Philip Brooks' Patent Infringement Updates

Prosecution Strategies: Tackling USPTO Obviousness Rejections

The American Bar Association Section of Intellectual Property Law, Young Lawyers Division, ABA-IPL Young Lawyers Action Group and the ABA Center for Continuing Legal Education are hosting the above titled webinar on January 20, 2012.

Program Description

The Supreme Court's decision in KSR v. Teleflex was widely discussed. On September 1, 2010, the United States Patent and Trademark Office (USPTO) released updated examination guidelines that provide guidance to examiners and practitioners for analyzing obviousness.

Starting with the examination guidelines, the panel will explore how the KSR standards have been applied in various technology areas and provide guidance for effective avenues of argument based on the technology area.

The panel will also discuss various arguments that may be effective, but may also narrow the scope of arguments that can be made during litigation.

Program Faculty

>Janet S. Hendrickson, Ph.D. (Moderator), Partner, Senniger Powers LLP, St. Louis, MO
>Gregory L. Hillyer, Member, Feldman Gale, Philadelphia, PA
>Michelle E. O'Brien, Partner, O'Brien Jones PLLC, McLean, VA
>Zachary S. Stern, Senior Attorney, Oblon, Spivak, McClelland, Maier & Neustadt, LLP, Alexandria, VA

Learn more and register here.

New USPTO Guidelines and the Obviousness Standard for Patents

Strafford Publications is hosting the above-titled live webinar/teleconference on January 12, 2011:

The Supreme Court’s 2007 decision in KSR v. Teleflex established a new standard for obviousness. In Sept. 2010, the USPTO published updated guidelines, which provide reasons and circumstances under which claims may or may not be found obvious.

In KSR, the Court changed the framework for evaluating obviousness, but it left a number of unanswered questions. Counsel can gain practical insights from how the courts and the USPTO Board of Appeals have applied the obviousness standard since KSR.

Our panelists, recruited from the country's top law firms, have developed this program to provide patent counsel with a review of the USPTO's new post-KSR guidelines and how the courts and the USPTO are applying the obviousness standard. We will discuss best practices for patent counsel to avoid obviousness rejections and defend patent validity.

The panel will review these and other key questions:  

• What insights into how the USPTO will perform obviousness analyses do the new USPTO Guidelines provide?
• Under what circumstances has the obvious-to-try standard supported a finding of obviousness—and when has it worked to nullify such a finding?
• What are the steps that patent applicants can take to stand up to obviousness rejections?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.

More information and registration are available here.

Updated Guidelines on What Is "Obvious"

The following is excerpted from an article by Bruce D. Sunstein, from Sunstein's September 2010 IP Update:

On September 1, the United States Patent and Trademark Office issued updated guidelines for use by patent examiners in determining when the subject matter claimed in a patent application should be rejected for being obvious.

The updated guidelines differ from the original guidelines, issued in 2007 in one major respect: They acknowledge that not all inventions are obvious. The original guidelines, occupying nine densely worded pages of the Federal Register, discuss not a single example of an invention that surmounts the obviousness hurdle.

The original guidelines were triggered by the decision of the Supreme Court in KSR v. Teleflex, which, as we reported in 2007, made it easier to reject patent applications and to invalidate issued patents for obviousness. The updated guidelines reflect developments in the law since KSR v. Teleflex.

Read the full article here.

2009 Patent Law Decisions of the Federal Circuit

The above-titled article by Donald R. Dunner, Bryan C. Diner, Esther H. Lim and Troy E. Grabow (all Partners with Finnegan, Henderson, Farabow, Garrett & Dunner, LLP) appears in Volume 59 (page 809) of the American University Law Review.

The following is an excerpt addressing Rule 11 sanctions in ICU Medical, Inc. v. Alaris Medical Systems, Inc.:

In ICU Medical, the Federal Circuit held that the district court did not commit clear error when it granted Rule 11 sanctions. The Federal Circuit noted that “the Supreme Court has advised all appellate courts to ‘apply an abuse-of-discretion standard in reviewing all aspects of a district court’s Rule 11 determination.’” Under this standard, “[a] district court would necessarily abuse its discretion if it based its ruling on an erroneous view of the law or on a clearly erroneous assessment of the evidence.” The Federal Circuit applied Ninth Circuit law in determining whether a sanctions award under Rule 11 was appropriate, explaining that “a district court must conduct a two-prong inquiry to determine (1) whether the complaint [or relevant document] is legally or factually ‘baseless’ from an objective perspective, and (2) if the attorney has conducted ‘a reasonable and competent inquiry’ before signing and filing it.” Applying these laws, the Federal Circuit found that the district court properly determined that ICU’s frivolous construction and assertion of certain claims in its amended complaint justified sanctions under Rule 11. The Federal Circuit also noted the district court’s decision not to award monetary sanctions for the violations of Rule 11, because the amount of the award of Rule 11 sanctions was “subsumed” by the amount of attorneys’ fees awarded under § 285, which “ha[d] sufficiently admonished ICU and its counsel for any improper conduct under Rule 11.”

Read the full article here.

Patents Obviousness Over Same Prior Art Raised During Ex Parte Reexamination

The following is excerpted from a March 4, 2010 Harness Dickey news item regarding Media Technologies Licensing, LLC. v. Upper Deck Co., 2009-1022(Fed. Cir. Mar. 1, 2010):

A divided Federal Circuit panel affirmed summary judgment that claims in Media Tech’s two patents to trading cards with attached items or fragments of memorabilia were obvious over prior art that had been considered in reexamination proceedings: a Marilyn Monroe trading card with diamond, hotel stationary with piece of sheet one of the Beatles slept on, a holy card of a Capuchin friar with attached piece of his clothing, and a James Dean greeting card with jeans material.  (In an interesting decision on petition to dismiss the reexamination because the unique cards with attached objects were not “printed publications,” the PTO held there was a “colorable argument” that they were so that the reexamination could proceed; the patent owner would be able to raise the issue again on appeal. The decision noted evidence showed public availability and accessibility.  Reexamination certificates were issued without an appeal being taken.)  The panel found the claims obvious as an expert opinion showed sports card designers adopted ideas from other card genres, with no mention of the PTO’s decision to issue reexamination certificates after considering the same prior art. 

Access the full news item and a link to the Federal Circuit's opinion here.  A 90-minute Strafford CLE webinar/teleconference titled, "Obviousness Standard for Patents Post-KSR" will take place on April 14, 2010.

Judge Orders New Trial in NewRiver v. Newkirk Products

The following is excerpted from a December 28, 2009 case summary by the Massachusetts Lawyers Weekly Staff available at LexisNexis:

Where a jury returned a verdict in a patent infringement case, a new trial is necessary because the court erred in allowing the issue of the obviousness vel non of claims 9-11 to go to the jury.

"On April 7, 2009, the jury returned a verdict finding that [defendant] Newkirk infringed claims 9-11, that its infringement was not willful, but that certain of the claims in suit, specifically including the crucial claims 9-11 which had been found infringed, '635 Patent claims 1, 3-5, and 8-11, were invalid as obvious. Jury Verdict (Doc. No. 301). In addition, the jury found that Newkirk did not breach its contract with [plaintiff] NewRiver. ...

"... Notwithstanding Rules 704 and 705, Federal Circuit case law renders legally inadequate the opinions of qualified experts on the ultimate issues of anticipation, obviousness, and doctrine of equivalents unless the bases therefor are spelled out on the record. ...

"I told the jury that they were the sole judges of the facts. I instructed concerning making credibility judgments and told the jury they could believe (or disbelieve) any witness who had testified before them. I cautioned the jury as to experts (I refer to them as 'opinion witnesses') but told them it was open to them to believe what the experts, including Dr. Syzmanski, had said. I instructed (accurately) as to the legal concept of obviousness and told the jury to make the determination concerning whether claims 9-11 were obvious. NewRiver made no objection to these aspects of the jury charge. Yet, on all of these matters, the jury charge was palpably wrong. ...

"Yet simply to set aside the jury's verdict will not do. Here, I failed to appreciate the applicable legal framework and thus sent the jury off on a wild goose chase. ..."

See the full U.S. District Court case summary and a link to the full text of the decision here.

Fresenius Med. Care Holdings, Inc. v. Baxter Int’l, Inc.

The following is excerpted from a Dewey & LeBoeuf IP Watch regarding Nos. 08-1306, -1331, Fed. Cir. (Newman, Gajarsa,* Dyk):

Just as a patentee who seeks to prove infringement must provide a structural analysis by demonstrating that the accused device has the identified corresponding structure or an equivalent structure, a challenger who seeks to demonstrate that a means-plus-function limitation was present in the prior art must prove that the corresponding structure—or an equivalent—was present in the prior art.

On September 10, 2009, the Federal Circuit affirmed-in-part, reversed-inpart, vacated-in-part and remanded the district court’s judgment that Fresenius infringed U.S. Patents No. 5,247,434, No. 5,744,027, and No. 6,284,131, which related to a hemodialysis machine integrated with a touch screen user interface. The Federal Circuit stated:

The district court determined that Fresenius failed to present substantial evidence that various non-touch-screen limitations of the asserted claims were present in the prior art. The district court also found that Fresenius did not present substantial evidence of a motivation to combine the elements of the prior art to achieve the invention claimed in the ’131 and ’434 patents. Fresenius argues that the non-touch-screen limitations in the asserted claims were standard in prior art hemodialysis machines and that it presented substantial evidence of such to the jury. Baxter contends the asserted claims are nonobvious, or at a minimum, that Fresenius failed to meet its burden of proving invalidity by clear and convincing evidence. For the following reasons, we reverse the district court’s grant of Baxter’s JMOL motion, except as to claims 26–31 of the ’434 patent. . . .

All of the claims on appeal are directed to a hemodialysis machine integrated with a touch screen user interface, which Baxter contends was novel and nonobvious at the time the relevant patent applications were filed. Fresenius contends that touch screens were well-known in the prior art and had been widely employed—even on other medical devices—such that Baxter’s addition of a touch screen interface to an otherwise conventional hemodialysis machine would have been obvious and thus unpatentable. . . .Under KSR, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”

Read the full IP Watch here.

The Economics of Commercial Success in Pharmaceutical Patent Litigation

The above-titled article by Rahul Guha, Jian Li, and Andrea L. Scott appeared as the cover article for the May/June 2009 print issue of Landslide (a publication of the ABA Section of Intellectual Property Law).  The following is an excerpt from the article:

Under the 1984 Hatch-Waxman Act, a generic drug manufacturer may seek FDA approval to enter a market before patents on the branded drug expire by claiming that the relevant patents are invalid or not infringed. Since the Act’s passage, the share of generic manufacturers’ Abbreviated New Drug Applications (ANDAs) that make such claims has been increasing substantially. The result has been an increase in patent infringement litigation by branded drug manufacturers against generic manufacturers.

When an accused infringer attacks a patent as invalid, the patent holder may need to establish that the patented invention is “nonobvious.” The Supreme Court decision in Graham v. John Deere Co. first structured a three-part test for determining the nonobviousness of a patent. In addition to examining evidence on the intrinsic or scientific features of an invention, the Court in Graham also expressly approved the use of “secondary” considerations such as the commercial success of an invention in the nonobviousness determination. Other secondary considerations that have been considered by the courts include copying by competitors, fulfillment of a long-felt need, failures of others, and the extent of licensing of the patented invention.

From an economic perspective, commercial success supports a conclusion of nonobviousness because it suggests that an economic incentive existed to produce the invention. Thus, if the invention was obvious, it would have been brought to market sooner by some other party in response to that incentive. Some of the economic indicators that have traditionally been accepted by the courts as proof of commercial success include significant levels of and rapid growth in sales and market share of the patented product.

In the presence of scientific evidence that the therapeutic attributes of a drug flow from the patent, several types of economic analyses can be conducted to support a conclusion that the commercial success is due to the patent’s claimed invention. This includes sales that respond to new information about drug benefits, sales that respond to patented formulation improvements, and favorable formulary placement based on therapeutic considerations. When evaluating the contribution of marketing efforts to the success, it is important to account for several factors that drive marketing intensity. In particular, marketing intensity is normally higher early in the product life cycle and for later entrants and will increase in response to new information about product quality. Finally, marketing serves an important function in disseminating information about the therapeutic benefits of pharmaceuticals. Ultimately, those benefits, and not marketing, are likely to determine whether or not it is a commercial success.

Read the full article here.

Federal Circuit's Patent Ruling Could Broadly Affect Biotech

Donna Young, Washington Editor, writes on April 8, 2009 for BioWorld Today:

A ruling last Friday by a three-judge panel from the U.S. Court of Appeals for the Federal Circuit, which affirmed the government's rejection of a patent application filed by two Amgen Inc. scientists, could not only impede gene patenting, but could make all medical-related patents more difficult to obtain.

The case, known as In re Kubin, involved claims directed to the cDNA encoding the human natural killer cell activation inducing ligand (NAIL) protein.

For the cells to become active, they need to be triggered. The inventors involved in the patent application, Marek Kubin and Raymond Goodwin, discovered the trigger and cloned the gene that codes for the trigger protein.

Prior to the filing of the Kubin patent, which is owned by Thousand Oaks, Calif.-based Amgen, other scientists also had been working on the killer cells and had identified the receptor protein but had not fully characterized it.

While an earlier scientist had partially characterized the protein and had created an antibody against it, he did not know the amino acid sequence or the gene that was later claimed by Kubin in the Amgen patent application.

When the U.S. Patent and Trademark Office (PTO) examiner evaluated the Kubin patent application, the examiner determined that because the protein was already known and there were reliable methods in place for working on such a discovery, that any scientist in that area could have identified the amino acid sequence and conducted all of the same experiments as Kubin to arrive at the same conclusion with the cloned gene.

Therefore, the PTO examiner determined that Kubin did not do anything that other scientists could or would have inevitably done in due course. And so the PTO rejected Kubin's patent on the grounds of obviousness.

Amgen appealed the PTO's decision to the Court of Appeals for the Federal Circuit.

Hans Sauer, associate general counsel for intellectual property at the Biotechnology Industry Organization, said the patent office's decision, as well as the Federal Court's decision, were wrong because they failed to follow controlling legal authority in the court's 1995 ruling in a patent rejection case known as In re Deuel.

...the Federal Circuit determined that a 2007 ruling by the Supreme Court in KSR International v. Teleflex Inc. voided the Deuel decision.

If taken to its logical conclusion, the Federal Circuit's decision "is quite disconcerting because it would make many biotech inventions that we now think are legitimate inventions obvious and make it much harder to get a patent for what today are legitimate discoveries of patentable inventions."

Read the full article here.

Actavis UK Ltd v Novartis AG

Barrister Jane Lambert writes in her 500th post at her NIPC blog:

This was a claim by Actavis for the revocation of a Novartis's European patent for a preparation which released fluvastatin (a cholesterol inhibiting drug) gradually rather than in an immediate burst on grounds of obviousness and insufficiency. There was also a counterclaim by Novartis for infringement of its patent. Novartis conceded that the claims as granted could not be granted and applied for their amendment.   The claim and counterclaim came on before Mr Justice Warren and is reported at Actavis UK Ltd v Novartis AG [2009] EWHC 41 (Ch) (16 January 2009)

This case is important because it is one of the first cases since Conor Medsystems Inc v Angiotech Pharmaceuticals Inc amd others [2008] UKHL 49 (9 July 2008).  Mr Justice Warren reviewed that case and others such as Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd [1985] RPC 59 and Pozzoli SPA v BDMO SPA [2007] FSR 872 in determining the extent to which Conor had changed the law.

Comparing the teaching of the patent to the pleaded prior art and common general knowledge the judge found that the patent was obvious. The claim on insufficiency failed.    There was no dispute that the claimant's preparation would have infringed the defendant's patent had it been valid but in view of the finding of obviousness the counterclaim failed.

Read the full post here.