Amgen will soon find itself in a price war with Sandoz – a Novartis company – as it tries to maintain its share of the market for Neuprogen (filgraslim). The drug is used to treat neutropenia –often a side effect of anti-rejection drugs or chemotherapy. No matter what you think of “Obamacare,” whoever slipped in a relatively small section authorizing biosimilar products and outlining a pathway to approval, may end up saving many consumers much more than they might realize from affordable health care. Sandoz will market the drug as Zarxio. Read more here.
Archive for the ‘Patenting Methods/Processes’ Category
In Interval Lighting v. AOL, Inc., Appeal no. 2013-1282, -1283, -1284, -1285 (Fed. Cir. Sept. 10, 2014), the appealed indefiniteness finding by the district court was affirmed by the Fed. Cir. panel. This was not surprising, since the disputed term was that some sort of extraneous information– like an advertisement – would be displayed on a computer screen during use in an “unobtrusive manner.” This term (one of “degree”) was termed “highly subjective” by the panel, that found that “its scope…depends ‘on the predictable vagaries of any one person’s opinion.’”
Interval Lighting’s last hope was to convince the panel that the term “unobtrusive manner” should be defined by reference to a “narrow example” from the specification, such as displaying the image in a limited area of the screen. However, the relied-upon embodiment was disclosed in the following way: “e.g., the information is presented in areas of a display screen that are not used by displayed information associated with the primary interaction with the apparatus.”
In Perricone v. Medicis, 432 F.3d 1368 (Fed. Cir. 2005), the court reversed the Board, and found that a claim to treating sunburn with certain vitamin esters was patentable in view of art disclosing the same compounds to benefit normal skin. The Board had found the claim invalid as inherently anticipated by the prior art use, but the court found no disclosure in the prior art of applying the compounds to sunburned skin.
In Ex parte Matsubara, Appeal 2009-006581 (Feb. 10, 2010), the Board affirmed the Examiner’s rejection of a claim to a method for improving bone metabolism by (a) selecting a human or animal having a tendency toward a decrease in bone density (e.g., afflicted with osteoporosis), and (b) therapeutically administering to said human or animal certain types of fermented soy milk or “FSM.” The Examiner rejected the claim as inherently anticipated by a publication that disclosed studying the lipid metabolism in aged, ovariectomized rats after giving them FSM, in view of a publication that established that such rats were an art-recognized model of osteoporosis. Applicants argued that the prior art showed no effect of FSM on osteoporosis and no “selection step” of choosing the rats to evaluate, since the prior art was not concerned with studying osteoporosis.
After quoting sections of Perricone discussing inherency, that the Fed. Cir. panel found inapplicable to the decision that it reached, the Board affirmed the rejection, stating that “the claimed method ‘is inherent and in the public domain if it is the “natural result flowing from” the explicit disclosure of the prior art’…regardless of whether the inherent result is recognized.” Although I have argued that the use of an old compound for a “different purpose” than disclosed in the art should be sufficient to distinguish the prior art use if a “new use for an old compound” is being claimed, Perricone may deserve a closer reading.
It may well be that the Fed. Cir. reversed in Perricone because no manipulative step of applying the esters to sunburned skin was disclosed in the prior art, not simply because the claimed purpose was not in the prior art. The panel did begin by agreeing: “If [the prior art] discloses the very same methods, then the particular benefits must naturally flow from those methods even if not recognized as benefits at the time of [the art’s] disclosure. Thus [the art] anticipates if its disclosure of ‘topical application’ satisfies the application step in Dr. Perricone’s various asserted claims.” The panel went on to find that the art did not disclose the application step of applying the esters to sunburned skin.
So, given that new uses of old compounds remain statutory subject matter and can be extremely valuable, how do we claim them? I think it is important that the prior art rats given FSM and the rats treated by Matsubara were both models for osteoporosis. At least some Examiners give weight to the value of “selection” or recognition that a specific subpopulation can be helped by administration of an “old drug.” For example, consider a claim to “a method of treating a human male afflicted with prostate cancer comprising administering an effective anti-cancer amount of Lipitor to said human male.” Hopefully, the prior art does contain a publication on the treatment of prostate cancer with a chemotherapeutic agent, e.g., docetaxel, that also incidentally discloses that some of the patients were given Lipitor to lower cholesterol. Then you are left hoping that the inventor’s dosing regimen is different than the standard dosing regiment used to lower cholesterol. The noose tightens.
In my post of April 22, 2009, I spent quite a lot of time discussing why “mechanism of action” claims may issue but, like the “Hail Mary” pass in football, remain vulnerable to invalidation as inherently anticipated by the prior art, taken with discoveries made long after the filing date of the claims. Much of this discussion was in the context of the reexamination of the NF-kB patent claims asserted by Ariad against Lilly. I posited that the PTO had effectively taken the position, with respect to such claims, that:
(A) Method claims whose only recited steps are altering biological mechanisms of action are invalid as anticipated, under principles of inherency, by a prior use of a biologically active compound that meets two requirements:
1. More than a year prior to the effective filing date of the claim at issue, an “old compound” was administered, so as to treat a condition or achieve a result encompassed by the condition or result recited by the claim at issue; and
2. At any time, it is shown that the mechanism of action of the “old compound,” when used to treat the condition or achieve the result, is the mechanism of action recited in the claim.
In the Ariad reexamination, at one point, the PTO Examiner cited the Old Testament of the Bible against the claims, in combination with a recent publication that demonstrated that reservatrol, a compound present in red wine, inhibited the NF-kB pathway. Thus, Bible stories in which red wine was consumed inherently anticipated claims to a method of inhibiting NF-kB activity in a cell by contacting the cell with an NF-kB inhibitor (some of the claims at issue in the patent asserted by Ariad were even broader than this).
This principle was applied by the Board on February 12, 2010, again in Lilly’s favor, to invalidate claim 24 of Pfizer’s Viagra patent (U.S. Pat. No. 6469012):
Claim 24. A method of treating erectile dysfunction in a male human, comprising orally administering … an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition containing either entity. (Ex parte Pfizer, Appeal No. 2009-004106, Bd. App. Feb. 12, 2010).
Pfizer had sued Lilly for infringing claim 24 by selling Cialis, admittedly a PDEv inhibitor. Lilly requested reexamination and urged that claim 24 was invalid as inherently anticipated by a (I assume “ancient”- as it is described in Chinese Herbal Medicine Materia Medica) treatment for impotence involving inter alia, drinking rice wine and imbibing an herb whose Latin name translates as “horny goat weed,” in combination with later evidence that demonstrated that the herb in fact contained icariin, a selective cGMP PDEv inhibitor, that would be effective to treat ED when administered in regimens disclosed in the Chinese literature. The Board found the evidence convincing, and affirmed the Examiner’s invalidation of the claim.
So the next time a professor-client or tech transfer person wants you to write this sort of claim, based on a newly discovered mechanism of action, remember that, like the Hail Mary pass, you can put it up there, but it might not stay up for long.
You can read more about it at Law36o.