Federal Circuit Affirms EDTex Ruling that Iovate’s Muscle Building Patents are Invalid

Iovate & University of Florida Research Foundation v. Bio-Engineered Supplements & Nutrition 200911201103.jpg (BSN) (Fed. Cir. 2009) (Download 09-1018)

Iovate is the exclusive licensee of UF's patented method for "enhancing muscle performance or recovery from fatigue." Pat. No. 6,100,287. The method includes the single step of administering a coposition that contains a ketoacid and either a cationic or dibasic amino acid. Eschewing their home-state courts, the patentee filed suit in the Eastern District of Texas — alleging that BSN was selling infringing supplements.

On summary judgment, district court judge Ron Clark held the patent invalid as anticipated under 35 U.S.C. 102(b). The most relevant prior art was a series of advertisements found in Flex Magazine.

Each ad includes a list of ingredients, directions for administering the dietary supplement orally to humans, and marketing claims and testimonials from bodybuilders extolling the virtues of the product. . . . The ad also describes how the product is made, including the four steps used to isolate the protein components from milk whey; lists a price of $24.99; states that the product is available at GNC and other health food stores or by phone; instructs the user on the amount to take; and offers a manufacturer’s rebate of $5.00 for mailing in a coupon with proof of purchase before July 31, 1996.

Judge Clark ruled that the advertising served as proof that the invention public use and on sale under § 102(b) based on the fact that the ads "show an actual product and state that it is available for purchase in health food stores, gyms, or by catalog." The district court also held that the ads explicitly disclose "all of the limitations of the asserted claims, including each of the claimed chemical components as well as the stated function of oral administration to a human to speed muscle recovery."

Under § 102(b) a patent is invalid if "the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States."

On appeal, the Federal Circuit affirmed, but narrowed its grounds to focus only on the prior art as a "printed publication." Writing in a concurring opinion, Judge Mayer indicated that he would have found that the ads place the products "on sale" as well.

Iovate raised two arguments regarding the prior art. First, the patentee argued that the ads did not disclose each element in the claims because the preamble included the goal of "enhancing muscle performance" and while the ad merely touted promotion of "muscle synthesis and growth." The appellate panel not only rejected that argument, but also found that it "borders on the frivolous" since the specification and Iovate's briefs at the district court suggested that muscle growth was a proxy for enhancing muscle performance.

Iovate also argued that the ad was not sufficiently enabling as prior art. In rejecting that suggestion, the appellate panel held that "all one of ordinary skill in the art would need to do to practice an embodiment of the invention is to mix together the known ingredients listed in the ad and administer the composition as taught by the ad."

Affirmed.

This case leave open the question of when an advertisement would be evidence of public use or on sale.

30 thoughts on “Federal Circuit Affirms EDTex Ruling that Iovate’s Muscle Building Patents are Invalid

  1. “Does that ad place the invention on sale in the US?”

    You can’t sell a method Ned. You can instruct someone for a fee, but you can never sell the actual method. That is something going on in this case that I should have noticed at the beginning had I have bothered to read the specifics rather than focusing on the “on sale” aspect.

  2. Also, did we not just have a case that held sale of components for use OUTSIDE the US in practicing a patented method was not an infringement? How could that case stand if the sale of components themselves placed the invention on sale in the US?

  3. Assume, for the sake of argument, that the ad is for a service of practicing a patented method, but the method is practiced outside the US.

    Does that ad place the invention on sale in the US?

  4. *****The statute does not require a “sale”, it only requires the product to be “on sale”. If the product is shown in an ad with a price and a place to call to order, is not the product “on sale”?******

    I don’t know for sure about that, but we were discussing whether the advertisement constitutes an “offer for sale” under legal contract terms. I don’t think anyone suggested that an actual sale had to occur, but maybe an “offer for sale.”

    As I said before, I don’t think that the advertisement meets the requirements for an “offer for sale” under contract law. Apparently, the CAFC was looking for an “offer for sale” to satisfy the definition of “on sale.” Or perhaps they were looking for it to be “on sale,” as in a “Thanksgiving Day Sale.” So maybe, if you charge full price, and don’t place it “on sale,” then it’s not prior art under 102(b). I knew there was a quip in their somewhere. Maybe that’s why the “rebate” was an issue?

    This has not been legal advice.

  5. Over 1000 old issues of bodybuilding magazines were acquired in an effort to find invalidating prior art, which made the office look quite bizarre.

    LOL. Had a similar experience once invalidating some “technology” where the best prior art was in the area of prizes offered on boxes of breakfast cereal and candy.

  6. The advertisements at issue included a list of ingredients and indicated they were for building muscles by ingesting the product. Many included claims from bodybuilders as to what it did for them after they ingested it. In that sense, the ads arguably put both the product and method “on sale.”
    Over 1000 old issues of bodybuilding magazines were acquired in an effort to find invalidating prior art, which made the office look quite bizarre.

  7. The statute does not require a “sale”, it only requires the product to be “on sale”. If the product is shown in an ad with a price and a place to call to order, is not the product “on sale”?

  8. I see your argument – if you called the number on the ad and no one answered you wouldn’t be in a position where sale was promised. However if you mailed in the rebate… Isn’t that a further step in the process that does imply a sale?

  9. Lionel,

    Re:
    “To answer your specific question JAOI, i think NYC is probably a hostile venue, so yes the terrorists should probably be tried elsewhere to obtain a fair trial. Is that what you were looking for? The fact that I believe most of these guys haven’t confesses so much as taken credit, mitigates my concern on that front.”

    I have had it with you —
    you are no longer my friend you son of a witch.
    You Just do not get it!

    What would you do with those who have
    (i)“taken credit” for the cruelest attack
    on our nation, in the name of God no less, and
    (ii) others who sympathize with the phucking terrorists?

    You may consider yourself a “real American,”
    but, with all due disrespect,
    I consider you good-for-nothing.

    O’ Lord, hear my prayer.
    link to youtube.com

  10. LOL @ Moe.

    I prefer adding “a step of transforming investment capital into patent attorney greens fees.”

  11. Well, I’d say an ad is an “offer for sale” in the normal meaning of that word, and I’ll have to read Rader’s concurrence.

    However, if I remember correctly from Contracts an ad doesn’t normally constitute an offer such that one can accept it and create a binding contract. If you read the ad and go to buy the product, you are normally making the offer and then the seller can accept (though I believe in some cases the ad could be an offer).

    Of course, I don’t recall if the patent law follows this. I guess I should read the opinion (but seriously, who reads the case before spouting off in the comments section?).

  12. Nah, yapex, they’re busy inventing. And when I say that, I mean that they’re inventing new ways to patent old ideas. I mean, IBM already patented patent trolling, so they’re running out of old ideas to recycle with novel theories of how to make unpatentable crap patentable. I’ll be happy to give them free ideas. Like if you have a business process that’ll get Bilski’d, you could add “then make me a sammich” to some part of it, so that you have a transformation to satisfy the ‘particular machine or transformation’ test in Bilski (unpatentable bread it transformed into a tasty transformative sammich). I’m sure there are plenty of other ideas…

  13. Letterman: “1. Way too much time goofing around on this board for someone with a real job.”

    I’ve always been curious about contributors of this blog. It seems some 90% of the postings are from patent practitioners. Where do y’all find the time to read and post so much? Some nice, stress-free job being a patent attorney, eh?

  14. Wouldn’t a rejection under 102(b) on sale bar be incorrect, even assuming the product was actually sold?

    The ad is selling a product not a method of administering the product. The ad would clearly anticipate product claims but I think you’d have to go 103(a) for the method claims of the patent (based on 102(b) on sale bar art of the product).

    From MPEP “A claimed process, which is a series of acts or steps, is not sold in the same sense as is a claimed product, device, or apparatus, which is a tangible item. “‘Know-how’ describing what the process consists of and how the process should be carried out may be sold in the sense that the buyer acquires knowledge of the process and obtains the freedom to carry it out pursuant to the terms of the transaction. However, such a transaction is not a ‘sale’ of the invention within the meaning of § 102(b) because the process has not been carried out or performed as a result of the transaction.” In re Kollar, 286 F.3d 1326, 1332, 62 USPQ2d 1425, 1429 (Fed. Cir. 2002).”

  15. “Wouldn’t basic contract law principles hold that the ad is an offer for sale, and thus the product was on sale?”

    Skyywise,

    That was nnother basis for Judge Mayer’s concurring opinion. But the “printed publication” bar was the sure thing.

    You could tell how desperate the patentee was when they tried to distinguish the prior ads based on language in the claim preamble. You’re not going to get even Judge Newman to buy that argument.

  16. Top ten clues that MM is a PTO employee:

    10. Posts less on Friday.

    9. Beleives all claims are obvious.

    8. Cannot provide reasoning to support 9.

    7. Clearly frustrated in life.

    6. Hates all patent practitioners and patent owners.

    5. Refers to PTO “bending over backwards” for applicants.

    4. When losing arguments resorts to using profanity, insult, and ALL CAPS instead of providing counterargument.

    3. Believes that patent prosecution is inequitable conduct per se.

    2. Lousy communication skills.

    1. Way too much time goofing around on this board for someone with a real job.

  17. NWPA I’ve notice that MM posts less frequently on Fridays.

    Everybody posts less frequently on Fridays.

    A clear indication that he works for the government.

    Or it could be the day that I fly to Area 51 to confer with the other Sasquatch.

  18. zak: Of course, determining a dose response curve is standard fare in drug development.

    Yes, but determining a dose response curve is hardly necessary to meet the limitation of “effective amount.” I mean, what do people do when they take an aspirin and it doesn’t get rid of the headache?

    The plaintiff’s here were in one of the weakest positions I’ve seen in a long time. I have no problem with Clark’s ruling and I agree with Mayer’s analysis regarding what constitutes “on sale”.

    A better question is when would a 102(b) ad disclosing all the limitations of the claims, the price, and where to purchase NOT be sufficient to find that the claimed product or method was “on sale”? I think it would be reasonable to bar a patent even if the ad were fraudulent (e.g., because the product did not yet exist) as long as it was enabled *or* if the ad were placed by the patent owner.

  19. “A muscle-building supplement? Did you and Dudas share tips at the gym?”

    No, an ad for a 102b under it showing that the machine in question was on sale.

  20. I like how the court responded to the effective amount limitation the patented holder attempted to read into the claims. Such limitations are common in pharmaceutical patents and seen in medical device patents.

    Basically, they dismissed the presence of such a limitation by noting that the claims “do not restrict the administration of the claimed amino acid and ketoacid composition to any specific dosage or amount” and “do not require any further measurement or determination of any result achieved by administering the claimed composition.” This really reminded me of the holding from Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d 1244 (Fed. Cir. 2008). I guess then that if one wants to claim an “effective amount” a specific dosage or a manner of measuring and determining the intended therapeutic result must be recited in the claims or at least enabled by the specification.

    Of course, determining a dose response curve is standard fare in drug development. So as long as you give the composition and claim an effective amount for something that has standard means of measuring (blood pressure, heart rate, etc.) a claimed effective amount should be enabled by the specification without undue experimentation. It is just novel metrics and possibly those without standard means of measuring that may create problems.

  21. ********Wouldn’t basic contract law principles hold that the ad is an offer for sale, and thus the product was on sale? Or is the ad oblique enough to be considered an invitation to make an offer to buy?*******

    It’s been a while since I studies contracts, but I think there is lack of consideration sufficient to make it a unilateral offer or the like. So I don’t think that the advertisment itself would the offere for sale, but rather evidence that the product is being offered for sale at retail locations and over the telephone. Ask yourself, if somone called the number, and no one answered, would they be able to sue under breach of contract? What if someone answered but offered it at a different price, would the caller be able to sue for the price difference under breach of contract? I don’t think so.

  22. I’ve notice that MM posts less frequently on Fridays. A clear indication that he works for the government. My best guess is still a SPE at the PTO.

  23. “Wouldn’t basic contract law principles hold that the ad is an offer for sale, and thus the product was on sale?”

    No.

  24. “I don’t know, but I sure used one about a year ago for that specific purpose.”

    A muscle-building supplement? Did you and Dudas share tips at the gym?

  25. Wouldn’t basic contract law principles hold that the ad is an offer for sale, and thus the product was on sale? Or is the ad oblique enough to be considered an invitation to make an offer to buy?

    I’m reading what I just wrote, and all I can think of is how The Law makes everyday actions so much more complex than they really ought to be.

  26. Good thing the Judge noted the mail in rebate – that fact was necessary to clinch the case for the offer for sale. . .

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