PharmaPatents

Timely Insight on Emerging Legal Developments

Supreme Court Finds For Monsanto In Seed Harvesting Case

Posted by Courtenay Brinckerhoff on Posted in Infringement; Supreme Court Decisions

In Bowman v. Monsanto Co., the Supreme Court held that the doctrine of patent exhaustion does not give a farmer who has bought patented seeds the right to “reproduce” them through planting and harvesting without the patent holder’s permission. This decision presents a straight-forward application of the patent exhaustion doctrine, and is refreshing in its recognition of the right of the patent owner to reap the rewards of its invention.Continue reading this entry

Federal Circuit Issues Fractured Affirmance In CLS Bank v. Alice Corporation

Posted by Courtenay Brinckerhoff on Posted in 101; Federal Circuit Decisions

In a fractured en banc decision, the Federal Circuit affirmed the district court’s holding that the claims at issue in CLS Bank v. Alice Corporation are invalid under 35 USC § 101. The multiple opinions reveal the judge’s fundamental differences as to the meaning and role of the statute, and the difficulty of applying Supreme Court precedent. The court’s inability to agree on even an appropriate framework for assessing patent-eligibility guarantees that this fundamental inquiry will be a murky area of law for the foreseeable future.

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USPTO Reshuffles The RCE Deck

Posted by Courtenay Brinckerhoff on Posted in Patent Office Practice

The USPTO still is considering information gathered during its RCE Outreach program, but it has made some internal changes that should lead to more prompt examination after a Request for Examination (RCE) is filed. However, because that the backlog of RCEs awaiting examination has climbed to over 110,000, it could be some time before applicants notice an appreciable difference in RCE processing times.

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Federal Circuit Upholds One Claim Covering Combigan

Posted by Courtenay Brinckerhoff on Posted in 103; Federal Circuit Decisions

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim because it recites a non-obvious result. Some of the court’s reasoning in this opinion is troubling, and the non-obvious result may be difficult to extrapolate to other cases, but this case illustrates the value of including a variety of claims that focus on different aspects of the same invention.Continue reading this entry

Federal Circuit Holds That Patent Indefiniteness Requires Insoluble Ambiguousness

Posted by Courtenay Brinckerhoff on Posted in Federal Circuit Decisions

In Biosig Instruments, Inc. v. Nautilus Inc., the Federal Circuit reversed the district court’s finding that the claims at issue were invalid as indefinite, because the claims were not “insolubly ambiguous.” This case underscores the difficulty of challenging a patent under 35 USC § 112, second paragraph.

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Dispelling The Myriad Gene Patent Harmonization Myth

Posted by Courtenay Brinckerhoff on Posted in 101; International Patent Practice; Myriad

In the wake of the Supreme Court oral arguments in the Myriad “gene patent” case, most commentators are predicting that the Court will uphold the patent-eligibility of non-naturally occurring DNA sequences (such as cDNA), but will decide that even “isolated” forms of naturally occurring DNA cannot be patented under 35 USC § 101. I have heard some say that such a decision would “harmonize” U.S. patent law with European patent law, but that is not correct.

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Federal Circuit Finds Yaz Patent Obvious

Posted by Courtenay Brinckerhoff on Posted in 103; Federal Circuit Decisions

In Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court and held that Bayer’s patent covering its Yaz® birth control pill product is invalid as obvious. The court found a strong prima facie case of obviousness, and rejected each of Bayer’s arguments relating to secondary indicia of non-obviousness.

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Federal Circuit Finds Prosecution History Disclaimer In Enablement Arguments

Posted by Margareta Sorenson on Posted in Claim Construction; Federal Circuit Decisions

In Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit upheld a narrow claim interpretation based on prosecution history disclaimer. The court held that the applicants’ arguments against an enablement rejection served to disclaim the broader claim scope sought in the infringement action. This case highlights the risk that any statement made during prosecution can be used to construe the scope of the claims.

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Challenging The Enabling Quality Of Prior Art

Posted by Courtenay Brinckerhoff on 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 by Courtenay Brinckerhoff on 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