alertmeipp
14時間前
You are a smart man, I started buying at 11+. Didnt sell when it ran up to 13+, thinking it's still way too cheap, especially with RSV PED data pending. Also, I didnt want to sell and wake up the next day seeing ENTA got bought out at 50s+. It would happen, although, now I would be happy with 30s+ given the # of shares I have now.
Happy New Year.
Rocky3
1日前
Appreciate the thoughts but other than cash your analysis effectively discounts all other assets such as retained royalties and Zelicapavir - just to name two.
The retained royalties are not enough to pay the company's expenses, so I would argue that they have no value for a going concern business. Zelicapavir may have value (maybe significant), but its development costs are an offset against whatever value it has. A long here has to be very comfortable that those expenses all be covered by its cash. Most here clearly are.
If you’re not willing to “take the risk now” in what situation would you ever be comfortable investing in a biotech if that is your investment risk threshold?
Right now only TGTX and VKTX fit my risk threshold - for very different reasons. TGTX is profitable (barely) and has a huge runway (or at least I think it does). VKTX's upside is enough for me (though my position is 1/6 the size of TGTX), especially at 40. Together they are larger than my positions in GILD, MRK, NBIX, BMY, and ABBV. And all of pharma is less than 10% of the total portfolio. But I find biotech fun to follow.
alertmeipp
2日前
Agreed, nothing in investing is guaranteed. However, the odds here remain compelling, with the potential upside significantly outweighing the downside. The current cash burn guidance already factors in RSV Phase 3, and a partnership seems like the more probable scenario. It’s unlikely the CEO would risk the entire company on RSV alone. A deal with substantial upfront payments could drastically improve the outlook.
I had a similar perspective when the stock was trading at twice its current price just weeks ago, so WDIK.
Rocky3
2日前
From Fall 2023:
annual decrease in shareholder equity - down to $216,735K from $321,334K last year. With the decreased expenses projected next year, the reduction should be less, but if the loss from operations is still $80M, instead of $133M, net worth might be ~$135M after 09/24.
Actual number as of 9/24 for shareholder equity was $128,814K. Again, expenses should be lower in next 12 months since at least lawyer fees should be reduced since appeal should cost less than preparing for trial. But by 9/25 shareholder equity will probably be around $50M. With "debt" being non recourse, probably won't have "going concern" issue for a few more quarters after 9/25. But pressure to partner/sell/refinance will mount each and every quarter. And whatever bargaining power they have may disappear.
With tax loss selling season over, let's see if we get a stock price bounce in next couple weeks. If not, no real reason to think a turn around will happen until the partner/sell/refinance occurs. I am not willing to take that risk now. Those who think that the only possible direction is up were often saying the same thing in late 2023 when the price was significantly higher than now.
alertmeipp
6日前
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
1週前
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
1週前
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
1週前
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.
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