being the CEO, that time is over. Everyone in the executive suite can buy a really fancy car, vacation home, and then some, but you don’t know how to manage the nuts and bolts of producing a drug in bulk quantities under sterile conditions, nor how to package, sell, and distribute it. Thank you for your initial insight, but you’d be bored to tears with the minutia from here on in.
Plus, if you were clever, your employees will at most get a severance pay, if that. If you can, get them to sign away any vacation time they are due. No pensions. No stock options. Nothing that will be a debit on the balance sheet should someone be looking to buy you out. If you are a certain kind of person, you will brag about this to your employees and rub it in their face.
dewophile
7 days ago
Yeah, the Covid drug pivot really killed this company last couple years
covid itself hurt the RSV program - there was no RSV to speak of in the 2020-2021 season, and a very atypical spike much earlier seasonally than expected that was severe but very short in 2021-2022 that seemed to catch them off guard. So that cost the RSV program 2 years
As for the covid drug, after seeing ensitrelvir succeed in the prevention setting where paxlovid failed which could create a new regulatory path, and reviewing PFE's second gen data I think ENTA's program is mostly dead, but not completely dead.
PFE’s second gen sars cov 2 PI showed a virologic response, but did not show any resolution in symptoms in standard risk patients https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae529/7863440?login=false, while EDP DID show a reduction in total symptom scores https://www.enanta.com/wp-content/uploads/2024/04/P0423_ECCMID_2024_SPRINT_Poster_FINAL.pdf
I know 235 is collecting dust, but hey it seems to have some oomph on symptoms that PFE's drug is lacking, and PFE is trying to run a PBO controlled phase 3 in high risk patients with hospitalization as an endpoint which seems awfully challenging to me with paxlovid available for those at high risk. The study listing has not been updated for a while now fwiw, so who knows if it started recruiting last week as planned https://clinicaltrials.gov/study/NCT06679140?term=PF-07817883&rank=8
The rub on 235 was virology, but if you compare the data closely PFE showed a virologic response but they also restricted enrollment to those with more than 4 log virus at baseline and ended up with 5 log baseline VL vs ENTA at 4 log. Remember enta did show a modest virologic response in those with 5 log or more at baseline.
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