By Kevin E. Noonan —

On October 2nd, District Court Judge William G. Young (D. Mass) issued a decision on post-trial motions and a permanent injunction in Amgen Inc. v. Hoffmann-LaRoche, Amgen’s patent infringement suit over Roche’s Mircera® drug product.  In a 150-page opinion, Judge Young handed Amgen nothing less than a complete victory.

Amgen procured a jury judgment on October 23, 2007 that Mircera® infringed several Amgen patents, including U.S. Patent Nos. 5,547,933; 5,441,868; and 5,618,698.  In addition, the jury found these and two other patents (U.S. Patent Nos. 5,955,422 and 5,756,349) not to be invalid (see "Amgen Survives Another EPO Challenge").  The District Court entered a preliminary injunction on February 28, 2008, which prevented Roche from launching Mircera® (the FDA approved Mircera® in November 2007).  In entering the preliminary injunction, Judge Young assessed whether Amgen was entitled to an injunction using the four-factor test set forth by the Supreme Court in eBay Inc. v. MercExchange, L.L.C.  Judge Young found that Amgen satisfied all the eBay requirements except the public interest prong.  The District Court expressly did not enter any findings on the fourth prong, but left open the possibility that the injunction could be modified under four conditions.  Roche agreed to the Court’s conditions (see "Roche Agrees to Court’s Conditions for Modifying Preliminary Injunction"), but Amgen did not, and the Court appointed a special master to consider the question of how dosing and pricing of Amgen’s and Roche’s products should be compared (see "Court Still Cannot Decide on Amgen’s Permanent Injunction").  Roche responded by filing its notice of appeal to the Federal Circuit on April 11, 2008 (see "Hoffmann-LaRoche Can’t Wait, Files Notice of Appeal to the Federal Circuit"); that appeal was scheduled to be argued today (October 8).

In last Thursday’s ruling, the District Court ruled in Amgen’s favor on all issues.  An earlier post discussed the Court’s reasoning on its decision that the claims are not invalid under the judicially-created doctrine of obviousness-type double patenting (ODP) (see "Victory for Amgen in District Court Decision – Part I").  This post will discuss the Court’s reasons for granting a permanent injunction to Amgen (subject to Roche’s appeal of the preliminary injunction, or a consolidated appeal that Roche may file in response to this decision).  The remaining grounds for the Court’s decision will be addressed in future posts.

The Court first reiterated its earlier opinion that Amgen fulfilled the first three of the four equitable considerations enunciated by the Supreme Court in eBay:  Amgen’s asserted claims were infringed and not invalid; Amgen’s injury would not be adequately compensated merely with money damages; and the balance of the hardships weighed in favor of granting the injunction.  The District Court opined that while eBay has made it easier to deny an injunction to a non-practicing entity (aka a "patent troll"), in the Court’s view eBay "changed little where a prevailing plaintiff seeks an injunction to keep an infringing competitor out of the market."  (The Court stated that, with but two exceptions, district courts have granted permanent injunctions in 26 cases where infringement was found between direct competitors.)  The Court also opined that the Supreme Court "does not appear to have intended eBay to be pathbreaking precedent," calling the decision  a "barebones majority opinion" that did "little more than remind court[s] that they must exercise discretion in accordance with the framework Congress approved" (i.e., that a court "may" enter an injunction "in accordance with the principles of equity," see 35 U.S.C. § 283).

The District Court then discussed the factors it considered in determining whether the public interest would favor granting Amgen a permanent injunction.  Judge Young conceded that, initially, he was inclined to decide in Roche’s favor, on the grounds that introducing Mircera® would increase competition in the pharmaceutical market place and reduce prices accordingly.  The Court was not willing to rest on this initial assumption, however, but held "extensive evidentiary hearings" on the effects of permitting Roche to introduce Mircera®, as well as appointing both a special master and a technical advisor to help the Court understand the economics of the pharmaceutical industry.  The result was that "[t]he Court’s initial impression [did] . . . not withstand a reflective and detailed analysis."

In coming to its decision, the Court identified three factors it balanced in considering the public interest:  patient health, Medicare savings, and "the public’s interest in a robust patent system."  With regard to patient health, the Court found no compelling evidence that the more limited dosing Roche asserted for its Mircera® produce would greatly increase benefits to patients.  The Court’s conclusion was based to some extent on how erythropoiesis stimulating agents (ESAs) like Mircera® are administered:  kidney dialysis patents, for example, receive dialysis three times a week, so more frequent administration of an ESA has no effect on the patient (albeit perhaps incurring additional ancillary administrative costs).  The Court also credited expert testimony that more frequent dosing may have beneficial effects in titrating the effect of the drug, leading to more stable and consistent red blood cell levels.  The Court also considered the benefits of reducing the "vulnerability" to patients from manufacturing problems stemming from a sole source of approved ESAs, as well as "expanding the armamentarium" available to physicians to treat anemia.

On the other hand, the Court considered testimony that the longer dosing intervals achieved with Mircera® were associated with greater variability in blood hemoglobin levels, and with some evidence from clinical trials that there was a greater mortality rate for patients treated with pegylated erythropoietin.  The Court appreciated that the parties’ experts would disagree on the relative patient benefits of their respective products.  The Court took a slightly longer view of the question, however, in terms of the risks associated with introducing a new product into a treatment regimen:

[O]ne set of facts is clear and warrants particularly strong consideration.  Although clinical studies in support of a Biologics License Application at the United States Food and Drug Administration or at the European Medicinal Evaluation Agency frequently involve several thousand patients, it often takes many years before the medical community learns how new therapies are to be used safely and effectively, for what patients and at what doses, and conditions under which their use is not advised.  As physician/patient experience accumulates and scientific evidence evolves, the benefit/risk calculation underlying treatment often shifts as well.

The Court noted that even for Amgen’s erythropoietin products (Aranesp® and Epogen®) the FDA was continuing to evaluate risks and changing labeling requirements and treatment guidelines (see "FDA Makes Changes in Erythropoietin Labeling"), despite their longevity as approved drugs (Epogen® was launched in 1989 and Aranesp® in 2001).

The Court concluded that:

Given that both the FDA and the European Medicines Agency have approved MIRCERA as safe and effective for the treatment of anemia in patients with chronic renal failure, it seems likely that some patients might well benefit from MIRCERA being on the market as an additional element in the physicians’ armamentarium due to clinical, convenience, and quality-of-life concerns.  Nevertheless, with major changes in recommended treatment modalities still occurring many years after the initial product launch for currently available ESAs, it is also plausible that, were MIRCERA allowed to be marketed in the United States, information and consensus on its risk/benefit profile relative to those of EPOGEN, Procrit, and Aranesp would also evolve and change, perhaps substantially.  . . .  Hence, it is difficult if not impossible to predict with any reasonable level of confidence what the net clinical, convenience, and quality-of-life benefits of Mircera will be relative to those of the existing ESAs.

Turning to the second consideration, Medicare savings, the Court set forth a detailed "primer" on drug pricing under Medicare.  This factor was an important consideration for the Court because "government purchasers comprised approximately 80% of EPOGEN sales," with 75 of that 80% being incurred under the Medicare Part B program.  The Court acknowledged the assistance of "Ernest Berndt, an applied economics professor at the Massachusetts Institute of Technology Sloan School of Business," a court-appointed special master and technical advisor on these matters.  (A detailed explication of this analysis would overly burden this post and risk introducing inaccuracies into the Court’s careful analysis; thus, only a brief synopsis of the Court’s conclusions is provided here.)  Simply put, under the complex scheme for calculating reimbursements to drug providers and physicians, the Court found that introducing a new drug into an established market was likely to have the paradoxical effect of causing drug prices to increase.  In this case, such increases could arise from Roche charging at least as great a price for Mircera® as Amgen charges for Aranesp® or Epogen®.  The Court was clear to acknowledge that this outcome was the result of Medicare’s method for calculating reimbursement rates, which provided an incentive to keep ESA prices high.  The Court also noted that Amgen’s expert testified that there were at least three differences between "textbook" or "plain vanilla" competition and competition between drug providers caused by Medicare reimbursement policies:  first, that under Medicare it is the physician rather than the patient that makes drug choice decisions; second, that end-users (i.e., patients) pay only a small fraction of the drug costs, thereby reducing patient incentive for cheaper drugs; and third, "perhaps most important," "providers are drawn to the drugs that offer the largest difference between the amount the provider is reimbursed  . . . under Medicare . . . and that the provider actually paid for the drug," a difference the Court said is called "cost recovery" in the industry.

The result of this economic analysis convinced the Court that Roche was "likely to enter the market at a price higher than that of Amgen’s products and to maintain high prices over time."  This conclusion was supported by testimony from Roche witnesses that cost recovery was "a major factor" in developing Roche’s pricing strategy for Mircera®.  The Court also recognized that Roche’s pricing behavior would be dependent, in part, on Amgen’s reaction to Mircera® entering the market.  And on top of these uncertainties, the Court also recognized that Congress and administrative agencies could alter the Medicare drug reimbursement calculation at any time and in unpredictable ways.  On balance, the Court concluded that Mircera® market entry was unlikely to reduce Medicare costs for ESA products, saying that "[i]t is simply impossible to predict with certainty the effect that MIRCERA’s entry would have on prices and, accordingly, on Medicare expenditures."

Finally, the Court opined that "[p]ermitting Roche to enter the [ESA] market would undermine the incentives for innovation" provided by patenting.  The Court relied on testimony from Amgen’s CEO on the importance of patents in protecting pharmaceutical innovation, citing statistics on the cost of bringing a successful drug to market, and more importantly, the costs associated with the very many more failures incurred for every successful drug product.

The Court synopsized these considerations, and its ultimate determination, as follows:

If the Court allowed Roche to introduce MIRCERA into the market, perhaps a few patients would benefit, and maybe Medicare would save a few dollars.  These arguments, however, could be made for almost any infringing drug.  Were courts to refuse injunctions on the basis of such speculation, then pharmaceutical patents would be worth far less than they are today because they would no longer include a right to exclude infringers from the market.  The diminishing returns would disincentivize research and development for pathbreaking drugs by lowering the expected value of discovery.  By contrast, granting injunctions encourages companies to devote their energies toward developing drugs that
will satisfy unmet medical needs.

As for the equities, as to Roche:

At bottom, Roche attached a sugar to a patented protein.  As the jury concluded, this was not innovation.  Of course, Roche’s efforts to modify Amgen’s patented product will not go entirely unrewarded.  As it stands, European companies such as Roche can profit from building upon American discoveries by producing and selling infringing products in Europe and throughout the rest of the world.  Nevertheless, the fact that Roche "built up its manufacturing facility in [Europe] and prepared to market its product was simply a risk it took with eyes open to the" possibility that it would not be permitted to market MIRCERA in the United States.

And as to Amgen:

The Court has relinquished any notion that the long-suffering or terminally ill among our number may rely upon "the benevolence of" pharmaceutical companies.  Companies like Amgen invest in risky research and development to discover drugs like EPO because such drugs are worth tens of billions of dollars, period.  If America is to continue to be an engine of medical innovation it will be because we protect the right of inventors to exploit the limited monopoly granted in the Patent Clause.

Accordingly:

[T]he Court cannot conclude with any certainty that MIRCERA will save lives or money.  Failure to enter a permanent injunction, however, would risk undermining the incentives for innovation that have produced, and hopefully will continue to produce, medical advances that extend and enhance the value of life.  The Court therefore concludes that the public interest will not be disserved by a permanent injunction.

Injunction granted.

For additional information regarding this topic, please see:

• "Victory for Amgen in District Court Decision – Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche’s Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can’t Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit’s Pfizer v. Teva Decision Spell the End of Amgen’s Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen’s Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court’s Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche’s Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007

    By Kevin E. Noonan —

On October 2nd, District Court Judge William G. Young (D. Mass) issued a decision on post-trial motions and a permanent injunction in Amgen Inc. v. Hoffmann-LaRoche, Amgen’s patent infringement suit over Roche’s Mircera®  drug product.  In a 150-page opinion, Judge Young handed Amgen nothing less than a complete victory.

Amgen procured a jury judgment on October 23, 2007 that Mircera® infringed several Amgen patents.  That verdict found Roche’s Mircera® infringed claims 3, 7, and 8 of Amgen’s U.S. Patent No. 5,547,933 (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of U.S. Patent No. 5,441,868; and claims 6 through 9 of U.S. Patent No. 5,618,698.  Two other patents asserted in the litigation were found not invalid:  U.S. Patent Nos. 5,955,422 (claim 1) and 5,756,349 (claim 7); and the jury did not reach a determination with respect to infringement and validity for U.S. Patent No. 5,621,080.  Amgen’s infringed claims were directed to recombinant methods and recombinant EPO protein, and Roche’s Mircera® drug product is a form of recombinant EPO that has been covalently linked to polyethylene glycol.  In addition, the jury found that Roche had not sustained its burden of establishing that any of Amgen’s asserted claims were invalid (see "Amgen Survives Another EPO Challenge ").

The District Court then entered a preliminary injunction on February 28, 2008 foreclosing Roche from launching Mircera®; Roche had been granted approval by the U.S. Food and Drug Administration to market Mircera® almost a year ago (in November 2007).  In entering the preliminary injunction, Judge Young assessed whether Amgen was entitled to an injunction using the four-factor test set forth by the Supreme Court in eBay Inc. v. MercExchange, L.L.C.  Judge Young expressly found that Amgen satisfied three of the four requirements (Amgen’s asserted claims were infringed and not invalid; Amgen’s injury would not be adequately compensated merely with money damages; and the balance of the hardships weighed in favor of granting the injunction).  However, the Court at that time did not decide in Amgen’s favor as to the fourth prong, the public interest, particularly in view of Roche’s representations of the advantages of its Mircera® product over Amgen’s version of EPO (including inter alia less frequent dosing; see "Long-Acting Drug for Dialysis Anemia Equivalent to Weekly Agent").

The Court left open the possibility that the injunction could be modified under the following four conditions:  that Roche would pay Amgen a royalty of 22.5% (Amgen having already rejected an offer for a 20% royalty from Roche; see "Amgen Rejects Roche’s Micera [sic] License Payment Offer"); that Roche would introduce Mircera® to the Medicare patient population at a cost no more than the average sales price of Amgen’s EPO products (sold under the names Epogen® and Aranesp®); that Roche would have to provide clinical evidence to permit the District Court to determine a "dosage conversion factor" between Mircera® and Epogen®; and that Roche would pay for an independent agency to monitor sales and determine royalty payments owed to Amgen.  In addition, Roche would agree to supply Mircera® to any patient needing it, at or below the authorized price.  Although Roche ultimately agreed to these conditions (see "Roche Agrees to Court’s Conditions for Modifying Preliminary Injunction"), Amgen did not, and the Court appointed a special master to consider the question of how dosing and pricing of Amgen’s and Roche’s products should be compared (see "Court Still Cannot Decide on Amgen’s Permanent Injunction").  Roche responded by filing its notice of appeal to the Federal Circuit on April 11, 2008 (see "Hoffmann-LaRoche Can’t Wait, Files Notice of Appeal to the Federal Circuit"); that appeal is scheduled to be argued on October 8th.

In last Thursday’s ruling, the Court ruled in Amgen’s favor on all issues, including:  1) affirming the jury’s infringement decision by denying Roche’s motion for judgment as a matter of law (JMOL); 2) reaffirming its pretrial decision to grant summary judgment regarding infringement of claim 1 of the ‘422 patent; 3) "explaining" its reasoning for ruling, also pretrial, that the claims of Amgen’s patents-in-suit are not invalid for obviousness-type double patenting (despite the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.); 4) denying Roche’s motion for JMOL that claim 1 of the ‘422 patent and claims 3, 7, and 9 of the ‘933 patent are not invalid for indefiniteness for reciting the term "human erythropoietin"; and 5) granting Amgen a permanent injunction barring "Roche, its agents, servants, employees, counsel, and all persons and entities acting in concert therewith" from infringing the claims of the patents-in-suit for the remaining life of those patents.

This post will discuss the Court’s reasoning on its decision that the claims are not invalid under the judicially-created doctrine of obviousness-type double patenting (ODP).  The remaining grounds for the Court’s decision will be addressed in future posts.

The relationships between Amgen’s various patents-in-suit, and the earlier-filed ‘008 patent, are set forth in the following diagram:

Roche argued that the claims of the patents-in-suit were invalid for obviousness-type double patenting (ODP) over claim 10 of U.S. Patent No. 4,667,016:

10.  A process for the efficient recovery of recombinant erythropoietin from a mammalian cell culture supernatant fluid, said process comprising the following steps in sequence:
    (1)  subjecting the fluid to ion exchange chromatographic separation at about pH 7.0, thereby to selectively bind erythropoietin in said sample to a DEAE agarose cationic resin;
    (2)  stabilizing materials bound to said resin against degradation by acid activated proteases through treatment with urea;
    (3)  selectively eluting bound materials having a pKa greater than that of erythropoietin by treatment with aqueous acid at a pH of about 4.3.
    (4)  selectively eluting erythropoietin by treatment with an aqueous salt at a pH of about 7.0;
    (5)  subjecting erythropoietin -containing eluent fractions to reverse phase liquid chromatographic separation involving an immobilized C.sub.4 resin, thereby to selectively bind erythropoietin in said fluid to said resin;
    (6)  selectively eluting bound erythropoietin from said resin with an aqueous ethanol solution of about 60 percent at a pH of about 7.0; and,
    (7)  isolating erythropoietin -containing fractions of the eluent.

The Court denied Roche’s summary judgment motion based on claim 10 of the ‘016 patent pretrial, and granted (in part) Amgen’s cross-motion for summary judgment that the claims of its patents-in-suit were not invalid for ODP over both the ‘016 patent and U.S. Patent No. 4,703,008.

In its October 2nd decision, the Court explained that it had made its determination by application of the "two-way" test for ODP.  Under the Court’s understanding of Federal Circuit precedent, this was a case of a patent on a "follow-on" invention granting before a patent on an earlier-filed application to an "original" invention.  Moreover, the order in which the patents were granted was "a function of a restriction requirement imposed by the PTO," and the claims of the patents in suit were "consonant" with this restriction requirement.  Thus, according to the Court, "the claims of the ‘933, ‘422, and ‘349 patents are immune from ODP" over the ‘016 or ‘008 patents pursuant to 35 U.S.C. § 121.

The Court set forth its legal analysis:  "[i]n most cases, courts employ a ‘one-way’ test where the court compared the claims according to the order in which the patents issued."  There are exceptions to this rule under Federal Circuit precedent, according to the Court, citing In re Berg, 140 F.3d 1428 (Fed. Cir. 1998).  These circumstances are the result of "the reality that the Patent Office is perennially underfunded and slow."  Accordingly, occasionally patents will issue such that "a patent covering a subsequently conceived follow-on invention" will issue "before the patent covering the underlying invention."  Using the two-way test prevents the inequity that would arise from applying the one-way test under circumstances where the internal workings of the Patent Office invert the order in which patents are granted on such "underlying" and "follow-on" inventions.

Which test is to be used is, according to the Court, a matter of law, depending on a two-prong test:  first, that an applicant could not have filed the claims in the same (i.e., the earlier-filed) application; and second, that the applicant did not cause a delay in prosecution of the earlier-filed application.

The Court found that any delay in the grant of the earlier-filed application was caused by the Patent Office.  The application resulting in the ‘008 patent (USSN 06/675,298; see diagram) was filed November 20, 1984, while the application resulting in the ‘016 patent (USSN 06/747,119) was filed on June 20, 1985.  Claim 10 is clearly directed to a specific 7-part process for purifying erythropoietin.  The Court characterized as "undisputed" that the ‘016 patent inventors did not conceive of their process until after Amgen filed the ‘298 application.  Under these circumstances, the Court found the first prong of the test was satisfied, that the applicants could not have filed claim 10 of the ‘016 patent in the earlier-filed ‘298 application because it had not been invented yet.

As to the second prong, the PTO imposed a restriction requirement on the claims of the ‘298 application as follows:

I.  Claims 1-13, 16, 39-41, 47-54 and 59, drawn to polypeptide, classified in Class 260, subclass 112.
II.  Claims 14, 15, 17-36, 58 and 61-72, drawn to DNA, classified in Class 536, subclass 27.
III.  Claims 37-38, drawn to plasmid, classified in Class 435, subclass 240.
IV.  Claims 42-46, drawn to cells, classified in Class 435, subclass 240.
V.  Claims 55-57, drawn to pharmaceutical composition, classified in Class 435, subclass 177.
VI.  Claim 60, drawn to assay, classified in Class 435, subclass 6.

Amgen elected to pursue claims in Group II in the ‘298 application, and the granted claims of the ‘008 patent were confined to claims from that Group.  Amgen also filed two divisional applications, USSN 07/113,178 (having claims from Groups I and VI) and USSN 07/113,179 (having claims from Group I) (see diagram).  The Court defined the co-pendency period of the applications resulting in the ‘008 and ‘016 patents narrowly (between the time the application resulting in the ‘016 patent was filed on June 20, 1985 and when it granted on May 19, 1987), and found that during that period Amgen did nothing to delay prosecution of the ‘298 patent application.  "[I]t was the PTO, not Amgen, that caused the later-filed ‘016 patent to issue before Dr. Lin’s ‘298 application" in the Court’s estimation.

The Court expressly rejected Roche’s contention that recitation of the term "recombinant erythropoietin from a mammalian cell culture supernatant fluid" in claim 10 of the ‘016 patent was sufficient to satisfy ODP requirements.  The decision characterized as "fatally flawed" the assumption (attributed to Roche by the Court) that the disclosure found in the ‘016 patent specification was relevant to the question of whether the claims of the patents-in-suit were patentably-distinct over claim 10 of the ‘016 patent.  According to the Court, the Federal Circuit had "made clear that ‘[d]ouble patenting is altogether a matter of what is claimed," citing General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1277 (Fed. Cir. 1992).  The Court expressly distinguished the Federal Circuit decision, relied upon by Roche, in Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003).  Roche argued that this case stood for the proposition that a court can rely on disclosure in the parent specification as well as the parent’s granted claims in determining whether claims in a later-granted patent are invalid for ODP.  According to Judge Young, the reason that the Federal Circuit considered the specification in Geneva was a part of construing the claims to understand their metes and bounds.  Reliance on the specification is not only unnecessary but improper where, as here, that scope and meaning are evident from the express language of the claims of the patents-in-suit and claim 10 of the ‘016 patent, and thus the Court found that Geneva did not support Roche’s position.

The Court also noted that Roche had the burden of establishing ODP by clear and convincing evidence, a burden made more difficult in this case because the Patent Office had twice rejected that argument in finding that the claims of the patents-in-suit were not invalid under ODP over the claims of the ‘016 patent.

Finally, the Court turned to the question of whether the claims of Amgen’s patents-in-suit were entitled to the safe harbor of 35 U.S.C. § 121.  In addition to "the express requirements" of § 121 (i.e., the plain meaning of the statute), the Court interpreted Federal Circuit precedent to require "consonance":  "the applicant must maintain the line of demarcation between the independent and distinct inventions that prompted the restriction requirement," citing Pfizer Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1358, 1359 (Fed. Cir. 2008).  Consonance thus required the Court to determine whether the patents-in-suit were the product of applications filed in response to a PTO-imposed restriction requirement, and whether the claims in those patents "remained faithful" to the claim groupings that made up the restriction.  In answer to the first question, the Court found that the ‘178 and ‘179 applications (that resulted ultimately in the ‘933, ‘422, and ‘349 patents-in-suit; see diagram) were filed in response to the restriction requirement imposed on the ‘298 application.  The Court also found that these claims "remained faithful" to the groupings that made up the restriction.  In coming to this conclusion, the Court was persuaded by the fact that none of the claims prosecuted in the ‘178 or ‘179 applications, or granted in the ‘933, ‘422, or ‘349 patents-in-suit, were members of restriction Group II that had been elected in response to the restriction requirement in the ‘298 application and comprised the claims granted in the ‘008 patent.

In reaching this decision, the Court rejected Roche’s argument that Amgen had "broken consonance" by including claims from Groups I and V in the ‘178 application, and similarly rejected Roche’s argument that Amgen’s combining claims from Groups V and VII had the same effect during prosecution of the ‘422 patent.  The Court held that these arguments were "without legal foundation" because Roche cited no case supporting the proposition that Amgen was required to file a separate divisional for each restriction group to maintain consonance with the original restriction requirement.  The Court cited Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 1579 (Fed. Cir. 1991) for the rule that "new or amended claims in a divisional application are entitled to the benefit of [section] 121 if the claims do not cross the line of demarcation drawn around the invention elected in the restriction requirement."  In addition, the Court rejected Roche’s contention that reciting erythropoietin as a "non-naturally occurring glycoprotein" in the claims of the ‘933 patent implicated the DNA claims of restriction Group II (based in the premise that such "non-naturally occurring erythropoietin required recombinant DNA for its production).  While agreeing that the Examiner’s written description of the restriction groupings was consistent with Roche’s argument, the Court drew the "relevant line of demarcation" between the claims as "the grouping restriction actually imposed by the examiner (rather than her characterization thereof), citing Texas Instruments Inc. v. ITC, 988 F.2d 1165, 1179 (Fed. Cir. 1993) (which interpretation did not support Roche’s argument).

This portion of the opinion was directed towards the Court’s grant of partial summary judgment to Amgen prior to trial.  However, this did not decide the issue, since Roche was able to convince the Court that there were fact issues remaining to be determined relating to two additional theories (that the Court termed "number 3 and number 4") and that the Court decided in this opinion.  These issues were tried to the Court and not to the jury, since the Court held that ODP was related to the metes and bounds of how claims were construed and thus solely within its province.

Roche theory number 3 relates to the claims of the ‘868 and ‘698 patents that are clearly outside the scope of the § 121 safe harbor.  The asserted claims of the ‘868 and ‘698 patents are process claims, and the task for the Court was to determine whether they are patentably distinct from the claims of the ‘008 patent.  Simply put, Roche’s argument was that claim 1 of the ‘868 patent:

1.  A process for the production of glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    (a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and
    (b) isolating said glycosylated erythropoietin polypeptide therefrom.

" . . . simply tells one skilled in the art to ‘take the cells that were claimed in the ‘008 patent and grow them, let[ting] them do what they normally do.’"  The Court disagreed, adopting Amgen’s argument that the cells claimed in the ‘008 patent were not required to "actually express any EPO polypeptide" (a rationale that would seem to call into question satisfaction by such a claim of the utility requirement of 35 U.S.C. § 101).  The Court opined that "simply having the starting material" (the cells claimed in the ‘008 patent) was not equivalent to "having an actual process that successfully" produces useful quantities of erythropoietin.  This clarity of this reasoning improves when the Court puts it in proper context, that Roche did not carry its burden of establishing by clear and convincing evidence that the claims of the ‘868 and ‘008 patents are not patentably distinct and thus invalid for ODP.

The Court came to the same conclusion for claims 6-9 of the ‘698 patent:

6.  A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    (a) growing, under suitable nutrient conditions, vertebrate cells comprising amplified erythropoietin amino acid sequence of [figure] 6, and
    (b) isolating said glycosylated erythropoietin polypeptide expressed by said cells.

7.  The process of claim 6 wherein said vertebrate cells further comprise amplified marker gene DNA.

8.  The process of claim 7 wherein said amplified marker gene DNA is Dihydrofolate reductase (DHFR) gene DNA.

9.  The process according to claims 2, 4, and 6 wherein said cells are mammalian cells.

For these claims, limitations relating to the presence of amplified EPO-encoding DNA provided additional points of patentable distinction supporting the Court’s decision.

Finally, Roche’s theory number 4 was that the claims of the ‘933, ‘422, and ‘349 patents-in-suit were invalid over the claims of the ‘868 and ‘698 patents for ODP.  The viability of this argument rested, according to the Court, on whether Amgen could avail itself of the § 121 safe harbor.  This, in turn, depended on whether the ‘933, ‘422, and ‘349 patents-in-suit "arose from" an application resulting from a PTO restriction requirement and whether these claims "are consonant with the restriction requirement."  The Court relied in its analysis on its decision in granting partial summary judgment that the ‘933, ‘422, and ‘349 patents-in-suit all "arose from" the restriction requirement imposed by the PTO in the ‘298 application.  The Court also determined that, while the issued claims of the ‘933, ‘422, and ‘349 patents-in-suit were not identical to the claims in the two divisional applications (the ‘178 and ‘179 applications) as filed, they maintained the required consonance with the restriction requirement imposed in the ‘298 patent.

In making this determination, the Court directly addressed the question of whether the § 121 safe harbor was available in a continuation application claiming priority to a divisional application that itself was clearly within the § 121 safe harbor.  This is because the ‘698 patent was granted on a continuation application claiming priority to the ‘179 divisional application.  In making its determination, the Court appeared to adopt Amgen’s position that Federal Circuit precedent established that such a continuation application would fall within the protection of the § 121 safe harbor.  The Court cited in support of its determination Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563 (Fed. Cir. 1996) and Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991), cases cited by Amgen in its bench brief submitted in response to the Federal Circuit’s Pfizer v. Teva Pharmaceuticals decision (see "Will the Federal Circuit’s Pfizer v. Teva Decision Spell the End of Amgen’s Patent Rights to Recombinant Human Erythropoietin? ").  In something of an anticlimax, the Federal Circuit’s recent decision in Pfizer v. Teva Pharmaceuticals had little impact; the Court relegated its discussion of the decision to a footnote (no. 8), and limited the Pfizer decision to its facts, that the § 121 safe harbor does not apply to continuation-in-part applications:

Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. does not invalidate this precedent.  As an initial matter, Pfizer did not name Symbol Technologies as one of the decisions that was possibly at odds with the Pfizer decision.  See Pfizer, 518 F.3d at 1362 (naming other cases).  Furthermore, Pfizer addressed the scope of section 121 in the context of a continuation-in-part application filed in lieu of a divisional application when responding directly to a restriction requirement.  Id. at 1362.  It said nothing about what happens if an applicant files a divisional application – which is eligible for section 121’s safe harbor – and then files a continuation application to that divisional application.

For additional information regarding this topic, please see:

• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche’s Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can’t Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit’s Pfizer v. Teva Decision Spell the End of Amgen’s Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen’s Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court’s Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche’s Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007