PharmaPatents

Timely Insight on Emerging Legal Developments

Challenging The Enabling Quality Of Prior Art

Posted in Federal Circuit Decisions

In In re Morsa, the Federal Circuit reversed an anticipation rejection where the applicant had challenged the enabling quality of the cited prior art reference, even though the applicant had not submitted evidence in support of its position. While the court agreed with the USPTO that a prior art reference is presumptively enabled, it held that an applicant need not always bring forth evidence of non-enablement in order to shift the burden to the USPTO. This decision may make it easier to challenge the enabling quality of prior art, but pursuing an appeal without developing a supporting factual record still can be risky.

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Supreme Court Oral Arguments in ACLU Myriad Gene Patent Case

Posted in 101; Myriad; Supreme Court Decisions

On April 15, 2013, the Supreme Court heard oral arguments in one of the most controversial and publicized biotech patent cases–the “ACLU/Myriad” gene patent case (e.g., The Association For Molecular Pathology v. USPTO). While it is always risky to predict the outcome of a Supreme Court case from the oral arguments, the Justices seemed to have accepted the U.S. Solicitor General’s arguments that cDNA molecules satisfy § 101, but seem unlikely to find that human genes can be patented.Continue reading this entry

Federal Circuit Finds Patent Marking Is Circumstantial Evidence Of Infringement

Posted in Federal Circuit Decisions; Infringement

In Frolow v. Wilson Sporting Goods Co., the Federal Circuit refused to adopt the doctrine of marking estoppel, but held that evidence that Wilson had marked some accused tennis racket models constituted evidence of infringement sufficient to raise a genuine issue of material fact and prevent summary judgment of non-infringement. Continue reading this entry

Pinpointing Invention Conception Date In A Patent Interference

Posted in Federal Circuit Decisions

In Dawson v. Dawson, the Federal Circuit considered an unusual case with a question that often arises in interferences: when did the inventor invent the subject matter at issue. While the decision does not break new ground in the law of conception, it highlights the issues that can arise when an inventor changes employment before an invention has been reduced to practice.Continue reading this entry

USPTO Rules Eliminate Inter Partes Review Dead Zone

Posted in Patent Reform; Patent Trials; USPTO Proposed Rule Changes

On March 25, 2013, the USPTO published final rule changes to “Implement the Technical Corrections to the Leahy-Smith America Invents Act as to Inter Partes Review.” The rule changes have an effective date of March 25, 2013, and relate to statutory changes with an effective date of January 14, 2013.

The Dead Zone

The AIA created two new procedures for challenging a patent within the USPTO: Post Grant Review and Inter Partes Review. As enacted, Post Grant Review only can be requested within the first nine months after a patent grants, and Inter Partes Review only could be requested thereafter. However, Post Grant Review only is available for patents examined under the first-inventor-to-file provisions of the AIA (which only apply to certain applications filed on or after March 16, 2013). This created a “dead zone” for patents that are not subject to Post Grant Review, because they could not be challenged within the USPTO within the first nine months after grant or reissue.

The AIA Technical Corrections Act

The AIA Technical Corrections Act stemmed from HR 6621, and eliminated the Inter Partes Review dead zone by providing that the nine month time period restriction does not apply to patents that are were not examined under the first-inventor-to-file provisions of the AIA. Thus, under the AIA Technical Corrections Act, an Inter Partes Review proceeding to challenge a “first-to-invent” patent or reissue can be brought anytime once the patent or reissue is issued.

By the terms of the AIA Technical Corrections Act, these statutory changes took effect on January 14, 2013 (the date of enactment) and apply to proceedings commenced on or after that date.

The USPTO Rule Change

To implement these statutory changes, the USPTO has amended 37 CFR § 42.102(a) to read as follows:

(a) A petition for inter partes review of a patent must be filed after the later of the following dates, where applicable:
(1) If the patent is a patent described in section 3(n)(1) of the Leahy-Smith America Invents Act, the date that is nine months after the date of the grant of the patent;
(2) If the patent is a patent that is not described in section 3(n)(1) of the Leahy-Smith American Invents Act, the date of the grant of the patent; or
(3) If a post-grant review is instituted as set forth in subpart C of this part, the date of the termination of such post-grant review.

A “patent that is not described in section 3(n)(1) of the Leahy-Smith American Invents Act,” is a patent that was not examined under the first-inventor-to-file provisions of the AIA, the applicability of which is set forth in section 3(n)(1) of the AIA. Using the short-hand used in the Federal Register Notice, a “patent that is not described in section 3(n)(1) of the Leahy-Smith American Invents Act,” is a “first-to-invent” patent.

No Notice And Comment Period

As noted above, the USPTO published the final rule changes on March 25, 2013 and the rule changes have an effective date of March 25, 2013. The USPTO explained why this rule change was not subject to a notice and comment period:

Good cause exists to make these procedural changes without prior notice and opportunity for comment and to be effective immediately so as to avoid inconsistencies between regulations and the AIA Technical Corrections Act.

An Important Correction

This correction could be important to patents that may be involved in litigation, because the Inter Partes Review statute requires that a petition for Inter Partes Review be brought within one year after the petitioner has been served with a complaint alleging infringement. Without the correction, an accused infringer would have to wait until nine months after grant to petition for Inter Partes Review, even if  the one year clock was running.

USPTO Implements Significant Patent Term Adjustment Changes Pursuant To The AIA Technical Corrections Act

Posted in Patent Term Adjustment

On April 1, 2013, the USPTO published an “interim final rule” relating to Patent Term Adjustment (PTA), to implement changes to the PTA statute embodied in the AIA Technical Corrections Act. Although the rule changes have an immediate effective date, the USPTO will consider written comments submitted within 60 days, e.g., by May 31, 2013.Continue reading this entry

Briefing The Supreme Court In Myriad

Posted in 101; Myriad; Personalized Medicine; Supreme Court Decisions

March 15, 2013 was a big deadline for patent applicants seeking to secure first-to-invent filing dates for U.S. patent applications, but April 15 will be a big day for the biotechnology industry, when the Supreme Court hears oral arguments in The Association of Molecular Pathology v. Myriad Genetics, Inc. (also known as the ACLU/Myriad “gene patent” case). Here I provide a brief summary of the parties’ briefs to the Supreme Court.Continue reading this entry

Australia’s April 12 Deadline For Raising The Bar

Posted in International Patent Practice

Now that we have made it past the March 16, 2013 effective date of the first-inventor-to-file provisions of the America Invents Act, it is time to turn our attention to Australia, and the April 15, 2013 effective date of the Intellectual Property Laws Amendment (Raising the Bar) Act.

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Federal Circuit To Reconsider De Novo Review Of Claim Construction

Posted in Claim Construction; Federal Circuit Decisions

In a nonprecedential order issued March 15, 2013, the Federal Circuit granted rehearing en banc in Lighting Ballast Control, LLC v. Philips Electronics North America Corp., to consider the following questions:

  1. Should this court overrule Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998)?
  2. Should this court afford deference to any aspect of a district court’s claim construction?
  3. If so, which aspects should be afforded deference?

The order expressly invites amicus briefs:

The court invites the views of the United States Patent and Trademark Office as amicus curiae. Other briefs of amici curiae will be entertained, and any such amicus briefs may be filed without consent and leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29.

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Preserving First-To-Invent Status Under The America Invents Act

Posted in Patent Reform

Now that the first-inventor-to-file provisions of the America Invents Act (AIA) have taken effect, stakeholders should understand how to preserve the first-to-invent status of patent applications that were filed before March 16, 2013.Continue reading this entry