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Top Adding - Proofs Of Claims In Indiana Bankruptcy Courts - 6 Things To Remember
Although my blog primarily is devoted to issues surrounding Indiana state court foreclosure and lien enforcement actions, some discussion of bankruptcy matters will be warranted. This is because, n
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ot infrequently, a real estate foreclosure or UCC lien enforcement proceeding that starts in state court will end up in bankruptcy court. So, I would be remiss if, from time to time, I did not addr
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ss legal opinions arising out of Indiana bankruptcy courts. One such case is In The Matter Of: David Burr Fink, 2007 Bankr. LEXIS 1149 (N.D. Ind. 2007), a March 15, 2007 decision by Judge Robert E
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Grant that tackles questions regarding whether a late-filed proof of claim should be allowed.
1. General bankruptcy rule. An unsecured creditor that has notice or knowledge of a bankruptcy case b
1. General bankruptcy rule. An unsecured creditor that has notice or knowledge of a bankruptcy case b
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t fails to timely file a proof of claim may have its claim disallowed or, in a Chapter 7 liquidation case, subordinated (see #3). 11 U.S.C. 502(b)(9). Fink at 2.
2. “Excusable neglect” exception.
2. “Excusable neglect” exception.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
In a chapter 11 proceeding only, a court can, but is not required to, allow late filed claims if the failure is due to excusable neglect. Bankr. Rule 3003(c) and 9006(b)(1). Fink at 2, n.1. Provi
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
g “excusable neglect” can be difficult, particularly where a creditor is sophisticated and/or represented by counsel.
3. Chapter 7 late claims. In Chapter 7 cases, theoretically the failure to fi
3. Chapter 7 late claims. In Chapter 7 cases, theoretically the failure to fi
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
e a timely proof of claim is not fatal. 11 U.S.C. 726(a)(3); Fink at 2. The result is the subordination of the claim to the full payment of all other timely filed unsecured claims. Thus the tardy
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
reditor is at the back of the line for any distribution. 11 U.S.C. 726(a)(3). Fink at 14. But chapter 7 plans that pay unsecured creditors in full are extremely rare. For all practical purposes,
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
a late-filed claim in a Chapter 7 case ultimately will mean no distribution to an unsecured creditor.
4. “No asset” cases. In most Chapter 7 cases, courts will issue an order indicating that there
4. “No asset” cases. In most Chapter 7 cases, courts will issue an order indicating that there
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is no need to file a proof of claim until further notice. The reason for this is that, absent a finding that there are assets, there may well be no distribution to unsecured creditors.
5. Secured c
5. Secured c
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
reditors and deficiency claims. As a general rule, only unsecured creditors need to file proofs of claim in order to be placed “in the distributional queue.” But if a secured creditor desires to re
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ain a deficiency claim, it too should file. Fink at 14. In other words, secured creditors should file in order to preserve possible distribution on account of any unsecured deficiency. Significan
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ly, the failure to file a claim will not destroy or eliminate a secured creditor’s lien or interest in the property of the estate. Fink at 14-15. A lien remains unaffected by bankruptcy unless it
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
pecifically is altered by the court.
6. Informal proof of claim. Bankruptcy courts have developed an equitable doctrine known as an “informal proof of claim” that can sometimes permit a claim to b
6. Informal proof of claim. Bankruptcy courts have developed an equitable doctrine known as an “informal proof of claim” that can sometimes permit a claim to b
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
asserted via something other than a formal proof of claim. The Fink opinion provides a thorough analysis of this doctrine. Judge Grant found that the situations in which “informal claims” should
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e allowed are extremely narrow. In Fink, the Court found that a creditor had not, via a motion for relief from stay, asserted an informal claim. The creditor was unable to avoid strict enforcement
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
of the claims bar date.
Turning to this blog’s true purpose, which is to provide a resource for secured lenders facing loans in default, Judge Grant’s opinion provides a nice refresher on the rules
Turning to this blog’s true purpose, which is to provide a resource for secured lenders facing loans in default, Judge Grant’s opinion provides a nice refresher on the rules
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
for filing proofs of claims. The message is to determine quickly whether you need a proof of claim and, if so, to ensure you timely file it, even if you have or will be seeking other relief in the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ankruptcy proceeding such as an order modifying the automatic stay. Actually, the filing of a proof of claim is fairly painless, and there really is no downside to filing one. When in doubt - file
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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