AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

ICH M8 “Specification for Submission Formats for eCTD”

 regulatory  Comments Off on ICH M8 “Specification for Submission Formats for eCTD”
May 172016
 

This additional specification describes the way files should be constructed for inclusion in the eCTD.

Key Points:

  • It is not necessary to use a product from Adobe or from any specific company to produce PDF documents.
  • All ICH regional regulatory authorities are able to read and accept PDF files saved as PDF version 1.4 through 1.7, PDF/A-1, or PDF/A-2 compliant to ISO 32000-1:2008.
  • The size of a PDF file should not exceed 500MB.

  • Regulatory authorities cannot guarantee the availability of any fonts except Times New Roman, Arial, and Courier and fonts supported in the Acrobat product set itself. Therefore, all additional fonts used in the PDF files should be embedded to ensure that those fonts would always be available to the reviewer.
  • Times New Roman, 12-point font, is adequate in size for narrative text and should be used whenever possible. Times New Roman font sizes 9-10 or an equivalent size of other recommended fonts are considered acceptable in tables but smaller font sizes should be avoided.
  • The use of a black font color is recommended. Blue can be used for hypertext links. Light colors can be difficult to read on a monitor as well as when printed, and should be avoided. The use of background shadowing can be difficult to read and should be avoided.
  • Pages should be properly oriented so that all portrait pages are presented in portrait and all landscape pages are presented in landscape.
  • A sufficient margin of at least 2.0 cm on the left side of each page for portrait and top of the page for landscape should be provided to avoid obscuring information. The remaining margins should be a Page 6 of 9minimum of 0.8 cm. Header and footer information can appear within these margins but should not appear so close to the page edge to risk being lost upon printing.
  • All pages of a document should include a unique header or footer that briefly identifies its subject matter.
  • Scanning should be avoided where possible.
  • It is recommended that scanning be undertaken at a resolution of 300 dots per inch (dpi) to balance legibility and file size. The use of grayscale or color is discouraged because of file size. After scanning, resampling to a lower resolution should be avoided.
  • Paper documents containing hand-written notes should be scanned at a resolution of at least 300 dpi. Hand-written notes should be done in black ink for clarity, 600 dpi is recommended. High-pressure liquid chromatography or similar images should be scanned at a resolution of at least 300 dpi.

  • Applicants should validate the quality of the renditions.
  • Hypertext links can be designated by rectangles using thin lines or by blue text as appropriate. Bookmarks are expected even if there is no TOC In the document. The use of no more than 4 levels in the hierarchy is recommended, but additional levels could be created for study reports if such bookmarks contribute to efficient navigation.
  • Relative paths should be used when creating hypertext links to minimize the loss of hyperlink functionality when folders are moved between disk drives.

  • The bookmarks should be collapsed when document is opened so that all bookmarks are at the first level.
  • The first page of the document should be numbered page 1, and all subsequent pages (including appendices and attachments) should be numbered consecutively with Arabic numerals. Roman numerals should not be used to number page. The only exception should be where a document is split because of its size, the second or subsequent file should be numbered consecutively to that of the first or preceding file.
  • Security fields should be set to allow printing, changes to the document, selecting text and graphics, and adding or changing notes and form fields. The exception to this rule includes regulatory forms with pre-existing security and literature references that need to be copyright protected.

 

Reference

http://estri.ich.org/ssf/Specification_for_Submission_Formats_for_eCTD_v1_0_.pdf

////////ICH M8, Specification, Submission Formats,  eCTD

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What is 35 U.S. Code § 112 – Specification, ………..it is so easy to understand, try

 PATENTS, regulatory  Comments Off on What is 35 U.S. Code § 112 – Specification, ………..it is so easy to understand, try
Feb 032015
 

 

                U.S. Code› Title 35 › Part II › Chapter 11 › § 112………more explanation see below

Law is easy, …. learn with me and explained by cornell

I picked this up from site………..http://www.law.cornell.edu/uscode/text
Cock can teach you
thanks to cornell
Cornell law school

U.S. Code: Table of Contents  U.S. Code

U.S. Code: Title 35 – PATENTS Title 35 ›

35 U.S. Code Part II – PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS Part II ›

35 U.S. Code Chapter 11 – APPLICATION FOR PATENT Chapter 11 ›

 § 112. specification explained in this article

(a) In General.— The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
(b) Conclusion.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
(c) Form.— A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form.
(d) Reference in Dependent Forms.— Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(e) Reference in Multiple Dependent Form.— A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.
(f) Element in Claim for a Combination.— An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
SO EASY TO UNDERSTAND 35 U.S.C. § 112

35 U.S.C. 112  Specification.

[Editor Note: Applicable to any patent application filed on or after September 16, 2012. See 35 U.S.C. 112 (pre-AIA)for the law otherwise applicable.]

  • (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
  • (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
  • (c) FORM.—A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form.
  • (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
  • (e) REFERENCE IN MULTIPLE DEPENDENT FORM.—A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.
  • (f) ELEMENT IN CLAIM FOR A COMBINATION.—An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

(Amended July 24, 1965, Public Law 89-83, sec. 9, 79 Stat. 261; Nov. 14, 1975, Public Law 94-131, sec. 7, 89 Stat. 691; amended Sept. 16, 2011, Public Law 112-29, sec. 4(c), 125 Stat. 284, effective Sept. 16, 2012.)

 

35 U.S.C. 112 (pre-AIA)   Specification.

[Editor Note: Not applicable to any patent application filed on or after September 16, 2012. See 35 U.S.C. 112 for the law otherwise applicable.]

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form.

Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.

A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.

An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

(Amended July 24, 1965, Public Law 89-83, sec. 9, 79 Stat. 261; Nov. 14, 1975, Public Law 94-131, sec. 7, 89 Stat. 691.)

 SO EASY TO UNDERSTAND 35 U.S.C. § 112

 

 

 

SO EASY TO UNDERSTAND 35 U.S.C. § 112

 

Cornell law school

 

Cornell seal beneath the tower of Myron Taylor Hall

Interior of Cornell Law School quad

View of Cornell Law School from Central Avenue

Banner outside the law school’sJane M.G. Foster wing

The Cornell Law Library is one of 12 national depositories for print records of briefs filed with the U.S. Supreme Court.

Entrance to Myron Taylor Hall, Cornell Law’s principal building for instruction

Cornell Law School is the law school of Cornell University, a private Ivy League university located in Ithaca, New York. It is one of the five Ivy League law schools and offers three law degree programs (JD, LL.M., and J.S.D.) along with several dual-degree programs in conjunction with other professional schools at the university.
Ithaca
City
From top left: Ithaca during winter, Ithaca during autumn, Cornell University, Ithaca Commons (downtown), Hemlock Gorge in Ithaca, Ithaca Falls

From top left: Ithaca during winter, Ithaca during autumn, Cornell University, Ithaca Commons (downtown), Hemlock Gorge in Ithaca, Ithaca Falls
Ithaca is located in New York

Ithaca
Ithaca
Coordinates: 42°26′36″N 76°30′0″WCoordinates42°26′36″N 76°30′0″W
Country United States
US state New York
County Tompkins

 

Tompkins County, New York
Seal of Tompkins County, New York
Seal
Map of New York highlighting Tompkins County
Location in the state of New York
Map of the United States highlighting New York
New York’s location in the U.S.

 

LEARN A CASE STUDY WITH DR ANTHONY,    SO EASY TO UNDERSTAND 35 U.S.C. § 112

ME

case study on this

The Attack of 35 U.S.C. § 112

http://www.google.com/patents/US8598219

September 2, 2014, Accord Healthcare, Inc. (“Accord”) filed what appears to be the second-ever Post-Grant Review (“PGR”) (see Petition).  This PGR was for U.S. Patent No. 8,598,219 (“the ‘219 Patent”), which is jointly assigned to Helsinn Healthcare S.A. and Roche Palo Alto, LLC (collectively “Helsinn”). 

Helsinn Healthcare SaRoche Palo Alto Llc

As a reminder, PGRs are the third type of post-issuance review procedures established by the America Invents Act (“AIA”) — the other two being Inter Partes Review and Covered Business Method Patent Review (IPR and CBM, for short).  However, the reason that only one other PGR has been filed to date is because this type of proceeding only applies to patents that were examined pursuant to the new First Inventor to File scheme established by the AIA.

And because such applications could only be filed on or after March 16, 2013, there are only a limited number of such patents that are presently eligible for PGR.  One of the other significant differences between IPRs and PGRs is that the latter is not limited to certain types of prior art validity attacks (such as 102 or 103), but instead any type of validity challenge available in District Court is essentially available in front of the Patent Trial and Appeals Board (“PTAB”).

This includes attacks under 35 U.S.C. § 112, such as allegations of a lack of enablement, a lack of written description, and a failure to distinctly claim the invention.  Accord took full advantage of this in its petition for PGR2014-00010, in which Accord alleged that Helsinn’s patent related to liquid pharmaceutical formulations of palonosetron should not have been issued by the Patent Office.

Accord Healthcare

The ‘219 patent had been asserted in several Hatch-Waxman litigations involving ALOXI®, which is a palonosetron formulation indicated to help prevent nausea and vomiting following chemotherapy.  Palonosetron hydrochloride, the active pharmaceutical ingredient, has the following structural formula:

Structure
The ‘219 patent is a member of a family of patents directed to formulations of palonosetron hydrochloride.  Importantly, this patent was filed as a continuation-in-part application on May 23, 2013, with a letter that asserted that claim 9 only had support because of a newly added example, and therefore was subject to the AIA.  Only claims 1-5 and 8 of the ‘219 patent are the subject of this petition, with claim 1 reading:

1.    A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:
palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;
from 0.005 mg/mL to 1.0 mg/mL EDTA;
and from 10 mg/mL to 80 mg/mL mannitol,
wherein said formulation is stable at 24 months when stored at room temperature.

Claim 8 is the only other challenged independent claim, and it reads identically, except for a stability limitation of 18 months when stored at room temperature.  This patent issued on December 3, 2013, and the PGR petition was filed within the requisite nine months.

What is claimed is:

1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:

palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;
from 0.005 mg/mL to 1.0 mg/mL EDTA; and
from 10 mg/mL to 80 mg/mL mannitol,
wherein said formulation is stable at 24 months when stored at room temperature.
2. The pharmaceutical formulation of claim 1, wherein said EDTA is in an amount of 0.5 mg/mL.
3. The pharmaceutical formulation of claim 1, wherein said mannitol is in an amount of 41.5 mg/mL.
4. The pharmaceutical formulation of claim 1, wherein said solution further comprises a citrate buffer.
5. The pharmaceutical formulation of claim 4, wherein said citrate buffer is at a concentration of 20 millimolar.
6. The pharmaceutical formulation of claim 1, wherein said solution is buffered at a pH of 5.0 ±0.5.
7. The pharmaceutical formulation of claim 1, wherein said EDTA is in an amount of 0.5 mg/mL, wherein said mannitol is in an amount of 41.5 mg/mL, wherein said solution further comprises a citrate buffer at a concentration of 20 millimolar, and wherein said solution is buffered at a pH of 5.0 ±0.5.
8. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:

palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;
from 0.005 mg/mL to 1.0 mg/mL EDTA; and
from 10 mg/mL to 80 mg/mL mannitol, wherein said formulation is stable at 18 months when stored at room temperature.

 SO EASY TO UNDERSTAND 35 U.S.C. § 112

The petition pointed out that during the prosecution of the ‘219 patent and its family, the Patent Office had rejected the claimed formulations as obvious.  In response, the applicants submitted a declaration from inventor Daniele Bonadeo (“the Bonadeo declaration”) and argued that one of skill in the art would not have combined the features of the invention as a matter of routine optimization.  Instead of routine, the applicants continued, the claimed formulations were obtained after a sequence of experiments, each of which built upon the others like building blocks.

If the experimental sequence had varied, the applicants alleged that they would have obtained a different formulation.  The Bonadeo declaration explained that the first two parameters studied were palonosetron concentration and pH.  None of the studies described in this declaration, however, occurred at a pH other than 5.0, which makes sense because palonosetron was described as extremely stable at this pH.

Considering that the ‘219 patent ultimately issued, the applicants were apparently successful in overcoming these obviousness rejections.  In other words, the applicants convinced the examiner that a person of ordinary skill in the art would not have found it obvious to combine the teachings in the prior art to derived the claimed inventions.

The positions taken by the applicant, however, were utilized by the petitioner, Accord, to allege that a person of ordinary skill in the art would not have, for example, found the specification enabling.  This highlights the problem that PGRs pose for patent applicants.  Before such procedure, arguments could be made without much fear that they would be coopted by the Office for making alternative rejections.  And, if the Office did, there would still an opportunity to provide a response or amend the claims.  Even if such arguments were made in district court litigation, the patent would at least enjoy a presumption of validity.

Now, all applicants must take extreme caution in making any arguments, because anything said can (and probably will) be used against them at the PTAB.

What follows is an identification of the 35 U.S.C. § 112 arguments made by Accord.  Considering that the patent owner has not yet filed any response, and the PTAB has not weighed in, no position is taken here as to the merits of these arguments.

Written Description – Stability

Accord first alleged that the ‘219 was unpatentable for failing to provide an adequate description of the claimed subject matter being stable at 18 or 24 months when stored at room temperature, as required by 35 U.S.C. § 112(a).  Specifically, the petition asserted that the specification does not show that the inventors were in possession of any formulation that would have achieved the stability limitations of the claims.

Instead, the argument went, the patent contained general statements that it is possible to increase the stability of the formulations, but did not provide any examples with stability beyond a couple of weeks.  Accord included a declaration from Dr. Arnold J. Repta, which explained how a person of ordinary skill in the art would have understood the teaching of the specification.  However, Dr. Repta did not include any additional testing of the formulations taught in the application in his declaration.

Enablement

The second assertion made in the petition was that the ‘219 patent does not enable a pH range for the claimed formation outside of about 4.0 to 6.0, and therefore it is not enabled as required by 35 U.S.C. § 112(a).  This is because, according the petition, the only relevant formulation in the specification was disclosed as having a pH of 5.0±0.5.  Moreover, the specification was alleged to claim that palonosetron is most stable at pH 5.0.

Accord also cited to the Bonadeo Declaration, which was submitted during prosecution by the applicants, which alleged claimed that palonosetron formulations containing mannitol or EDTA required a pH of 4-6.  Therefore, according to the petition, because the challenged claims do not recite any pH limitations, they were broader than the teaching of the specification.

“Regards as the Invention”

35 U.S.C § 112(b) requires that a patent “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.”  Accord challenged the claims of the ‘219 patent as not including the invention as regarded by the inventors.  Specifically, the petition alleges that the Bonadeo Declaration made clear that palonosetron was extremely stable at a pH of 5.0, and that there was no hint that a pH outside of the range of about 4.0 or 6.0 would be suitable.  A similar argument was made about the language found in the specification.  The petitioner concluded by pointing out that, even though the inventors believed that the inventive formation should be in a range of 4.0 to 6.0, such a limitation was not included in the claims.

Written Description – pH Range

Finally, Accord made a similar argument when alleging that the specification did not support claims that did not include a pH range of 4.0 to 6.0.  Citing to the Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998), line of cases, the petitioner alleged that the pH range was an essential or critical feature which was omitted from that claims.  In other words, Accord alleged that the broad claims without a pH limitation were invalid because the “entirety of the specification” demonstrates that the invention was of much narrower scope.

Of course, similar to an IPR, the patent owner now has a chance to submit a preliminary response to the petition.  The standard used for instituting a PGR differs from that required for an IPR.  Instead of the “reasonable likelihood” standard, a PGR will only be instituted when it is more likely than not that at least one of the claims challenged is unpatentable.  In essence, this should be a slightly more stringent standard, because with both positions being equally likely, an IPR petition would have a reasonable likelihood of demonstrating claims as unpatentable, but a PGR petition would not be more likely than not to demonstrate unpatentable claims.

However, it remains to be seen if less PGRs are instituted than IPRs.  We will continue to monitor PGR2014-00010, and provide updates as warranted.

SO EASY TO UNDERSTAND 35 U.S.C. § 112

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